journal of the licensing executives society international
Transcription
journal of the licensing executives society international
SEPTEMBER 2014 les Nouvelles JOURNAL OF THE LICENSING EXECUTIVES SOCIETY INTERNATIONAL Volume XLIX No. 3 September 2014 LES NOUVELLES Advancing the Business of Intellectual Property Globally Determining An Appropriate Royalty Rate For Reasonable Royalty Trademark Damages—A Modified Georgia-Pacific Framework DAVID DREWS — Page 150 Advanced Citation Analysis Can Help Identify Licensing Candidates JOURNAL OF THE LICENSING EXECUTIVES SOCIETY INTERNATIONAL MIKE LLOYD — Page 156 Customs Value, Licensing And Royalties—The Russian Perspective SERGEY MEDVEDEV — Page 166 Radioisotope Pharmaceutical Licensing PAUL R. BETTEN — Page 172 How Does Europe Deal With The Question Of How To Transfer Rights From The Author To The Exploiter?—The European Perspective On The Work Made For Hire Doctrine JULIAN KLAGGE AND CHRISTIAN CZYCHOWSKI — Page 178 The Unitary Patent And The Unified Patent Court CHRISTOPH CORDES — Page 184 Protecting Traditional Knowledge As Cardinal Technology In The Philippines ROBERT NEREO B. SAMSON AND GONZALO D.V. GO III — Page 192 The Impact Of Australian Goods And Services Tax On Assignments And Licences Of Intellectual Property STEPHEN ADRIAN — Page 202 EU State Aid Policy: A Model To Assess Intellectual Property Rights And Knowledge Dissemination In R&D Cooperation—Part II MARIO CISNEROS — Page 206 UniLink: A New Model For Increasing Academic And Industry Partnerships HESTER TAK AND BOB SMAILES — Page 215 New Age Intellectual Property: Emerging Global Benefits LAWRENCE J. UDELL — Page 224 www.e-mergeglobal.com Deep and Wide We are the patent and technology research company Advancing the business of intellectual property globally LES young members (under 41 years old) are invited to attend the 2nd PAN-EUROPEAN YOUNG MEMBERS EVENT In Paris, France | November 14, 2014 Patent Search Services Technology/Innovation Research White Space Analysis Claim Charting/Infringement Analysis Portfolio Analysis Patent Licensing Support Services Portfolio Management Patent Due Diligence Landscaping Studies Patent Drafting Reach us RECENT EVOLUTIONS IN EU LAW: USA: 1-888-247-1618 India: +91-44-2231 0321 IMPACT ON LICENSING [email protected] Don’t miss this unique opportunity to: meet Young Licensing Professionals from all over Europe; listen to presentations from top specialists in licensing and Rate For Royalty Trademark Damages Determining An Appropriate Royalty Rate For Reasonable Royalty Trademark Damages A Modified Georgia-Pacific Framework By David Drews W hen a plaintiff believes that its trademark has been infringed, an important element is oftentimes the determination of damages suffered by the plaintiff. At the federal level, the calculation of damages is dictated by the Lanham Act.1 Once liability has been proven, the Lanham Act provides for the recovery of defendant’s profits, actual damages sustained by the plaintiff and the costs of the action, subject to principles of equity.2 Although the Lanham Act does not explicitly list a reasonable royalty as a valid remedy in trademark infringement matters, the award of a reasonable royalty as compensation for trademark infringement damages has been recognized as an appropriate alternative for decades.3 This makes sense from an economic perspective since royalty rates have long been utilized as pricing and value indicators for intellectual property of all kinds, including trademarks. However, it is important to note that a reasonable royalty is not appropriate in every trademark infringement situation. It should also be noted that the recovery of a reasonable royalty in a trademark infringement action is limited by some jurisdictions to those situations in which the licensing of the mark has already taken place with a third party, or has at least been contemplated by the plaintiff.4 Other jurisdictions accept a hypothetical negotiation between the plaintiff and the defendant, even in situations where the plaintiff 1. This article is concerned with reasonable royalty damages in a federal trademark infringement action. While damages associated with state or common law trademark infringement actions may utilize similar approaches, they are outside the scope of this discussion. Also, this article assumes that a reasonable royalty has been determined to be an appropriate damages remedy for a particular infringement scenario. 2. 15 U.S.C. § 1117(a). 3. For example, see Sands, Taylor & Wood Co. v. Quaker Oats Co., 978 F.2d 947, 963, 24 U.S.P.Q.2d 1001 (7th Circuit 1992). 4. For example, see Trovan Ltd. v. Pfizer, Inc., No. CV-98-0094 WL 709149 (United States District Court, Central District of California, May 24, 2000). In this case, the court explicitly stated that the Ninth Circuit would not recognize a reasonable royalty as a measure of damages where no evidence had been proffered that a party intended to license its trademark. has categorically stated that it would not license its mark to anyone, including the defendant.5 Depending on the facts of the case, the use of a reasonable royalty to calculate damages is a fairly straightforward exercise once the infringing revenue and appropriate royalty rate have been identified. ■ David Drews, Royalty rates can also figIPmetrics LLC, ure prominently in a lost President, market value assessment San Diego, CA, USA of the damages resulting from trademark infringeE-mail: [email protected] ment. In a lost market value assessment, an analysis calculating the change in the value of the brand or trademark resulting from the defendant’s alleged infringing actions can be based on the fact that the owner of a trademark does not have to pay royalties to a third party in order to use it.6 However, the selection of an appropriate royalty rate has typically been one of the most contentious areas of disagreement among parties involved in a trademark infringement action, even when both plaintiffs and defendants agree that a reasonable royalty is the proper method for calculating damages. With patent infringement damages, the identification of an appropriate royalty rate has been guided for several decades by the fifteen-factor test described in Georgia-Pacific Corp. v. U.S. Plywood Corp., which takes into consideration numerous aspects of the relevant economic, financial and competitive characteristics associated with the infringing use and the parties involved.7 As of yet, a preferred method for 5. For example, see Sands, Taylor & Wood v. Quaker Oats Co., 978 F.2d 947 ¶57 (7th Circuit 1992). In this case, the court stated that a “generous approximation of the royalties Quaker would have had to pay STW for the use of the THIRST-AID mark had it recognized the validity of STW’s claims seems to us an appropriate measure of damages…” 6. Known as a “Relief from Royalty” analysis, it measures the value of the trademark by quantifying the present value of avoided costs, i.e., the royalty payments not made due to ownership of the asset. September 2014 150 Rate For Royalty Trademark Damages identifying an appropriate royalty rate for trademark damages purposes has not been as well documented by the courts. This has led to an inconsistent application of reasonable royalty analyses across the various federal circuits. In my experience, I have found that using a modified Georgia-Pacific analysis can oftentimes provide a framework for identifying an appropriate royalty rate in trademark infringement situations. Georgia-Pacific and Trademark Infringement The Georgia-Pacific factors used in patent infringement reasonable royalty analyses were originally selected to help determine the outcome of a hypothetical negotiation between the two parties involved in the lawsuit. The framework was designed to identify and incorporate the respective negotiating positions of the two parties for a hypothetical grant of rights associated with the infringed patent under circumstances similar to the use of the patent embodied in the infringing activities. A similar analysis may be appropriate when determining the royalty rate to use in trademark infringement damages analyses. Most of the factors are analyzed in the context of the hypothetical negotiation, which is usually set at a point immediately preceding the start of the infringement period. The analysis is therefore typically restricted to what was known or knowable at the time of the hypothetical negotiation, including reasonable forecasts of expected results. Some of the factors, however, suggest the inclusion of analysis that considers activity that is subsequent to the date of the hypothetical negotiation, which oftentimes incorporates information beyond that which would have been known or knowable at the time of the negotiation. Without getting too far into the “Book of Wisdom”8 or ex ante versus ex post damages analyses discussions,9 which are deserving of their own articles, the potential use of any information that becomes available after the hypothetical negotiation takes place should be considered on a case-by-case basis when determining a reasonable royalty rate in a trademark litigation. Also, there is more involved with using a Georgia7. Georgia-Pacific Corp. v. U.S. Plywood Corp., 318 F. Supp. 1116, 166 U.S.P.Q. 235 (S.D. N.Y. 1970). 8. Sinclair Refining Co. v. Jenkins Petroleum Process Co., 289 U.S. 689, 53 Supreme Court 736, 77 L. Ed. 1449 (1933). 9. For example, the “Litigation Services Handbook: The Role of the Financial Expert,” by Roman L. Weil and Peter B. Frank has a chapter on ex ante versus ex post damages calculations. 151 les Nouvelles Pacific factor analysis in relation to trademark infringement than simply substituting the word “trademark” for the word “patent” in each of the factors. As is noted below, modifications within some factors are oftentimes necessary, and the differences between patents and trademarks in general need to be acknowledged. With patents, for example, attention has to be paid to the “Entire Market Value Rule, which, inter alia, is concerned with the extent to which the patented invention is the basis for consumer demand for the product that features the invention. As was highlighted in Paper Converting Machine Co. v. Magna-Graphics Corp.,10 when the invention is the basis for consumer demand, one should calculate the reasonable royalty on total sales of the accused products. However, if other aspects are responsible for a portion of the consumer demand, it is necessary to determine the portion of sales associated with the patented invention and limit the calculation of the reasonable royalty to one based only on that portion of accused sales. Since all of the infringing sales in trademark litigation typically feature the use of the trademark, no such limitation is necessary. The discussion that follows identifies each GeorgiaPacific factor, as well as indications of some of the modifications necessary to make it more relevant to a trademark infringement action. Factor One—The royalties received by the patentee for the licensing of the patent in suit, proving or tending to prove an established royalty. As discussed above, the concepts in each factor are analyzed for their applicability to trademarks. Obviously, information regarding the royalties earned by licensing the trademark in suit is extremely relevant. When assessing the plaintiff’s licensing of the trademark in suit, the expert should take into consideration the timeframe, geography and product categories of the various licenses, including how those factors may have changed during the period between when the actual license was negotiated and when the hypothetical license would have been negotiated. The form of compensation and royalty rate struc10. Paper Converting Machine Co. v. Magna-Graphics Corp., 745 F.2d 11 (Federal Circuit 1984). This precedent has been refined numerous times since 1984, recently by Lucent Technologies, Inc. v. Gateway, Inc., 580 F.3d 1301 (Federal Circuit 2009) and Uniloc USA, Inc. v. Microsoft Corp., 632 F.3d 1292 (Federal Circuit 2011), and perhaps most significantly by Laserdynamics, Inc. v. Quanta Computer, Inc., 694 F.3d 51 (Federal Circuit 2012), in which the court indicated that the royalty base should be the “smallest saleable patent-practicing unit.” Rate For Royalty Trademark Damages ture are important elements as well. Items such as guaranteed minimums, marketing contributions, per unit versus percentage of net sales royalty bases and upfront payments all need to be analyzed. In addition, the comparability of the plaintiff’s previous licensing activity to the set of circumstances in the lawsuit needs to be considered. Information associated with offers to license the trademark in suit made by the plaintiff can provide information on the plaintiff’s perception of value. Care must also be taken to distinguish between licenses granted via unforced negotiations and those that result from settled litigation, or between arm’slength agreements and those entered into by related parties, and some of the plaintiff’s licenses may not be relevant to the instant case at all. In general, not much modification from the patent framework may be necessary with this factor. Factor Two—The rates paid by the licensee for the use of other patents comparable to the patent in suit. Like Factor One, the information related to what the defendant has paid to license similar trademarks may also be relevant. Here again, there is not much need for modification. Generally, it is important to assess the comparability of the defendant’s past licensing activity in terms of timing, scope, compensation terms, geographical constraints and approved product categories, as well as the comparability of the actual asset or assets being licensed, including the relative strength, awareness or heritage of the respective marks. Factor Three—The nature or scope of the license, as exclusive or non-exclusive; or as restricted or non-restricted in terms of territory or with respect to whom the manufactured product may be sold. Factor Three is concerned with making sure that the hypothetical negotiation tracks closely with the parameters surrounding the alleged infringing activity. This factor is not necessarily modified from the patent scenario in terms of how it is analyzed; rather, the existing elements are simply applied to the trademark infringement scenario. As with a patent infringement analysis, the hypothetical negotiation is typically constructed on a non-exclusive basis and is restricted to those geographies in which the infringement activity allegedly took place. In addition to the exclusivity and territory characteristics mentioned in the factor description, when applied to a trademark infringement this factor is also associated with items such as approved product categories, distribution channels and other con- straints or requirements that may be applicable to the infringing situation. The closer the comparable license agreements from Factors One, Two and Twelve match with the parameters of the infringing activity, the more relevance they may have to the hypothetical negotiation. Factor Four—The licensor’s established policy and marketing program to maintain its patent monopoly by not licensing others to use the invention or by granting licenses under special conditions designed to preserve that monopoly. When analyzed in the context of a trademark infringement, Factor Four is concerned with more than the license/not license question or special conditions listed in the description. It is also concerned with the overall trademark licensing policy of the plaintiff, including marks other than those in suit. While the license/not license question and any special conditions will certainly be important, the plaintiff’s policies regarding other elements, such as those having to do with required compensation, required or forbidden product categories, exclusivity versus non-exclusivity, geographical constraints and required or forbidden distribution channels will also be significant. A plaintiff with a long history of licensing its trademarks on an arm’s-length basis will be better positioned to defend its royalty rate demands than one that has only limited experience in this area. Also, a trademark owner that has defended its mark against all instances of alleged infringement helps demonstrate its willingness and ability to maintain its rights in the trademark. Factor Five—The commercial relationship between the licensor and licensee, such as whether they are competitors in the same territory in the same line of business, or whether they are inventor and promoter. The commercial relationship between the parties is naturally important. If the two are direct competitors, the plaintiff would typically demand a higher royalty rate since the defendant is likely either (1) making sales that the plaintiff believes it could have made or, (2) in a case where the plaintiff does not distribute its products in the defendant’s territories or distribution channels, preventing the plaintiff from expanding its operations. Situations in which the two are not direct competitors typically argue for a relatively lower royalty rate conclusion, although a supplier/customer relationship between the parties can complicate matters. The complication arises because a defendant who is also a key supplier or customer may induce the plaintiff September 2014 152 Rate For Royalty Trademark Damages to accept even lower compensation than would otherwise be the case. Factor Six—The effect of selling the patented specialty in promoting sales of other products of the licensee, the existing value of the invention to the licensor as a generator of sales of his nonpatented items, and the extent of such derivative or convoyed sales. It is very rare when a trademark infringement situation features a concept akin to “convoyed sales,” i.e., sales of products that do not utilize the trademark but should be included as part of the royalty base. In trademarks, there is scope to license a trademark to be used in marketing a composite good when a component’s trademark assists in differentiating the final good in the consumer’s perception. Such is the case with the use of the Intel Inside® trademark by several computer manufacturers. Competitive considerations in determining the reasonable royalty rate in these situations will likely include the competitive environment among licensees in addition to that between the plaintiff and the defendant. Also, a defendant may occasionally require customers to purchase products associated with one of its other (non-infringing) brands in order to purchase the products that feature the allegedly infringing trademark. Without convoyed sales, this factor is typically scored as neutral or slightly favorable to the defendant. If there are indeed convoyed sales, it argues for a higher royalty rate than otherwise since the defendant is enjoying additional sales activity and building a more extensive relationship with customers/retailers. Factor Seven—The duration of the patent and the term of the license. This factor provides one of the main contrasts between the patent-centric analysis typically found with Georgia-Pacific and the modified version used to analyze a reasonable royalty rate in a trademark infringement situation. As long as a trademark is continuously used in commerce, the registration fees are paid on a timely basis and the owner defends it against all instances of infringement, the trademark will continue to remain valid. For example, the Fruit of the Loom® and Coca-Cola® trademarks have been in continuous use since the late 1800s.11 The expected term of the hypothetically negotiated license is typically dictated by the duration of the infringing activity, although the previous licensing activity of the two parties and/or the industry com11. www.uspto.gov, Registration Numbers 0238146 and 0174998, respectively. 153 les Nouvelles parable license agreements may also be important. In general, this factor has little or no bearing on the determination of the royalty rate, unless different royalty rates are associated with different durations in the parties’ relevant licenses and/or the comparable agreements. Also, to the extent that a longer license term allows the defendant to develop customer relationships that may endure beyond the life of the hypothetical license agreement, it may indicate the need for a higher royalty rate. Factor Eight—The established profitability of the product made under the patent, its commercial success, and its current popularity. With this factor, in addition to the analysis of the product-related aspects listed in the description, one must also pay attention to the popularity and awareness of the trademark itself. The use of the trademark may enable a greater level of success than the product would achieve without it. Currently, Apple® is a good example of a trademark that instantly conveys status on a new product offering. With the demise of the 25% rule in patent litigation,12 it is safe to assume that this technique is no longer a suitable choice in trademark reasonable royalty rate analyses either. Therefore, the established profitability of products featuring the infringed trademark can no longer be a direct input to the formula used to determine a reasonable royalty rate. However, the established profitability and commercial success of products that featured the trademark in suit prior to the hypothetical negotiation are still important indicators of the relative strength and level of consumer awareness of the trademark, and will help narrow a relatively wide range of comparable property royalty rates to one that is more appropriate. Generally, a more established, more successful trademark will command a higher royalty rate than one without a similar track record of success, ceteris paribus. Also, the profitability of the underlying product line typically is an important limit on the royalty rate, as no licensee would willingly transfer all or most of its profits to a trademark licensor. That said, trademark licensors typically demand higher royalty rates for uses in particularly profitable categories than in undifferentiated, commodity products. As stated above, most factors are analyzed in the 12. Uniloc USA, Inc. v. Microsoft Corp., 632 F.3d 1292, 1315, 98 U.S.P.Q.2d 1203 (Federal Circuit 2011). In this case, the court stated that “[t]he court now holds as a matter of Federal Circuit law that the 25 percent rule of thumb is a fundamentally flawed tool for determining a baseline royalty in a hypothetical negotiation.” Rate For Royalty Trademark Damages context of the hypothetical negotiation, which is usually set at a point immediately preceding the start of the infringement period. Factor Eight, however, explicitly requires analysis of the “current popularity” of the asset. Certainly, subsequent information regarding the level of sales actually achieved is required to calculate reasonable royalty damages. When analyzing the factors to determine the royalty rate, however, the potential use of any information that becomes available after the hypothetical negotiation takes place should be considered on a case-by-case basis. In trademark cases, Factors Nine and Ten are frequently analyzed together since they are similar and essentially define the impact that the trademark has in the marketplace. I have elected to follow that convention in this article. Factor Nine—The utility and advantages of the patent property over the old modes or devices (if any) that had been used for working out similar results; and, Factor Ten—The nature of the patented invention; the character of the commercial embodiment of it as owned and produced by the licensor; and the benefits to those who have used the invention. Factors Nine and Ten deal with the utility and nature of the assets being licensed. The utility and nature of a trademark is that it identifies the source of a product and it harbors any goodwill generated among its customers. It also conveys information regarding the reputation and characteristics of the associated brand. For example, Tiffany & Co.® and Wal-Mart® convey information to consumers about what they will find and experience at the two retailers’ establishments (e.g., luxury goods and low prices, respectively).13 Therefore, a trademark with high relative strength and awareness attributes and a long successful history in the marketplace (essentially, more “utility”) will generally command a higher royalty rate than one without those features. Also, a trademark will have more “utility” when used with products with which it has been associated for a long time than it will with products for which there is no history of use. For example, Apple® resonates with consumers when used with personal electronics, but may not have the same effect when used with garden tools or laundry detergent. From a financial perspective, the advantage that a trademark provides may sometimes be measured by the price or market share premia associated with 13. www.tiffany.com and www.walmart.com. the mark versus generic goods. There may also be a differential when compared to other branded goods, although that is typically a smaller advantage and more difficult to measure. Factor Eleven—The extent to which the infringer has made use of the invention; and any evidence probative of the value of that use. This factor is oftentimes used to inform the analysis surrounding Factor Three regarding the nature and scope of the license; the extent of use typically outlines the geographic scope, distribution channels and product categories covered by the hypothetical negotiation. This is also where evidence of actual confusion (or lack of) and surveys indicating likelihood of confusion (or lack of) will provide guidance as to the value of the use by the defendant. As with Factor Eight, this factor oftentimes requires analyzing data that is subsequent to the date of the hypothetical negotiation. If the use of the trademark allowed the defendant to generate increased sales and higher profits, or to enter a distribution channel or geography to which it had not previously had access, the royalty rate called for is typically higher than use that does not provide these kinds of benefits. Generally, the more extensive the use and the greater the benefit enjoyed by the defendant, the higher the royalty rate that is supported. Factor Twelve—The portion of the profit or of the selling price that may be customary in the particular business or in comparable businesses to allow for the use of the invention or analogous inventions. This factor incorporates any relevant third-party comparable licenses into the analysis. It is important to narrow the search so that it only includes license agreements for trademarks used during a similar timeframe, on similar product categories and in similar geographies. It is oftentimes possible to adjust for slight differences in these aspects, but the impact of this factor should count for less weight in the overall analysis when these adjustments are utilized. As with Factors One and Two, the form of compensation and royalty rate structure are important elements. Items such as guaranteed minimums, marketing contributions, per unit versus percentage of net sales royalty bases and upfront payments all need to be analyzed. Also, any constraints, requirements or restrictions need to be considered, as well as differences in the negotiation context. The relative strength and awareness of the trademark September 2014 154 Rate For Royalty Trademark Damages in suit as compared to the trademarks included in the comparable licenses is also a key aspect of this factor analysis. Finally, it is important that the risks borne by the licensors and licensees in the relevant comparable agreements match up with those hypothetically borne by the plaintiff and defendant in the constructed negotiation framework. Depending upon which trademarks are included in the third-party comparable agreements, this factor analysis will help determine where the trademark in suit should fall on the spectrum of relevant royalty rates. Factor Thirteen—The portion of the realizable profit that should be credited to the invention as distinguished from non-patented elements, the manufacturing process, business risks, or significant features or improvements added by the infringer. This factor is modified from the typical patentoriented analysis to more closely follow a typical trademark apportionment analysis. Ultimately, the determined royalty rate will provide the concluded apportionment; this factor analysis will help to determine what that reasonable royalty rate should be. Elements that may need to be considered include other trademarks owned and used on the accused sales by the defendant, non-infringing trade dress and packaging elements, an experienced and effective management team and sales force, the distribution network utilized by the defendant, relationships with retailers, marketing efforts (trade shows, websites, advertising, etc.), any technology that is incorporated in the products (patents and/ or trade secrets), and any other elements that are specific to the products being sold. Factor Fourteen—The testimony of qualified experts. Occasionally, evidence related to experts other than the damages experts in a trademark case may have some bearing on the determination of a reasonable royalty rate. Rarer still is the expert analysis or opinion not associated with the instant case that is targeted enough to provide guidance on this question in a litigation environment. When expert opinion is available and relevant, it should be relied upon, at least to the extent that it is deemed to be reliable and accurate. Otherwise, this factor is typically scored as being neutral, or having no impact on the determination of a reasonable royalty. Factor Fifteen—The amount that a licensor (such as the patentee) and a licensee (such as the infringer) would have agreed upon if both 155 les Nouvelles had been reasonably and voluntarily trying to reach an agreement; that is, the amount which a prudent licensee—who desired, as a business proposition, to obtain a license to manufacture and sell a particular article embodying the patented invention—would have been willing to pay as a royalty and yet be able to make a reasonable profit and which amount would have been acceptable by a prudent patentee who was willing to grant a license. Essentially, this factor is the conclusion of the hypothetical negotiation described via the analysis of the preceding fourteen factors. All of the quantitative and qualitative factors that are relevant to the infringement situation should be weighed by the damages expert to determine an appropriate reasonable royalty rate. Conclusion When using a modified Georgia-Pacific factor analysis to determine a reasonable royalty rate in a trademark infringement action, it is crucial to understand how the various factors should be applied to trademarks, trademark licensing and the alleged infringement. For example, there are numerous differences between the rights granted by a patent and those associated with a trademark. In general, a patent grants the right to exclude others from practicing the revealed invention for a period of time, whereas a trademark identifies the source of the goods and serves as a repository for any goodwill generated. In practice, the analysis for a trademark-related reasonable royalty rate will be the same as that for a patent-related reasonable royalty rate for some factors and markedly different for others. The differences may be related to items such as the potential presence of non-infringing alternatives and design-arounds (patents, but not trademarks), the implications of the “Entire Market Value Rule” (again, patents, but not trademarks) and the fact that patents have an explicit expiration, whereas trademarks can continue indefinitely (when certain conditions are met). As long as the analysis of the various factors has captured the nature and scope of the potential license and trademark in suit, the financial and logistical aspects of the usage, the impact of comparable licensing situations and the relevant risk profiles for both parties, the resulting reasonable royalty rate conclusion for the use of the trademark in the context of the alleged infringing activity should be appropriate and defensible, and could be informative to the trier of fact in considering a suitable remedy. ■ Advanced Citation Analysis Advanced Citation Analysis Can Help Identify Licensing Candidates By Mike Lloyd Abstract Citation analysis is used by many patent owners to search for potential licensing candidates, with many licensing managers reviewing forward citations for their patents to help find these candidates. In this paper we suggest some additional approaches that may also be useful. These include a statistical review of the forward citation patents, the Forward Rejection analysis available from Patent River, and the similarity and importance filters available in the AmberScope patent citation searching tool. any patent applicants will be very familiar with patent citations. For a patent to be granted it needs to be both novel and inventive over the prior art. While the exact definition of ‘novel’ and ‘inventive’ can vary between different jurisdictions, in almost every case the patent examination process includes a review of older published documents that may disclose similar subject matter to the claims of the patent application. These earlier published documents can be identified by a patent search run by the patent examiner, be based on a search conducted by another patent office examining the same application, or be submitted by the applicant either in the body of the patent specification or within an ‘Invention Disclosure Statement’ or similar document supplied by the patent applicant. Published documents can include scientific papers, other documents and in the vast majority of cases will include earlier published patents. Prior art patents are so popular in search reports both because the patent M literature is unusually well organised, catalogued and searchable, and also because the patent literature is so voluminous, with ca 2 million new patent publications every year. These earlier published documents are often referred to as ‘backward’ or ‘reverse’ citations. Similarly, after a patent has been published it may be cited ■ Mike Lloyd, by later patents. Relative Griffith Hack, to the patent in question, Consultant, these later patents are often referred to as ‘forMelbourne, Victoria, Australia ward citations,’ as shown E-mail: mike.lloyd@ in Figure 1. griffithhack.com.au Both forward and backward citations can be very helpful to people reviewing the patent literature. Essentially each citation connection between two patents is an acknowledgement that an expert in the area (being a patent examiner or applicant) sees two patent as similar—or having overlapping subject matter. Given a relevant patent in any area, we can quickly identify similar patents simply by following patent citation connections. Practically, these can be easily found on many patent search websites or subscription services. An example of this is shown in Figure 2 for the Google Patent search site, but there are many other sources of this data. These include Espacenet, Patentbuddy, the USPTO patent search site, and a number of paid patent search sites. Figure 1: Forward And Backward Citations b) Reverse or Backward Citations Earlier Patents Considered to be Similar a) Patent Publication c) Forward Citations Later Patents Considered to be Similar September 2014 156 Advanced Citation Analysis Citation searching, like other forms of patent searching, is not perfect. Citation searching tends Example of where to find forward and backward citations for a patent shown to be more effective for ICT and within Google patent. In this site, backward citations are simply referred to as mechanical engineering patents “Patent Citation” while forward citations are referred to as “Referenced by.” Selecting either of these options will open up a list of these citations. than for pharmaceutical patents. U.S .patent examiners appear to Publication Number US6123456 A have a bias to selecting U.S. based Publication Type Grant rather than foreign prior art, but Application Number US 09/108,452 the prior art patents listed on IDS Publication Date Sep. 26, 2000 statements may help to counteract this bias. Regardless, citation Filling Date Jul 1, 1998 searching can be a very useful adPriority Date ? Jul 1, 1998 dition to existing patent searching Fee Status ? Lapsed processes and help provide what Also Published As US6632970 can be a useful second opinion that Inventors Robert J. Lyons avoids the risk of missing relevant patents due to what turns out to Original Assignee General Electric Company be erroneous assumptions about Export Citation BBTeX, EndNote, RefMan the best keywords or patent classes. Patnet Citations (5) Referenced By (6) Classifications (8) Legal Events (6) While these principles are generally well known, it can be time Forward citation connections can be particularly consuming for owners of large patent portfolios to helpful to patent owners looking for potential licensmake this objective review of their portfolio. Coning candidates. Later patent applicants who cite your sider, for example patent US5343970 for a Hybrid patents in their patent applications may be using Electric Vehicle, filed by Alex Severinsky and then asinventions claimed by your patent in their products signed to the company he founded, Paice Corporation and services. While patents per se do not infringe (and subsequently to a number of other assignees). other patents, patent filings can provide useful inforWhile this patent has now expired, this patent was mation on the commercial intentions of the patent successfully asserted against Toyota including in the applicants, providing earlier patent owners with clues Federal Circuit. Paice had earlier settled with Ford on where they should be looking for infringement. A over the same patent, but this litigation has recently conventional infringement analysis on products and restarted. Paice has also filed a suit against Hyundai services produced by the later patent applicants can and Kia, alleging that these two companies were then provide the information needed to determine infringing their patents. if infringement is occurring. As we might expect from a widely litigated patent Citation Patent Searching vs. Keyword and Patent that was one of the earliest patents in its field, this Code Searching patent has been widely cited by later patents. The The vast majority of patent searching is done using patent searching website Espacenet lists 326 forward queries based on keyword or patent class codes. patent citations. While undoubtedly useful, these technique can This raises the question—if a patent analyst withsuffer limitations due to inconsistencies in selecout specific information about an industry was asked tion of technical terms by different applicants for to review these forward citations to suggest potential the same concept, and inconsistent application of licensing partners, where would they start? Such a patent class codes by different patent examiners or scenario is in fact surprisingly common, for example offices. In contrast, patent citations are nominated in the review of a patent portfolio that might be held by either patent examiners or applications based by the likes of universities that may hold patents filed on recognition of similarity, regardless of keyword in a very broad range of subject areas. or patent codes. Accordingly, the proportion of relevant patents for citation based patent searching There are in fact a series of techniques that alcan be in many cases higher than the proportion low the patent analyst to filter through such a large amount of forward citations. Some of the techniques of relevant patents for a more conventional search. Figure 2. The Google Patent Search Site 157 les Nouvelles Advanced Citation Analysis First Case Study— ‘Paice Patent,’ US 5343970 a) General statistical review of citations. Although it is more conventional to only look at forward citations in this sort of analysis, there are some good reasons to also review backward citations as well. Applicants for backward citation patents also have a proven interest in the technology and can be worth investigating for this reason. Figure 3 shows that the filing of forward and backward patent citations peaked in the year 2002. There were relatively few backward citations. Figure 4 shows that Ford was by far the leading applicant of forward cita- Number of Citations Filed may be familiar to some readers, but for some it will be tion patents with 84 known citations, a long way ahead new. To review these techniques, we will consider the of Toyota and Aisin (a leading supplier of automotive Paice patent discussed above, and then a patent filed parts, partly owned by Toyota). Toyota was unique in by Carnegie Mellon University which has been sucthis list of top citers in that it also had a backward citacessfully litigated for over $1 billion dollars in damages. tion from the Paice patent. For a patent owner such as Paice, any of these leading companies would be worth We will discuss these techniques below in separate investigating to see if any of their commercial products sections, first for Paice, consecutively for Carnegie were infringing the ‘970 patent. It is worth noting that Mellon. It should be noted that the examples shown Paice has successfully completed litigation against both are for illustrative purposes only. The value of an Ford and Toyota after asserting US5343970. analysis such as this is that it can help to suggest who should be investigated. Any references to any companies owning Figure 3: Citation Filing Trends For ‘Paice Patent’ US5343970 forward citation patents Known Citation Links To Paice Patent US5343970 in this article is not to im45 ply in any way that these 40 companies are infringing 35 any patent discussed—instead only that the owners 30 of the prior art patents 25 Forward might review the activities 20 Backward of these later patent filers 15 as part of their general in10 fringement investigation. 5 0 1968 1974 1979 1984 1989 1995 2000 2005 2010 Filing Year Figure 4: Leading Owners Of Forward Citation Patents For The ‘Paice Patent’ Known Patent Citations To Paice Patent US5373970, By Applicant Ford Toyota Aisin 84 19 16 Paice Railpower Nissan Chrysler 11 11 8 Forward Citation 8 8 Hitachi Suzuki Deere & Co BYD Backward Citation 7 6 6 6 Honda 0 20 40 60 80 100 Number of Known Patent Citations September 2014 158 Advanced Citation Analysis b) Identification of forward citation patents that refer to the subject patent in examiner’s reports (Patent River ‘Forward Rejection’ analysis). As discussed earlier, citation links can be supplied by both patent applicants and patent examiners. While some analysts believe that backward citations supplied by patent applicants as part of their ‘Information Disclosure Statement’ (IDS) are of lower quality than examiner citations and should be ignored, we have seen plenty of evidence of highly relevant patent citations supplied by patent applicants. Examiner patent citations can also be further classified according to whether they were specifically mentioned by the examiner in the examination report as either a reference to: • The patent being examined lacking novelty in the light of the cited patent (e.g section 102 of the U.S. patent code), • Or a reference to the patent being examined lacking inventive step in the light of the cited patent (Section 103 of the U.S. patent code). Patent data analysts Patent River (not affiliated with Ambercite) can supply lists of the forward citation patents from any nominated U.S. patent where these forward citation patents were specifically referred to by the examiner in either a novelty or obviousness objection. This can include citation references to patent applications that are subsequently abandoned—whereby these forward citation links may not be available in conventional databases. To help educate the readers of this article, Patent River has generously supplied this data for the Paice Patent. These results are supplied in table form listing the individual objections. For the purpose of this paper, these results have been summarised in Table 1 below. Table 1. List Of Novelty And Obviousness Rejections For The ‘Paice Patent’ Applicants with Patents Where the Paice Patent is Referred to in Examination Reports Novelty (102) ‘Rejections’ Patent Application Ultimately Abandoned or Rejected Abell Foundation/Paice Patent Application Granted 2 Patent Still Pending at Time of Review Total Number of Rejections 2 4 Hitachi 2 2 Luke Clawson 2 2 Railpower LLC Tesla 1 1 1 1 Daimler Group 1 1 Denso Corporation 1 1 ISE Corporation 1 1 McCutcheon Company 1 1 Sanyo Electric Company 1 1 Toyota 1 1 BMW 1 1 Chrysler 1 1 Delta Electronics 1 1 Ford 1 1 GM 1 1 Nissan 1 1 None Recorded 1 1 Sunyen Company 1 1 Gate SEL 159 Patent Application Granted Obviousness (103) ‘Rejections’ Patent Application Ultimately Abandoned or Rejected les Nouvelles 1 1 Advanced Citation Analysis While technically the reference to an earlier patent to a given patent, along with the interconnections in an examination report is more akin to an ‘objecbetween these cited patents. Moving a mouse over tion,’ Patent River prefers to use the term ‘rejection’ these citations opens up details of these citations. for a direct reference in an examination report, and The size of each patent node governs the relative so the term ‘rejection’ will be used in the remainder importance of a patent. There are options for manuof this paper. ally classifying patents from 1 to 4, which changes the colour of the node of each patent and so can be Table 1 shows that: used to highlight patents belonging to nominated • Abell Foundation (an investor in Paice) along patent owners. with Paice were the most common patent owners The AmberScope patent network for the Paice patto have the Paice patent cited against it. This is ent is shown in Figure 5. often seen in citation analysis, where an earlier patent of a patent owner is cited against later While for smaller patent networks a manual review patents from the same owner. of the patent network can help to quickly identify the most likely to be important connections, for a • Hitachi and an individual inventor by the name complex network such as this it can be hard to know of Luke Clawson each had the Paice patent cited where to start. against two of their patents. For this reason, AmberScope provides two filters • Railpower LLC and what became a Tesla patent to help this process. each had the Paice patent cited against two of their patents in novelty rejections. i)A similarity filter. Interconnections between the different cited patents can be used to predict —The Tesla patent (abandoned after grant) was the similarity between the ‘focus patent’ (the ‘970 US7228925 and covered Electrical systems for patent in this case) and its connected patent. The electric powered vehicles, which referred to a similarity filter can be used to hide all but the most voltage controller, an element found in some similar patents. of the claims of the Paice Patent. —The Railpower company patent was US20050206331, Figure 5: AmberScope Patent Network Map covering a Hybrid locomotive For The Paice Patent configuration, and which has now been abandoned. • Both novelty rejections have significant similarity between the Carnegie Mellon patent and the Seagate patent application. For a patent owner such as Paice, any of these leading companies would be worth investigating to see if any of their commercial products were infringing the Paice patent. In addition, we might have a special focus on Tesla and Railpower as both companies had patent applications rejected for being too similar to (disclosed by) the Paice patent. c) AmberScope analysis. AmberScope has been developed by the patent analyst company Ambercite to visualise the network of patents connected to a patent of interest. Each network displays the backward and forward citations September 2014 160 Advanced Citation Analysis Four of these forward citation patents are also filed by Paice, again a very common finding in citation analysis. The other three patents are US5697466, AmberScope patent network map for the Paice Patent, with the filing filter set to exclude patents filed by Equos Research (part of Aisin, filed before 1993 and the similarity filter set to only show the most similar 3% of patents to the Paice Patent. affiliated with Toyota), US6367570, filed by Electromotive, and US6116363, filed by the University of California. This is only illustrative of the process. For example, if the similarity filter is reset to ‘10’, i.e. to show the most similar 10 percent of forward citation patents, the 25 most similar patents are shown, as in Figure 7. ii) An importance filter. Ambercite has developed a metric called AmberScore, which is designed to measure the role and impact of a patent in the patent network and so to suggest the relative importance of the patents. AmberScore has been scaled so that the average U.S. patent has an AmberScore value of 1.0—in practice patents with AmberScores above 2 are worth looking at. The value of AmberScore as a filter Figure 7: AmberScope Patent Network Map For The for forward citation patents is that Paice Patent—Most Similar 10 Percent Of Patents higher scoring patents can suggest that AmberScope patent network map for the Paice Patent, with the filing filter set to exclude its owner applicant is making a large patents filed before 1993 and the similarity filter set to only show the most similar 10% of patents to the Paice Patent. investment into a technology, and in most cases is being recognised by others for doing so. We can use the importance filter to limit patents to the highest scoring patents. In Figure 8, the importance filter has been set to only show the leading 10 percent of the connected patents in combination with the filing filter, again set to exclude patents filed before 1993. Of note, this network of patents includes five patents filed by Aisin or Equos, three patents filed by Ford, three patents filed by Toyota, and two patents filed by General Motors. This analysis shows that the ‘leading’ patents (by AmberScore) for each of In Figure 6, the similarity filter has been combined these applicants were: with a filing year filter so that only the most similar • Aisin or Equos: US5806617, for a Hybrid Vehicle. 3 percent patents (seven patents in total) filed after • Ford: US5713425, for a Parallel hybrid drivetrain 1993 are shown. The arrows point to the forward for an automotive vehicle. citations, i.e. patents that were filed later. Figure 6: AmberScope Patent Network Map For The Paice Patent—Similar 3 Percent Of Patents 161 les Nouvelles Advanced Citation Analysis Second Case Study—Two Patents Asserted by Carnegie Mellon Against Marvell AmberScope patent network map for the Paice Patent, with the filing filter set to exclude patCarnegie Mellon University in 2012 ents filed before 1993 and the importance filter set to only show the most important 10% of had a 1.13 billion dollar patent judgepatents connected to the Paice Patent. ment against Marvell Semiconductor, a judgement upheld in January 2014. The two patents concerned where US6201839 and US6438180, both covering a method to separate the signal from the noise when reading hard disc drives. These two patents are closely related, and Espacenet regards them as being in the same patent family. For the purposes of this analysis, I will combine the results from these two patents (hereafter ‘Carnegie Mellon patents’), which is recommended for closely related patents. a) General statistical review of citations. For ward citations outnumbered Figure 9: Combined Citation Filing History backward citations, with filing activFor The Carnegie Mellon Patents ity peaking between 2003 and 2006, Figure 9. Known Citation Links To Carnegie Mellon Patents Marvell and Quallcom (including US6201839 And US6438180 acquisition Flarion Technologies) were 15 the leading owners of these patents, Figure 10. 10 b) Patent River analysis. Using the exact same process as 5 used with the Paice patent, but looking for forward rejections for both of 0 the Carnegie Mellon patents, we can produce Table 2. Forward Citation Backward Citation This shows that: • Broadcom had the Carnegie Mel• General Motors: US8285432, for a Method and lon patents mentioned in obviousness rejections apparatus for developing a control architecture for to two of their patents, but both patents were coordinating shift execution and engine torque ultimately granted. control. • Seagate had a Carnegie Mellon patent cited • Toyota: US5839533, covering an Apparatus for (US6438180) against one of its patent applications controlling electric generator of hybrid drive ve(US20040268208) in a novelty rejection, and this hicle to control regenerative brake depending upon patent application was ultimately abandoned. This selected degree of drive source brake application suggests significant similarity between the Carnegie Mellon patent and the Seagate patent application. The value of this list is that it can help uncover the commercial plans of these applicants—along • Nokia, Realtek and Sony also had Carnegie with careful due diligence required for any sort of Mellon patents cited in an obviousness rejecinfringement analysis on the products of a potentially tion against patent applications which were infringing company. ultimately abandoned. 2012 2011 2009 2010 2008 2006 2007 2005 2004 2001 2002 2003 2000 1997 1998 1999 1996 1995 Figure 8: AmberScope Patent Network Map For The Paice Patent—Most Important 10 Percent Of Patents September 2014 162 Advanced Citation Analysis Figure 10: Leading Owners Of Forward Citation Patents For The Carnegie Mellon Patents Known Patent Citations To Carnegie Mellon Patents US6201839 And US6438180 Of note, all three are to Marvell patents, with AmberScope telling us the very most similar patent being US7000177. Discussion and Conclusions Before comparing these three sets of results, there is another method many Qualcon/Flarion Technologies licensing managers use to identify potenSeagate tial licensees—namely scanning the list Forward Citation of the owners of forward citation patents, Broadcom Backward Citation such as what might be found by reviewLSI Corporation ing the patent in a suitable patent search Direct TV website. There is no doubt that in these Hitachi two examples, that this simple method Infineons Technologies would have worked. The Paice manage0 10 20 30 40 ment would have seen the likes of Ford and Toyota listed as owners of forward citation Number of Forward and Backward Citations patents, while the managers of the Carn• Marvell, Direct TV and Spreadtrum Communicaegie Mellon patents would have seen Qualcomm tions had one of the Carnegie Mellon patents cited and Marvel listed as owners of forward citations. against patents which were ultimately granted. And indeed there is nothing wrong with this, c) AmberScope analysis. but this assumes a level of knowledge about the industry that the patents belong in. Many licensUS6438180 has the most citation links, so we will ing managers have good industry knowledge, but concentrate on this. An AmberScope network map from this patent is shown in Figure 11. In this map, not all do for all industries. Also patents may be patents filed by Marvell are highlighted. owned by subsidiaries of large companies where the link to the large company is not immediately i) Most similar forward citation patents. obvious. So a more objective approach that is less The three most similar (most similar 4 percent) dependent on industry knowledge can be helpful forward citation patents to US6438180 are shown in some situations. in Figure 12. Marvell Table 2. List Of Novelty And Obviousness Rejections For The Carnegie Mellon Patents Novelty (102 Rejections) Applicants Patent Application Ultimately Abandoned or Rejected Patent Application Ultimately Abandoned or Rejected Broadcom Seagate Technology 163 Patent Application Granted Total Number of Patent Applications Where the Paice Patent was Referred to in Examination Reports 2 2 Obviousness (103 Rejections) 1 1 Nokia 1 1 Realtek Semiconductor 1 1 Sony 1 1 Carnegie Mellon University 1 1 Direct TV 1 1 Marvell 1 1 Spreadtrum Communication 1 1 les Nouvelles Advanced Citation Analysis are probably very interested in this area of technology, and probably applications, even if not all of these developments are eventually commercialised. However the limitation with the ‘look for known applicants’ and the ‘count the patents’ approach is that not all forward citation patents are the same—in both commercial value and the similarity to the patent being licensed. While all of us would inherently understand this, this principle is too often ignored in patent analysis. From a valuation principle, this would be akin to valuing say a portfolio of houses simply on the number of houses in the portfolio. Many patent analysts do go further and classify the patents being reviewed by the patent classification code applied to the patents. Returning to the real estate analogy, this would be akin to classifying a portfolio of houses by area code. Without doubt, this is a step forward in the valuation model— but a bigger step forward would be to look at the value of the individual houses. Figure 12: AmberScope Patent Network Map The Patent River approach and the AmFor The Carnegie Mellon Patent US6438180 berScope approach both look at licensing potential for the forward citation patents AmberScope patent network map for the Carnegie Mellon patent US6438180, with the being reviewed on an individual basis. The filing filter set to ignore prior art patents, and the similarity filter set to show only the most similar 4% of patents to this Carnegie Mellon patent. Patent River approach relies on the U.S. patent examiner identifying the specific similarities between the earlier patent and its forward citations in a written examination report. When these similarities are found they can be very powerful pieces of information, especially if the forward citation patent is ultimately rejected on the basis of the earlier patent—which can be strong evidence of similarity. The Patent River approach can also be very helpful where, due to the earlier patent, the later patent application is rejected before grant. In many cases this means that these forward citation links are not formally available as backward citations from un-granted patent applications are not always published. Accordingly, the Patent River approach can find potential licensees where patent citation connections are not formally published. The next most common approach is the statistical An alternative approach is to combine all the approach, which essentially is just counting the foropinions of all of the examiners in an area of techward citation patents by patent owner. Again this is nologies, and effectively triangulate these opinions widely practiced, and well worth doing. Companies to identify the most similar, and the likely to be the that file lots of patents that cite an earlier patent Figure11: AmberScope Patent Network Map For The Carnegie Mellon Patent US6438180 September 2014 164 Advanced Citation Analysis most important patent. This in turns can potentially identify citation links where the ‘collective wisdom’ of the patent examiners and applicants are suggesting a high degree of similarity—or an important patent which may be a valuable patent. This is the AmberScope approach, and this can be very effective where there is a large number of forward citation patents. Such an approach could be very useful, for example, where the listed owner of a very similar patent is not recognisable as a major company in the area of interest. Identification of these very similar patents can encourage further investigation of these patents, which may uncover opportunities which may be missed by a simple review of listed owners. It should also be noted that the statistical Patent River and AmberScope approaches are all able to be automated and the results provided in a report suitable for review of a large portfolio—ideal for IP managers responsible for large or new portfolios. Going Beyond Listed Citations The Patent River approach can find links to patents where no forward citation links are formally published. The AmberScope approach also allows this type of analysis, on the basis that if a patent A is similar to a patent B based on citations analysis, and patent B is also similar is patent C based on citation analysis, then patent A must also be similar to patent C—even if no formal citation analysis exists. These analyses can be done manually using AmberScope, or via an automated report now 165 les Nouvelles available from Ambercite. Further details of this type of analysis are found at the Ambercite website. Summary In summary, this paper has considered four different approaches for identifying potential licensees or commercial partners from forward citation data for a patent being reviewed: •Scanning lists of forward citation patents to take note of owners. •Identifying the most common owners of forward citation patents. • The Patent River approach of identifying forward citations where a patent being reviewed is specifically mentioned by the patent examiner. • The AmberScope approach of identifying the most similar and important forward citation patents. All of these approaches have their strengths and can have their limitations. In the two examples shown, these separate analyses have produced a range of results, some overlapping. The observation that they are overlapping to some extent is not surprising and provides some comfort as to their predictive capability. The observation that each approach produces a slightly different set of suggestions for licensing partners suggests that each analysis has its own value. In practice, using all of these techniques is recommended for patent managers looking for the best possible source of information regarding commercial options for their patents. ■ Customs Value, Licensing And Royalties Customs Value, Licensing And Royalties— The Russian Perspective By Sergey Medvedev C ross-border trade is a driver of the global economy and the world’s better financial condition. According to the World Trade Report 2013, the rise of a world economy, the spread of investment and technology, the growth of international specialization, the ascent of new economic powers, and the dramatic surge in growth and population would not have been possible without a massive expansion of global trade over the past 200 years.1 Being a constantly developing BRICS region, Russia persistently fights to conquer first place by vying with its competitors and improving its commercial status. In fact, Russia has always been an attractive platform for doing business, especially from the supply and distribution standpoint. Different foreign companies and brand owners have gotten used to bringing their brands, technologies and products to Russia every day in order to have them reach the hands and minds of Russian consumers. Before that happens though, these companies and brand owners have to tackle certain customs and border clearance procedures established for imports by Russian laws. And, that is where different issues, including on the point of determination of the exact customs value of products being declared, can arise during or after the process of release of the same onto the market place. Background and Issue When involved in the business of trade and participating in various import campaigns, foreign companies and brand owners will normally undertake the international customs planning matters to consider the calculation of relevant fees and duties in advance. However, as the Russian customs practice shows, many contracted business partners (buyers, distributors, agents, licensees, etc.) may sometimes ignore the aspect of royalties or license fees in the context of determination of the correct customs value by trying to turn the saved funds into another transaction benefit. Although it is not clear, whether such actions depend on the mere lack of knowledge of the Russian intellectual property and customs laws, or on the intention to pay less money to the Russian government, or on improper communications (negotiations) and documentation (e.g. supply and license 1. http://www.wto.org/english/res_e/booksp_e/wtr13-2b_e.pdf. agreements) involved in the course of the customs clearance proceedings, or on some other factors, it is obvious that such negligence can lead to severe legal consequences, including customs fines and other charges. Therefore, before implementing any specific customs planning for the Russian market, it is important to understand in each particular case, whether royalties or license fees, if they do exist under the executed license ■ Sergey Medvedev, PhD, LLM agreement(s) underlyGorodissky & Partners, ing the signed supply Senior Lawyer, agreement(s), will be Moscow, Russia included or excluded E-mail: MedvedevS@ from the customs value gorodissky.ru of the imported goods, since proper calculation and settlement of the same will help the businesses to avoid any potential problems and monetary sanctions in the future. Laws and Regulations In accordance with paragraph 1 of Article 1235 of the Russian Civil Code (Part IV) (the “RCC”), under a license agreement one party—an intellectual property owner (licensor)—grants or is obliged to grant to the other party (licensee) a right to use the intellectual property subject matter within terms as set out by the subject agreement. Pursuant to paragraph 5 of Article 1235 of the RCC, a licensee is obliged to pay an agreed compensation to the benefit of the licensor under the license agreement, unless such agreement provides otherwise. Practically, an agreed compensation will take the form of royalties in most licensing transactions, where royalties will be repeated instalments paid on a monthly, quarterly or annually basis. Normally, these instalments will be computed as a percentage of proceeds of sales of the licensed products imported in the contractual territory (e.g. Russia). According to Article 64(1) of Customs Code of the Customs Union,2 adopted on November 27, 2009 (the “Customs Code”), the customs value of 2. On July 6, 2010 Russia, Belarus and Kazakhstan established a new and regional Customs Union within the framework of the Eurasian Economic Community (EAEC). September 2014 166 Customs Value, Licensing And Royalties the goods imported into the customs territory of the customs union shall be determined in accordance with the international treaty3 of member-states of the customs union that regulates the issues of determination of the customs value of the goods moved through the customs borders. According to Article 64 (2) of the Customs Code, the customs value of the goods imported into the customs territory of the customs union shall be determined if the goods actually cross the customs borders and such goods are moved to the customs proceedings for the first time right after traversing the customs borders, except for the customs proceedings related to customs transit. According to Article 64(3) of the Customs Code, the customs value of the goods shall be determined by the customs declarant or customs representative acting on behalf of the customs declarant, and in cases set forth by the Customs Code—by the customs agency. Pursuant to Article 65(3) of the Customs Code, the customs value shall be the integral part of the declaration of goods. Pursuant to Article 65(4) of the Customs Code, the declared customs value of the goods and evidence submitted related to its determination shall be based on the information that is true and can be determined and supported by documentation. Pursuant to Article 66 of the Customs Code, the inspection of the customs value of the goods shall be done by the customs agency before or after the release of the goods, including through the use of the risk management system. According to Article 5 of the Agreement between the Government of the Russian Federation, the Government of the Republic of Belarus and the Government of the Republic of Kazakhstan, dated January 25, 2008, “On Determination of the Customs Value of Goods Transported Across the Customs Borders of the Customs Union” (the “Agreement on Determination of the Customs Value”), royalties must be generally included into the customs value of goods. Specifically, in the sense of paragraph 1(7) of Article 5 of the Agreement on Determination of the Customs Value, license and other similar fees, set for the use of intellectual property (including royalty payments for patents, trademarks, copyrights), related to the valued (imported) goods, and which are directly or indirectly paid, or will be paid, by the buyer as a condition for the sale of valued (imported) goods in the amount not included into the price which has been de facto paid 3. The Agreement between the Government of the Russian Federation, the Government of the Republic of Belarus and the Government of the Republic of Kazakhstan, dated January 25, 2008, “On Determination of the Customs Value of Goods Transported Across the Customs Borders of the Customs Union.” 167 les Nouvelles or is subject to payment for such goods,—shall be considered during the determination of the customs value of the imported goods under the transaction cost in addition to the price which has been de facto paid or is subject to payment for such goods. In other words, there are two (2) basic requirements in Russia under which royalties or license fees will be included into the customs value of the imported goods: (a) royalty payments must relate to the imported goods; and (b) royalty payments must be made as a condition for the sale of the imported goods. Importantly, these conditions must both be met at the same time, meaning that if one of them is omitted, or not duly complied with, royalties will be excluded from the customs value of the imported goods. Hence, royalties shall be included into the customs value in the case when they are related with the imported goods and payment of the same stands as a condition precedent for the sale of such goods. This shall obviously mean that the documentation (i.e. supply agreement) submitted by the importer in the course of customs clearance proceedings (or afterwards) must provide for the contractual obligation of the importer to acquire the right of use of certain intellectual property under a license agreement in exchange for a purchase of the goods; otherwise, the goods will not be sold to the importer. Further, pursuant to paragraph 1(7) of Article 5 of the Agreement on Determination of the Customs Value, there are certain royalty payments, which shall not be added to the customs value of the imported goods. In particular, the following royalties or license fees shall be excluded from the customs value of the imported goods: (a) royalty payments related to the right of reproduction (copying) of the imported goods in the customs territory of the customs union; and (b) royalty payments related to the right of distribution or re-sale of the imported goods, if such payments do not attend to the condition for sale of the imported goods for the purpose of exportation to the customs territory of the customs union. There are no other exceptions provided by the law when royalties can be excluded from the customs value. Hence, if the documents (i.e. supply and license agreements) submitted by the importer in the course of customs clearance proceedings (or afterwards) clearly state that royalties or license fees, subject to payment for distribution or re-sale of the imported goods, do not stand as the condition precedent for sale of such goods in the territory of the customs union (e.g. Russia), then such royalties or license fees will be excluded from the customs value as per the above “statutory exception rule.” In addition, it should be noted that the right Customs Value, Licensing And Royalties of reproduction, as referenced above, does not mean copying of the imported goods only. It can also relate to manufacture of the patented product (or process) or reproduction of know-how. Court Practice and Case Law In the opinion of many local customs officials, the dutiable customs value produce more than 30 percent of all income of the Russian government. Hence, it is not a surprise that the Russian Customs Authorities will try to increase the customs value of the imported goods in order to bring more income to the country. Sometimes, they may do it correctly and the calculations they make (or add to the declared customs value) will match with the records of the importers, who then remit the required outstanding amounts in favor of the state budget. At the same time, some Russian Customs Authorities make mistakes by correcting the customs value in an incorrect or ungrounded manner leaving the bona fide companies a chance to challenge the customs calculations in court. In fact, many locally-based entities representing foreign businesses and brands in Russia, including Beiersdorf, Procter & Gamble, ABB, Oriflame Cosmetics, Colgate Palmolive, Quelle, Rockwool, ZARA and others, have already had to struggle with the decisions of the Russian Customs Authorities on the judicial basis. These actions eventually helped to establish specific precedents on the issue. Although Russia is a civil-law jurisdiction, and the national case law does not necessarily have any binding legal effect for future analogous situations, as opposed to the U.S., UK or other common law countries, certain court decisions and opinions, especially those issued by the highest local tribunals, may be taken into account in similar cases. In view of the fact that the issue of inclusion of royalties into the customs value has not been finalized to date at the highest judicial level, and no judicial recommendations or suggestions have been announced by the supreme court so far, the court practice with respect to this area is rather diverse in Russia, meaning that there are judgments issued in favor of the Russian Customs Authorities4 as well as judgments issued in favor of the businesses (importers, licensees).5 Of course, such court decisions will vary depending on the specific circumstances surrounding the referenced cases and material evidence submitted in the course of the civil proceedings. Interestingly, the very recent court practice tends to be more reasonable and positive for the businesses. The review of the “unfavorable case law,” where the judgments have been issued in favor of the Russian Customs Authorities, shows that many courts are of the opinion that royalties or license fees must be included in the customs value every time the license agreement is made in support of the supply agreement, since royalties or license fees would relate to the imported goods and be paid by licensees as a condition for further distribution of the same in Russia. According to the cited court decisions and additional customs guidance, the existence of a license agreement may be treated as a valid condition for the sale of the goods, notwithstanding the fact of whether such agreement is connected with (and referenced in) a supply contract or not, or the fact whether such agreement is made with a supplier or third party (i.e. intellectual property owner). Moreover, many Russian Customs Authorities believe that the connection between royalties and imported goods may be traced by the form of payment of contracted compensation (e.g. license fees dependent on net sales). It is curious, that some local courts would agree that the above can actually be applied not only to licenses, but to franchise agreements, which provide for the grant of right to trademark usage as a part of the franchised system conveyed to franchisees. The review of the “favorable case law,” where the judgments have been issued in favor of the importers/licensees, shows that there are courts in Russia that started to apply the “statutory exception rule,” under which royalties or license fees shall not be included in the customs value in the event when such royalties or license fees relate to the right of distribution or re-sale of the imported goods and do 4. Decision of the Federal Commercial Court of the Moscow District dated 5 May 2009 No. KA-A40/3422-09, Decision of the Federal Commercial Court of the Moscow District dated 26 March 2010 No. KA-A41/2366-10, Decision of the Ninth Commercial Appellate Court dated 18 May 2010 No. 09AP6825/201-AK, Decision of the Federal Commercial Court of the Moscow District dated 8 September 2011 No. A40-133761/10147-845, Decision of the Federal Commercial Court of the Moscow District dated 10 July 2012 No. A40-60752/11-149331, Decision of the Federal Commercial Court of the Moscow District dated 10 October 2013 No. A40-152783/12-92-1453, Decision of the Federal Commercial Court of the Moscow District dated 10 October 2013 No. A40-154132/12-120-1592, Decision of the Federal Commercial Court of the Moscow District dated 10 October 2013 No. A40-154144/12-21-1491. 5. Decision of the Federal Commercial Court of the NorthWestern District dated 6 June 2011 No. A44-3558/2010, Decision of the Federal Commercial Court of the Central District dated 12 March 2012 No. A23-1556/10A-18-68, Decision of the Federal Commercial Court of the North-Western District dated 16 April 2014 No. A56-31657/2013, Decision of the Thirteenth Commercial Appellate Court dated 28 February 2014 No. A56-7925/2013, Decision of the Seventeenth Commercial Appellate Court dated 5 May 2014 No. 17AP-3327/2014-AK. September 2014 168 Customs Value, Licensing And Royalties not attend to the condition for sale of the imported goods for the purpose of exportation to the customs territory of the customs union (see paragraph 1(7)(b) of Article 5 of the Agreement on Determination of the Customs Value). Specifically, according to the one recent court decision,6 in a situation when: (a) supply and license agreements are not linked together, (b) such agreements do not have any cross-references, including with regard to payment of royalties, and (c) payment of royalties under the license agreement is not a condition precedent to the execution of the supply agreement,—such royalties must be excluded from the customs value of the imported goods. This case is especially a good judgment to rely on in the event where three (non-inter-connected) parties are involved, where the importer has a supply agreement with one company (supplier/seller) and has a license agreement with another company (intellectual property owner/licensor), and where both agreements are not linked. However, when the licensor and the buyer are different but inter-connected entities (see paragraph 1 of Article 3 of the Agreement on Determination of the Customs Value), the payment of royalties may be a condition for sale of goods, consequently— they will be included into the customs value. Another “favorable” recent court decision7 is a perfect example of how businesses need to distinguish royalties paid for the use of the franchised trademark from royalties paid for the use of the other franchised intellectual property objects (i.e. trade name, knowhow and software) which are usually included in the franchised system. The court held that while a trademark might have a direct relation to the product since it was a source identifier, the relation of the franchised trade name, know-how and software to the product had to be proved, but that was not done in that case by the plaintiff (customs office). The court also referred to some additional documents (deeds of conveyance) accompanying the franchise agreement where it was expressly mentioned that neither these intellectual property subject matters (i.e. trade name, know-how, software), nor the payments for the use of the same were related to the imported products. Hence, the franchisee was not supposed to be paying royalties for the use of the franchised trade name, know-how and software as a condition for sale of the imported products in Russia. The court summarized that when different royalty payments were set 6. Decision of the Federal Commercial Court of the NorthWestern District dated 16 April 2014 No. A56-31657/2013. 7. Decision of the Seventeenth Commercial Appellate Court dated 5 May 2014 No. 17AP-3327/2014-AK. 169 les Nouvelles for various contracted intellectual property subject matters in the franchise agreement, it was possible to include certain royalties into the customs value (i.e. trademark-related royalties) by excluding the other (trade name, know-how and software related royalties). By analogy, this court ruling may have a precedential effect for regular licensing transactions. In light of the existence of the conflicting case law, it will be very useful to know the judicial advice or position of the supreme tribunal on the issue. It is hoped that the highest Russian judiciary will provide certain guidance in the near future, as some of the cited court decisions are being appealed at this time and may finally reach the supervisory court. Discussion and Analysis Generally, royalties will relate to the imported goods in the event when such goods contain any particular form of intellectual property, such as copyrights, patents, trademarks, know-how, etc. For instance, if the imported product, or its packaging, has been trademarked, and the use of the trademark provides for the payment of royalties, they will most probably be related to the imported product. At the same time, the affixation of the trademark on the product, or its packaging, does not necessarily mean that the corresponding royalties or license fees will always relate to the imported products. For example, royalties may not simply be related to the imported products in case when the trademarked packaging is being imported into Russia for further packaging of the products in Russia, and the trademark use is supposed to be made in connection with such products, while the payment of royalties is not a condition for sale of the packaging in Russia. Further, if the imported goods are used as components in the product manufacture process in Russia, where a licensee will be using the licensed know-how in exchange for the payment of royalties, such royalties will be excluded from the customs value, as they will relate to the licensee’s activities committed after the importation of the products into Russia. And, in the case where in exchange for the payment of royalties a buyer acquires the right to use the owner’s know-how in order to manufacture a specific product in Russia, and it separately buys some machinery from the manufacturer for the purpose of making the use of the licensed know-how in Russia, royalties will also be excluded from the customs value, since the payment of the same does not clearly attend to the condition for sale of the machinery in Russia, even though royalty payments are linked with the whole manufacture process. Customs Value, Licensing And Royalties In any event, all circumstances, contracts and documents of the subject transaction(s) must be subject to due diligence each time before reaching a final conclusion as to the inclusion of royalties into the customs value of the imported goods, products, components and/or ingredients (as applicable). According to the recommendation of the European Commission, in determining whether a particular royalty relates to the goods to be valued, the key issue is not how the royalty is calculated, but why it is paid (i.e. what in fact the licensee receives in return for the payment). Thus, in the case of an imported component or ingredient of the licensed product, or in the case of imported production machinery or plant, a royalty payment based on the realization on sale of the licensed product may relate wholly, partially or not at all to the imported goods.8 As to the second requirement, more specifically, whether royalties are paid as a condition for sale of the goods to be imported, the European Commission states that the question to be answered in this context is whether the seller would be prepared to sell the goods without the payment of a royalty or license fee. The condition may be explicit or implicit. In the majority of cases it will be specified in the license agreement whether the sale of the imported goods is conditional upon payment of a royalty or license fee. However, it is not essential that it should be so stipulated.9 Hence, the direct provision in the licensing contract that the trademark usage, and, therefore, payment of royalties, shall not be regarded as a valid condition for the sale of the trademarked goods can mitigate the whole situation, essentially when different contracts (e.g. supply and license agreements) governing the supply of goods and the exploitation of intellectual property will be made with different noninter-connected companies (e.g. supplier and intellectual property holder). For example, if the importer makes royalty payments to a third party owner for the right to use certain intellectual property subject matters in Russia, such intellectual property subject matters relating to the goods imported under a supply agreement which is made with a different supplier may not be a condition for exporting these goods for sale into Russia, and as a result—such royalty payments will be excluded from the customs value. At the same time, pursuant to the opinion of the European Commission, when goods are purchased from one person and a royalty or license fee is paid to another person, the payment may nevertheless be regarded as a condition of sale of the goods under certain conditions. The seller, or a person related to him, may be regarded as requiring the buyer to make that payment when, for example, in a multinational group goods are bought from one member of the group and the royalty is required to be paid to another member of the same group. Likewise, the same would apply when the seller is a licensee of the recipient of the royalty and the latter controls the conditions of the sale.10 The following elements should be analyzed to determine if there is control: (a) the licensor selects the manufacturer and specifies it for the buyer; (b) there is a direct contract of manufacture between the licensor and the seller; (c) the licensor exercises actual control either directly or indirectly over the manufacture (as regards centers of production and / or methods of production); (d) the licensor exercises actual direct or indirect control over the logistics and the dispatch of the goods to the buyer; (e) the licensor nominates/restricts who the producer can sell their goods to; (f) the licensor sets conditions relating to the price at which the manufacturer/seller should sell their goods or the price at which the importer/ buyer should resell the goods; (g) the licensor has the right to examine the manufacturer’s or the buyer’s accounting records; (h) the licensor designates the methods of production to be used/provides designs etc.; (i) the licensor designates/restricts the sourcing of materials/components; (j) the licensor restricts the quantities that the manufacturer may produce; (k) the licensor does not allow the buyer to buy directly from the manufacturer, but, through the trademark owner (licensor) who could as well act as the importer’s buying agent; (l) the manufacturer is not allowed to produce competitive products (nonlicensed) without the consent of the licensor; (m) the goods produced are specific to the licensor (i.e., in their conceptualization/design and with regard to the trademark); (n) the characteristics of the goods and the technology employed are laid down by the licensor. It should be noted that, in individual cases, other kinds of indicators may also exist.11 8. Paragraph 11 of the Commentary No. 3 of the Customs Code Committee (customs valuation section) on the incidence of royalties and license fees in customs value (EC Compendium of Customs Valuation). 9. Paragraph 12 of the Commentary No. 3 of the Customs Code Committee (customs valuation section) on the incidence of royalties and license fees in customs value (EC Compendium of Customs Valuation). 10. Paragraph 13 of the Commentary No. 3 of the Customs Code Committee (customs valuation section) on the incidence of royalties and license fees in customs value (EC Compendium of Customs Valuation). 11. Paragraph 1 of the Commentary No. 11 of the Customs Code Committee (customs valuation section) on the application of Article 32 (1) (c) CC in relation to royalties and licensee fees paid to a third party according to Article 160 of Reg. (EEC) No. 2454/93. September 2014 170 Customs Value, Licensing And Royalties Basically, in the absence of any local clarifications or guidance from the Russian Customs Authorities as well as the Russian highest judiciaries, these recommendations of the European Commission may play a persuasive role and be tested in Russia. However, if the Eurasian Economic Commission (EEC) approves the draft of Rules for Inclusion of License and Other Similar Fees for Use of Intellectual Property in Customs Value,12 which have been prepared and submitted by the Russian non-commercial organizations, including by the Chamber of Commerce and Industry of the Russian Federation, the nationally oriented recommendations may enter into force to be applied in intellectual property/customs practice of Russia, Belarus and Kazakhstan. Conclusion and Comment When considering whether to include or exclude royalties in the customs value, it is important to carefully analyze all facts, circumstances and documents involved in the particular importation of the goods into Russia. Different facts, circumstances and documents may produce different advice and strategies. Therefore, before taking any steps forward, assistance of local counsel should be obtained. Generally, there are a few practical recommendations that might help to deal with or mitigate the issue of customs value vs. royalty: • Form the contractual relationship of the parties on the basis of a single agreement (e.g. supply, distributorship) by simply permitting the contractor to use the associated intellectual property (e.g. patent, trademark) in connection with the sale of products without royalty payments—applicable for a situation when: (i) the seller and the intellectual property owner are one and the same business entity, and (ii) manufacture of products stays beyond the scope of the transaction at issue; • Form the contractual relationship of the parties on the basis of a single agreement (e.g. supply, distributorship) and grant a separate letter of authorization by permitting the contractor to use the associated intellectual property (e.g. patent, trademark) in connection with the sale of products without royalty payment—applicable for a situation when: (i) the seller and the intellectual property owner are different business entities, and (ii) manufacture of products stays beyond the scope of the transaction at issue; • Omit cross-referencing or citation of the subject 12. http://www.ank.kz/projects/npa/54883/. 171 les Nouvelles transaction documentation (e.g. supply and license agreements)—applicable for a situation when inter-connected business entities (e.g. supplier and licensor) are involved in the transaction at issue; • Clearly indicate in the subject transaction documentation (e.g. supply and license agreements) that the use of the associated intellectual property subject matter is not a condition for sale of the imported goods—applicable for a situation when: (i) product components or product packaging are involved in the transaction, and (ii) manufacture of products stays within the scope of the transaction at issue; • Split royalty payments for the use of various contracted intellectual property subject matters—applicable for a situation when the license/ franchise agreement set out different intellectual property subject matters. As to the appropriate method of calculation of the exact amount of the customs value, this aspect is beyond the scope of the present article. The Agreement on Determination of the Customs Value as well as different customs resolutions provide for a diversity of options in this regard. In one of the above-referenced “unfavorable” cases, the Supreme Commercial Court of the Russian Federation, when refusing to hear the appeal of the importer, upheld the lower courts’ holding. In its ruling, delivered on November 8, 2012,13 the Russian Supreme Commercial Court stated that considering the principle of freedom of contract, the variety of intellectual property forms, the individual characteristics and terms of license agreements, it is not possible to develop unified methods of calculation of license fees subject to inclusion into the customs value. Basically, the supreme court confirmed that a particular method of calculation of customs value of the imported goods should be followed in terms of the factual matters and relevant provisions of the subject license agreement depending on the documents submitted by the importer in the course of the customs clearance proceedings. In any event, the choice of the optimum method of determination of the customs value can always be made in the framework of negotiations and consultations between the customs office and the importer.14 ■ 13. Ruling of the Supreme Commercial Court of the Russian Federation dated 8 November 2012 No. VAS-13933/12. 14. Letter of the Federal Customs Service of Russia dated 22 September 2008 No. 05-33/39045. Radioisotope Pharmaceutical Radioisotope Pharmaceutical Licensing By Paul R. Betten Abstract This paper discusses radioisotope pharmaceutical licensing and provides background information on the manufacturing process, supply chain, and how royalties are developed, using the radioisotope Molybdenum-99, which decays into technetium-99m, as an example. Technetium-99m is the world’s leading isotope for medical imaging. Radioisotope pharmaceutical licensing involves “stacked” royalties, with royalties going to the isotope manufacturer, isotope separation, monoclonal antibody licensee, and final sale to end users at the hospital level on the supply chain, with the majority of the costs being charged by the hospital. This paper provides a literature review on licensing fees for the production of other isotopes and our experience with an otherwise rare isotope, copper-67, which holds promise as a Non-Hodgkin Lymphoma therapy. While Tc-99m is a diagnostic isotope and Cu-67 is a therapeutic, the business models for both are based on government subsidized isotope production. Currently, many isotopes are produced using research-scale nuclear reactors; however, this manufacturing method entails a large capital cost. In addition, these research reactors are aging and have maintenance issues. New approaches to radioisotope production using particle accelerators, which are less capital intensive, appear to provide a more efficient and economical method of isotope production. Introduction T he addressable medical isotope market is multi-billion dollars worldwide.1,2,3 The most widespread isotope used in medical imaging is molybdenum-99 (Mo-99), which decays into technetium-99m (Tc-99m). However, there are other medical isotopes used for medical imaging, such as thallium-201 (Tl-201) for cardiac imaging and xenon-133 1. http://www.snm.org/docs/SNM%20poster%20low%20res%20 1001.pdf, Society of Nuclear Medicine, “An Outlook on New Sources of Mo-99 and Other Medical Radionuclides.” 2. Strategic and Commercial Considerations in the Producton and Supply of Radisotopes,” WNA Symposium, NESCA, Rob Adam, CEO., Sept. 2010. http://www.world-nuclear.org/sym/2010/ presentations/adamppt.pdf, indicates a global $5 billion market. 3. “Making Isotopes at the Hospital Could Relieve Chronic Shortages,” Innovation, Vol 10 No 4, Aug/Sept 2012, indicates a global $5 billion market, http://www.innovation-america.org/ making-isotopes-hospital-could-relieve-chronic-shortages. (Xe-133) for lung imaging. There are a number of isotopes used in vitro oncology for the treatment of solid tumors using brachytherapy seeds, such as iodine-125 (l-125), yttrium-90 (Y-90), and iridium 192 (Ir-192). Another important isotope is cobalt-60 (Co-60), which has a wide variety of medical applications and is used in stereotactic tumor radiotherapy, commonly known as the Gamma Knife, as well as a wide variety of industrial applications such as the sterilization of ■ Paul R. Betten, PhD foods, elimination of pest insects, and in Independent Consultant, medical equipment. Naperville, IL, USA The majority of the E-mail: betten69@ aforementioned isogmail.com topes are produced in government-subsidized nuclear test reactors, the sales of which supplement the primary purpose of these reactors: basic research. Particle accelerators are now becoming important as sources for isotopes, due to the aging of these governmentsubsidized test reactors. This paper discusses the novel and exciting development of a copper-67 (Cu67) isotope, which is produced using accelerator technology, for the treatment of non-solid white blood cancers, such as Non-Hodgkin Lymphomas (NHLs). Overview and Economics of the Mo-99/ Tc-99m Supply Chain An instructive example of the licensing and economics of medical isotopes may be found by examining the Mo-99 product supply chain. Mo-99 decays into Te-99m and is the most commonly-used medical isotope, being used in roughly 80-85 percent of medical imaging applications.4,5 Currently, the United States and Canadian supply of Mo-99 is provided by the Atomic Energy of Canada Limited (AECL) nuclear research reactor at the Chalk River Laboratories, 4. http://www.snm.org/docs/SNM%20poster%20low%20res%20 1001.pdf, Society of Nuclear Medicine, “An Outlook on New Sources of Mo-99 and Other Medical Radionuclides.” 5. “Making Isotopes at the Hospital Could Relieve Chronic Shortages,” Innovation, Vol 10 No 4, Aug/Sept 2012, indicates a global $5 billion market, http://www.innovation-america.org/ making-isotopes-hospital-could-relieve-chronic-shortages. September 2014 172 Radioisotope Pharmaceutical Canada, using highly enriched uranium-235 (HEU) targets. The Chalk River reactor has a unique design that permits selected fuel rods to be withdrawn while the reactor is still in operation, and is therefore suitable for isotope production. Although there are about 250 test reactors in the world, only five (including Chalk River) are multifunctional enough to be used for industrial-scale isotope production.6 Nordion, Inc.7 holds an exclusive license with AECL to purify and distribute the Mo-99 produced by their research reactor. Mo-99 has a half-life of 2.7 days and decays into Tc-99m (with the “m” indicating a metastable half-life of 6.0 hours). Nordion processes enriched uranium and separates out the Mo-99 within a hot cell2. The isotope is then delivered to hospitals with a Tc-99m generator to separate the technetium from the Mo99. Mo-99 is first applied to the Tc-99m generator, a shielded chromatography column—also known as Moly Cow—that initially binds technetium; subsequent application of saline solution elutes technetium in the form of sodium pertechnetate (NaTcO4), which is then directly injected into a patient. Tc-99m decays with a 140 keV gamma ray, which is recorded by normal x-ray imaging equipment. The Chalk River reactor is over 40 years old, has aging equipment problems, and temporary maintenance shutdowns may become increasingly frequent or even permanent. A permanent Chalk River decommission would be a major shock to the medical imaging industry. Concerns regarding a potential Mo-99/Tc-99m shortage has triggered a number of organizations to look to other methods of isotope production. Nuclear reactors—even test reactors— are expensive capital investments requiring hundreds of millions of dollars. Commercial utility reactors for the production of electricity utilize a different design, and are not suitable for medical isotope production. A number of alternatives for commercial manu6. Report on Molybdenum-99 production for Nuclear Medicine—2010-2020, Association of Imaging Producers & Equipment Suppliers (European Industrial Association for Nuclear Medicine and Molecular Healthcare) p. 8. http://www.oecdnea.org/med-radio/docs/200902_AIPESMolySupplyReport.pdf. Currently, the irradiation of the U-235 targets for more than 90 percent of Mo-99 production is manufactured in only five reactors: NRU reactor in Chalk River, Canada; HFR in Petten, The Netherlands; BR2 in Mol, Belgium; OSIRIS in Saclay, France and SAFARI in Pelindaba, South Africa. All are 40 years or older. http://www.euronuclear.org/1-information/news/medical-isotope-crisis.htm. 7. http://www.nordion.com/our_products/molecular_medicine_ products.asp. 173 les Nouvelles facture of medical isotopes exist, but these private business alternatives cannot compete with the lower cost of government subsidized Mo-99. Highenergy particle accelerators, whose costs can vary from $50-$200 million depending upon the isotope being manufactured, appear to be an efficient and cost-effective alternative to nuclear reactor isotope production.8 One approach is to use low enrichment uranium-235 (LEU). Low enrichment would minimize nuclear proliferation and diversion issues.9,10 Another accelerator approach is to use Mo-100 and fission it into Mo-99. In order to accomplish this, an accelerator must be specifically designed with the desired isotope(s) in mind. The U.S. Department of Energy (DOE) is considering refurbishing the test reactor at the University of Missouri, Rolla, as a possible Mo-99 source. The economics of the Mo-99/Tc-99m supply chain have been analysed by the Nuclear Energy Agency (NEA) and are summarized in Table 1.11 These numbers are taken to be illustrative and not exact, for a 6-day curie supply, at the end of processing (EOP) for each step. Table 1 shows that each step in the process has a substantial increase in incremental cost over the previous step, with the hospital setting the final price and having the largest increase of 4,210 percent over production costs. Another important factor to consider is that reactor costs are significantly subsidized by the government running the reactor; hence, prices do not accurately reflect the economic costs involved, such as depreciation of the reactor. The NEA report calculates the Mo99/Tc-99m cost at the reactor and discusses isotope production and its economic sustainability.12 Depending upon the depreciation rate and assuming payback periods of 10, 20, or 30 years, a “dedicated” reactor price could increase by a factor varying between 4 and 11 fold. Put another way, any private company 8. “Scientists Develop Affordable Way to Generate Medical Isotopes,” Argonne National Laboratory News Release, Oct 15, 2012, http://www.anl.gov/articles/scientists-develop-affordableway-generate-medical-isotopes. 9. Kramer, D., U.S. Output of Critical Medical Isotope to Begin this Year, Physics Today 67(1): 24-25 (2014). 10. National Academy of Sciences, “Medical Isotope Production without Highly Enriched Uranium, Committee of Medical Isotope Production without Highly Enriched Uranium,” National Research Council, The National Academies Press, 2009. 11. “The Supply of Medical Radioisotopes: An Economic Study of the Molybdenum-99 Supply Chain,” Nuclear Energy Agency Organisation for Economic Co-Operation and Development, ISBN 978-92-64-99149-1, OECD No. 6979, 2010, p. 14-92. 12. Ibid, p.73-87. Radioisotope Pharmaceutical Table 1. Representative Mo-99/Tc-99M Price And Supply Chain Mark-Up For A Six-Day Curie Supply Representative Selling Cost and Markup at Each Point of Sale in U.S. Dollars Percent Change From the Reactor Price Percent of the Final Cost Reactor Production $60 — 2.4% Hot Cell Processing $445 740% 17.6% Tc-99m Generator $520 870% 20.6% $2,525 4,210% 59.4% Mo-99/Tc-99m Isotope Supply Chain Hospital/Radiopharmacy involved in making isotopes will operate as a profitmaking business and charge as much as “the market can bear.” However, the hospital ultimately sets the Mo-99 end-user price, as they are the last step in the supply chain and are best able to determine the final market price. If a private company initiates production, the entire economics of the supply chain is expected to change; the company could increase their Mo-99 price (and profit margin), which will ripple through the supply chain. As the Affordable Care Act (ACA) is implemented to control health care costs, there may be pressure on the hospitals to maintain, for example, current imaging billing costs, thereby absorbing any cost increases in Mo-99/Tc-99m initiated at the supplier level. The U.S. government, by law, cannot compete with private companies in the open market if there is a U.S. commercial producer.13 Non-Hodgkin Lymphomas Non-Hodgkin Lymphomas (NHLs) are a form of non-solid white-cell blood cancers with more than 80 identifiable variations. NHLs exhibit rapid growth or changes in lymphoid cells with about 85 percent involving B-cells and about 15 percent being T-cell related. In 2009, it was estimated that there were about 484,300 cases of NHL in the U.S.14 This report projected 70,130 cases of NHL in 2012, of which 18,940 patients would die. The median age, based on 2005-2009 data, for NHL diagnosis was 66; however, NHL occurs in all age ranges from under 20 to over 85 years of age. The age-adjusted death rate was 6.6 13. DOE Order 481.1C Work For Others (Non-Department of Energy Funded Work); DOE Accounting Handbook, Chapter 13—Reimbursable Work, Revenues, and Other Collections; DOE Order 483.1—DOE Cooperative Research and Development Agreement; DOE Order 522.1—Pricing of Department Materials & Services; DOE Manual 481.1A—Reimbursable Work for Non-Federal Sponsors Process Manual. 14. Surveillance Epidemiology and End Results (SEER): Non-Hodgkin’s Lymphoma, http://seer.cancer.gov/statfacts/ html/hnl.html. per 100,000 men and women per year, with the death rate increasing as a function of age from 6.6 percent in the 45-54 age range to 14.2 percent in the 55-64 and 21.9 percent in those aged 65-74. The highest mortality rate is 33.4 percent for those in the 75-84 age range. Roughly 2.1 percent of people born will develop NHL. There are a number of chemotherapies and radioisotope therapies used to treat NHLs, and these therapies vary depending on the cancer stage and patient’s age. One radioisotope therapy for B-cell NHL uses Ibritumomab tiuxetan (Zevalin, Spectrum Pharmaceuticals), a monoclonal antibody attached to a Yr-90 or Indium-111 (In-111) isotope.15 Zevalin is used in 65 percent-95 percent of B-cell follicular lymphomas.16 Therapy costs vary from $30,000 for a single treatment of Zevalin.17 Another radioisotopebased NHL therapy is Tositumomab (Bexxar, GlaxoSmithKline), that is attached to I-131 isotope. Because of a smaller market, GlaxoSmithKline has decided to discontinue the sale of Bexxar in February 2014. Other antibody drugs, namely Rituximab (Rituxan, Biogen Idec), Veltuzumab and Epratuzumab (both from Immunomedics/Takeda Pharmaceuticals), which are currently under clinical trials, may also be used alone or in conjunction with a radioisotope. Depending upon the stage of the treated cancer and variations in location across the U.S., therapy costs can easily exceed $100,000. M.D. Anderson Cancer 15. Ibritumomab tiuxetan, http://www.accessdata.fda.gov/ drugsatfda_docs/label/2002/ibriide021902LB.pdf. A single treatment dose costs about $24,000, with other chemotherapies costing $40,000 or more. Time Magazine: Why Medical Bills are Killing Us, March 24, 2013, p. 18-55, indicates that one case of NHL chemotherapy costs $83,900. 16. The Therapeutic Antibodies Market to 2008, A. Pavlou and M. Belsey, European Journal of Pharmaceutics and Biopharmaceutics, 59, (2005) p. 389-396. 17. “The Cure and the Cost—Cincinnati Business Courier,” Bizjournals.com, 2002-06-17. Retrieved 2014-03-12. September 2014 174 Radioisotope Pharmaceutical Center reports that a procedure called the mini-BMT (nonablative bone marrow transplant), which employs chemotherapy and stem cell transplants, has had a success rate of 83 percent in five patients with B-cell follicular lymphomas.18 Bone marrow transplants alone generally cost in the range of $100,000 to $150,000. Isotope Production and the National Laboratories The Department of Energy (DOE) National Laboratory system has a long history of isotope production, with three Laboratories (Oak Ridge, Brookhaven, and Los Alamos) providing small quantities of rare or not commonly available isotopes, with other Laboratories producing other rare isotopes in even smaller quantities.19 These isotopes are intended for research purposes, and are produced as a secondary mission of these Laboratories, with basic research being the primary objective. Some Labs have developed commercial isotope programs; these licensing efforts will be discussed later. DOE may fund the test reactor at the University of Missouri, Rolla, to manufacture isotopes. DOE maintains an Office of National Isotope programs, and Federal legislation provides that the office receive a modest compensation for commerciallysold isotopes deriving from National Lab facilities. Copper-67 Therapy Cu-67 is a short-lived medical isotope with a halflife of 61.8 hours and decays by emitting an electron; this isotope was used in 2000 to treat patients with Non-Hodgkin Lymphomas (NHLs) at the University of California, Davis.20,21 At that time, Cu-67 was rare, and sufficient amounts for patient trials had to be flown in from three different National Labs located across the U.S. medical trials were in Phase I/II, with 11 of 12 patents having Stage III/IV NHL. The patients had been previously treated and found to have chemotherapy-resistant NHL. Patients were treated using the cu-67 radioisotope linked to a Lym- 18. c. mini-BMT: Non-Hodgkin’s Lymphoma Cure?, WebMD Health News, http://www.webmd.com/cancer/news/20071210/ mini-bmt-nonhodgkins-lymphoma-cure. 19. Oak Ridge National Laboratory, National Isotope Development Center, http://www.isotopes.gov/catalog/. 20. “Copper-67-Labeled Monoclonal Antibody Lym-1, A Potential Radiopharmaceutical for Cancer Therapy: Labeling and Biodistribution in RAJI Tumored Mice,” S. Deshpande, et. al, Journal of Nuclear Medicine, Vol. 29, No. 2, February 1988, p. 217-225. 21. “A Clinical Trial of Radioimmunotherapy with 67Cu-2ITBAT-Lym-1 for Non-Hodgkin’s Lymphoma,” Robert O’Donnell, et. al, The Journal of Nuclear Medicine, Vol. 40, No 12, Dec. 1999, p. 2014-2020. 175 les Nouvelles 1 monoclonal antibody. 58 percent of the patients responded positively to this treatment; however, the trials were ended abruptly in 2001 due to the September 11th terrorist attacks. The terrorist events of September 11th grounded all air flights, and Cu-67 clinical testing was halted due to insufficient quantities of the isotope. Argonne National Laboratory has recently upgraded an electron accelerator and has developed a commercial process for recovering Cu-67 from zinc-68 (Zn68); this process was developed under a Cooperative Research and Development Agreement (CRADA) with an industrial partner.22,23 Argonne’s contribution to the CRADA effort was the development of a novel method to recover Cu-67 from Zn-68 quickly and efficiently. Argonne’s method of manufacture should ensure an adequate Cu-67 supply for restarting medical trials. Argonne would like to manufacture limited quantities of the isotope, with DOE’s concurrence, to support clinical trials for FDA approval until the industrial partner develops a commercial accelerator and hot cell facility. Argonne’s radiotherapy may also be applicable to a wide variety of other non-solid blood cancers, such as leukemia. Science has progressed in the13 years since initial clinical testing was performed, and new monoclonals have emerged, which might also be suitable— or more suitable— for linking with Cu-67. Additional antibodies may increase the therapeutic use of Cu-67. Licensing Discussion A literature survey has provided some, but limited, information about medical radioisotope licensing from National Laboratories. The Pacific Northwest National Laboratory (PNNL), Hanford, Washington, has licensed Y-90 created by the Fast Flux Test Reactor (FFTF) to the NEN Life Science Products, lnc.24 The publicly available documents indicate an upfront fee of $75,000 with undisclosed running royalties based on net sales, paid to the Battelle Memorial Institute (BMI), operator of PNNL; Battelle estimates it will receive $500,000 in royalties over the course of 5 years. In addition, 22. D. Ehst, et al, “Copper-67 Production on Electron Linacs—Photonuclear Technology Development,” AIP Conference Proceedings 1509, 157 (2012). 23. “Methods for Producing CU-67 Radioisotopes with use of a Ceramic Capsule for Medical Applications,” D. Ehst and J. Willet, UChicago Argonne, LLC, Pub No US 2013/0083882A1, Pub. Date: April 4, 2013. 24. Isotope production at the Hanford Site in Richland, Washington, Pacific Northwest National Laboratory, Report # PNNL12228, June L999, P.4. Radioisotope Pharmaceutical DOE will receive an immediate payment of $25,000 and expects to receive $1 million over five years in leasing fees. A review of Techniclone SEC filings indicates that they have obtained exclusive rights to the Lym-1 and Lym-2 monoclonal antibodies when combined with I-131 for 3 percent royalties on net sales.25 Another Techniclone license agreement for a different antibody provides 4 percent royalties and milestone payments of $100,000 for the completion of Phase II trials and a $300,000 payment for the first commercial sale. It was noted that these licensing fees are in agreement with those university fees previously published by Betten as listed in Table 2.26 The data in Table 2 were tabulated in 2001 from 10 universities and represent 160 data points. Fees were not negotiated nor necessarily received for each Phase, with some phases involving no payments. Fees were most commonly associated with the IND Filed/Phase I and Phase III PLA/NDA Filed, and these fees are highlighted in italics. It is noted that pre-clinical fees tend to be annual payments. The university licensing staff indicated that these data represent small or modest market pharmaceuticals (not blockbusters), with some fees negotiated ahead of time but never executed in cases where the previous phase of testing had been unsuccessful. Despite being an older publication, many of the fees are still relevant and provide a licensing baseline due to the emerging nature and limited public information on these technologies. These licensing fees are further supported by the low licensing fee discussed next. Universities and government laboratories are research organizations and their discoveries tend to occur very early and before a market product is developed. This is especially true in the pharmaceutical area where many years of clinical testing are needed before final FDA approval is granted. The Advanced Medical Isotope Corp. (AMIC) in 2008-2009 executed an agreement with the University of Missouri, Rolla, for making Mo-99/Tc-99m with a $10,000 non-refundable upfront fee, a royalty agreement on sales, an equipment licensing fee on equipment sales, a milestone payment of $250,000 in five years, and a milestone payment of $250,000 upon reaching $50,000,000 in cumulative sales.27 In August 2010, AMIC executed an exclusive license agreement with BMI for its brachytherapy seed production technology. This license agreement calls for a $10,000 non-refundable license fee and a royalty based on a percent of net sales for licensed products sold; the license agreement also contains a minimum royalty amount to be paid each year beginning in 2012. In another license executed in February 2011, $5,000 was paid for a one year option agreement to negotiate an exclusive license with BMI regarding its patents for the production of a radiogel technology. This option agreement calls for a $5,000 upfront fee and expired in February 2012. In March 2012 AMIC entered into an exclusive license agreement with BMI for the use of its patented radiogel technology. This license agreement calls for a $17,500 license fee and a royalty based on a percent of gross sales for licensed products sold; the license agreement also contains a minimum royalty amount to be paid each year beginning in 2013. Royalties for radioisotope production hover in the 3–4 percent range. Newly-published data may push this royalty range towards 5 percent, but higher royalties appear difficult because of the number of intermediate steps on the supply chain, as noted in the Mo-99/Tc-99m supply chain, Table 1. Each step takes an additional markup, until the price reaches a value that “the market will bear,” and the gains are optimized for each step. Unlike a pharmaceutical company that can create a new drug or license promising new drugs from universities, the pharmaceutical company has the know-how and expertise to move through the stages of clinical testing and eventual market entry. The isotope producer, on the other hand, is quite familiar with isotope manufacturing and its separation from a target material using hot cell facilities, but is not well versed in the clinical drug testing process. Thus, it is expected that a pharmaceutical company will be sought to develop the clinical testing and marketing of the isotope. For the Cu-67 isotope, if manufacturing is initially subsidized by National Laboratory production, it can be assumed there will be a royalty of, 3–4 percent on net sales, an additional 3–4 percent royalty on the Lym-1 antibody, and the recovery of costs from the company doing the clinical testing and FDA approvals. Finally, the hospital(s) treating patients will add their fees and the physician’s fees. There is a royalty stacking at each step in the supply chain, with the hospital setting the final market price, just as occurs for the Mo-99 isotope. Once a private company decides to 25. Techniclone Corp., SEC 10-K documents. 26. “Pharmaceutical Up-Front Licensing Fees,” P. Betten, les Nouvelles, Dec. 2003, Vol 38, No. 4, p. 201-205. 27. Advanced Medical Isotope Corporation, SEC Filing, FORM S-1—September 4, 2012. See: http://www.faqs.org/ sec-filings/120904/ADVANCED-MEDICAL-ISOTOPE-Corp_S1/#ixzz2n83a2ozq. September 2014 176 Radioisotope Pharmaceutical cost-control measures, pressure on hospitals to Table 2. University Survey Of Pharmaceutical Payments maintain their current imaging billing costs Typical Range FDA Stage/Up-front Fees Typical Range ($1,000) Min/Max ($1,000) could mitigate any cost increases in Mo-99/TcPre-clinical $10-$50 $5/$100 99m costs derived from IND Filed $50-$250 $50/$500 private producers. Phase 1 $20-$50 $200/$1,000 Argonne is developing a new and novel method Phase 2 $50-$500 $50/$1,000 of producing Cu-67 for Phase 3 $200-$1,000 $200/$2,000 the treatment of NonPLA/NDA Filed/Approved $500-$2,000 $100/$5,000 Hodgkin lymphomas. This radiotherapy may build its own accelerator and hot cell facilities, it is also be applicable to a wide variety of other non-solid expected that the isotope price will eventually rise blood cancers, such as leukemia. For this therapy, such that a new pricing equilibrium occurs, over the the Cu-67 requires a cancer-targeting monoclonal subsidized isotope manufacturing price. antibody delivery vehicle. It is noted that there is Conclusion a royalty stacking occurring in the supply chain and it has been found that government national labs This paper reviews the status of the Mo-99/Tc-99m generally seek a royalty of 3–4 percent for providing radioisotope pharmaceuticals and how an impending the isotopes. The university royalties for monoclonal shutdown of government-subsidized test reactors, antibodies appear to be in the 3–4 percent range, due to aging and maintenance issues, may affect although for a blockbuster therapy, these royalties isotope pricing. Accelerator technology has advanced may rise slightly. As in the case of private producsignificantly and there is a high probability that private tion of Mo-99, the cost of production for Cu-67 will industry will begin to provide Mo-99 commercially. likely increase beyond subsidized levels. However, As the government cannot compete with private inthe overall cost of NHL therapy with a radioisotope dustry, it is estimated this will lead to a cost increase between a factor of 4 to 11, and this increase will may not increase substantially over current therapy ripple through the supply chain up to the hospitals. As costs, as there is pressure from the ACA to reduce the Affordable Care Act (ACA) stimulates healthcare medical costs in the long run. ■ 177 les Nouvelles European Perspective On Transfer Rights How Does Europe Deal With The Question Of How To Transfer Rights From The Author To The Exploiter? The European Perspective On The Work Made For Hire Doctrine By Julian Klagge and Christian Czychowski I. Introduction The claim that the legal framework concerning the work made for hire doctrine in U.S. copyright law needs reforming has consistently arisen in the recent past. Among others, Haviland46 argues for a fundamental revision of the current provisions with respect to works made for hire. In his article he posits in particular the legal recognition of the actual creator of the work as the “author” in a legal sense, combining this change with an automatic and exclusive assignment of the exploitation rights to the hiring party for a 56 year term. In our article we take the proposition made in Haviland’s46 article and discuss the work made for hire doctrine from the Continental European perspective. Starting with a brief exposition of the essential differences between the U.S. work made for hire doctrine and the European droit d’auteur system. This article analyzes how European law deals with the work made for hire doctrine using the example of German copyright law. In doing so, we emphasize various provisions of the German copyright law that—at least from an economic point of view—converge with the work made for hire doctrine. Finally, Haviland’s46 proposed revision of the U.S. copyright law can be analyzed in terms of whether and how a rejection of the work made for hire doctrine would bring improvements to European legal practice. II. The Major Differences Between the Work Made for Hire Doctrine and the Droit D’auteur System A t the European level a uniform definition of the legal term “author” does not exist. Despite numerous harmonization measures conducted by the European Union affecting the copyright law of the Member States, a common understanding of the term “author” cannot be identified.1 However, at the national level the Continental European Member States’ copyright systems are governed by the authorship principle; namely, the droit d’auteur system. It is the central idea of the authorship principle that only the actual creator of a work can be considered as the “author” in a legal sense and that all initial rights comprised in the copyright are assigned to that person.2 According to this, § 7 of the German Copyright Act (“GCA”) simply states: “The author is the creator of the work.” Pursuant the authorship principle, copyright ■ Julian Klagge, is regarded philosophiScientific Assistant, cally as an individual Boehmert & Boehmert, right on the basis of Berlin, Germany natural law. Given this approach, copyright as E-mail: [email protected] such derives from the ■ Christian Czychowski, author ’s intellectual Boehmert & Boehmert, property concerning his 3 Attorney of Law, work and the legal protection provided by the Berlin, Germany copyright law focuses E-mail: czychowski@ strictly on the author’s boehmert.de moral and economic interests. 4 The moral imprint of the authorship principle results in the presumption of a spiritual bond between the author, who can only be a natural person, and his work.5 According to this, under Article 14 of the German Constitution copyright enjoys constitutional protection.6 As there is regarded as being a moral bond between the author 1. See Wirtz, in Fromm/Nordemann, Urheberrecht [Copyright Law] § 7 note 6; Dreier, in Dreier/Schulze, Urheberrechtsgesetz [German Copyright Act] Einl. note 10. 2. See Ulmer, Urheber-und Verlagsrecht [Copyright and Publishing Law] p. 183 ff.; Wöhrn, in Wandtke, Urheberrecht [Copyright law] 2nd chapter note 141; Loewenheim, in Schricker/ Loewenheim, Urheberrecht [Copyright Law] § 7 note 1; Dreier, in Dreier/Schulze § 7 note 1. 3. See Ulmer, p. 183; Loewenheim, in Schricker/Loewenheim, Einl. note 10. 4. See Wilhelm Nordemann/Jan Bernd Nordemann, in Festschrift für Gerhard Schricker zum 70. Geburtstag [Festschrift for Gerhard Schricker’s 70th birthday] p. 473, 475. 5. See Dietz, in Wandtke, 3rd chapter note 4; Dustmann, in Fromm/Nordemann, before §§ 12 ff. note 2. 6. See German Federal Constitutional Court GRUR 1972, 481 —Kirchen-und Schulgebrauch; GRUR 1980, 44, 46 ff.—Kirchenmusik; GRUR 1989, 193—Vollzugsanstalten. September 2014 178 European Perspective On Transfer Rights and his work, pursuant § 29 GCA copyright as such is not transferrable; except in the case of inheritance. Instead, the author can only grant rights of use to another. But it is fair to say, that these principles of Continental European copyright law are qualified in terms of economic considerations, in ways resulting in a factual approximation to the work made for hire doctrine; particularly with regard to software development and audiovisual production. In contrast to the Continental European authorship principle, the Anglo-American copyright system is based substantially upon a utilitarian understanding.7 The “copyright clause”8 of the U.S. Constitution empowers Congress “… To promote the Progress of Science and useful arts, by securing for limited Times to Authors and Inventors the exclusive Right to their respective Writings and Discoveries.” An immediate effect of this utilitarian approach, is that American copyright law protects the economic investment standing behind the creation of the work.9 The work made for hire doctrine must be considered before this background.10 § 101 of the 1976 Copyright Act (“1976 Act”) defines a work made for hire as: “a work prepared by an employee within the scope of his or her employment.” In addition, certain “commissioned works” can qualify as works made for hire pursuant § 101 of the 1976 Act; however, only on condition that a written agreement has been made. Where there is a work made for hire, the initial copyright with all its present and future rights is vested in the employer or the commissioning party, as § 201 (b) of the 1976 Act states: “In the case of a work made for hire, the employer or other person for whom the work was prepared is considered the author for purposes of this title, and, unless the parties have expressly agreed otherwise in a written instrument signed by them, owns all of the rights comprised in the copyright.” For this reason, the work made for hire doctrine is in stark contrast to the Continental European authorship principle, which vests copyright only in the creator of the work. As the employer or commission7. See Dreier, in Dreier/Schulze, Einl. note 10; de la Durantaye GRUR Int. 2012, 989, emphasizing a stronger moral approach of the U.S. copyright law in the recent past. 8. U.S. Constitution Art. I Sec. 8 Clause 8. 9. See Wirtz, in Fromm/Nordemann, § 7 note 4. 10. See xy, Fundstelle les Nouvelles in terms of the historical development of the work made for hire doctrine. 179 les Nouvelles ing party is considered to be the author, the question of copyright protection for the actual creative author of the work does not even arise.11 III. How European Conflict of Laws Rules Deal With the Work Made for Hire Doctrine Given the fundamental differences between the Continental European and the American copyright system, the question arises: how does Europe deal with the work made for hire doctrine in terms of conflict of laws. In order to solve this set of problems, it is appropriate to distinguish two dimensions of the work made for hire doctrine: on the one hand the question of authorship, on the other hand, the question of who owns the exploitation rights.12 With respect to authorship, the question of the applicable law governing ownership of copyright as well as its transferability, is governed on the European level by the law of the country of protection.13 The principle of the country of protection follows basically the principle of territoriality, recognizing that a uniform worldwide copyright law does not exist, but rather a collection of various national copyright laws.14 Since January 11, 2009, in all cases where there is a conflict between laws on the European level, the application of the principle of the country of protection, without exemption, is mandatory pursuant Art. 8 Sec. 1 of the Rome II Regulation15 (“Rome II”). Thus, only the law of the country in which protection is claimed is applicable.16 As a result of this construction, within the European Union, U.S. copyright law cannot be applied to determine the initial authorship under the work made for hire doctrine, so that, in Europe, the actual creator of the work is recognized as the author.17 11. See Jan Bernd Nordemann, Journal of the Copyright Society of the USA, Vol. 53 (2006), No. 3-4, 603, 606. 12. See Wilhelm Nordemann/Jan Bernd Nordemann, p. 473, 477 ff.; Jan Bernd Nordemann, p. 603, 609 ff. 13. See the leading case in Germany: Federal Court of Justice (FCJ) GRUR Int. 1998, 427, 429—Spielbankaffaire. 14. See Jan Bernd Nordemann, p. 603, 607 f.; NordemannSchiffel, in Fromm/Nordemann, before §§ 120 ff. note 59; dissenting the followers of the principle of universality, according to whom there exists only one worldwide coypright, determined by the country of origin; see in particular Schack, Urheber-und Urhebervertragsrecht [Copyright and Copyright Contract Law], note 894 ff. 15. Regulation (EC) No. 864/2007 of the european parliament and of the council of 11 July 2007 on the law applicable to noncontractual obligations. 16. See Nordemann-Schiffel, in Fromm/Nordemann, before §§ 120 note 59. 17. See Jan Bernd Nordemann, p. 603, 608. European Perspective On Transfer Rights Under the copyright law of a European country of protection, the exploitation rights would also be vested in the creator of the work. In doing so, the work made for hire doctrine would be completely disregarded. In order to avoid this unsatisfactory result, the second limb of the work made for hire doctrine, namely contractual provisions, can become relevant.18 Section 201 (b) of the 1976 Act provides that “… unless the parties have expressly agreed otherwise in a written instrument signed by the, [the hiring party] owns all of the rights comprised in the copyright..” Section 202 (b) of the 1976 Act then provides that“… [the hiring party] is considered the author for the purposes of this title..” The fact that the 1976 Act attaches sole economic power to the deemed author raises the issue under European law as to whether the same result could be obtained by contract in the same way, or at least in a similar way.19 This two limbs of the work made for hire doctrine enable a second analysis to be made in accordance with European private international law: with regard to contractual terms, whether those terms can determine the question of who owns the exploitation rights20 in a copyright work. Since December 17, 2009 conflicts of laws concerning the law applicable to contractual obligations are harmonized on the European level by the Rome I Regulation21 (“Rome I”). Pursuant Article 3 Rome I a contract is governed generally by the law chosen by the parties. In the absence of an express choice of law, according to Article 4 Sec. 1 Rome I, the law of the country which has the closest links with the contract, is to be applied. Article 4 Sec. 2 Rome I presumes a contract to have the closest links with the country in which the party providing the characteristic performance of the contract has his, her or its usual residence or place of business at the time the contract was concluded. According to the prevailing view within Germany, at least with regard to an exclusive exploitation right being granted, the characteristic performance is by the assignee of this right—the exploiter—because the main emphasis in the contractual relationship is on the exploitation of the copyright-protected work,22 especially against the background that the work has 18. See Jan Bernd Nordemann, p. 603, 609 ff. 19. See Jan Bernd Nordemann, p. 603, 610; Wilhelm Nordemann/Jan Bernd Nordemann, p. 473, 477 ff. 20. See Jan Bernd Nordemann, p. 603, 611. 21. Regulation (EC) No 593/2008 of the european parliament and of the council of 17 June 2008 on the law applicable to contractual obligations. 22. See Jan Bernd Nordemann, p. 603, 612. only been created for the purpose of exploitation by the exploiter.23 The consequence is that in work made for hire situations U.S. copyright law should be applied as the relevant law of contract.24 Apart from that, in most cases U.S. copyright law might expressly be chosen by the parties. [Is this only where you have a U.S. resident commissioning a work in Germany? If so, this needs to be made clear.] IV. Provisions of European Copyright Law Converging With the Work Made for Hire Doctrine Given the authorship principle, the initial copyright and all its associated exploitation rights are vested in the creator of the work. Despite the fundamental differences between the Continental European and the U.S. copyright laws, European copyright systems (in our case: the German Copyright Act) likewise contain provisions aiming for the protection of the party that bears the financial risk of the creation of the work. In this context, specific provisions converge with the work made for hire doctrine, both for political reasons and economic impact. The most relevant provisions of the German copyright law are exemplified in the following. 1. Contractual grant of exploitation rights. The vesting of the initial copyright in the hiring party is unthinkable under the authorship principle. Therefore, third parties who want to exploit copyrighted works need the exploitation rights to be granted to them by contract. The contractual grant of rights is the core of the economic exploitation of copyrighted works within Continental European copyright systems. § 31 (1) GCA is the central provision of the German copyright contract law as it states: “The author may grant a right to another to use the work in a particular manner or in any manner (exploitation right). An exploitation right may be granted as a non-exclusive right or as an exclusive right, and may be limited in respect of place, time or content.” With respect to the primary protection of the moral and economic interests of the author, § 31 (5) GCA, 23. See Katzenberger, in Schricker/Loewenheim, before §§ 120 note 156. 24. Article 4 Sec. 3 Rome I remains unaffected: “Where it is clear from all the circumstances of the case that the contract is manifestly more closely connected with a country other than that indicated in paragraphs 1 or 2, the law of that other country shall apply.” Such cases are likely to happen rarely in work made for hire situations. September 2014 180 European Perspective On Transfer Rights which aims at the purpose of the contract in cases of absence of an express agreement, provides that as many exploitation rights as possible shall remain with the author.25 In addition, the particular protection of the author’s interests is manifested in § 34 GCA, according to which the author must agree to the transfer of the exploitation right. Furthermore, the author must also agree to the granting of further exploitation rights by a person holding an exclusive exploitation right to a third party(§ 35 GCA). 2. Legal fictions converging with the work made for hire doctrine. In principle, the axiom of the contractual granting of exploitation rights also applies in cases that would be subordinated to the work made for hire doctrine under U.S. copyright law. However, by legislation certain rules have been promulgated in order to protect those who do not create works on their own but bear the economic risk of their creation. a.) § 43 GCA: employer-employee relationships. § 43 GCA states a first step towards the work made for hire doctrine. This provision is of high practical importance to employer-employee relationships.26 At first sight, § 43 GCA recapitulates the natural consequence of the authorship principle: “The provisions of this Subsection shall also apply where the author has created the work in the fulfilment of obligations resulting from an employment or service relationship, unless otherwise provided in accordance with the terms or nature of the employment or service relationship.” In fact, it has exactly the opposite effect: all exploitation rights associated with a work created within the scope of an employer-employee or service relationship are vested in the employer insofar as the employer needs them for his, her or its business.27 Thus, in general terms only the employer will be entitled to exercise all economic rights concerning the works created within the employer-employee relationship. § 43 GCA modi25. See FCJ GRUR 2010, 623 note 20—Restwertbörse; Jan Bernd Nordemann, in Fromm/Nordemann, § 31 note 109; Schricker/ Loewenheim, in Schricker/Loewenheim, § 31 note 65. 26. § 43 GCA does not apply to commissioning relationships, see Dreier, in Dreier/Schulze, § 43 note 5. 27. See FCJ GRUR 1974, 480, 482—Hummelrechte; Axel Nordemann, in Fromm/Nordemann, § 43 note 1; Rojahn, in Schricker/Loewenheim, § 43 note 51. 181 les Nouvelles fies the rule of interpretation of § 31 (5) GCA in favor of the employer who bears the economic risk and pays the employee’s living wage.28 As the employee generates a continuous income, his or her need for economic protection remains much weaker compared to freelance authors.29 The political motivation for § 43 GCA is very similar to the U.S. copyright law as it protects an employer’s financial investment. But there still exists material differences to the work made for hire doctrine: First, the initial copyright always remains with the actual creator of the work, namely the employee. Second, as long as an express agreement has not been concluded, pursuant to a legal fiction only those exploitation rights are assigned to the employer that are needed for business purposes. Accordingly, the terms and the nature of the employer’s business limit the grant of exploitation rights in respect of place, time or content. Such a limited grant of rights does not comply with the work made for hire doctrine where the initial copyright with all its associated exploitation rights would be immediately vested in the employer. In addition, it is the employer’s burden to proove that the exploitation right in question falls within the purposes of his, her or its business.30 b.) § 69b GCA: employer-employee relationship in the field of software production. The employer31 finds himself in a much more comfortable position in cases where the work in question is a work of software. § 69b (1) GCA states: “Where a computer program is created by an employee in the execution of his duties or following the instructions of his employer, the employer exclusively shall be entitled to exercise all economic rights in the computer program, unless otherwise agreed.” § 69b GCA forms a specific rule with respect to software production.32 The provision derives 28. See Axel Nordemann, in Fromm/Nordemann, § 43 note 27; Kotthoff, in Dreyer/Kotthoff/Meckel, Heidelberger Kommentar zum Urheberrecht, § 43 note 14. 29. See Axel Nordemann, in Fromm/Nordemann, § 43 note 3. 30. See FCJ GRUR 1978, 244, 246—Ratgeber für Tierheilkunde; Wandtke, in Wandtke/Bullinger, § 43 note 61. 31. § 69b GCA does not apply to commissioning relationships, see Kotthoff, in Dreyer/Kotthoff/Meckel, § 69b note 4. 32. See Czychowski, in Fromm/Nordemann, § 69b note 2; Loewenheim, in Schricker/Loewenheim, § 69b note 11. European Perspective On Transfer Rights immediately from European law as it implements Article 2 (3) of the Directive 91/250/EEC on the legal protection of computer programs (“Software Directive”).33 According to Recitals 2 and 3 of the Software Directive, uncertainties in the protection of computer programs are to be removed and the partly extensive financial investment in the field of software development are to be secured.34 Again, the political background of § 69b GCA is very similar to the work made for hire doctrine as it protects the person who bears the costs and the risk of the creation of the work. Compared to § 43 GCA, the employer, whose business is software production, enjoys a much stronger protection of his investment. The actual creator of the computer program, indeed, remains the author of the program according to the authorship principle, because the legal fiction of § 69b GCA only provides a derivative grant of exploitation rights.35 But the grant of exploitation rights is not restricted to the employer’s business purposes, rather it comprises all exclusive rights of use with regard to the computer program without limitations in space, time or content and the rights even remain with the employer after the employee has left the entity.36 Additionally, it does not matter if the employer exercises his rights of exploitation or not37 and the legal assumption of § 69b GCA can only be rebutted by a contrary contractual agreement which must be demonstrated by the employee. Thus, § 69b GCA achieves, in fact, the same economic result as the work made for hire doctrine. c.) § 88 GCA: cinematographic works. Finally, § 88 GCA contains a special rule for cinematographic works. § 88 (1) sentence 1 states: “If the author permits another person to make a film of his work, this shall, in cases of doubt, be deemed to involve the granting of the exclusive right to use the work in unaltered form or following adaptation or transformation in the production of a cinematographic work and to use the cinematographic work as well as translations and other cinematographic adaptations in 33. Now Directive 2009/24/EC. 34. See Czychowski, in Fromm/Nordemann, § 69a ff. note 2 and § 69b note 1. 35. See Czychowski, in Fromm/Nordemann, § 69b note 5; Loewenheim, in Schricker/Loewenheim, § 69b note 11. 36. See Dreier, in Dreier/Schulze, § 69b note 9. 37. See Czychowski, in Fromm/Nordemann, § 69b note 2. all manners of use.” This provision intends to concentrate all rights of use required to exploit a cinematographic work38 as it recognizes that it is generally the film producer who bears the economic risk of the film production by making a large investment. Therefore, he should be able to recoup his expenses through exploitation of the film with the minimum of obstructions.39 The parallel to the work made for hire doctrine and its characteristics to “commissioned works” are obvious. § 88 GCA, again, stipulates a rule of interpretation subsidiary to contrary contractual agreements.40 It contains a legal fiction specifying that, if the author permits another person to make a film of his work, all exclusive rights of use are vested in the film producer, including the rights to adapt the cinematographic work and to exploit it in all manners of use.41 In cases of doubt, the film rights are deemed to be granted without limitations in space and time,42 but only with restriction to cinematic types of use, for example those that are linked with the promotion of the film.43 E.g. a book of the film or merchandising articles would not be covered by the application of § 88 GCA.44 Ultimately, the rule of § 88 GCA concentrates the exclusive exploitation rights with the film producer whose legal position, therefore, is comparable with the status of the “commissioning party” in work made for hire situations. The film producer’s position gets even stronger, as it is the obligation of the actual creator to disprove the legal presumption.45 But in contrast to the work made for hire doctrine the initial copyright remains with the author. Furthermore, not all potential exclusive exploitation rights are 38. See Jan Bernd Nordemann, in Fromm/Nordemann, § 88 note 1. 39. See Jan Bernd Nordemann, in Fromm/Nordemann, before §§ 88 ff. note 1; Katzenberger, in Schricker/Loewenheim, before §§ 88 ff. note 9; Meckel, in Dreyer/Kotthoff/Meckel, § 88 note 1. 40. See Jan Bernd Nordemann, in Fromm/Nordemann, § 88 note 21; Meckel, in Dreyer/Kotthoff/Meckel, § 88 note 9. 41. See Jan Bernd Nordemann, in Fromm/Nordemann, § 88 note 42 ff. 42. See Jan Bernd Nordemann, in Fromm/Nordemann, § 88 note 48 f.; Schulze, in Dreier/Schulze, § 88 note 27 f. 43. See Jan Bernd Nordemann, in Fromm/Nordemann, § 88 note 69. 44. See Schulze, in Dreier/Schulze, § 88 note 54. 45. See Manegold, in Wandtke/Bullinger, § 88 note 66. September 2014 182 European Perspective On Transfer Rights assigned to the film producer, rather only the rights named in § 88 GCA. The work made for hire doctrine goes considerably further and vests the initial copyright immediately in the commissioning party. 3. Résumé and consequences in legal practice. The aforesaid provisions demonstrate, that in copyright systems following the droit d’auteur principle, economic aspects play an important role, too, and as a result in certain cases protect those who carry the financial risk of the creation of the work. But unlike the work made for hire doctrine, these rules do not vest the copyright in the employer or other commissioning party. Instead, they must be qualified as legal fictions providing for a grant of derivative rights. The extent of the grant of these exploitation rights in cases of doubt is regularly restricted to specific purposes. It is only with regard to software production, that there is grant of all of the exclusive exploitation rights, which, from an economic perspective, factually mirrors the work made for hire doctrine. In practice, both approaches mostly differ in terms of enforcement. Pursuant the authorship principle the person who claims an infringement of his rights is obligated to prove his ownership of the exploitation rights, if necessary, by exposing a proper license chain. In this context, legal assumptions concerning the authorship may be used by the plaintiff, e.g. § 10 GCA. Of course, giving such evidence does not apply to the work made for hire doctrine. Rather, the commissioning party has to prove that the legal conditions of a work made for hire are met. V. Conclusion Which improvements would bring a reform of the work made for hire doctrine as suggested by Haviland46 from the European perspective? With regard to conflicts of laws, there will not be any differences compared to the current legal situation. The application of the two rules regarding the applicable law described above, the question of authorship, is governed by the principle of the country of protection, which will be the specific copyright law of the European Member State relevant to the issue whereas the ownership of the exclusive exploitation rights must be determined by ascertaining the law governing the contract. In doing so, it does not matter if the work made for hire doctrine would remain unchanged or if the actual creator would be legally deemed the author under U.S. copyright law. In both cases, the actual creator of the work will be recognized as the author under European copyright law whereas the exclusive exploitation rights would be vested in the hiring party. Instead, reforming the work made for hire doctrine would materially improve the situation for creative employees within the U.S.A., especially by vesting the copyright in the creator of the work and extending the author’s protection under copyright law in terms of his moral interests. From the European perspective, such a reform, resulting in a copyright system mainly identical with the European droit d’auteur system, can only be appreciated as it respects the creator’s intellectual property in his or her work. ■ 46. Haviland, M., Superman and Statutes: The Case for Restructuring the U.S. Legal System and Awarding Copyrights to Authors Behind Works for Hire, les Nouvelles, Vol. XLIX, No. 2, 2014, p.126. 183 les Nouvelles The Unitary Patent The Unitary Patent And The Unified Patent Court By Christoph Cordes Abstract In the European Union a major change in the existing patent system is underway. By the end of 2012 and in spring 2013, the so called Unitary Patent was created and 25 of the 28 Member States of the European Union have signed the Unified Patent Court Agreement (UPCA). This Agreement now needs to be ratified by at least 13 Member States. The European Commission hopes that the required number of ratifications will be reached in spring of 2015 and that the new patent system will then come into force. The Unitary Patent and the Unified Patent Court (UPC) will cause significant changes in the European patent landscape: For the first time, a uniform patent protection throughout the European Union is envisaged. The application and procurement procedure will be simplified. The enforcement will be concentrated on a few European courts. With the coming into force of the so-called Patent Package, the new Unified Patent Court will start working. The court will not only have jurisdiction over disputes arising out of Unitary Patents, but also arising out of already existing European patents. Therefore, already today applicants and owners of European patents have to consider whether to stay in the Unified Patent Court system with their European patents or to opt out. 1. Introduction 1.1 Existing Patent Protection urrently, technical inventions may be protected in Europe by: • National patents and • European patents. National patents are granted by national patent offices (in Germany by the German Patent and Trademark Office). They usually require representation by local counsel and follow with regard to procurement, legal effects and enforcement as well as with regard to revocation and declaration of nullity, the respective national law. European patents are granted by the European Patent Office (EPO) on the basis of the Convention on the Grant of European Patents (EPC). They are granted in a centralized procurement procedure which is followed by a centralized opposition procedure before C the EPO. After its grant, a European patent dissolves into a bundle of national parts which have the same effect as national patents, i.e. enforcement, revocation and nullification follow the respective national patent law. The EPC comprises at present 38 European states; ten of them are not member states of the European Union. These are, for example, Norway, Switzerland and Turkey. The applicant designates the states in which the Euro■ Christoph Cordes LL.M., pean patent shall come Partner, into force upon its grant, Esche Schümann Commichau, i.e. in which states it Hamburg, Germany shall be validated. There are different validation E-mail: [email protected] requirements in each contracting state, for example with regard to translations and costs. Also the renewal fees vary from state to state. The main advantage of the European patent is its uniform procurement and opposition procedure which has cost advantages in so far as only fees for attorneys and the patent office accrue once only. However, a European patent does not distinguish itself from national patents with regard to its enforcement. 1.2 Creation of the Unitary Patent In order to provide a uniform enforcement, efforts were made over decades to create a patent which has a uniform effect within the whole European Union. The long way to the Unitary Patent with all its trials and tribulations is not to be discussed here in detail. Only two core issues shall be highlighted. A stumbling block has always been the language issue. Under the EPC, the official languages for the procedure before the EPO are limited to three languages only (English, French and German), whereby different translation requirements exist in the contracting states. It has been a major demand that likewise there should be a minimum of translation requirements with regard to the Unitary Patent to be created. A further obstacle has been the issue where the new EU patent courts should be located. In the European Union currently by far the most patent infringement proceedings are dealt with by the GerSeptember 2014 184 The Unitary Patent man courts.1 Germany had no interest to impair its position by the creation of a new European patent court system. A breakthrough was finally reached when, by the end of 2012, the Unitary Patent was created by way of the so-called enhanced cooperation. 1.3 Legal Basis—The “Patent Package” The Unified Patent Court system is based in essence on three pillars, the so-called patent package: •The Unitary Patent Regulation,2 •The Translation Regulation3 and •The Agreement on the Unified Patent Court (UPCA).4 The Unitary Patent is created by the Unitary Patent Regulation. The Translation Regulation deals with the language regime for this Unitary Patent. Unitary Patent Regulation and Translation Regulation came into force on 20 January 2013. However, both regulations shall apply only as of the date of entry into force of the UPCA. The UPCA has the character of an international treaty. It is a so-called special agreement in the meaning of art. 142 et seq. EPC has been signed on 19 February 2013 by all EU member states with the exception of Spain and Poland. It will enter into force as soon as at least 13 member states have ratified the Agreement, among them are the three member states with the highest number of European patents in force, i.e. Germany, the United Kingdom and France (art. 89 par. 1 UPCA). Furthermore, there are to be created: 1. According to Kühnen/Claessen, GRUR 2013, 592, 593, in 2011 the patent infringement actions were distributed within the European Union as follows: Germany some 1.250 actions, France and Italy each some 250 actions, the United Kingdom and the Netherlands each some 50 actions, in further 14 Member States less than 10 actions were filed and in the remaining eight Member States to the European Union no patent infringement actions were filed. 2. Regulation (EU) No. 1257/2012 of the European Parliament and of the Council of 17 December 2012 implementing enhanced cooperation in the area of the creation of unitary patent protection, OJ of EU no. L 361 of 31 December 2012, page 1. 3. Council Regulation (EU) No. 1260/2012 of 17 December 2012 implementing enhanced cooperation in the area of the creation of unitary patent protection with regard to the applicable translation arrangements, OJ of EU no. L 361 of 31 December 2012, page 89. 4. Agreement on the Unified Patent Court, Council document no. 16351/12 of 11 January 2013, OJ of EU no. C 175 of 20 June 2013, page 1. 185 les Nouvelles •A schedule of fees for the application procedure, and •Rules of procedure and a schedule of fees for the Unified Patent Court. With regard to the former schedule of fees there do not exist yet any drafts, so that it is not yet possible to estimate the future costs of an applications for a Unitary Patent. However, with regard to the rules of procedure, there already exist drafts. 2. The Unitary Patent 2.1Application Procedure The Unitary Patent system uses the application procedure before the EPO. Thereby the building of a complete new procurement authority was avoided. Instead, it was possible to revert to the proven competence of the EPO. The whole application and examination procedure before the EPO remains unchanged. The applicant for a European patent may apply for it having unitary effect within one month after the mention of the grant is published in the European Patent Bulletin.5 In this case it becomes retroactively unitarily effective within all participating member states as of the date of its grant (art. 4 par. 1 Unitary Patent Regulation). For the application a fee is to be paid of which the amount is not yet determined. 2.2The Languages Regime The languages regime of the EPO principally applies as stated here: A patent application may be filed in English, French or German. Furthermore, a patent application may also be submitted in any other language to the EPO; in such a case a translation into English, French or German has to be filed within two months. The official language of the EPO in which the application was submitted or into which the application was translated, is the language of the procedure before the EPO. European patent specifications are published in the language of the procedure and contain a translation of the patent claims into the two other official languages of the EPO (art. 14 par. 6 EPC). In principle this also applies to Unitary Patents. A validation of a Unitary Patent will not be necessary and therefore also any translation requirements with regard to validation will fall away. However, within the transitional period of art. 6 Translation Regulation: 5. See art. 9 par. 1 (g) Unitary Patent Regulation. The Unitary Patent •Unitary Patents granted in French or German have to be translated completely (that is not only with regard to the patent claims) into the English language, and •If the Unitary Patent was granted in the English language, a complete translation of the patent specification into any other official language of the European Union has to be submitted (art. 6 par. 1 Translation Regulation). The transitional period of art. 6 Translation Regulation ends no earlier than six and no later than twelve years after the date of application of the Translation Regulation. Whether this transitional period already ends before the above-mentioned twelve years have elapsed, depends on whether or not high quality machine translations of patent applications and patent specifications into all official languages of the European Union are then available (art. 6 par. 3 Translation Regulation). Such machine translations from English into German are already offered by the EPO on its Internet homepage. Once the transitional period has elapsed, an application in one of the three official languages of the EPO (English, French or German) with a translation of the patent claims into the respective two other official languages only will be sufficient. However, there is an exception in case of litigation: In the event of a dispute relating to an alleged infringement of a Unitary Patent the patent proprietor shall provide at the request of the alleged infringer a full translation of the patent specification into the official language of the member state in which the alleged patent infringement has taken place or in which the alleged infringer is domiciled. Also the court may request a complete translation of the patent specification into the language of the court proceedings. In both cases the costs for translations are to be borne by the patent owner (art. 4 par. 3 Translation Regulation). 2.3 The Unitary Effect The Unitary Patent provides uniform protection and has equal effect in all the participating member states. It may only be licensed, transferred, revoked or lapsed in respect of all the participating member states. However, it may be licensed in respect of the whole or also only a part of the territories of the participating member states (art. 3 par. 2 Unitary Patent Regulation). The substantive provisions regarding the effect of the Unitary Patent are surprisingly not provided for in the Unitary Patent Regulation. This has the background that the United Kingdom suggested to delete entirely the provisions of art. 6 through 8 of the former draft regulation which dealt with the substantive effects of the Unitary Patent. The United Kingdom feared that otherwise the European Court of Justice would have to rule on substantive patent law which might have overburdened the court. However, the complete elimination of any substantive law provisions in the Unitary Patent Regulation could have made it questionable whether this regulation may be based on art. 118 of the Treaty on the Functioning of the European Union (TFEU). As a compromise, art. 5 Unitary Patent Regulation now provides that the Unitary Patent confers on its proprietor the right to prevent any third party from committing acts against which that patent provides protection. What acts these are may be concluded from the UPCA: Art. 25 and 26 UPCA prohibit direct and indirect patent infringement. Art. 27 UPCA provides limitations thereof such as, e.g., acts done privately or for experimental purposes. Art. 28 UPCA provides for a right on prior use of the invention. From the perspective of the law maker, all of this has the character of national law and therefore is not subject to control by the European Court of Justice. The Unitar y Patent therefore provides some specialties from the perspective of the law of the European Union: The Unitary Patent is granted by the EPO which is not an organization of the European Union. Decisions of the procurement and opposition proceedings cannot be reviewed by European courts; legal protection is only granted within the EPO by its Boards of Appeal. And finally, the substantive effect of the Unitary Patent is not provided for by a regulation of the European Union, but rather—this is the conception of the law maker—on the level of the national law, and therefore is also beyond the reach of control by the European Court of Justice. 3. Unified Patent Court System 3.1The Unified Patent Court 3.1.1 Organisation of the Court The UPCA creates a complete new jurisdiction: the Unified Patent Court. The Unified Patent Court comprises two instances, a Court of First Instance and a Court of Appeal. Furthermore, a registry and various committees exist, i.e. an administrative committee and a budget committee. The Court of First Instance is divided into various divisions. It comprises: •A central division, •Regional divisions, and •Local divisions. September 2014 186 The Unitary Patent The Court of Appeal has no divisions. 3.1.1.1 The Central Division The central division has its seat in Paris, with sections in London and Munich. The central division sits in a composition of two legally qualified judges which have to be nationals of different contracting states and one technically qualified judge. The central division is chaired by a legally qualified judge. With regard to the substance of the matter, the panels of the central division are allocated in accordance with the International Patent Classification (IPC) of the World Organization for Intellectual Property (WIPO). The section in London deals with IPC classes A (human necessities) and C (chemistry, metallurgy) and the section in Munich deals with IPC class F (mechanical engineering, lighting, heating, weapons, blasting). All other substantive matter is dealt with in Paris. 3.1.1.2 Local and Regional Divisions Any contract member state is free to apply for the installation of a local division for its territory. The decision is made by the administrative committee. Regional divisions are built the same way for the territory of multiple member states. Local and regional divisions comprise each three legally qualified judges. Upon request of the parties or if the court deems this to be necessary, a technically qualified judge is allocated to the panel. Again, the panel is chaired by a legally qualified judge. Local and regional divisions have a multi-national composition, as is the case with each panel of the Unified Patent Court. Of the three legally qualified judges in principle only one is a national of the respective member state or member states hosting the local or regional division, respectively. In member states where, during a period of three successive years prior or subsequent to the entry into force of the UPCA, 50 or more patent cases per calendar year on average have been commenced, two of the three legally qualified judges are nationals of the respective member state hosting the local division. For each 100 patent cases commenced per calendar year, a contracting member state may apply for an additional local division, with a maximum of four local divisions for one member state. For the time being, this will only be the case with Germany where the local divisions will be domiciled in Düsseldorf, Mannheim, Hamburg and Munich. 3.1.1.3 The Court of Appeal The Court of Appeal has its seat in Luxembourg. 187 les Nouvelles The Court of Appeal is composed of five judges: three legally qualified judges who shall be nationals of different contracting member states and two technically qualified judges. 3.1.2 Jurisdiction 3.1.2.1 Jurisdiction as to Subject Matter The Unified Patent Court has the exclusive jurisdiction for court proceedings provided for in art. 32 par. 1 UPCA insofar as they are based on: •Unitary patents, •“Classical” European patents, or •Supplemental protection certificates. The court proceedings provided for in art. 32 par. 1 UPCA comprise in particular patent infringement actions, actions for revocation of patents (also in the form of counter claims for revocation of patents) as well as provisional injunctions. The enumeration in art. 32 par. 1 UPCA is exclusive; any other court proceedings will remain with the jurisdiction of the national courts. The Unified Patent Court therefore has, for example, no jurisdiction over actions arising from patent license agreements or actions for the transfer of patents and patent applications filed by a third party which came into the position of the invention in bad faith. The Unified Patent Court will therefore not only have jurisdiction with regard to Unitary Patents, but also for “classical” European patents, i.e. for European patents without unitary effect. For a transitional period, the patent owner may give a declaration that his European patent shall not fall under the jurisdiction of the Unified Patent Court. This transitional period will last seven years and may be prolonged for further seven years. However, thereafter all European patents will fall under the jurisdiction of the Unified Patent Court. The only alternative will be to file a national patent application. 3.1.2.2The Competence of Central, Local and Regional Divisions The parties may agree on a division to be competent for infringement and revocation actions. If no such agreement is concluded the following rules apply: 3.1.2.2.1 Patent Infringement Actions Patent infringement actions are to be filed with the local or regional division at the domicile of the defendant or at the place where the patent infringement took place or threatens to take place. The central division is competent for infringement actions if the defendant has no domicile in any contracting member state or if in the respective member The Unitary Patent state no local or regional division exist. The central division has, furthermore, jurisdiction over actions for declaration of non-infringement of a patent. Such action pending with the central division is stayed if, within three months upon filing the declaration action, patent infringement proceedings based on the same patent are commenced between the same parties at a local or regional division. This safeguards that infringement proceedings cannot be withdrawn from a local or regional division against the will of the plaintiff. However, there is an exception to this rule in case the alleged infringement has taken place in the territory of at least three regional divisions. Then, upon request of the defendant, the regional division shall transfer the case to the central division (art. 33 par. 2 UPCA). This exception makes infringement actions before the regional division less attractive because, in case of a presumably massive patent infringement, the plaintiff must fear that the case is transferred to the central division. Such transfer may cause a loss of time and has potentially the disadvantage of a change of language of the proceedings. It may further have the disadvantage that not the principle of bifurcation will apply, but rather that the central division will most likely hear both actions, i.e. infringement action and revocation action, at the same time. This may cause an additional loss of time. 3.1.2.2.2 Revocation Actions Revocation actions are to be filed with the central division. Counterclaims for revocation of patents may also be filed with the local or regional division where a respective patent infringement action is pending. It is then in the discretion of the local or regional division: •To decide on both actions and to seek the aid of a technically qualified judge, •To transfer the revocation action to the central division and to stay or continue the infringement action, or •To transfer the whole case to the central division upon consent of both parties. Therefore it will in principle be possible that a local division practices a procedure as it is currently done by the German patent infringement courts, i.e. that revocation actions are transferred to the central division and to stay infringement actions only if there is a high likelihood that patent will be revoked. Revocation actions do not require prior opposition proceedings before the EPO. Pending opposition proceedings before the EPO do not block revocation actions before the Unified Patent Court. However, the Unified Patent Court may stay its proceedings in such a case if a rapid decision may be expected from the EPO. 3.1.3 Qualification of the Judges Legally qualified judges shall possess the qualifications required for appointment for judicial offices in a contracting member state. Technically qualified judges shall have a university degree and proven expertise in a field of technology. They are appointed from a pool of judges on a case by case basis for a certain technical field. According to art. 15 par. 1 UPCA judges shall ensure the highest standards of competence and shall have proven experience in the field of patent litigation. This requirement can hardly be balanced with the further requirement of a multi-national composition of all panels of the Unitary Patent Court. The problem is that in the vast majority of the contracting member states only a few or no patent litigation at all is commenced. Judges from such contracting states will have little or no experience in the field of patent litigation. However, the UPCA solves this conflict of objectives by letting it suffice that judges have only theoretical knowledge which can be obtained by training. Whether this will safeguard confidence of the potential plaintiffs in the qualification of the panels of the Unified Patent Court remains to be seen. 3.2Rules of Procedure The main features of the proceedings are outlined in the UPCA. For details the UPCA refers to rules of procedure which still need to be created. The signatory states have set up a preparatory committee which has developed draft rules of procedure. The current draft of 31 January 2014 comprises 382 rules. 3.2.1 Stages of Proceedings The court proceedings are divided into three parts: First there is an exchange of briefs. In principle only four briefs are to be exchanged (statement of claim, statement of defense, reply to statement and rejoinder to the reply) which shall safeguard a speedy procedure. The written procedure is followed by an interim procedure which may include an interim conference led by the juge-rapporteur and which may be held as a video or telephone conference. Thereafter again written submissions may be exchanged. Finally, an oral hearing will be held before the entire panel, which is led by the presiding judge. 3.2.2 Language of the Proceedings Before the central division the language of the proceedings is always the language in which the patent was granted. September 2014 188 The Unitary Patent The language of the proceedings before a local division is in principle the official language of the hosting member state. Notwithstanding the above, the respective member state may designate one of the official languages of the EPO (English, French or German) as the language of the proceedings before the respective local division. The same applies for proceedings before the regional divisions, whereby the respective contracting member states determine the official language of one of the contracting member states as language of the proceedings. The parties may agree on the use of the language in which the patent was granted as language of the proceedings, subject to approval by the competent panel. If the panel objects, the parties may request that the case will be referred to the central division. Furthermore, the president of the Court of First Instance may, on the grounds of fairness, decide on the use of the language in which the patent was granted as the language of the proceedings upon request of one of the parties and after having heard the other party and the court panel. The language of the proceedings before the Court of Appeal is the language of the proceedings before the Court of First Instance, unless the parties agree on the use of the language in which the patent was granted as language of the proceedings. Subject to an agreement by the parties, the Court of Appeal may decide on another official language of a contracting member state as language of the proceedings. 4. Entry into Force and Transitional Provisions 4.1 Entry into Force The UPCA now needs to be ratified by at least 13 signatory states, among them Germany, France and The United Kingdom. As the first signatory state, Austria has deposited an instrument of ratification with Brussels on 7 August 2013. On 23 October 2013 a bill was introduced to the French Senate which shall be dealt with in accelerated proceedings. However, ratification has not yet happened. Denmark will most likely hold a referendum on 25 May 2014 on the ratification of the UPCA. Spain and Italy have not concurred in the enhanced cooperation but rather filed actions against the Unitary Patent Regulation and the Translation Regulation with the European Court of Justice. Both law suits have been rejected on 16 April 2013.6 Italy has in the meantime signed the UPCA. Spain has filed two further law suits on 22 March 2013 which are still pending.7 Poland has participated in the enhanced 189 les Nouvelles cooperation; however Poland did not sign the UPCA. Poland and Spain as well as (since June 2013) Croatia may join the Agreement since they are member states to the European Union. However, the EPC member states which are not European Union member states8 do not have this possibility. A joinder of these states would only be possible after them becoming member states to the European Union. 4.2 Transitional Provisions For at least a transitional period, Unitary Patents will not have effect in all member states of the European Union: According to art. 18 par. 2 Unitary Patent Regulation, a Unitary Patent has only effect in such member states in which at the time of the grant of the patent the UPCA was in force. An extension of the territorial scope of already granted Unitary Patents to later ratifying or joining states is not provided for in the Agreement. Since most likely not all participating member states will ratify the UPCA at the same time, there will be Unitary Patents with different territorial scope for at least a transitional period. Art. 83 par. 1 UPCA allows for a transitional period of seven years from the coming into force of the Agreement during which patent infringement actions and actions for revocation with regard to “classical” European patents may be filed either with the Unified Patent Court or with the national patent courts. The applicant or owner of a European patent can exclude the competence of the Unified Patent Court by giving a declaration in accordance with art. 83 par. 3 UPCA (opt out). The declaration must be given at least within one month prior to the end of the transitional period. This is to safeguard proprietors of European patents from being forced into the Unified Patent Court system against their will. The applicant or owner of a European patent may withdraw this exclusion declaration at any time (art. 83 par. 4 UPCA; opt in). The transitional period may be extended for seven further years (art. 83 par. 5 UPCA) which will give the Unified Patent Court system an opportunity to establish confidence in its quality. 5. Strategic Considerations 6. ECJ C-274/11 and C-295/11. 7. ECJ C-146/13 and C-147/13. 8. These states are Switzerland, Turkey, Norway, Lichtenstein, Monaco, Island, Republic of Mazedonia, San Marino, Albania, and Serbia. The Unitary Patent 5.1 Application Procedure The unitary effect of Unitary Patents will clearly simplify matters. It will allow the applicant to assess the effects of patent protection in the participating member states on the basis of only one legal regime. Also the patent administration will be considerably simplified: instead of administering a number of patents, there only will be a single patent to be administered with deadlines being surveyed and annual fees being paid in time. Also the reduced translation requirements will bring fundamental simplification compared to the current status in a number of EPC states. Whether in the future it is advisable to apply for Unitary Patents, “classical” European patents or national patents (or in Germany, utility patents) is of course also a question of costs. Since there are not yet any cost schedules this question cannot yet be answered. However, it is expected that the Unitary Patent will have its price. At the moment, a majority of European patents are validated only in a small number of states. Therefore the Unitary Patent will most likely often cause an increase of costs. 5.2 Court Proceedings 5.2.1 The Need for a Decision with regard to “classical” European Patents. It is a complex task to balance the pros and cons of national jurisdiction on the one side and of the Unified Patent Court on the other side. This will become very clear already during the transitional period of art. 83 par. 1 UPCA. This art. provides that lawsuits before the national courts have no exclusive effect on lawsuits before the Unified Patent Court and vice versa. Such an exclusive effect exists only with regard to the opt-out or opt-in declaration in accordance with art. 83 paras. 3 and 4 UPCA, respectively; an opt-out or opt-in declaration is blocked if a lawsuit (patent infringement action or revocation action) is already pending before a national court or the Unified Patent Court. However, if no opt-out or opt-in declaration is given, there is an alternative competence between the Unified Patent Court and national courts for matters based on “classical” European patents, i.e. during the transitional period lawsuits with regard to “classical” European patents may be filed with either the national courts or the Unified Patent Court. The patent owner may, for example, decide to file a patent infringement action with a national court (for example, with the Regional Court of Düsseldorf in Germany) which then is answered by the defendant with a revocation action before the central division of the Unified Patent Court. This might happen quite frequently. The possibility of a forum shopping following from art. 83 par. 1 UPCA for patent infringement and revocation actions forces the proprietor of European patents already now to consider the pros and cons of each court system. 5.2.2 Pros and Cons of the Unified Patent Court System (Opt in or opt out?). So what are the pros and cons? Court proceedings under the Unified Patent Court system will tend to be easier and more cost effective since only a single patent infringement action and only a single revocation action, if any, is to be filed instead of a number of respective national court proceedings. Consequently, court costs and attorneys fees will be reduced. The decision for the Unitary Patent and the Unified Patent Court will furthermore have the huge advantage that effective patent protection can be obtained for a number of states in which currently no effective enforcement of patents is possible. At the moment, only in a handful of European states is patent litigation commenced: The judgments of national courts are limited to the respective national territory. It would theoretically also be possible that, e.g., before a German court, one litigates the infringement of a French patent. However, since the decision “GAT/LuK”9 of the European Court of Justice this possibility is practically barred. The introduction of the Unified Patent, which will be enforced in one single court proceedings for all participating member states, will have the effect that in a wide range of European Union member states for the first time ever patent protection will effectively be enforced. The most striking disadvantage of the Unitary Patent will clearly be that it can be nullified with one single revocation action. The patent owner “raises the stakes” if he makes a decision for the Unitary Patent and the Unified Patent Court system. A further disadvantage of filing a patent infringement action with the Unified Patent Court lies in art. 63 par. 1 UPCA: Under German law, the patent owner has a mandatory claim for injunctive relief in case of patent infringement. Under the UPCA, it is in the discretion of the Unified Patent Court to grant injunctive relief. It remains to be seen which aspects the Unified Patent Court will consider in its 9. ECJ C-4/03. September 2014 190 The Unitary Patent discretionary decision. However, it is not unlikely that collecting companies as well as other non-practicing entities will have to face an additional hurdle for obtaining injunctive relief. There is an ongoing discussion whether non-practicing entities shall be entitled to monetary relief only. The same applies for owners of standard-essential patents. A further important issue will be how local and regional divisions will handle counterclaims for revocation of patents, i.e. whether they will transfer such counteractions or whether they will hear both, the patent infringement action and the revocation action. It is widely expected that the local divisions domiciled in Germany, which will comprise experienced German patent judges, will transfer revocation actions to the central division. If this should become common practice for the local divisions in Germany, it could possibly become equally attractive to file patent infringement actions with a local division of the Unified Patent Court in Germany as with a national 191 les Nouvelles German patent court. However, the assessment of the pros and cons in this respect also depends on the quality and speediness of decisions of the central division. It might well be that it remains more attractive to keep on filing patent infringement actions with the national German patent courts rather than with the Unified Patent Court since the former procedure often awards the plaintiff the advantage of being able to enforce a judgment of first instance long before patent validity has been assessed by the German Federal Patent Court. And finally the biggest obstacle for the Unitary Patent to overcome might be the uncertainty how the new patent regime and the new courts will prove themselves. The question whether the users will gain confidence in the Unified Patent Court system will depend in the first place on whether it will be possible to recruit highly qualified judges and to establish a body of high quality decisions. We will follow up this interesting future development. ■ Traditional Knowledge In The Philippines Protecting Traditional Knowledge As Cardinal Technology In The Philippines By Robert Nereo B. Samson and Gonzalo D.V. Go III Abstract Technology is an important tool for the sustainable development of society. Far from being known for robotics and high-level technologies, the Philippines has its own formidable technology to offer the world: the traditional knowledge (TK) of its indigenous peoples and communities (“Indigenous People”). TK originated from the intellectual creations of Indigenous People, and has been passed on from generations to generations. Its scope spans from agriculture, science, ecology, medicine, biodiversity, and such other fields of knowledge relevant to Indigenous People’s continued existence. TK possesses global importance for its proven benefits to society in general. Blessed with 110 diverse groups of Indigenous People in its 7,107 islands, the Philippines’ TK collection may be the key to economic development and the sustainability of the indigenous cultures and traditions of the Philippines, truly worth identifying, developing, and protecting. This paper explains the legal framework of TK, how the contemporary Philippine intellectual property system protects it, and the reservations of Indigenous People in availing of such protection. Introduction A n archipelago of 7,107 islands, the Philippines is the home to 110 groups of indigenous peoples and communities, each continuously living as an organized community and sharing common bonds of cultural resources: “the tangible and intangible effects of an individual or group of people that define their existence, and place them temporally and geographically in relation to their belief systems and their familial and political groups, providing meaning to their lives.”1 Their field of cultural resources includes tangible items, such as land, sacred sites, and religious and funerary objects; and intangible knowledge and customs, such as tribal names, symbols, stories, and ecological, ethnopharmacological, religious, or other traditional knowledge (“TK”).2 TK serves an element of their cultural heritage, contributes to the sustain1. Angela R. Riley, ‘‘Straight Stealing: Towards an Indigenous System of Cultural Property Protection,” 80 Wash. L. Rev. 69, 77 (2005). 2. Felix Cohen, Handbook Of Federal Indian Law § 20.01 (2012). able use and preservation of biodiversity, and is fundamental to their sustainable development. Overshadowed by the pomp and promise of modern science and technology, TK has been disregarded until recently. While scientists and development agencies are only beginning to acknowledge its significance, its enduring role as the mainstay of local food ■ Robert Nereo B. Samson, production and health Intellectual Property care in the developing Office of the Philippines, world cannot be quesAttorney V, 3 tioned. The TK system Taguig City, Philippines encompasses a broad E-mail: robertnereo.samson@ range of knowledge such ipophil.gov.ph as the use of biological resources for medi■ Gonzalo D.V. Go III, cal treatment, water Jollibee Foods Corporation, management strategies, Senior Legal Counsel, agricultural timing and Pasig City, Philippines production techniques, climate change adaptaE-mail: gonzalo.go@ tion policy and practice, jollibee.com.ph visual arts, designs, performances, literature, folklore, and other literary and artistic materials. There is a lot to learn from the indigenous knowledge systems and practices, which the law seeks to control, develop and protect.4 TK is considered a species of intellectual property (“IP”) and a form of technology the Philippines may truly take pride from and claim an abundance of. The Philippines, being one of the world’s repositories of diverse biological resources in terms of plant and animal species, has an immense potential for the production of medicines and food through TK. If only this can be developed and utilized using proper contracts and monitoring systems, substantial benefits will accrue to benefit national food requirements and provide medical security, while preserving biodiversity, and 3. Douglas Nakashima and Marie Rou´e, Indigenous Knowledge, Indigenous People and Sustainable Practice, 5 Social And Economic Dimensions Of Global Environmental Change, Encyclopedia Of Global Environmental Change 314, (2002), available at http://portal.unesco.org/science/fr/files/3519/10849731741IK_ People/IK_People (last accessed April 10, 2014). 4. The Indigenous Peoples’ Rights Act of 1997, Republic Act No. 8371, sec. 34 (1997). September 2014 192 Traditional Knowledge In The Philippines lead to improvements in Indigenous People’s lives.5 However, in spite of existing laws and guidelines, there are still substantial implementation challenges to IP rights being adapted to the protection of TK. These challenges include the role and the use of the IP system in the recognition and respect of the free and prior informed consent of the indigenous peoples in the use of their TK, as well as provisions for ensuring the fair and equitable benefit-sharing arising from the utilization of the TK of the indigenous peoples. This article provides a legal framework to understanding the concept of TK and the concerns it poses to the Filipino IP system and Indigenous People. Part I explains TK as a concept, its legal framework, and its connection to IP and human rights. Part II discusses the extent of protection being afforded to TK by the contemporary IP system in the Philippines, and the ideological conflicts it poses to the Indigenous People. I. Demystifying TK Indigenous People celebrate TK as a vital part of their individual lives and their community’s continued solidarity. TK forms part of a holistic world-view, and is inseparable from the way of life of Indigenous People and their cultural values, spiritual beliefs, and customary legal systems.6 It is imperative for their future well-being, sustainable development, and intellectual and cultural vitality for them to maintain not only the distinct knowledge systems that give rise to TK; but also the social and physical environment of which TK forms an integral part. A. Definition and Criteria for Protection Eligibility The basic issues for the protection of TK are terminology and concept. There is as yet no universally accepted definition of TK at the international level. TK, as a broad description of subject matter, generally includes the intellectual and intangible cultural heritage, practices and knowledge systems of Indigenous People. In other words, TK in a general sense (lato sensu) embraces the content of knowledge itself as well as traditional cultural expressions, including distinctive signs and symbols associated with TK. In international debates, TK in the narrow sense refers to knowledge as such, in particular the knowledge resulting from intellectual activity in a traditional 5. Andrea B. Agillon, Traditional Knowledge in the Philippines: Progress of IPR Protection, Tech Monitor 57 (2007), available at http://www.techmonitor.net/tm/images/7/70/07mar_apr_sf6.pdf (last accessed April 10, 2014). 6. World IP Organization, IP And Traditional Knowledge: Booklet II 1 [hereinafter Booklet], available at http://www.wipo.int/ export/sites/www/freepublications/en/tk/920/wipo_pub_920.pdf (last accessed April 10, 2014). 193 les Nouvelles context. It includes know-how, practices, skills, and innovations. TK can be found in a wide variety of contexts, including: agricultural knowledge; scientific knowledge; technical knowledge; ecological knowledge; medicinal knowledge, including related medicines and remedies; and biodiversity-related knowledge.7 TK has developed over time and has been used to sustain communities. It consists of the experiences, culture, environment, local resources, animal knowledge and or plant resources generally considered to be owned collectively by a community; and transmitted across generations through traditional stories to selected persons in the community.8 As an IP asset, TK should be protected from misuse or misappropriation, whether through copying, adaptation, or use by unauthorized third parties. IP protection can take the form of the grant of exclusive rights, i.e., in the context of TK, excluding others from making certain uses of TK; but can also take the form of non-proprietary forms of protection like moral rights, equitable compensation schemes, and protection against unfair competition.9 In order to be eligible for IP protection, the WIPO Intergovernmental Committee on TK considered the proposition that TK should possess all of the following characteristics: 1. It should be distinctively associated or linked with the cultural, social identity, and/or cultural heritage of (a) Indigenous People who hold, maintain, use and/or develop the TK, or (b) any other national entity defined by national law,10 2. It should have been generated, maintained, shared, or transmitted in a collective context, 3. It should be intergenerational or passed on from generation to generation, and 7. Glossary of Key Terms Related to Intellectual Property and Genetic Resources, Traditional Knowledge and Traditional Cultural Expressions, WIPO Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore, 27th Sess. 2014. 8. See Stephen A. Hansen & Justin W. Vanfleet, Traditional Knowledge And Ip: A Handbook On Issues And Options For Traditional Knowledge Holders In Protecting Their IP And Maintaining Biological Diversity 3 (2003) [Hereinafter Hansen & Vanfleet]. 9. WIPO, Frequently Asked Questions, available at http://www. wipo.int/tk/en/resources/faqs.html (last accessed April 10, 2014). 10. The Protection of Traditional Knowledge: Draft Articles, WIPO Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore, 27th Sess. 2014 [hereinafter Draft Articles], art. 2.1, available at http://www.wipo.int/meetings/en/doc_details.jsp?doc_ id=261910 (last accessed April 10, 2014). Traditional Knowledge In The Philippines 4. It should have been used for a term not less than fifty years, as may be determined by each Member State or Contracting Party.11 Furthermore, TK protection should not be given to TK that is (a) widely known or used outside the community of its beneficiaries for a reasonable period of time, (b) in the public domain, (c) protected by an IP right, or (d) protected by the application of principles, rules, skills, know-how, practices, and learning normally and generally well-known.12 The paragraphs citing the draft articles under the WIPO negotiations may be deleted in view of the development and subsequent discussions in the WIPO. B. Legal Framework under International Law Michael Brown, a renowned anthropologist, observed that “in the late 1980s ownership of knowledge and artistic creations traceable to the world’s indigenous societies emerged, seemingly out of nowhere, as a major social issue.”13 Yet it was not from nowhere that the issue burst onto the international stage; TK’s emergence as an issue of global importance can be traced to at least two major political and legal shifts: (1) the unprecedented expansion and internationalization of first-world style IP rights, most notably with the passage of the Agreement on Trade-Related Aspects of IP Rights (TRIPS);14 and (2) the increased global recognition of Indigenous People’s rights.15 1. Applying the IP System to TK Historically, IP development has had three distinct periods of evolution: (1) a territorial period characterized by local protection but an absence of international protection; (2) an international period highlighted by several international countries joining the WIPO and agreeing to form the international Paris16 and Berne17 Conventions to protect industrial 11. Draft Articles, supra note 12, art. 1.3. 12. Draft Articles, supra note 12, art. 1.4. 13. Michael F. Brown, Who Owns Native Culture? ix (2003), and the amended WIPO/GRTKF/28/5. 14. Agreement on Trade-Related Aspects of IP Rights art. 41, Apr. 15, 1994, Marrakesh Agreement Establishing the World Trade Organization, Annex 1C, Legal Instruments—Results of the Uruguay Round, 1869 U.N.T.S. 299, 33 I.L.M. 1195 (1994) [hereinafter TRIPS]. 15. Deepa Varadarajan, A Trade Secret Approach to Protecting Traditional Knowledge, 36 Yale J. Int’l L. 371, 379 (2011) [hereinafter Varadarajan]. 16. Paris Convention for the Protection of Industrial Property of Mar 20, 1883, done July 14, 1967, 21 U.S.T. 1583, 828 U.N.T.S. 305; [hereinafter Paris Convention]. 17. Berne Convention for the Protection of Literary and Artistic Works of Sept. 9, 1886, concluded July 24, 1971, 25 U.S.T. 1341, 1161 U.N.T.S. 3 [hereinafter Berne Convention]. property and literary and artistic works respectively; and (3) the global period characterized by TRIPS that links trade and IP.18 IP protection has morphed from having protection only in the country of origin to global agreements on reciprocal IP protections; wherein member countries that subscribe to global agreements agree to abide by specific protection rules and regulations in consideration for receiving the same protections for their own IP in all other member countries.19 The global IP protection agreements most significant to TK originated from the World Trade Organization (WTO) and WIPO. WTO protects IP within the scope of international trade, and is notable for TRIPS which focuses on national and territorial IP treatment. TRIPS has opened the door to nations to trade globally without fear of theft of innovations, streamlined IP protection, and paved the way for Indigenous People to break into the global trade market.20 TRIPS has revolutionized global IP standards, but its effects seem to have compromised TK identification and protection mechanisms. Other international agreements [such as the Paris and Berne Conventions] may have preceded TRIPS, but TRIPS expanded, strengthened, and homogenized global IP standards in unprecedented ways.21 First, the high minimum standards mandated by TRIPS curtailed much of the flexibility that countries previously enjoyed in tailoring national IP laws.22 Subject to limited exceptions, countries must make patents available “for any invention, whether products or processes, 18. See Peter Drahos, Panel Discussion: The Universality of IP Rights: Origins and Development, World IP Organization 13 (1999). 19. Lindsey Schuler, Modern Age Protection: Protecting Indigenous Knowledge Through IP Law, 21 Mich. St. Int’l. L. Rev. 751, 757-8 (2013) [hereinafter Schuler]. 20. Schuler, supra note 21, at 758. 21. For a description of the industry lobbying efforts that led to the passage of TRIPS, see Susan K. Sell, Private Power, Public Law: The Globalization Of IP Rights 96-120 (2003). 22. TRIPS, supra note 16, art. 27. Prior to TRIPS, some countries such as India did not recognize patents in pharmaceutical products, only pharmaceutical processes. This flexibility allowed for a thriving generics industry. Several firms could produce the same drug, so long as they found an alternate way of producing it. TRIPS eliminated such flexibility by requiring patents to be available for “any inventions, whether products or processes, in all fields of technology,” subject only to limited exceptions. In terms of required standards, TRIPS is a floor, not a ceiling. But under the national treatment principle of TRIPS, if a country does provide stronger IP to its own citizens, it must generally extend those same rights to the citizens of other member countries. For a description of patent protection variation among countries prior to TRIPS, see generally Paul Goldstein, International IP Law 354 (2d ed. 2008). September 2014 194 Traditional Knowledge In The Philippines in all fields of technology,” including pharmaceuticals, modified micro-organisms, and microbiological processes (such as those used in biotechnology), “provided that they are new, involve an inventive step and are capable of industrial application.” Moreover, while countries can exclude from their patent laws “plants and animals other than micro-organisms, and essentially biological processes,” they must protect plant varieties.23 The controversial protection of plant varieties and bioengineered goods is particularly relevant to the emergence of traditional knowledge protection as a hot global topic.24 Several countries oppose patents on any life forms, man-made or otherwise, and resent the TRIPS requirement that such patents be recognized.25 Controversial U.S. and European patents on inventions derived from developing country genetic resources and traditional knowledge—such as patents for neem-based pesticides—further fueled the fires.26 These widely publicized cases led advocates for indigenous groups, local farmers, and developing country governments to coin the term “biopiracy.”27 This term describes the industrial practice of patenting products based on traditional knowledge or genetic resources, without providing compensation or recognition to the source countries or communities. Not only does TRIPS homogenize and strengthen minimum standards in unprecedented ways, but its formidable enforcement mechanism also stand in 23. TRIPS, supra note 16, art. 27(3)(b) (requiring protection “either by patents or by an effective sui generis system or by any combination thereof”). 24. See Graham Dutfield, Ip, Biogenetic Resources And Traditional Knowledge 260 (2004) (describing the convergence of “biodiplomacy and IP diplomacy” as a result of this requirement). The genesis of the requirement that patents be extended to bioengineered goods—an explicit nod to the biotechnology sector--can be traced to the controversial decision in Diamond v. Chakrabarty, 447 U.S. 303 (1980), in which the U.S. Supreme Court permitted the patenting of a genetically engineered, oileating microbe, as well as earlier cases that allowed the patenting of isolated and purified chemical compounds, see, e.g., Merck & Co. v. Olin Mathieson Chem. Corp., 253 F.2d 156, 164 (4th Cir. 1958) (upholding a patent on purified Vitamin B-12). Following Chakrabarty, inventors have obtained patents on “anything under the sun that is made by man,” Chakrabarty, 447 U.S. at 309, from isolated genetic sequences to modified plants and animals. See also Sabrina Safrin, Hyperownership in a Time of Biotechnological Promise: The International Conflict To Control the Building Blocks of Life, 98 AM. J. INT’L L. 641, 645-46 (2004). 25. Even in the United States, the seemingly limitless scope of biotechnology patents are contested, as exemplified by a district court decision invalidating patents held by Myriad Genetics on genes linked to breast and ovarian cancer. See Ass’n for Molecular Pathology v. U.S. Patent & Trademark Office, 702 F. Supp. 2d 181 (S.D.N.Y. 2010). 195 les Nouvelles stark contrast to previous international IP instruments. Unlike other agreements, “TRIPS has teeth.”28 Because it is linked to the WTO’s dispute resolution system, member states must comply and submit to mandatory adjudication of disputes initiated by member governments or risk retaliatory trade sanctions.29 Developing countries agreed to the draconian conditions imposed by TRIPS in exchange for favorable trade treatment and the promise of foreign direct investment.30 The troubling politics of TRIPS, and its linkage to the WTO enforcement mechanism, have triggered numerous, trenchant critiques…31 26. In the case of neem, a type of tree native to South and Southeast Asia, the specialty chemicals company W.R. Grace obtained U.S. and European patents on pesticides derived from neem extracts. For centuries, Indian farmers have used a mixture of soaked neem seeds and alcohol as a pesticide. Grace’s patents covered processes that increased the shelf life and storage of azadirachtin, an active agent in neem; the company claimed their patents were improvements on the traditional process because the neem mixture used by farmers begins to degrade if not used within a few days. A number of advocacy groups challenged these patents in 1995, arguing that Grace’s extraction process did not sufficiently differ from the traditional process. In 2000, the European Patent Office revoked Grace’s patent on grounds that it was not novel, but the U.S. patent remains valid. The U.S. neem example demonstrates the difficulty of challenging patents for products or processes derived from traditional knowledge and genetic resources through chemical isolation or a genetic engineering process, because of the way novelty is assessed under U.S. patent law. For discussions of the neem and other “biopiracy” controversies, see, for example, Shubha Ghosh, Traditional Knowledge, Patents, And The New Mercantilism (Part II, 85 J. Pat. & Trademark Off. Soc’y 885 (2003). 27. See Dutfield, supra note 26, at 237 (describing the coinage of the term as “part of a counterattack strategy on behalf of developing countries”). 28. Laurence R. Helfer, Regime Shifting: The TRIPS Agreement and New Dynamics of International IP Lawmaking, 29 Yale J. Int’l L. 1, 2 (2004). 29. Id. (describing the WTO’s dispute settlement system). Only member governments can initiate dispute settlement proceedings in the WTO; private individuals, companies, and NGOs do not have direct access to the dispute settlement system. But these nongovernment entities can and often do pressure WTO member governments to bring disputes where another member violates their obligations. And several WTO member governments have “formally adopted internal legislation under which private parties can petition their governments to bring a WTO dispute.” 30. For a nuanced view of the politics of TRIPS, see Amy Kapczynski, The Access to Knowledge Mobilization and the New Politics of IP, 117 YALE L.J. 804, 848 (2008) (explaining that the “success of TRIPS required not just pressure and transfer payments, but also interventions in the realm of ideas” in order to “produce the acquiescence of developing countries”—i.e., the industry lobby “made the case that TRIPS was not only good for American business, but also good for global innovation, and for developing countries specifically”). 31. Varadarajan, supra note 17, at 379-82. Traditional Knowledge In The Philippines On the other hand, WIPO is a United Nations (UN) agency serving as the global forum for IP services, policy, information, and cooperation. WIPO has developed a balanced and effective international intellectual IP system that enables innovation and creativity for the benefit of all.32 WIPO has organized the Intergovernmental Committee and is currently crafting an international legal instrument for the protection of IP, genetic resources, traditional knowledge, and the folklore of Indigenous People.33 This will be exceptionally important to Indigenous People on a global level, developing a forum for rigorous TK protection through modern legal application.34 2. Linking TK Protection to Human Rights Around the same time that TRIPS began to shake the international IP landscape, Indigenous People had become more politically aware and begun to demand increased recognition and protection of, and control over, their indigenous culture, resources, and TK.35 The Universal Declaration of Human Rights pronounced the Indigenous People’ right to freely participate in their community’s cultural life, to enjoy the arts, and to share in scientific advancement and its benefits.36 Indigenous People have the right to own property37 (including TK); not to be deprived thereof;38 and to protect their moral and material interests resulting from their own scientific, literary, or artistic production.39 The United Nations Declaration on the Rights of Indigenous People acknowledged that the diversity of Indigenous People, cultures, languages, and spiritual traditions constitutes the genuine richness of human existence, guaranteeing the continued survival and development of humankind.40 It underscored the right of Indigenous People to IP,41 self-identification, and to know, learn, preserve and develop their own culture, history, language, religion, and customs.42 The Declaration on the Rights of Indigenous People43 expressed the right of Indigenous People to practise and revitalize their cultural traditions and customs; including the right to maintain, protect and develop the past, present and future manifestations of their cultures, such as archaeological and historical sites, artifacts, designs, ceremonies, technologies and visual and the performance of arts and literature.44 It categorically pointed out the Indigenous People’s right over their TK, and to maintain, control, protect, and develop their IP over it.45 The International Covenant on Civil and Political Rights seeks to protect the right of ethnic, religious or linguistic minorities to enjoy their own culture.46 The Convention on the Elimination of All Forms of Racial Discrimination attempts to insure that Indigenous People can exercise their rights to practise and revitalize their cultural traditions and customs.47 The International Convention on the Elimination of All Forms of Racial Discrimination desires to implement the principles embodied in the United Nations Declaration on the Elimination of All Forms of Racial Discrimination and to secure the earliest adoption of practical measures to that end. C. TK Through the Lens of Philippine Laws The Philippine Constitution recognizes and promotes the rights of Indigenous People within the framework of national unity and development,48 by 32. WIPO, Inside WIPO, available at http://www.wipo.int/aboutwipo/en/ (last accessed April 10, 2014). 33. See WIPO, Intergovernmental Committee, available at http://www.wipo.int/tk/en/igc/index.html (last accessed April 10, 2014). 34. Schuler, supra note 21, at 759. 35. See, e.g., U.N. Econ. & Soc. Council, Subcomm. on Human Rights, Written Statements Submitted by International Indian Treaty Council 3, U.N. Doc. E/CN/4/2003/NGO/127 (Mar. 17, 2003); see also Stephen R. Munzer & Kal Raustiala, The Uneasy Case for IP Rights in Traditional Knowledge, 27 Cardozo Arts & Ent. L.J. 37, 51 (2009) (“Indigenous peoples increasingly cooperate globally on a range of shared issues, such as land tenure and language preservation.”). 36. Universal Declaration of Human Rights, G.A. Res. 217 (III) A, U.N. Doc. A/RES/217(III), art. 27(1) (1948) [hereinafter UDHR], available at http://www.un.org/en/documents/udhr/ (last accessed April 10, 2014). 37. Id., art. 17(1). 38. Id., supra note 38, art. 17(2). 39. Id., supra note 38, art. 27(2). 40. Universal Declaration of the Rights of Indigenous People, Unrepresented Nations and Indigenous People Organization, at Preamble (2004) [hereinafter UDRP], available at http://www. unpo.org/article/105 (last accessed April 10, 2014). 41. Id., art. 5. 42. Id., art. 15. 43. United Nations Declaration on the Rights of Indigenous Peoples, G.A. Res. 61/295 Annex, U.N. Doc. A/RES 61/295 (2007) [hereinafter UNDRIP], available at http://www.un.org/esa/socdev/ unpfii/documents/DRIPS_en.pdf (last accessed April 10, 2014). 44. Id., art. 11(1). 45. See Id., art. 31. 46. International Covenant on Civil and Political Rights, G.A. Res. 2200A (XXI), art. 27 (1976), available at http://www.ohchr.org/en/ professionalinterest/pages/ccpr.aspx (last accessed April 10, 2014). 47. Committee on the Elimination of Racial Discrimination, General Recommendation 23, Rights of indigenous peoples (Fiftyfirst session, 1997), U.N. Doc. A/52/18, annex V at 122 (1997), available at http://www1.umn.edu/humanrts/gencomm/genrexxiii. htm (last accessed April 10, 2014). 48. Phil. Const. art. II, sec. 22. September 2014 196 Traditional Knowledge In The Philippines recognizing, respecting, and protecting their rights to preserve and develop their cultures, traditions, and institutions.49 The Indigenous Peoples’ Rights Act50 established the necessary mechanisms to enforce and guarantee the realization of the Indigenous People’s rights to their ancestral domain, cultures, traditions, and institutions. It provided them with the right to the restitution of cultural, intellectual, religious, and spiritual properties taken without their free and prior informed consent or in violation of their laws, traditions, and customs.51 Zeroing in TK, Indigenous People are entitled to the recognition of the full ownership, control, and protection of their cultural and IP rights;52 and to control, develop, and protect their scientific developments, technologies, and cultural manifestations, including TK on medicines and health practices, vital medicinal plants, animals and minerals, fauna and flora, oral traditions, literature, designs, and visual and performing arts.53 Indigenous People are even allowed to collect wildlife for their traditional use and not primarily for trade.54 The National Cultural Heritage Act55 mandates the documentation of traditional and contemporary arts and crafts, including their processes and makers, and the sustaining of the sources of their raw materials.56 It also extends assistance to Indigenous People in preserving their particular cultural and historical properties.57 The Traditional and Alternative Medicine Act58 49. Phil. Const. art. XIV, sec. 17. 50. An Act to Recognize, Protect and Promote the Rights of Indigenous Cultural Communities/Indigenous Peoples, Creating a National Commission on Indigenous Peoples, Establishing Implementing Mechanisms, Appropriating Funds Therefor, and for Other Purposes, Republic Act No. 8371, sec. 2 [hereinafter IPRA]. 51. Id., sec. 32. 52. Id. sec. 34. 53. Id., sec. 34. 54. Wildlife Resources Conservation and Protection Act, Republic Act No. 9147 (2001). 55. An Act Providing for the Protection and Conservation of the National Cultural Heritage, Strengthening the National Commission for Culture and the Arts (NCCA) and its Affiliated Cultural Agencies, and for Other Purposes, Republic Act No. 10066 (2010). 56. Id., sec. 16. 57. Id., sec. 21. 58. An Act Creating the Philippine Institute of Traditional and Alternative Health Care (PITAHC) to Accelerate the Development of Traditional and Alternative Health Care in the Philippines, Providing for a Traditional and Alternative Health Care Development Fund and for Other Purposes, Republic Act No. 8423 (1997). 197 les Nouvelles seeks to provide a legally workable basis by which Indigenous People would own their knowledge of traditional medicine. When TK is used by third parties, Indigenous People can require them to acknowledge its source and can demand a share of any financial return from its commercial use.59 The IP Code of the Philippines60 has nothing specific to say about TK. It merely posits for consideration the enactment of a law providing sui generis protection of plant varieties and animal breeds and a system of community intellectual rights protection.61 In this regard, its major roadblock in practice is the availability and sufficiency of the existing mechanisms in the IP system to provide legal protection to TK to address the concerns of the TK right holders on their IP rights. Nonetheless, a deeper understanding of the contemporary Philippine IP system may narrow its limitations in protecting TK, and enable the sharing of benefits arising from TK access and use. II. TK Protection Afforded by Contemporary Philippine IP System The dynamic landscape of the contemporary IP system in the Philippines can be applied to various fields of disciplines including the innovations derived from the indigenous knowledge systems and practices of the Indigenous People. However, for the effective application of the IP system, it is necessary that there must be a clear identification of TK that is recognized as the intellectual creation of Indigenous People, and consequently, recognized as being owned and controlled by the Indigenous People. A. TK in the Form of Other IP Rights The Subheading “A” May be Titled as “IP Rights Protection for TK.” The essence of IP protection is to encourage creation and innovation that is useful and beneficial to the public. As to the patent system, it is not the reward to the individual which is paramount in public policy terms, but the advancement of science. The function of a patent is to add to the sum of useful knowledge; and one of its purposes is to encourage dissemination of information concerning discoveries and inventions.62 TK owners or holders may secure patent protection on their innovations and practices if they can satisfy 59. Id., sec. 2. 60. An Act Prescribing the IP Code and Establishing the IP Office, Providing for its Power and Functions, and for Other Purposes, Republic Act No. 8293 (1998). 61. Id., sec. 22.4. 62. Manzano v. Court of Appeals, G.R. No. 113388 (1997). Traditional Knowledge In The Philippines the elements of novelty, inventive step, and industrial applicability. “TK, just because it is ‘traditional’ is not necessarily old. Tradition, in the context of TK, refers to the manner of producing such knowledge, and not to the date on which the knowledge was produced… Besides, even TK that is “old”—in the sense that it has been produced yesterday or, eventually, many generations ago– can be novel for the purposes of several areas of IP. Novelty, in general, has been defined by laws according to more or less precise criteria according to which the specific piece of technical knowledge has been made available to the public. In the field of patents for example, it is disclosure (or the lack thereof) that establishes whether the condition of novelty (and of inventiveness) has been met. The date on which the invention was realized is not necessarily taken into account for that purpose.”63 Clearly, TK not forming part of prior art can still be considered new. Patented TK brings about a bundle of exclusive rights effective for a limited period of time as an incentive to further intellectual contributions. A product patent holder has the exclusive right to prevent third parties not having the owner’s consent from making, using, offering for sale, selling, or importing that product. A patented process holder can prevent third parties not having the owner’s consent from using the process, and from using, offering for sale, selling, or importing the product obtained directly by that process. Patent owners also have the right to assign, or transfer by succession, the patent and to conclude licensing contracts.64 In South Africa, a patent involving a pharmaceutical composition extracted from the “Hoodia” plant and identified as having an appetite suppressing activity was the subject of a benefit sharing agreement between the San people in South Africa and pharmaceutical companies from developed countries. The San have used the Hoodia plant for centuries as a food and water source. This practice was brought to the attention of the South African Council for Scientific and Industrial Research, which undertook research on the plant, and with the agreement of the San, filed 63. World IP Organization Intergovernmental Committee on IP and Genetic Resources, Traditional Knowledge and Folklore [hereinafter IGC], Third Session, Review of Existing IP Protection of Traditional Knowledge WIPO/GRTKF/IC/3/7 (06 May 2002) at 11. 64. Agreement on Trade-Related Aspects of IP Rights (TRIPS Agreement), Art 28, Final Act Embodying the Results of the Uruguay Round of Multilateral Trade Negotiations, Annex 1(c) of the Marrakesh Agreement Establishing the World Trade Organization, 15 April 1994, 1869 U.N.T.S. 299. a patent application on the various properties of the Hoodia plant in 1998.65 In Samoa, traditional healers were acknowledged in a benefit-sharing agreement concerning the development of an anti-AIDS compound. The TK of these healers guided the researchers in developing this compound and the expected revenues will be shared with the village and the families of the traditional healers.66 On the other hand, assuming that the patentable TK holder is not interested in securing exclusive rights over an invention but would rather maintain such knowledge in the public domain, patent laws also extend “defensive” protection by effectively providing a bar to third parties from patenting the invention or its equivalent through the novelty requirement.67 To illustrate, if we assume the existence of a patent application for an “anti-obesity” invention with a filing date of March 20, 2014. If, prior to this date, a “Traditional Knowledge Journal” published an article citing the “anti-obesity” characteristics of a fruit or a plant which happens to be the source of the invention the subject of the patent application which claims that since the 1950’s, various groups of Indigenous People have used this fruit of the plant to suppress their appetite, the patent examiner could use the publication to rule against the novelty of the invention claimed in the patent application. TK in the form of traditional cultural expressions may be protected by copyright and, if so, it will be protected from the moment of creation. These may be treated as literary or artistic creations referring to tangible and intangible forms in which TK and cultures are expressed, communicated, or manifested. Examples are traditional music, performances, narratives, names and symbols, designs, and architectural forms.68 The owner of a copyright in TK has the right to prohibit its reproduction in various forms, public performance, recording (fixation), broadcasting, translation into other languages, and adaptation.69 65. WIPO, PCT Notable Inventions: Hoodia appetite suppressant, available at http://www.wipo.int/pct/en/inventions/hoodia/ index.html (last accessed April 10, 2014). 66. Booklet, supra note 8, 24. 67. An invention is deemed equivalent to a prior invention if it performs substantially the same function in substantially the same way to achieve substantially the same result. Smith Kline Beckman Corporation v. Court of Appeals, 409 SCRA 33, 40 (2003). 68. IGC, Glossary of Key Terms Related to IP and Genetic Resources, Traditional Knowledge, and Traditional Cultural Expressions, Annex Page 40, WIPO/GRTKF/IC/22/INF/8 (2012). 69. WIPO, Copyright, available at http://www.wipo.int/copyright/en/ (last accessed April 10, 2014). September 2014 198 Traditional Knowledge In The Philippines Over the years, many Indigenous People have condemned the unauthorized reproduction of their fixed and unfixed cultural expressions such as artistic works, handicrafts, designs, dances, and musical and dramatic performances.70 As holders of copyright of TK pertaining to artistic and literary creations, the indigenous peoples have the right to secure or share in the benefits arising from their contemporary works. They may object to any distortion, mutilation or other modification of, or other derogatory action in relation to the traditional cultural expression, prejudicial to their interests. Moreover, the expressions of the Indigenous People that have become distinctive may be the subject of trademark protection if they are capable of distinguishing the goods or services of the Indigenous People.71 If a product has gained a reputation because of its characteristics attributed to its geographic origin, the system of protection on geographical indication may be used. Indigenous People who have been identified as living and residing in this particular geographical location can then take advantage of this reputation. Geographical indications protect certain traditional know-how and help maintain the economic value of locally produced goods.72 Production must be in that particular geographical area associated with the geographical indication; thereby creating rural employment niches and supporting rural economies indirectly through associated industries such as tourism.73 Trade secrets may also be used to ensure TK protection and provide economic incentives and benefits to the TK holders, subject to the free and prior informed consent of the Indigenous People concerned. In broad terms, therefore, both IP and TK protection follow the same principles of acknowledging the author or creator and preventing the use of the intellectual creations without the consent of the owner. Often, the enhancement of an old technology generates valuable new inventions, or the adaptation of an old artistic tradition results in new creative works. The economic value of TK 70. Graham Dutfield, IP, Biogenetic Resources And Traditional Knowledge 101 (2004) [hereinafter Dutfield]. 71. TRIPS, supra note 16, art. 15. 72. Dutfield, supra note 26, at 107. 73. Domnina T. Races. Tatak Pinoy: Towards the full protection of Philippine Geographical Indication, at 77, (2008) (J.D. Thesis, Ateneo de Manila University). 199 les Nouvelles could, therefore, be enhanced by the use of IP.74 TK protection includes giving the Indigenous People the control over these intellectual assets, which is essentially similar to the rights given to the holders of IP rights. The IP system can, therefore, be used within the broader scope of TK protection for the economic development of the Indigenous People considered as TK holders. B. Option to Exclusively Appropriate or Share to Public Some Indigenous People regard it as being inappropriate to cloak TK with rights to exclusive use but rather see it as part of their culture, traditions, and way of life. They argue that using the IP system is incompatible with their culture and traditions. The IP system does not prevent them from refusing to take advantage of its benefits. IP rights are private in character, and whether or not they are exercised is a matter for the owner. There is nothing in the IP system which would prevent an innovation or TK which is patentable to be freely used by the public if that was desired by the Indigenous People. What is necessary, however, is for the Indigenous People to be informed that there is the legal framework in the present IP rights system which may be available to them for the protection of their TK. Thus, in the case of copyright works in the form of traditional cultural expressions of an Indigenous People, any derivative works would be subject to control by the owners of the original works. But if the Indigenous People believe that these derivative works are only inspired by their traditional cultural expressions and that they do not want to exercise their IP rights, they are not compelled to do so. In the same vein, if Indigenous People intend to keep as a “trade secret” their TK, the IP system recognizes the protection of undisclosed information. In order for the Indigenous People to maximize the benefits of the IP system, TK mapping through databases or inventory is needed, to serve as the guidelines on which of their TK may be subject to protection, management and commercialization. In examining patent and trademark applications, the TK databases or inventory would be valuable for prior art searches and for identification of TK owners. Certificates of registration could be issued in favor of the TK holders, which would simultaneously bar other parties from securing protection that would 74. Kamil Idris, Intellectual Property: A Power Tool for Economic Growth, at 27, available at http://www.wipo.int/export/ sites/www/freepublications/en/intproperty/888/wipo_pub_888_1. pdf (last accessed April 10, 2014). Traditional Knowledge In The Philippines be contrary to those rights. The mapping activities could extend to cultural documentation that could safeguard the Indigenous People’s cultural heritage for future generations and enable a system under which use by third parties could be regulated through prior informed consent.75 Furthermore, the mapping activities could identify the potential IP rights that are appropriate to the commercialization of the TK and consistent to the way of life, values, and aspirations of the Indigenous People concerned. The Indigenous People may themselves opt to directly initiate the TK commercialization activities using the trademarks or copyright on their intellectual creations, while ensuring that their TK is preserved, recognized, and given due respect. Adopting collective marks or certification marks is recommended in their merchandising activities to ensure the proper recognition of their distinctive and original intellectual creations. Collective marks are often used to promote products deriving from a given region. Products may have certain characteristics which are specific to the producers in a given region, linked to the historical, cultural, social conditions of the area. In such cases, the creation of a collective mark has not only helped to market such products domestically and occasionally internationally, but has also provided a framework for cooperation between local producers. The creation of the collective mark, in fact, must go hand in hand with the development of certain standards and criteria and a common strategy; powerful tool for local development.76 To illustrate, the indigenous women weavers in South Cotabato, Philippines embarked on using the trademark system in their weaving of the “T’boli T’nalak” products; while the Lake Sebu Indigenous Women Weavers Association, Inc. (LASIWWAI) secured a trademark registration in 2011 for “LASIWWAI and logo” which they are using to distinguish their products. C. Indigenous Peoples’ Potential Concerns on TK Protection Many countries have attempted to extend TK protection to their respective Indigenous People by legislating their own protective laws. Difficulties remain because the schools of thought between western legal systems as opposed to the Indigenous People 75. WIPO, Cultural Documentation and IP Management Training Program, available at http://www.wipo.int/tk/en/training/cult_ doc_ip_man.html (last accessed March 22, 2013). 76. WIPO, Collective marks, available at http://www.wipo.int/ sme/en/ip_business/collective_marks.htm (last accessed February 27, 2013). are vastly contradictory. Indigenous People can rarely meet the rigorous legal prerequisites because they simply are not aligned and do not correspond to the norms of their community. A glaring example is the communal ownership over TK. Individualized forms of ownership in western legal systems, are unsuitable for Indigenous People’ culture and traditions because it is the Indigenous People community which owns the traditions and culture, and not one individual person or entity. TK is generally passed down over generations, and is not able to be identified with a single author or origination date. In the tribal context, rights to TK and other forms of intangible cultural resources may be cascaded among members in ways in which IP would recognize as placing them in the public domain. Consequently, if and when TK fails to meet the demanding criteria for protection, it will not be secure and will be open for appropriation. Indigenous People want TK to function in a way that allows them to control the use of cultural information to preserve their way of life, and not necessarily become the subject of global processes of commodification and appropriation.77 Copyright protection for TK may not necessarily be acceptable to the Indigenous People who believe that property ownership extends to perpetuity, whereas copyright ownership in the Philippines ends after the passing of fifty years after the death of the author.78 Not all TK of Indigenous People are sacred, but those considered sacred are usually kept as secret and require special usage.79 IP law offers trade secret and patent protection, but it does not offer protection for TK such as knowledge of religious rituals or folktales. Trade secret protection requires that the information is “used in one’s business” and is “not generally known.”80 Neither of these is characteristic of traditional knowledge. The element of “used in one’s business” demonstrates that the aims of IP law diverge from tribal interests because the primary goal of IP law is the commoditization of knowledge, whereas tribes want protection from that very process, as well as privacy.81 Some Indigenous People even fear that instead of 77. See Peter Drahos, The Universality of IP Rights: Origins and Development, available at http://citeseerx.ist.psu.edu/viewdoc/download?doi=10.1.1.106.7755&rep=rep1&type=pdf (last accessed April 10, 2014). 78. IP Code, supra note 62, sec. 198. 79. See Felix Cohen, Handbook Of Federal Indian Law § 20.01 (2012). 80. 1 Melvin F. Jager, Trade Secrets Law §§ 5:6-5:7 (2012). 81. Gerald Carr, Protecting Intangible Cultural Resources: Alternatives to IP Law, 18 Mich. J. Race & L. 363, 365 (2013). September 2014 200 Traditional Knowledge In The Philippines paving the way for the continued flourishing of their TK assets, protection from laws will create reduced access to traditional remedies, produce legal monopolies on certain biological resources, and limit, rather than stimulate, the sharing of knowledge because of economic prospects.82 Efforts of the current IP rights system are largely focused on creating TK databases to increase the likelihood that patent examiners will locate and consider TK as “prior art” searches and deny subsequent applications. But for many Indigenous People, disclosure of TK in publicly available databases is a double-edged sword. By making otherwise secret or inaccessible knowledge public, this form of defensive protection can actually facilitate the unauthorized use of TK that the community wishes to prevent. Documentation can thus have the perverse effect of “tipping off outsiders to knowledge that will ultimately aid them.”83 Conclusion The Indigenous People, and the society in general, cherish TK as a precious intellectual response to the necessities of life. Several important technologies are being derived from TK, and the resulting temptation to exploit, misappropriate, or misuse it for industrial or commercial advantage ought to be curbed. For TK 82. See Lidewyde H. Berckmoes, Protecting Indigenous Knowledge In South Africa: Debates On IP Rights And Development, Radboud University Nijmegen 36 (2008). 83. Varadarajan, supra note 17, at 385. 201 les Nouvelles to continue to exist and develop, the Philippines has to maintain not only the distinct knowledge systems where TK originated, but more importantly, the Indigenous People’s social and physical environment, their very ways of life, and their cultural values, spiritual beliefs and customary legal systems. Inasmuch as existing IP laws have been successfully utilized to protect Indigenous People against some forms of TK misuse and misappropriation, material adaptations or modifications to IP law ought to be implemented to make the existing IP rights system respond better to serious problem of misappropriation and the lack of appropriate recognition of the value of TK. Enabling laws must nurture and strengthen the roots of TK, even in times of social dislocation and change, so that its fruits may continue to flourish and be enjoyed by future generations, and so that Indigenous People can continue to thrive and develop in ways consistent with their own values and interests. Legislators should seriously consider enacting a law which will particularly address the challenges currently being faced by TK; a more appropriate law categorically recognizing TK as a distinct IP right, and goes beyond the basic protections currently extended to it as a clone of copyright, patent, trademark, or any other traditional IP. ■ Australian Goods And Services Tax Impact The Impact Of Australian Goods And Services Tax On Assignments And Licences Of Intellectual Property By Stephen Adrian Introduction 1. What is a Taxable Supply? s with many other countries, Australia imposes a tax on the supply of goods and services in certain situations. In some countries this will be called a goods and services tax and in others a value added tax. In Australia, the tax is to be found in the rather oddly named, “A New Tax System (Goods and Services Tax) Act 1999” (the “GST Act”). In this article, we provide guidelines as to how the GST Act will apply to common transactions involving the transfer of technology. Basically, the article deals with assignments and licences of intellectual property rights and the disclosure of confidential information. The GST Act is complex and it is important to note that these guidelines are not intended as a substitute for professional advice in relation to technology transfer transactions. Furthermore, in any technology transfer transaction, appropriate clauses dealing with GST ought be included in the documentation whether or not the transaction is thought to be subject to GST. The choice, in most situations, is between making the transaction inclusive of GST or exclusive of GST. In situations where the consideration is increased by the amount of GST, in most cases, the effect will be cash flow neutral provided that the acquirer of the services is registered for GST and is entitled to claim a credit for the amount of GST paid against GST payable in respect of other transactions. The situation is very different however where the acquirer of the right is unable to obtain an input tax credit because it does not otherwise pay GST. The language of the GST Act would be foreign to many licensing practitioners. For instance, licences and assignments are included in the omnibus term “supply,” carrying on a business in Australia is subsumed into the phrase “in the course of or furtherance of an enterprise” and one of the touchstones for liability to Australian GST is that the transaction is “connected” to Australia. So, before we embark on trying to establish some guidelines as to whether or not a transaction will be subject to GST, we need to deal with the concepts on which liability is founded. Under the GST Act, the following conditions need to be satisfied for a licence or assignment (“a supply”) to be a taxable supply: • The supply is made ■ Stephen Adrian, for consideration; Moore Stephens, • It is made in the Director, course or furtherMelbourne, Victoria, Australia ance of an enterprise; E-mail: sadrian@ moorestephens.com.au • The supply is connected with Australia; and • The acquirer of the rights is registered or required to be registered for GST. A supply will be connected with Australia where: • The thing is done in Australia; or • The thing is done through a permanent establishment that the non-resident carries on in Australia. 1.1The Thing is Done in Australia If a right to use intellectual property is granted by the execution of a written contract, the grant of the right is done in Australia if the contract is executed in Australia. Accordingly, a supply will be connected with Australia if the agreement is executed in Australia. There may be other circumstances where the thing is done in Australia. 1.2The Thing is Done Through a Permanent Establishment That the Non-Resident Carries on in Australia The meaning of the term permanent establishment must be considered in light of the double taxation agreements between Australia and various other countries. In most cases, the primary meaning of permanent establishment is a fixed place of business through which a business is wholly or partly carried on. The meaning of the term may be extended to things such as a construction site, which exists for A September 2014 202 Australian Goods And Services Tax Impact more than 90 days, factory, quarry or mine. Some double tax agreements may deem certain supervisory activities and the maintenance of substantial equipment by a non-resident company to be a permanent establishment. If the non-resident company has a permanent establishment in Australia, and the agreement is executed through that permanent establishment, the supply will be connected with Australia. If the above conditions are satisfied, prima facie, the supply will be a taxable supply. For the purpose of these guidelines, we have assumed that the supplies are made for consideration and in the course or furtherance of an enterprise. Furthermore, we have assumed that the entities are registered for GST. An entity is required to be registered for GST if its annual turnover meets or exceeds the GST registration turnover threshold of A$75,000. Non-resident entities are required to register for GST where their GST turnover from supplies connected with Australia exceeds A$75,000. With respect to whether a supply is connected with Australia, this will depend on the circumstances of the supply and is considered below in more detail. However even if a supply is a taxable supply, there are specific provisions in the GST Act which allow for certain supplies to be GST-free. Of particular relevance is the exemption in respect of a supply of rights which will be GST-free if: (a) The rights are for use outside Australia; or (b) The supply is to an entity that is not an Australian resident and is outside Australia when the thing supplied is done. 2. Australian Statutory IP Rights 2.1The assignment or Licence of Australian Statutory IP Rights by an Australian Company to an Australian Company The assignment or licence of Australian IP rights by an Australian company to another Australian company will be a taxable supply as the supply is connected with Australia on the basis that the assignor is carrying on an enterprise in Australia. Therefore, the supply will be subject to GST. 2.2 The assignment or Licence of Australian Statutory IP Rights by an Australian Company to a Foreign Company Outside of Australia The assignment or license of Australian IP rights by an Australian company to a foreign company will be a taxable supply as the supply is connected with Australia on the basis that the assignor is carrying on an enterprise in Australia. 203 les Nouvelles However, the assignment or license of Australian IP rights to a foreign company will be GST free if the supply is made to a non-resident entity and the non-resident entity is outside of Australia when the agreement is executed. 2.3The Assignment or the Licence of Australian Statutory IP Rights by a Foreign Company to an Australian Company The assignment or the licence of Australian Statutory IP rights by a foreign company to an Australian company will be subject to GST where the assignor (i.e. the foreign company) is registered for GST. A foreign company will be required to register for GST if: • It is carrying on an enterprise; and •The GST turnover from supplies that are “connected” with Australia in the course of carrying on that enterprise exceeds the registration threshold of A$75,000. In summary, the supply of a license of Australian IP rights by a foreign company will be subject to GST if the non-resident company is required to be registered for GST and: •The contract for the right to use the intellectual property is signed in Australia; or •The non-resident company has a permanent establishment in Australia, and the agreement is executed through that permanent establishment. Otherwise, the supply will not be subject to GST. 2.4The Assignment or License of Australian IP Rights by a Foreign Company to a Foreign Company with the Agreement Being Executed in Australia The assignment of Australian statutory IP rights by a foreign company to another foreign company may be subject to GST where the assignor (i.e. the foreign company) is registered for GST. In these circumstances, if the particular supply of Australian IP rights is more than A$75,000, the nonresident entity will be required to be registered for GST (even if no other business is being conducted in Australia) as the supply is connected with Australia given that the contract is executed in Australia. However, the supply may be GST-free where the foreign company recipient is a non-resident of Australia and is outside of Australia when the Australian statutory rights are granted. A company would be considered outside of Australia if it doesn’t carry on a business in Australia: •At or through a fixed and definite place for a suf- Australian Goods And Services Tax Impact ficiently substantial period of time; or •Through an agent at a fixed and definite place for a sufficiently substantial period of time. The Australian Tax Office takes the view that generally a company would be in Australia if: •The company is registered with the Australian Securities and Investment Commission; or •The company has a permanent establishment in Australia for tax purposes. Accordingly, if a foreign company does not satisfy any of the above criteria, it will be outside of Australia and the supply of statutory rights will be GST-free, despite the agreement being executed in Australia. 3. Foreign Statutory Rights 3.1 The Assignment or the Licence of Foreign IP Rights by an Australian Company to an Australian Company The licensing or assignment of foreign IP rights between Australian companies will be GST-free provided that the rights are solely for use outside of Australia. 3.2The Assignment or the Licence of Foreign IP Rights by an Australian Company to a Foreign Company The assignment or licence of foreign IP rights will be GST-free as the rights are for use outside of Australia. 3.3The Assignment or the Licence of Foreign IP Rights by a Foreign Company to an Australian Company The assignment or the licence of foreign IP rights by a foreign company to an Australian company will be subject to GST where the assignor (i.e. the foreign company) is registered for GST. However, the assignment or licence of foreign rights will be GST-free if the rights are for use outside Australia. 3.4The Assignment or License of Foreign IP Rights by a Foreign Company to a Foreign Company with Agreement Being Executed in Australia The assignment or license of foreign IP rights by a foreign company to a foreign company may be subject to GST where the assignor (i.e. the foreign company) is registered for GST. However, the assignment or licence of foreign rights will be GST-free if the rights are for use outside of Australia. This will be the case even if the agreement is executed in Australia. 4. Worldwide Rights Where an Australian company provides rights to another Australian company for use in and outside of Australia (e.g. worldwide rights), an apportionment will be required. The same would apply to a foreign company providing such rights to an Australian company if the foreign company is required to be registered for GST and the supply is connected with Australia. In instances where worldwide rights are provided to Australian entities, the portion of the rights relating to use outside of Australia will be GST-free. The rights to be used in Australia will be subject to GST. Accordingly, the consideration will be apportioned between the part of the rights that is made in relation to rights for use in Australia and the part in relation to use outside of Australia. The GST Act provides that any reasonable method of apportionment may be used. The factors to be taken into account in making this determination include: •Expectations of the recipient, based on reasonable grounds, as to the likely use of the right over the period for which the right is granted; •Economic, social, cultural, and political conditions the nature of the right itself; •Past revenue, royalty or profitability patterns evident from the use of similar rights—through industry statistics or similar. For completeness we note that where worldwide rights are provided to foreign companies who are not Australian residents and are not in Australia when the rights are supplied, the supply will be completely GST-free. 5. Common Law IP Rights—Confidential Information 5.1 Disclosure by an Australian Company to a Foreign Company Intellectual property is defined in the GST Act to include the provision of confidential information. Accordingly, the provision of confidential information will be GST-free provided that the information is for use outside Australia or the recipient of the rights is a non-resident of Australia and is outside Australia when the thing supplied is done. 5.2 Disclosure by a Foreign Company to an Australian Company The provision of confidential information by a foreign company to an Australia company will be GSTfree if the information is for use outside of Australia. In instances where the information is used in Australia, the rights to this information will be subject to GST if the foreign company is registered for GST or required to be registered. September 2014 204 Australian Goods And Services Tax Impact 5.3 Disclosure by an Australian Company to an Australian Company The provision of confidential information by an Australian company to another Australian company will be subject to GST as the supply is connected with Australia. The supply would be GST-free if the rights were for use solely outside Australia. 6. Supplies of a Going Concern The GST Act has special provisions dealing with the sale of a business as a going concern. These will be GST-free if: •The supply is for consideration; •The recipient is registered or required to be registered; 205 les Nouvelles •The supplier and recipient have agreed in writing that the supply is of a going concern; •All things that are necessary for the continued operation of an enterprise are supplied; and •The supplier carries on the enterprise until the day of the supply. Accordingly, where the assignment of statutory or common-law rights is part of the supply of a going concern, the supply will be part of the GST-free supply of a going concern. Conclusion The position of GST, as with any tax, can have a significant impact on a transaction. It is therefore important for those involved in the transfer of rights to have an appreciation as to when GST might be imposed and when to seek specialist advice. ■ EU State Aid Policy—Part II EU State Aid Policy: A Model To Assess Intellectual Property Rights And Knowledge Dissemination In R&D Cooperation Part II By Mario Cisneros 1. Introduction I n Part 1 dynamic efficiency and potential distortion of competition caused by State aid and IPRs allocation in collaborative R&D projects has been discussed. It was shown how different IPR ownership schemes are connected to potentially distortive competition practices, the generation of market power, the distortion of dynamic incentives and the maintenance of inefficient market structures, all elements under assessment from the perspective of EU State aid law. In Part 2, an analysis on how State aid law should be applied to knowledge dissemination and licensing practices involved in publicly funded R&D cooperation is presented. Part 2 is structured in two sections. Firstly, the alternatives for the rules on knowledge dissemination are evaluated from the perspective of the benefits generated by knowledge spillovers, the problem of asymmetric information and coordination and network failures. Secondly, the alternative rules to define how parties regulate access rights to the resulting knowledge are weighted, focusing on potential effects to dynamic incentives and distortion of competition through the enforcement of IPRs. 2. Knowledge Dissemination Knowledge dissemination represents one of the main arguments for the justification of State aid for R&D activities, particularly R&D cooperation.1 By providing aid for the accomplishment of R&D, States can generate positive externalities to other economic activities by the generation and dissemination of technological knowledge. That technological knowledge, incorporated into products and processes, can be used to develop further knowledge and to improve the competitiveness of the industry, which generates 1. For example, State aid N 667/2007 (Germany, Land Mecklenburg-Vorpommern). R&D&I-scheme, ‘Guidelines for R&D&IPromotion.’ “By granting this type of aid, the German authorities hope to remedy market failures in the form of insufficient dissemination of information,” para 51. benefits for the society and the economy. Under the economic foundations of the EC Framework for State aid for R&D, aid measures are justified only in cases of market failures while information asymme■ Mario Cisneros, Ph.D, LL.M. try and limitations for knowledge disseminaUniversidad Austral and tion are identified as two NOVATIO Consulting, of the main target probAdjunct Professor and Director, lems responsible for Buenos Aires, Argentina productivity and competitive limitations of E-mail: [email protected] technology industries. Restrictions on the possibility to disclose knowledge generated from R&D projects are of primary concern for universities and research organizations. One of the primary goals of these institutions is to conduct fundamental research, industrial research or experimental development and to disseminate the results by way of teaching, publication or technology transfer. At the same time, scientists are evaluated by measuring quantity and quality of publications, while the reputation of research institutions is also weighted on the presence of their scientists in conferences, seminars and scientific journals. All these referred activities involve in one or another way disclosure of information resulting from R&D activities, including disclosure in the context of R&D cooperation with the industry. Nevertheless, a recent survey has indicated that no more than 25 percent of researchers in the EU make data generated from R&D projects available for everyone.2 Around 40 percent of researchers base their decision on potential legal problems generated as a consequence of the dissemination of those data. Several EU Governments have recently recognized the importance of the dissemination of research results generated from 2. Van der Hoeven J., “Insight into digital preservation of research output in Europe,” PARSE.Insight, June 2010. September 2014 206 EU State Aid Policy—Part II public funds.3 They believe that research results from publicly funded projects should be made available as widely as possible with no barriers to access and that improving access to the results benefits the economy and facilitates more effective knowledge exchange. This has raised awareness about the need for actions to increase access to the publications arising from R&D activities.4 At the same time, industrial partners are usually interested in protecting the results of R&D activities to avoid third parties free riding on those results. The use of secrecy over technological developments or scientific knowledge is one of the strategies followed by the industry in order to appropriate the benefits of investments in R&D activities. By avoiding the disclosure of valuable information, industrial undertakings can avoid competing companies to access the technology and the benefits generated by the use of knowledge.5 Theor y indicates that non-collaborative R&D levels decrease with higher spillovers, while investment in cooperative projects tend to increase with spillovers, and thus imperfect appropriability of knowledge increases the benefits from collaborative agreements.6 As expected, the presence of spillovers increases the incentive for R&D collaboration through the internalization of the positive externality, i.e. the knowledge acquired during the collaboration. But, imperfect appropriability of the generated knowledge also encourages third parties to free ride on the generated R&D results.7 Unfortunately, most of the theoretical models only consider horizontal R&D co-operation. Despite the fact that this theoretical approach has been of key importance in the development of competition policy in the field of horizontal agreements, the interest of State aid law is to assess vertical 3. For example, see the letter to Dame Janet Finch on the Government Response to the Finch Group Report: “Accessibility, sustainability, excellence: how to expand access to research publications,” July 2012. 4. Media Release, “Universities UK welcomes Dame Janet Finch report on open access,” June 2012. 5. Confidentiality or trade secret protection can only be implemented where the information is not disclosed by the mere commercialization or use of the product that embodies the technology. Typical examples of knowledge that can be protected by secrecy practices are technologies related to manufacturing processes. 6. Czarnitzki D, Ebersbergerc B., Andreas F., “The Relationship Between R&D Collaboration, Subsidies and R&D Performance: Empirical Evidence From Finland and Germany, Journal of Applied Econometrics,” J. Appl. Econ. 22: 1347–1366, 2007, pp. 1347–1366. 7. Id. 207 les Nouvelles cooperation, i.e. cooperation between industry and universities or ROs. 2.1 Existence of State Aid as a Consequence of Limitations to Knowledge Dissemination The Community Framework for State Aid for R&D&I requires the dissemination of results as one of the possible conditions for the Commission to consider that no indirect State aid is granted to the industrial partner through the research organization.8 Where the results of an R&D project are widely disseminated through technical and scientific conferences or published in scientific or technical journals or in open access repositories, a bonus in the ceiling thresholds to R&D projects is used to consider a State aid measure compatible with the internal market within the meaning of Article 107(3)(c) TFEU. Despite knowledge spillovers represented by the level of information dissemination foreseen in an R&D project being regarded as a positive effect of State aid measures, the Framework provides limited information on the mechanisms through which such spillovers take place, and no information on how disclosure mechanisms and incentives for disclosure should be assessed. Besides in the definition of the existence of indirect State aid, results dissemination prerequisites are also used to decide on the maximum amounts under which a State aid measure does not affect trading conditions to an extent contrary to the common interest.9 Thus, in establishing the rules for the calculation of the amount to determine compatibility of aid with Article 107(3)(c) TFEU, a bonus can be granted in the case that results are widely disseminated “through technical and scientific conferences or published in scientific or technical journals.”10 The provision implicitly accepts the fact that dissemination of R&D results can affect trading conditions and a competitive market. From these elements it can be proposed that dissemination of results as an assessment variable for the existence of indirect State aid finds its legal justification either in its effect on the selective advantage requirement, due to the favourable conditions of the collaboration, or in the distortion or the threat to distort trade and competition. 8. The requirement is limited to knowledge that does not give rise to IPRs. 9. Id. 10. Id. In many cases, the access to scientific publications and conferences is limited by fee payments by private publishers or conference organizers, which in practice reduce the possibility of third parties to access the related knowledge. EU State Aid Policy—Part II 2.2Distortion of Competition as a Result of Limitations in Knowledge Dissemination Knowledge spillovers can take place by several means. The most classic examples refer to scientific and technical publications, lectures, seminars, and presentations in specialized conferences. Other means of knowledge spillovers take place via the mobility of scientists, the licensing and commercialization of products and technology and the publication of patents. Knowledge dissemination is extensively referred to as a positive spillover in the creation of new technological knowledge, the increase of productivity and the commercialization of new products and services.11 Disclosure and dissemination being a necessary step in the process, effective knowledge transfer defined as the capacity of third parties to integrate such knowledge into processes and products, translates such spillovers into positive effects.12 Knowledge dissemination has to be understood as an intermediate step between knowledge generation and knowledge absorption.13 If it is assumed that knowledge dissemination requires not only the willingness to disclose, but also the resources to make such disclosure effective by publications in recognized journals or conferences presentations, it is reasonable to consider that parties will not make the resulting knowledge public or, at least, will not spend resources in making third parties aware of the knowledge except when they have an incentive to do so. In this perspective, it is clear that the generation of knowledge is not a sufficient condition to have positive externalities from dissemination and that State aid does not guarantee knowledge spillovers to take place. Studies show that researchers in the EU consider that up to 50 percent of additional effort, compared to the resources invested in production and analysis, is necessary to preserve R&D data and results in a re-usable form.14 Under this perspective, State aid measures that explicitly request disclosure of research results in an usable manner would assure more knowledge dissemination. 11. Block J., et al., “What turns knowledge into innovative products? The role of entrepreneurship and knowledge spillovers,” Journal of Evolutionary Economics, 2012. 12. Janczak S., “Knowledge and learning in strategic alliances: how to learn with cooperation,” Problems and Perspectives in Management, Volume 6, Issue 1, 2008, volume 6. 13. Eckl V., “Barriers of knowledge transfer,” Stifterverband für die deutsche Wissenschaft e.v., Druid, 2012. 14. Holzner A. et al, “First results from PARSE. Insight The HEP survey on data preservation, re-use and (open) access,” First Workshop on Data Preservation and Long Term Analysis in HEPv, 2009. As described, in projects carried out jointly by undertakings and research organizations, the Commission considers that no indirect State aid is granted to the industrial partner through the research organization, due to the favourable conditions of the collaboration, if the results which do not give rise to intellectual property rights may be widely disseminated.15 It should be noticed that the provision does not require that the results are widely disseminated but just that they may be disseminated. The condition implicitly assumes that market distortions are less likely to occur if results are open to be disclosed as a consequence of less favourable conditions granted to the industrial partner. Under this perspective, the opposite reasoning assumes that if dissemination of results is not possible, market distortion generated by knowledge access restriction may exist. Following the reasoning, cooperation agreements with restrictions on result disclosure can potentially generate a distortion in competition markets, which makes the State aid measure to be incompatible under Article 107(1) TFEU. In the same way, from the perspective of the incentive effect requirement, State aid measures should be focused not only on the generation of more R&D results but also on the generation of knowledge spillovers as a way to make State expenditure more efficient by producing more positive externalities. The essence of this view is shared by the ECJ, which agrees that confidentiality agreements between undertakings may occasionally prevent, restrict or distort competition.16 To be compatible with the internal market, State aid measures should modify the behaviour of the beneficiaries and generate an incentive to encourage more and better R&D. In a scenario where a reduction in the restrictions for use, open access and free publication policies are promoted,17 more effective State aid measures would imply a greater generation of positive externalities by the dissemination of R&D results. The EC has recently recognized the importance to improve access to scientific information produced in the EU to allow researchers and businesses to build on the findings of public funded research.18 While open access to scientific publications will be a general 15. Other conditions apply. 16. C-7/95, John Deere Ltd v Commission, ERC I-03111, 1998. 17. “Accessibility, sustainability, excellence: how to expand access to research publications,” Letter to Dame Janet Finch on the Government Response to the Finch Group Report, July 2012. 18. EC Press Release, Scientific data: open access to research results will boost Europe’s innovation capacity, July 2012. September 2014 208 EU State Aid Policy—Part II principle in the Horizon 2020 Program,19 the EU’s Research & Innovation funding plan for 2014-2020, the Commission has also recommended Member States to take a similar approach for the results of R&D funded under their own programs.20 Restrictions on knowledge dissemination may create positive or negative incentives. In any case, the assessment of such practice should take place in the context of the R&D project and the aim of the aid measure. When knowledge spillovers want to be favoured, no dissemination restrictions should be allowed. In cases where a comparative competitive advantage of the aided undertaking is the objective, the use of tools that favour the appropriation of R&D results, including secrecy, should be promoted. While an obligation to disclose and effectively transfer the generated knowledge may in some cases deter the participation of industrial partners in R&D cooperation projects, disclosure limitations in collaboration projects should be allowed only under certain circumstances. The assessment of such limitations should be explicitly promoted by State aid law. 2.3The Grant of an Advantage and Knowledge Dissemination Restrictions Advantage requirements refer to a specific and selective State aid benefit granted to one or several undertakings. According to Article 107(1) TFEU, an advantage can be granted “in any form whatsoever.”21 A direct transfer of IPRs from a research organization to the industry is the obvious example of a transfer of intangible resources from a State controlled institution to an industrial undertaking. Another less obvious resource transfer can be represented by the transfer of knowledge, generated either during the execution of the collaborative project, the foreground technology, or in possession of the research organization before the start of the project. Confidentiality requirements, restrictions for open dissemination and the limitations for the research undertaking to make technological knowledge available by disclosures to third parties is a less obvious element to evaluate in assessing the transfer of resources under State aid law. Industrial partners in R&D cooperation are usually interested to limit the disclosure of information in 19. Horizon 2020 is the financial instrument implementing the Innovation Union, a Europe 2020 flagship initiative aimed at securing Europe’s global competitiveness, running from 2014 to 2020 with an $80 billion budget. 20. Id. 21. Id. 209 les Nouvelles order to avoid third parties to free ride on the project results. Firms with higher incoming spillovers and better appropriation mechanisms have a higher probability to cooperate in R&D.22 At the same time, consortia organize to avoid spillovers, and therefore do not achieve the cross-pollination of know-how that State aid partially wants to achieve.23 The interests of the industrial partner and the research organization on this subject are usually contradictory. While the industrial undertaking can be benefited from limited dissemination of research results, the research organization usually pursues the objective of publication and the possibility to use the results for teaching purposes. The divergence on the standpoint of both parties depends on factors like the nature of the technology, the characteristics of the research project and the objectives and internal policies of the cooperating parties. In case that a legal protection scheme, other than secrecy, is available, the parties usually agree on the proper timing to firstly apply for such protection and then, depending on the required procedures, to proceed with the publication by the research partner.24 Nevertheless, in cases that no alternative protection scheme is available, a common situation in projects dealing with basic research and the generation of knowledge without direct industrial applicability, secrecy may be the only protection at hand.25 In cases where protection by other means is not available, the industrial partner may request partial or total confidentiality over the resulted knowledge or a refusal right for any publication related to the project that is proposed by the research organization or the involved researchers. The possibility to maintain the results of R&D activities resulting from a State aided cooperation project secret may represent a benefit for the industrial partner. Such benefit, activated by the limitation of the RO to publish, represents a transfer of resources from the research institution to the industrial partner and an advantage under Article 107(1) TFEU. 22. Cassiman & Veugelers 2001. 23. Majewski S., “How Do Consortia Organize Collaborative R&D? Evidence from the National Cooperative Research Act,” Industry Studies Annual Conference, 2008. 24. Responsible Partnering Initiative 2009. For example, to permit the filing of patent application without loosing the novel character of the invention. 25. Patent law requires the invention to be plausible of industrial applicability to be patentable. Discoveries and general scientific theories are usually not patentable. EU State Aid Policy—Part II 3. Use and Licensing of IPRs The term exploitation of IPRs refers to the utilization of intangible assets in internal processes and the production of products or the licensing out of the technology for use by third parties. Traditional exploitation of IPRs by research organizations is limited to activities of research and teaching. Recently, more sophisticated approaches for IPR use and exploitation have included licensing out strategies and the creation of spin-off companies.26 In the context of cooperation projects, the agreement between the parties on the use and exploitation of IPR related foreground and background technology is of key relevance.27 The agreement will define the circumstances and conditions under which each party is allowed to exploit the resulted technology. Such agreements usually also determine how background IPRs are used for the execution and after completion of the cooperation project.28 Regarding the foreground technology, crucial points to decide are the use and scope of licensing practices and its scope by the participants for exclusive or non-exclusive, commercial or noncommercial use, limitation in time and territory or the allowed industrial field for commercial application and use.29 Use rights can be granted by the owner of the related IPRs or the proprietor of a related licensing right. For example, an RO may provide certain knowledge that needs to be used during the R&D cooperation project. In granting a license or a use right to the industrial partner, the research organization may decide the conditions under which that knowledge can be used, for example, that the authorization is limited to the cooperation project and that the industrial partner 26. Intellectual Asset Management for Universities, The Intellectual Property Office (IPO) Report, UK, 2011. 27. Background technology means “information which is held by participants prior to their accession to the grant agreement, as well as copyrights or other intellectual property rights pertaining to such information, the application for which has been filed before their accession to the grant agreement, and which is needed for carrying out the indirect action or for using the results of the indirect action,” Council Regulation (Euratom) No 1908/2006 of 19 December 2006 laying down the rules for the participation of undertakings, research centres and universities in action under the Seventh Framework Programme of the European Atomic Energy Community and for the dissemination of research results (2007 to 2011). 28. “Intellectual Property (IP) Management in International Research Collaboration Agreements between European and NonEuropean Partners,” Knowledge Transfer Working Group of the European Research Area Committee, June 2012. 29. Id. is forbidden from using the background technology with other purposes after the termination of the cooperation contract. Such kind of agreements may limit future development of the resulted technology by the industrial partner. In the same way, the industrial partner may decide that the foreground technology can not be used by the research organization for research or teaching purposes out of the cooperation project, which may limit the freedom of the research organization to use in the future the results of the cooperation. Thus, parties agree on access rights for the project, access rights for further research and access rights for future scientific or commercial development of the results and the previously owned knowledge.30 These agreements, while producing a market impact, can be the object of assessment under compatibility rules of State aid law. In evaluating licensing agreements between undertakings, the Commission has issued a block exception and guidelines to interpret how technology transfer practices can distort competition.31 While the referred framework is limited to assess transfer and licensing of IPRs in the context of Article 101 TFEU, the underlying reasoning may be extrapolated to other areas of competition law, like State aid law.32 In this context, the Commission has indicated that, “In order not to reduce dynamic competition and to maintain the incentive to innovate, the innovator must not be unduly restricted in the exploitation of intellectual property rights that turn out to be valuable. For these reasons the innovator should normally be free to seek compensation for successful projects that is sufficient to maintain investment incentives (…).” While this guideline indicates that distorting agreements between undertakings on the licensing of IPRs may still generate incentives to innovate, it 30. Id. 31. Commission Regulation (EC) No 772/2004 of 27 April 2004 on the application of Article 101(3) of the Treaty to categories of technology transfer agreements, and Communication from the Commission on Guidelines on the applicability of Article 101 of the Treaty on the Functioning of the European Union to horizontal co-operation agreements, (2011/C 11/01). 32. Article 101 TFEU rules “The following shall be prohibited as incompatible with the internal market: all agreements between undertakings, decisions by associations of undertakings and concerted practices which may affect trade between Member States and which have as their object or effect the prevention, restriction or distortion of competition within the internal market.” While Article 101 targets agreements between undertakings, Article 107 rules on measures taken by Member States, both articles belongs to the Chapter 1 of the TFEU, “Rules on Competition,” which is intended to avoid competition distortions in the internal market. September 2014 210 EU State Aid Policy—Part II is also true that in the case of State aid measures such incentives are produced by the grant of State benefits to the participating undertakings. Thus, the threshold under which IPRs exploitation agreements are evaluated from the perspective of State aid law should be much higher than the threshold used in the case of agreements between undertakings involving IPRs generated with private funds. Otherwise, a double cost on tax payers would be imposed: the cost of expenditure in State aid measures and the dead weight loss associated to the enforcement of IPRs. Certain characteristics of collaborative projects may lead to the transfer of IPRs at reduced price. ROs are becoming more interested during the last years in putting to use the technology developed by researchers. This objective, still not as important as publication but gaining relevance with the development of technology transfer activities, constitutes a pressure to the RO to agree on lower transfer prices. Either for a license or the transfer of ownership the RO usually considers that placing the technology in use is more preferable than to recover R&D costs or to generate an income to the institution. Usually, there is no more than one company interested in the technology and a public tender becomes impracticable, though a competitive procedure is not enough to eliminate State aid.33 Usually, the RO will include certain conditions in the contract, as to limit the license to the business field of the licensee or a clause establishing the termination of the contract in case the licensee does not commercialize the technology after a certain amount of time. Imposing conditions on the licensee will not automatically eliminate State aid in the transaction, and it is still the evaluation of the conditions under the perspective of a rational market player that counts. In case the State, in trying to speed up transfer of technology to the industry, encourages ROs to an undervaluation of intangible assets in order to sign more licensing contracts, those transactions are clearly under the scope of Article 107. From the perspective of case law, the requirement to an RO to behave as a market player trying to maximize income from a license agreement to eliminate State aid is still in place.34 33. Nicolaides P., “State Aid, Advantage and Competitive Selection: What Is a Normal Market Transaction?,” European State Aid Law Quarterly, 2010. 34. See C-334/99–Germany v Commission, 2003 I-01139 and C 56/06 (ex NN 77/06) Commission Decision on State aid implemented by Austria for the privatization of Bank Burgenland, 2008, cited in Nicolaides P., “State Aid, Advantage and Competitive Selection: What Is a Normal Market Transaction?,” European State Aid Law Quarterly, 2010. 211 les Nouvelles 3.1Limitations of Dynamic Incentives and IPR Use Limitations on the use of background and foreground technology in future R&D projects may affect the development of improvements and constrain further cooperation with third parties. A wide authorization to use background and foreground knowledge and IPRs would, in principle, prevent competition restrictions. A distinction should be made between background and foreground, and the different possible uses assigned to the technology. In the first case, it is a normal assumption that both parties are free to independently assign use rights over related IPRs and protected knowledge. Usual agreements grant crossed rights over background technology that need to be used during the execution of the cooperation project.35 The conflict may arise in connection to the use of background technology for purposes of those related to the cooperation project, which are rarely granted by the cooperating parties. From the perspective of dynamic incentives for further development of the technology, either for improvements or as a result of the need to use the background as a platform to enter in an R&D project in other technological field, it is of interest that use rights are granted by the parties. In principle, this would avoid further negotiation on the terms of use of such technology, simplifying the process and reducing transaction costs. In the second case, where foreground technology is the result of the joint effort between the research organization and the industrial partner, the same concepts concerning the possibility to further develop on the resulted technology apply. Barriers in the possibility to use the resulted knowledge to further develop an improvement would mutually block parties from the possibility to further invest in improvements. The effect could be more relevant in case that the resulted knowledge represents a platform technology or scientific concepts that can be used in a variety of industrial and academic fields. While blocking future use of foreground and background technology would protect the industrial partner from the possibility that competitors free ride over their proprietary technology, dynamic 35. A detailed analysis of the alternative use schemes proposed by industrial and research organizations is provided in M. Cisneros, “The Role of EU State Aid Law in Promoting a Pro-Innovation Policy—A Review from the Perspective of Public-Private R&D Cooperation.” Intersentia (UK), 2014. EU State Aid Policy—Part II incentives to further invest in R&D activities to improve the related technology will be diminished. The Commission has a clear position on the anticompetitive nature of agreements where the use of background technology is not allowed to one of the cooperating parties. Provided other competition provisions pursue the same objective of avoiding a distortion in the competing forces between undertakings, the analysis of some of those rules may provide an indication on how the Commission would assess agreements under the perspective of State aid law. Under this view, the Commission has indicated that to effectively protect competition “the research and development agreement must stipulate that each party must be granted access to any pre-existing know-how of the other parties, if this know-how is indispensable for the purposes of its exploitation of the results.”36 Regarding foreground technology, the Commission has indicated that “the research and development agreement must stipulate that all the parties have full access to the final results of the joint research and development (…), including any resulting intellectual property rights and know-how, for the purposes of further research and development and exploitation.”37 While these rules are applicable to any agreement under the scope of Article 101 TFEU, it is arguable that in cases where State funds are involved the restrictions to avoid for anti-competitive behavior between the parties should be strengthened. In this scenario, the view of this paper is that State aid measures should incorporate more clear rules on the allowed agreements for the use and exploitation of background and foreground technology. 3.2Selective Advantage and the Use of IPRs By granting the industrial partner the right to use IPRs and knowledge with other objectives than performing the R&D tasks contemplated in the cooperation project or using the generated technology in the commercialization of product or services, the research organization may transfer rights that are in most of cases not appropriately valued in the amount of remuneration agreed by the parties. One reason for this is that research institutions cannot always clearly identify the background information. Several times such information is in possession of individual researches but not recorded as an institutional asset. 36. Article 3, para. 3, Commission Regulation (EU) No 1217/2010 on the application of Article 101(3) of the Treaty on the Functioning of the European Union to certain categories of research and development agreements, December 2010. 37. Id., para 2. Besides, part of the information is not protected by any means, either because the information relates to non-patentable knowledge, as discoveries or basic scientific knowledge without industrial application or simply because the organization has not implemented the necessary steps to formally protect the asset. In other cases, protection is not possible as a consequence of publication of the results by the researchers or the research organization, which in most jurisdictions impedes later patenting of the invention. These limitations make difficult the possibility to grant a license to the industrial partner on background technology. The knowledge transfer is in these cases not documented or contemplated in the calculation of the resources involved in the cooperation project. Thus, no monetary retribution can be requested from the industrial partner. This fact may constitute both, a hidden transfer of resources from the research organization to the industrial undertaking and the grant of a selective advantage. Despite the differences between protected and non-protected intellectual assets, know-how should account in the assessment to calculate aggregated benefits transferred to the industrial partner. In referring to the exploitation of research results, the Commission accounts for both, intellectual property rights and the know-how required for the manufacture or application of the technology.38 The only requirement for the know-how to be accounted as such is that it needs to be secret, substantial and identified.39 In cases where no clear identification can be made of the transferred assets, the aid cannot be considered as transparent, and block exemptions on the aid measure would not apply.40 Selective advantage can also be defined by the conditions, namely price and exclusivity, of the transfer of IPRs generated during a collaborative R&D project. If several industrial partners are involved in the collaborative project, transference conditions should be maintained equal to all of them to avoid favouring certain parties. Thus, price for the technology, either for a license or for the transfer of ownership of IPRs, 38. Id., Article 1, (g). 39. Id., (i). “Secret” means that that the know-how is not generally known or easily accessible; “substantial” means that the know-how is significant and useful for the manufacture of the contract products or the application of the contract technologies; “identified” means that the know-how is described in a sufficiently comprehensive manner so as to make it possible to verify that it fulfils the criteria of secrecy and substantiality. 40. See General Block Exemption Regulation, Reg. (EC) No 800/2008. September 2014 212 EU State Aid Policy—Part II should be kept equal for all partners. Even more, if no partner decides to acquire the IPRs and the RO determines to offer the technology to third parties not involved in the cooperation project, such transaction should also keep the same price as offered to the cooperating parties. This element may be taken into account by the EC to assess indirect State aid measures. For example, in an aid measure granted to the Ludwig Boltzmann Institut für Krebsforschung (LBG), the EC considered aid as compatible with the internal market because the contractual conditions for the cooperation established that if the cooperating parties accept the offer to take ownership or a license on the technology, the RO can put up for sale the IPR “at a price not inferior, and conditions not more favourable than those offered to the cooperating parties.”41 3.3Distortion of Competition by Limiting the Use of IPRs to Third Parties Limitations in the use of background and foreground technology can also limit competition in innovation and technology markets. The most clear example is the limitation for third parties to make use of the resulted knowledge in further R&D activities out of the scope of the cooperation project. The agreement between parties in an R&D project forbidding the grant of licenses to third parties may limit the further development of the related technology. IPRs allocation may determine the further development of the technology that is the object of the cooperation project. In principle, there is no non-commercial and experimental use exemption for patented technology under the European Patent Convention. Rules on enforcement of patented developments are exclusivity national law of member states. While some countries have implemented exclusions on patent rights in the benefit of science by granting exceptions for non-commercial use of patented technology, there is no general criterion that can be extrapolated at EU level.42 Those EU countries where research activities are exempted from patent rights would not produce distortions in competition for innovation intended to improve the technology. Nevertheless, in Member States where such exemption is not implemented, an agreement between the cooperating parties to limit the possibility to allow third parties to further develop the related technology would deter dynamic 41. State aid NN 65/2007 Austria, Ludwig Boltzmann Institut für Krebsforschung. 42. Implementing Article 27(b) of the Community Patent Convention (CPC). 213 les Nouvelles incentives. Under this perspective, universities and research institutions should assure that further development and non-commercial use of the IPRs generated as result of the collaboration can still be used for research and teaching purposes. Allocation of IPRs on the industrial partner may in some cases lead to a disincentive to continue with research projects and collaboration with other parties. Any future improvements of State aid law and particularly the Framework should consider these factors not only as direct and indirect State aid measures assessment, but also as an economic perspective to improve the efficiency of public expenditures. 3.4Distortion of Competition by the Enforcement of IPRs Recent behaviour of non-practicing entities, also known as patent trolls, generates concerns about IPR allocation and about the potential distortion of innovation and product markets. In theory, research institutions and industrial partners may act as patent trolls in trying to stop third parties from making use of the developed technology exclusively with the purpose of making profits of such rights, even when the enforcing party is not interested to commercialize or produce the related product. In practice, due to the nature of public research institutions, acting as non-practicing IPR would be strange. IPR ownership with the industrial partner would in principle have a greater likelihood that an IPR generated as a consequence of the use of State aid ending up in the hands of a patent troll. State aid law should assure that R&D results generated from public funds are not used with these purposes. 4. Conclusions Diverse arrays of the available IPR ownership, disclosure and use schemes have been described. It was also shown how they may affect market competition under State aid measures compatibility assessment. This paper has provided an overview of contractual IPR provisions defined in collaborative R&D contracts and has discussed how these elements may determine the compatibility of State aid measures with the internal market. Generation of market power, distortion of dynamic incentives to innovation and the maintenance of inefficient market structures have been identified as potential consequences generated by certain IPR ownership models used in collaborative R&D contracts. A poor design of an aid measure, and the absence of IPR requirements in EU State aid law facilitates the possibility that parties organize in a way that the market can be distorted, either by distorting competition by some of the mentioned mechanisms or by the generation of adverse effects in the internal EU State Aid Policy—Part II market. It was also shown that IPR ownership models used by cooperating partners may be decisive in the assessment of selective advantage as defined by EU State aid law. The alternative schemes of exclusive vs. non-exclusive use of the resulting technology, free publication vs. secrecy, public vs. private ownership and intermediate IPR options have shown not to be neutral in assessing the effects of State aid measures on the market. One of the critical justifications for State intervention, the positive spillovers generated by R&D cooperation between ROs and industry, is highly affected by restrictions on knowledge dissemination. Moreover, the dissemination objective pursued by R&D aid measures may be offset by contractual limitations on disclosure and use between cooperating partners. In this way, it was shown that IPR schemes should be coherent with the market failures that State aid measures try to solve. Taking into account the fundamental effect that IPRs and disclosure models selected by collaboration partners may have on the spillovers pursued by R&D State aid measures, and considering the fundamental interest of the Commission in both market functioning and efficient use of State aid, it is crucial that some basic IPRs and disclosure conditions are imposed to aid measures targeting R&D cooperation in the new Framework. Today, IPRs are only mentioned as an ingredient to define the existence of indirect State aid in RO-industry cooperation. Nonetheless, the new Framework should go beyond this point to explicitly incorporate IPRs and knowledge dissemination as one of the fundamental elements in applying the balancing test. ■ September 2014 214 UniLink UniLink: A New Model For Increasing Academic And Industry Partnerships By Hester Tak and Bob Smailes Abstract Tech transfer models for university-industry licensing are essentially of three types. The classical model used by the majority of universities, the economic model and more recently, the Easy Access IP model, which is gaining popularity. The models are summarized with their advantages and disadvantages and an alternative model, UniLink, is presented which has been discussed with over 50 international companies with positive results. The views received from the international companies reflect their experiences worldwide. UniLink was developed in The Netherlands to overcome problems in the classical model. The problems described in the literature regarding the classical tech transfer offices primarily reflect the U.S. situation. However, the Dutch TTO’s seem to be suffering from the same problems. The model seeks to optimize academic-industry interaction by allowing early stage insight into unpublished research results in a controlled way. Benefits include reduced transaction time and costs, lower patent costs, an expected increase in the volume of research collaboration with industry, and an expected increase in the value of research collaboration for the universities. The benefits for the companies include insight into research outputs, shorter transaction time and costs, potential ability to influence the direction of translational research programs in the institutions, use of the research for their own internal programs, free access to research tools; and the research is expected to have greater societal, commercial and economic benefit. here are many different definitions for the term technology transfer. Generally speaking, the term is used for a process of transferring knowledge or technology from one entity or individual to another entity or individual. The movement may involve physical assets, know-how, and technical knowledge1 and in some cases relocating or the exchange of personnel.8 The term technology transfer can also 1) apply across or within firms, 2) across or within universities, and 3) also across university-industry collaborations. More recently the term knowledge exchange is also used to indicate the stream of information and knowledge is, or should be, both ways rather than coming from one direction. T 215 les Nouvelles As most universities will confirm, there has been a growing pressure to turn knowledge into commercially applicable products through partnering with firms. These innovations create both societal and economic impact. Traditionally, technology transfer is formalized through license contracts, royalty arrangements and patents. In collaborative research, exchange of know-how often occurs through direct interaction and is therefore an informal mechanism of technology transfer.6 With the pressure that has been put on the universities to demonstrate the impact of research funding, many academic institutions have a formal technology transfer mission as part of their core tasks besides teaching, research, education, further training, and if the institution has a medical hospital attached, patient care. Universities globally have been setting up Technology Transfer Offices (TTOs) whose main task is to carry out and manage the transfer of inventions and knowledge into the market. Particularly in university-industry collaborations, transfer of technology is often formalized through filing of patents and subsequently negotiating licenses and research agreements. There are three drivers for universities to engage in technology transfer or exchange activities: societal benefit, economic benefit and financial benefit. Each of these variables can be given a weighting. Some institutions will value societal benefit more than economic benefit perhaps, whereas others may find the financial benefit to the institution more important. Depending on how an institution ranks each of these drivers, the way the TTO carries out its task will follow from that. For example, an institution that focuses primarily on financial return will argue hard for upfront payment, milestones and royalties. There are three basic “business models” that can be identified that institutions use to carry out their technology transfer activities. Firstly, the traditional or classical technology transfer model. Secondly, the economic model and thirdly, a recently emerged model called Easy Access IP Each of these models will be discussed below. The Classical Technology Transfer Model In 1980 the Bayh-Dole act was introduced in the UniLink U.S. This Act allowed intellectual property rights generated using funds from federal research grants to be transferred to the institution. As a result, many universities started engaging in technology transfer as an out flow of their academic research mission. In order to encourage industrial parties to develop some of these technologies, universities were allowed to patent their inventions. Through this mechanism, industry would be able to protect their investments.16 Having universities being able to protect their inventions before offering them to industry, forms the basis of the classical technology transfer model. The classical model is a filtration process that eventually leads to a selection of inventions being disclosed to the commercial sector. Academics make the first selection of what is potentially of interest to industry. This selection is then brought forward to the TTO as a disclosure and the TTO will make a further selection of which inventions potentially have commercial interest (Step 2, Figure 1). In most cases, the inventions brought forward are often very embryonic. The third step is a “due diligence step” and includes looking at the science, the marketability and the patentability of the invention. In the event the inventions are patentable, have favorable market potential and the science data is sufficient, the TTO will move into the “patenting phase” (Step 4, Figure 1). The cost of filing a patent varies per area, but generally speaking, patenting process is regarded as a costly game and a risk for the institution as there is no assurance of finding a licensee or that the licensee will successfully take it to market.3 In the life sciences, there is an additional complication. Because these inventions are often very embryonic, some patents have to be re-filed because of new data, which in turn affect the claims. Patents can only be re-filed if there has been no publication yet and the first filing can be retracted. Once the patent is filed, the TTO staff will look for potential licensees, also known as the “marketing phase” (Step 5, Figure 1). Sometimes potential interest is brought forward by the academics that know from their industry network where the technology may potentially fit. If no prior licensee has been identified, a non-confidential document is produced giving a short summary of the invention and additional information such as the advantages over the golden standard (if there is one), the status of patent (filed, granted) and/or what the institution is looking for (e.g. license and/or collaboration transfer of rights, etc.) are mentioned. This non-confidential document (NCD) is subsequently targeted towards companies who have expressed an interest in a certain area. In addition, the NCD is posted on the university TTO website and some institutions may also post the NCD on more general showcase websites such as iBridge (www.iBridgeNetwork.org) or Innoget (www. innoget.com). Having identified a potential licensee, the TTO and the firm will subsequently start negotiating a license. This is the “negotiating phase” (Step 6, Figure 1). The art of negotiating is to incorporate the interests of the academic, the institution and the licensee into one agreement. Where some clauses will be relatively standard, the key clauses that are negotiated heavily in licenses ■ Hester Tak, are the financial comGunn & Twynmore, ponents (upfront payPartner, ments, milestones and Leiden, The Netherlands royalties). Regarding the research agreements, E-mail: [email protected] publication clauses and licenses to foreground ■ Bob Smailes, IP, for example, are Gunn & Twynmore, heavily negotiated. Partner, A license can be given to an existing company Leiden, The Netherlands or a start-up (Step 7 & E-mail: [email protected] 8, Figure 1). In some cases, the institution may choose to spin the technology out itself (spin-out) often negotiating both a license and an equity stake. The decision to set up a spinout company is often highly dependent on the entrepreneurial spirit of the academic.4 However, if the technology is regarded as radical or pioneering, most universities will make a decision to go for a spinout, even if the academic is not so entrepreneurial. In these cases, the academic will often stay closely involved in the research from within the institution.17 In summary, the commercialization of technology begins with an invention and is subsequently depicted as a linear process including evaluation, patenting, marketing and license negotiating.2 The Economic Model A second (economic) business model is primarily focused on developing the regional economy. The focus of this model is on developing spinouts and/or start-ups and licensing to existing companies in the local area. Like the traditional technology transfer model, it is a technology push model. However, this model is not found in Europe as most countries in Europe have to comply with the rules and regulations of the EU, which do not allow preferences to local firms for economic development. September 2014 216 UniLink Easy Access IP A third business model, Easy Access IP is a relatively new business model, but has gained quite some popularity in a short time period. This model, too, is focused on technology push. In this model, the technologies are offered for free to industry using standard license agreements in exchange for “anticipated future engagements” within a period of three years after the license has been granted. If this does not occur, the license is terminated. Companies have to indicate how they wish to use the technology, etc., when they apply for a license. Some universities have adopted this model in parallel to the traditional technology transfer model whereas others have adopted the model as their sole technology transfer model. The biggest criticism companies have, however, is that they feel that universities who have adopted Easy Access IP in parallel to the traditional technology transfer model, save the potentially revenue generating inventions for the traditional model and “the rest” is offered via Easy Access IP How the universities select which technologies go via which route is not disclosed to industry. Problems in Classical Technology Transfer Model As most institutions still operate under the classical technology transfer model, the most common problems are listed and described. The first problem arises at the start of the process. Before any invention reaches the TTO, the academics make a selection of their research output that they think may have a commercial application. These inventions are then brought forward to the TTO who then filters a second time. In other words, it begins with a double filtration process. Although the intentions of the Bayh-Dole act were good, the institutions have become real protectionists of the IP they generate and have become too concerned with the legal aspects.13 This has resulted in long negotiating times and because the negotiations take longer and longer, the actual deal flow decreases. One of the elements that takes up more and more time in the negotiations is the determination of the value of the technology. It can be argued that both sides have polarized views of what the value is. Institutions seem to start the negotiations with what they perceive is the potential value of the technology when it reaches the market whereas most firms start negotiating from the standpoint of the technology’s value at the time of negotiating and the risk they still need to take to develop the technology. These are two very different viewpoints and the basis for 217 les Nouvelles long and complicated discussions. Because of the long negotiating time, some academics and firms are avoiding the TTO. A recent study14 shows that it currently takes four years for 50 percent of the disclosures to go from the moment of disclosure to the TTO to the signature on the license agreement. During this time, a lot of the research related to the technology is on hold, which leads to a loss of value. This has led to situations where firms are contacting academics directly and arranging to work with them informally.12 This in turn means that many technologies are indeed “going out the back door.”7 Also, managers and entrepreneurs have expressed the lack of skillset with TTO staff regarding marketing and negotiations13 as well as their lack of dealmaking mentality,11 which also may be a reason for the firms to avoid the TTO. There also appear to be other problems of a more abstract nature such as the bureaucracy and inflexibility of the institution.13 But not only are the firms avoiding the TTO, also academics sometimes avoid the TTO.12 There also seems to be a mutual complaint from both academics and industry regarding the lack of understanding of the other party regarding the norms; academics do not sufficiently understand the industry environment and industry insufficiently understands the academic world. Thus, more efforts and time should be spent on developing a mutual understanding, also referred to as boundary spanning.13 An additional problem that causes delays is the fact that R&D activities by larger pharmaceutical companies are outsourced to smaller biotechnology SME’s. This in turn has led to a change in the number of potential licensees for an institution. Although the number of SME’s in biotechnology is far larger than the number of multinational pharmaceutical companies, it has become increasingly difficult to identify the right companies during marketing activities by the TTO as these SME’s potentially could be based anywhere around the world. Because it is taking longer to identify the right partners and subsequently negotiate a license, the institutions are inclined to maintain their patent portfolios beyond national phase. Taking patents into national phase can become very expensive if protection is sought in Europe. As most institutions have a limited patent budget, some technologies and inventions may be dropped before they’ve had a fair chance to be tested out in the market. Even if the process is successful and a license is agreed between the parties, there is no guarantee UniLink that there will be any financial benefit for the institution beyond the upfront payments that may have been negotiated. The rest of the financial benefit (milestones and royalties) is highly dependent on the research that still needs to take place and the sales figures. The financial share that the institution gets follows what has been negotiated. As has been described above, TTOs are often regarded as obstacles. In addition to these problems, the efforts and investments made by the TTO both in time and money do not seem to pay off. The majority of the TTOs are not profitable and even if the benefits are higher than the cost of running a TTO, the income stream is still a relatively small percentage of the total research volume. Trends The universities are part of a complex ecosystem and work together with many different bodies. In each part of the ecosystem, changes are taking place and putting pressure on the institutions to change as well. The two biggest “sectors” that the universities deal with and are evolving onwards are the government and the industry sector. Many governments seem to focus more on the valorization of the research they fund and stimulate (PPP) private partnerships. The EU, too, is investing heavily in public private partnerships with Horizon 2020, which has a total budget of EUR 79 billion. The interest in partnership models and different types of partnership models seems to exist amongst industry as well. More and more collaboration models are being tried but with various degrees of success. There is a clear shift in the pharma sector whereby companies are moving from a closed environment to an open environment; it is more about collaboration than deals. Companies have found that the classical technology transfer model does not work efficiently, especially without (academic) collaborations, and therefore, a shift can be seen from ownership of IP to freedom-to-operate (FTO). Companies are looking toward new ways of finding their technologies: collaborations, scouting networks such as innocentive, yet2com, nine sigma, etc., as well as their own innovation portals being used to post the challenges they face (“technology pull”). An Alternative Academic-Industry Partnership Model Given the above issues and the trends, there is room and opportunity to explore new alternative academic-industry partnership models. The model below starts from a different perspective than the models described earlier. The basis of UniLink is about giving insight into research output to industry in a structured way that goes beyond the inventions and research tools offered in the classical model. The model is aimed to lower the threshold for knowledge exchange, to increase collaboration between industry and academia both at a national level as well as an international level. The long-term goals of the model include long term partnerships between academia and industry, an enhanced quality of translational research and higher societal economic impact. Related to these goals, four pillars have been developed: 1) facilitating easier access to knowledge and IP 2) broadening the partner base (this can be for both the institution as well as the industry sector) 3) increasing the number of research collaborations between academia and industry, and 4) developing an ecosystem that is complementary to the model. Each of these pillars has a subset of “modules” (Table 1). Two of these modules can be regarded as compulsory for the model: a platform to exchange information and data and an industry community. A more detailed description of each of the modules of each pillar will be given below. Pillar 1: Platform The platform, a cloud, is an essential element in the UniLink model. It offers a platform for academics to post their unpublished research outputs that would be sufficient for a publication. The outputs are presented in a format that is similar to the information sheets that are used for marketing patented technologies. The information should be short, concise and legible for all companies. If the companies see something that is of interest to them they can choose to take a license, collaborate or do both. In this respect, the platform is a “technology push” tool. If there is interest in certain research data, the companies can contact the academic directly via the platform. However, the platform also allows companies to post their (unused) technologies, expertise and/or challenges (“technology pull”). This allows academics insight into the needs of the companies as well. Pillar 1: Express Licensing Licensing can be done through standardized terms and fees. The contracts should be downloadable from the website. The company can fill out the form, sign and submit the contract to the TTO. There are two different types of research output that can be distinguished: research tools and any other IP research tools can include software for analyses, cell lines, antigens, etc., that can be used for research purposed. In some cases, certain research September 2014 218 UniLink tools can be commercialized as a product in itself. If a firm wishes to take a license for purposes other than research within its own organization, a commercial license should be taken. Because the model encourages research progress and research collaboration, the price for research tools ideally should be free or as low as possible (e.g. a fee or reimbursement for production costs). IP that is to be used beyond research purposes, require a commercial license. Again, a standard agreement that is downloadable from the website should lower the threshold. As in the Easy Access IP model, a short form should be included as an appendix to the contract before it is sent to the TTO. This form, a bid, should explain how the company thinks it can utilize the technology or develop it into a product, the expected time to market, the intention to collaborate with the institution (is not required but preferred) and if the company wishes to have an exclusive or non-exclusive license. It is not the intention of the form for the company to disclose highly classified information to the institutions, but there should be some openness as to how the technology is to be used. The bid will be used for two reasons: to evaluate the proposals of (a) potential partner(s) and for the reports that are due annually. If the reports divert drastically from the original bid, this may be a reason for the institution to terminate their license with the company. If there are good reasons why the original bid is no longer valid, e.g. there is a delay in the research due to specific circumstances, then the institution should accept that. A second way of using the bid may be to evaluate preferred partners if multiple parties apply for a license for the same technology. Reasons for selecting one partner above the other may be time-to-market (clinical benefit can be reached more quickly) or perhaps collaboration with the institution. However, the selection may be different for different institutions based on their drivers for doing tech transfer. The cost of a commercial license should be low as the model aims to lower barriers and thresholds. The model has been discussed with more than 50 companies of which half have had very detailed presentations and all, having confirmed that the model lowers the barriers, are very supportive. In these same discussions, the size of various license fees was discussed. A one off fee of 10K and an annual lease fee was acceptable to all. A variable lease fee was proposed depending on the size of the company. Small companies with less than 50 employees pay the smallest fee. Companies with 50-250 employees pay an annual lease fee of a few thousand euros e.g. €5K whereas companies with more than 250 employees 219 les Nouvelles could afford a little more e.g. €10K. The lease fee essentially replaces the milestones and the royalties. The fees are not meant to raise barriers but are there to remind companies that there is an expectation from the institution to take the technology forward to market. Pillar 2. Industry Community Because of patent law in most countries around the globe, patent application need to be filed before there is a public disclosure. As the platform offers insight into unpublished and pre-patented data, the cloud must be closed off in order to allow companies to file a patent and take a license. By closing the cloud, an industry community can be established which companies could join for a small fee. Once the companies are a member of the community, they have insight into the unpublished data for a select period of time, e.g. 3 months. After this time period, the academics are free to publish their results. Membership includes the right to use the research output for internal research in the firm. If the company wishes to exploit the research output at a later stage, it may need to take a sublicense from a third party or if there is no existing license, the invention is not protected and freely accessible for all parties. Inventions or technologies that companies would like to take a license to will have to be evaluated in that time period, as well as prepare the bid, and if the license is awarded, file the patent application. If this time period is too short for the company, they will need to discuss this with the academics directly. Members of the industry community also have other privileges. If a company sponsors research at full economic cost, any foreground IP that is developed in the course of that research collaboration will automatically be licensed to the company and will be regarded as fully paid-up. Companies who are not a member of the community can also carry out research with the institution, but they will be required to pay an extra percentage over the full cost of the research project for the paid-up license to any foreground that arises. An additional privilege that the community members have is that they have access to specific industry days. Pillar 2: Industry Days The platform is a tool that has very little human interaction. However, to establish good relationships there is a degree of personal interaction required. Often academics and firms meet each other at conferences, symposia, etc., and are more opportunistic than structured. The industry day program allows a more structured way of industry UniLink and academia to meet and collaborate together. The first type of industry day is focused on multidisciplinary challenges. Either the institution or the firms can bring these challenges forward. The idea behind these events is to bring different parties together to brainstorm and develop new “out-of-thebox” roadmaps. These events are to be held in small groups with partners who are genuinely interested in forming a small consortium to tackle a multidisciplinary challenge. Companies in different parts of the value chain should therefore also not be excluded. The second type of industry day event is focused on bringing information on a very broad topic together. For example, many institutions carry out stem cell research, often in different departments. In other words, it is rather fragmented over the organization. Even within the institution there is not a good overview of what expertise there is in stem cell. These events are primarily aimed at bringing the existing expertise together, which may be beneficial to both the companies as well as the academics themselves. The topics for these events can either be selected by the academics themselves or by the industry community. Pillar 2: PR and Outreach Universities are generally speaking not very good at PR activities. Although most universities will have a newsletter or a magazine, the distribution of these is limited and does not reach many people outside of the university ecosystem. As mentioned above, this model focuses on societal impact. The definition of societal impact goes beyond new products that enhance patient care, etc. It can and should be extended to other parts of society. As most institutions receive a large part of their funding from the government, sharing the achievements an institution has accomplished in research is therefore part of this model. There are different ways of connecting with society outside of the university community. For example, annual diner events relating to the industry club, strategic industry days and their topics, themed industry day calls and/or topics can be announced in (inter)national newspapers as well as interviews in more local newspapers with academics and their research. Institutions can even hold an “open house” event where scientists and doctors show the immediate community and others interested the latest technologies and research progress in certain areas to give them an idea of what the taxpayer’s money is used for. Some universities have started offering science summer camps to children and teenagers to encourage science education. All of these activities are different ways of engaging society, which many universities have not yet developed to their full potential. Pillar 3. Express Research As mentioned before, the platform is aimed at giving insight and, thus, expertise into the research that is carried out within an institution. This may lead to companies wanting to collaborate with academics. As with the licensing agreements, research agreements, too, seem to require long negotiating times. However, many of the clauses can be standardized as well. This leaves the science to be “negotiated and discussed” between the scientists. Pillar 3: Finance Structure for Research Projects Having lowered the threshold for research contracts, the calculation of the cost can also be more transparent through moving towards standard fees for students, PhD’s, postdoc’s, etc. A lump sum for a professor’s time can be included. The size of the lump sum can depend on the size and duration of the collaboration. In addition, a minimum overhead rate of 100 percent is to be added to the labour cost. The overhead rate is meant to cover indirect costs such as office space, lab space, depreciation of lab equipment, etc. In medical faculties it is not uncommon to use higher overhead rates due to the high-tech labs and facilities. Naturally, the final cost element that needs to be added is the material cost. Pillar 4. Student Link An important element of knowledge exchange is the linkage to students. Often companies are eager to take on students for internships and participate in practical PhD programs such as DEng. Some universities have well developed placement structures for students and companies. As this is an important element of knowledge exchange, there are potentially other ways of engaging students more in practical challenges. Specialized programs could be developed between the institution and firms where companies give students challenges related to their coursework that they can brainstorm over in teams. Alternatively, some challenges may be more appropriate to have a multi-disciplinary team of students to brainstorm over. Through the interactions with companies, students may be stimulated to think in a more entrepreneurial way as well. Pillar 4: External Ecosystem Some institutions will have an existing science park nearby the university campus or science faculties. This external ecosystem can be an important mechanism for attracting potential research partners for the institution and some science parks have very strong September 2014 220 UniLink ties with the institution. Especially incubators with spin-offs and start-ups often work closely with the institution. However, young companies, particularly in biotech, often face problems regarding investments in facilities and equipment. Some universities will allow them to make use of their facilities and equipment for a fee (facility sharing). In some cases, however, certain equipment is not available for companies, either because the institution uses its full capacity or simply because the institution does not have the equipment in its arsenal either. Therefore, a shared facility building may have an added value to some science parks if it can house facilities that are not available within the institution. The industry community may also lead to new customers or partners for the Science Park or even new residency. A business gateway could be established to help new businesses find the right partners and/or find their way around the Science Park and institution. A different element of the ecosystem is an external funding platform or investment fund for new research and/or technologies. Proof of concept funds, seed funds, etc., are important for bridging the valley of death. Long-term partners of the institution or members of the industry community together with the science parks could help develop this part of the ecosystem with government bodies co-investing. Pillar 4. Sustainable Social Development and Social Entrepreneurship Another way of engaging with society on a different level is through sustainable social development programs and social entrepreneurship programs. Many institutions have internships for medical students in Africa, South America or Eastern Asia. However, structured programs to engage actively in social development, regardless whether it is at a national or international level, for both students and professional university staff, are often lacking. Social entrepreneurship is also a new development in some corporate organizations. Combining the industry community and the institution together, potentially with financial institutions dedicated to entrepreneurial development could lead to long-term structural programs with other countries enhancing both societal benefit and economic benefit on a different scale. 221 les Nouvelles Potential Pitfalls There are potential pitfalls that need to be taken into account. The model requires active participation from the academics. It is therefore important that they are motivated sufficiently. With the downward pressure from the government funding schemes, most academics will be looking for a balanced research portfolio. For an academic institution, this is vital. If the balance slides to primarily industry funding, the focus may shift too much to translational research with fundamental research decreasing. A second pitfall is that the research output offered on the platform may result in a jungle of output, which becomes difficult to search and find what companies are looking for. Therefore, clear guidelines need to be developed what research output would be suitable for the platform so that an effective insight can be given. Flexibility The model with its different modules is relatively flexible. Leiden University and Leiden University Medical Center, at the time of submission of the article, have the intention to adopt the model (currently known as LeidenLink) later this year. A selection of the modules has been made and preparations for the implementation are currently taking place. The two institutions will be using one platform to give insight into their research. Other universities may join this platform. Similarly other platforms could be set-up at a regional, national or international level. Summary of Benefits The model offers benefits to both the institution and the companies. For the institution, the biggest benefits include reduced transaction time and costs, lower patent costs, an expected increase in the volume of research collaboration with industry, an expected increase in the value of research collaboration, spill-over effect to an increase in large PPP such as Horizon 2020 from the EU and the nature and quality of translational research will increase, which will result in higher societal and economic impact. The benefits for the companies include insight into research outputs, shorter transaction time and costs, potential ability to influence the direction of translational research programs in the institutions, use the research for their own internal programs, free access to research tools and the research is expected to have greater societal, commercial and economic benefit. ■ UniLink Bibliography 1. Bozeman, B. (2000). Technology transfer and public policy: a review of research and theory. Research Policy, 29, 627-655. 2. Bradley, S. R., Hayter, C. S., & Link, A. N. (2013). Models and methods of university technology transfer. Working Paper 13-10. 3. Colyvas, C., Crow, M., Gelijns, A., Mazzoleni, R., Nelson, R., & Rosenberg, N. (2002). How do university inventions get into practice? Management Science, 48 (1), 61-72. 4. Feldman, M., Feller, I., & Bercovitz, J. (2002). Equity and the technology transfer strategies of American research universities. Management Science, 48 (1), 105-121. 5. Jensen, R., & Thursby, M. (2003). The disclosing and licensing of university inventions: the best we can do with the s*** we get to work with. International Journal of Industrial Economics, 21 (9), 1271-1300. 6. Link, A. N., Siegel, D. S., & Bozeman, B. (2006). An emperical Analysis of the propensity of academics to engage in informal university technology transfer. Retrieved 12-11, 2013, from Rensselaer Working Papers in Economics: http://www/rpi.edu/dept/economics/www/workingpapers. 7. Markman, G. D., Gianiodis, P. T., & Phan, P. (2006). An agency theoretic study of the relationship between knowledge agents and university technology transfer offices. Rensselaer Polytechnic Working Paper. 8. Osman-Gani, A. (1999). International technology transfer for competitive advantage: a conceptual analysis of the role of HRD. Competitiveness Review, 9, 9. 9. Ramanathan, K. (n.d.). An Overview of Technology Transfer and Technology Transfer Models. Retrieved 1-2, 2014, from Bogazici University Technology Transfer Office: http://tto.boun.edu.tr// files/1383812118_An percent20overview percent20of percent20TT percent20and percent20TT percent20Models.pdf. 10. Shane, S., & Stuart, T. (2002). Organizational endowments and the performance of university startups. Management Science, 48 (1), 154-171. 11. Siegel, D. S., Waldman, D. A., Atwater, L. E., & Link, A. N. (2003). Commercial knowledge transfers from university to firms: improving the effectiveness of university-industry collaboration. The Journal of High Technology Management Research, 14, 111-133. 12. Siegel, D. S., Waldman, D. A., Atwater, L. E., & Link, A. N. (2004). Toward a model of the effective transfer of scientific knowledge from academicians to practitioners: qualitative evidence from commercialization of university technologies. Journal of Engineering and Technology Management, 21, 115-142. 13. Siegel, D. S., Waldman, D., & Link, A. (2003). Assessing the impact of organizational practices on the relative productivity of university technology transfer offices: an explorator y study. Research Policy, 32, 27-48. 14. Stevens, A. J., & Kato, K. (2013). Technology Transfer’s Twenty Five Percent Rule. les Nouvelles, XLVIII (1), 44-51. 15. Wood, M. (2009). Does one size fit all? The multiple organizational forms leading to successful academic entrepreneurship. Entrepreneurship Theory and Practice, 33 (4), 929-947. 16. Wood, M. S. (2011). A process model for academic entrepreneurship. Business Horizons, 54, 153-161. 17. Zander, U., & Kogut, B. (1995). Knowledge and the speed of the transfer and imitation of organizational capabilities: an empirical test. Organisation Science, 6 (1), 76-92. September 2014 222 UniLink Figure 1. 7 University Scientist Makes A Discovery 1 Discloses Invention To Technology Transfer Office 2 TTO Evaluates Invention, Decides Whether Or Not To Patent 3 Patent Applications 4 Market Technology To Firms/ Entrepreneurs 5 Negotiate Licensing Agreements/ Royalties/ Equity Stake, Etc. 6 Existing Firms Adapt And Use Technology License Technology 8 Spinoffs & Startup Companies Ref: Bradley, Hayter, & Link, 2013 Table 1. Pillar 1 Access To Knowledge And IP Pillar 2 Broadening Of The Partner Base Pillar 3 Increase The Number Of Collaborations Pillar 4 Develop An Ecosystem Required Modules Platform Industry Community — — Optional Modules Express Licensing Industry Days Express Research Student Link PR And Outreach Finance Structure Of Research Projects External Ecosystem Sustainable Development 223 les Nouvelles New Age Intellectual Property New Age Intellectual Property: Emerging Global Benefits By Lawrence J. Udell I originally wrote this article in the year 2000, which was a hectic time, especially with the potential disruption of it being the start of a new century and how would “modern” technology survive in the dilemma of Y2K and the new millennium. Well it did and we all gained a better knowledge of the high-tech world. As I now look back at the exciting times that I have lived through over the past 83 years, this article today has a significant new meaning. Since the introduction of the Internet, intellectual property has not only found its special place in the world economic markets, but also is steadily establishing new values and new business opportunities. Hundreds of companies have been created over the last decade for the sole purpose of selling, licensing and transferring new technologies. The World Wide Web has become an effective tool for this process and can showcase new technologies to a myriad of potential users. Since there are no geographic boundaries, the world becomes the market and continually enhances what is today a knowledgebased global economy. This does present a great many intellectual property issues as to rights and the ability to transfer said rights. Potential infringement would not be recognized until exposed to the world. This of course is establishing new opportunities for not only law firms but international consulting conglomerates that not very many years ago were called accounting firms. An example of the success of this new process is the dramatic increase over the last few years in licensing revenue. License Global estimated that in 2012 the world’s top 150 brand licensors generated US$230 billion globally. The Disney Company alone generated $39.3 billion. It has been estimated that in the U.S. there are several trillion dollars’ worth of non-performing or dormant intellectual property assets. Considering that the U. S. Patent & Trademark office in the year 2013, issued 305,081 patents, which is 5,867 every week, and at the same time received 11,564 new applications every week, makes the potential value even greater. These figures have basically doubled in the last decade. Bill Gates in an interview with the Washington Post stated that, “Patents are the new gold rush.” According to statistics issued by OMB (April 2012) IP intensive industries create 27.1 million jobs and indirectly support another 12.9 million jobs. IP is also critical ■ Lawrence J. Udell, to our balance of trade; Intellectual Property IP intensive industries International, LLC, accounted for $5.06 trillion in value added, or Founder/CEO, 34.8 percent of the U.S. Castro Valley, CA, USA gross domestic product. E-mail: [email protected] It is a well known fact that over 95 percent of all patents issued are never commercialized. So, whether it is an individual inventor or a corporation, there are literally millions of patents that are not being exploited. We can understand that with the individual inventor, this is very often due to lack of funding or that the product has no market. However, with the corporation, after going to the extensive time and expense from concept to patent, and not following the commercialization process, you have to ask, why? There is a myriad of answers, from poor calculations of the market, to not having a competitive advantage, to other potential products taking priority, etc. These are but a few of the contributing factors to why companies end up with patent portfolios that are not producing income. This also applies to universities and research facilities, including private and federal laboratories. When you consider the thousands of websites currently featuring technology transfer information or access, is it any wonder that the filing cabinets are opening? The National Technology Transfer Center in Wheeling, West Virginia, was an early attempt to move technologies from NASA into the private sector. It was created in 1989 by Congress, to provide American companies with access to federal R&D for the purpose of competing in the international marketplace. They have expanded their efforts to where September 2014 224 New Age Intellectual Property they now have a great success record and proof that invested tax dollars in federal R&D can provide a real transfusion to the U.S. economy. This is also true of the SBIR program initiated by Senator Warren Rudman (D-NH) in 1982 which has provided over $30 billion to American small business and allocates over $2 billion a year by the eleven federal agencies. I had the pleasure of providing early input into the program with Lee Mercer, Chief of Staff to Senator Rudman. Since those early days over 30 years ago, the Internet has provided innumerable advantages. Information access has made it much more difficult for companies and people to protect valuable assets. What has become a big business and often overlooked, is corporate intellectual property espionage. According to the U.S. Chamber of Commerce, it is costing corporations well over $100 billion a year in IP losses. In the late 80’s and early 90’s I was teaching accredited courses in Entrepreneurship at California State University and lecturing throughout the U.S. and Canada on the ever-increasing value of IP. With a background in IP since the late 1950’s, I assembled a small team of business and university colleagues and created a new program called T-MAP. This was the acronym for “Technology Market Assessment and Profiling.” The program consisted of matching federal lab scientists and their technologies with teams of business school students. The student team motivation was, “If you owned this technology, how could you become independently wealthy?” The program was co-funded by DOE and the various labs, such as Sandia and Lawrence Livermore. Each student team had a volunteer retired or corporate executive who served as their technical and business mentor. Over the four years of its operations, hundreds of technologies were evaluated and several licenses consummated with corporations of all sizes. Stories of the program appeared in major publications, including the Wall Street Journal in 1993. It was truly a hands-on learning experience for not only the students, but the lab researchers who were educated in real world dynamics. We have all been witness to the fact that a single invention can create a huge industry. Consider just the last fifty years, with such shining examples as the: transistor, integrated circuit, Kevlar, fiber optics, personal computers, MRI scanner, space shuttle, microprocessor, the laser, DNA, GPS, etc. A great example that I had the privilege of witnessing was the LCD (Liquid Crystal Display) invented and licensed 225 les Nouvelles worldwide by my former colleague and dear friend James Fergason, who at the time of his passing on December 9, 2008 held over 150 U.S. and over 500 foreign patents. Jim was inducted into the National Inventors Hall of Fame in 1999. His invention has led to a multi-billion dollar industry that employs over a million people throughout the world. He was a shining example to inventors everywhere how a humble Missouri farm boy became a multi-millionaire entrepreneur. We often traveled together giving speeches for the USPTO. In 2006 he was awarded the Lemelson-MIT award of $500,000, which he donated to various children’s hospitals. I was proud to have nominated him. The federal government’s budget for research and development in 2014 is $140 billion. When you add the federal laboratories, universities, colleges, nonprofit R&D facilities, plus American corporations, collectively there is a staggering $450 billion-plus a year spent on R & D. The results are obvious with the employment and positive economic conditions that exist. This is a contributing factor to motivation for creativity and Invention which is the greatest stimulation for the creation of improvements and new technologies. Now consider the demise of hundreds of dot-coms that have failed over the past few years. If you look carefully at those who had a very limited lifespan, you will find that they did not own any intellectual property or, if they did, it could not be validated. They were basically smoke and mirrors. The perception of value was created by the hype and the extraordinary amount of private and venture capital that was invested. This was a great period in America, since multi-millionaires were being created on a daily basis. It proved that a good new idea could create a company, especially when supported by an experienced management team. Whether it survived or not was not always the criteria, the money chase obliterated good logic. Within the past several years the venture capital industry pumped billions of dollars into computer and Internet companies. Today the objective is still profits and return on investment, but done with far more conservative planning and much better detailed due-diligence on the technology, intellectual property and management team. The firms that sell the assets of the failed dot-coms can easily place a value on furniture, computers and other tangible inventory. The problem is attempting to put a value on the intangible, such as patents, etc. After burning through $135 million in venture capital, the British fashion site Boo.com sold off its IP New Age Intellectual Property system for just $375,000. An important negotiating ingredient is if the IP has any issued patents or pending. The intelligent comparison of values becomes obvious since there is no guarantee that the patent(s) will ever issue, so what is there to sell? By the same token, in bankrupt situations there may not be a clear written document of who really owns the technology. The inventor and so often a cofounder assigned his or her rights to the corporation in exchange for equity. When the company is dying, then the question is asked; “If I exchanged my intellectual property for stock, and the stock isn’t worth anything now, do I get my IP or patents back, or are they sold to satisfy the creditors?” Should the intellectual property not sell, the rights could revert to the bank that provided loans, or remain with the asset-management firm given fiduciary control over the assets. In such a situation, the original reason for the company’s founding may be based upon the IP, which has now been reduced in value, unless it is worth something to a competitor, who will buy it for a few cents on the dollar. A great many companies are waiting in the wings to pick over the carcasses of those who are dying on the roadway to success. Why invest lots of money in creating new IP if it can be purchased for almost nothing? Sherwood Partners in Los Angeles, which liquidated assets for several tech companies was quoted as saying; “You’re buying a dream that’s not completed yet.” However, there are more success stories than there are failures. Experience of success comes from the doing. Failures are a great lesson in what to do right the next time. The news media rarely provides stories on business failures. The new products and technologies of tomorrow will come from the fertile minds of today’s creative inventors. Whether they are working in laboratories or in the garages of America, what they can envision can become reality. Technological progress has and is moving at an accelerated rate, since what is invented today creates the spark for the improvements of tomorrow. Nothing is standing still. I can remember my participation in a challenge presented by Ken Olsen about 40 years ago. As the founder and Chairman of Digital Equipment Corporation and one of America’s early premier entrepreneurs, the patent portfolio owned by DEC included over 1,500 issued patents. The objective was to isolate those that had the potential to be licensed for a new source of income. The strategy that was created worked, however, in those days even the words “technology transfer” or “commercialization” was not seriously considered. Also, there was no Internet to utilize for broadcast, or companies that would even consider taking on the challenge. When you consider that today huge multi-national corporations are investing in the creation of their own incubators, which not only serve as a means to keep creative people within the company, but also allows them to be a part of a new entity that is funded by the mother corporation. The result is greater diversification, and the ability of the offspring to grow at a fast rate, because of its relationship with the parent. Over the last several years I have had personal experience working with not only companies, but countries that are establishing their new venture innovation incubators with the help of the United Nations and others. The obvious results are greater employment, increased exports and a healthier economy. This benefits both the World Bank, and all those who are providing much needed resources into nations that are attempting to become more self sufficient. In looking back, Edison was credited with hundreds of inventions and products that we have taken for granted. However, one of his greatest achievements is recognized as creating the research and development process and laboratories to prove the concepts. When you think of Henry Ford, you immediately relate to the automobile, however, one of his greatest recognized accomplishment’s was creating the manufacturing assembly line. Today, the driving force in the world economy is inventions and technologies. It was not long ago when material assets, such as equipment and buildings were the priority, but not today since they have been replaced by intellectual property which now has established value on the corporations’ books. Shareholder value has a whole new meaning. One great example of the new age focus on intellectual property is IBM. For the last twenty-one years they have been number one in patents granted. In 2013 they were issued 6,809. It is easy to understand why they earn over a billion dollars a year in licensing royalties and have over 250,000 scientists and researchers. This goes right to the bottom line. Instead of the conglomerates created in the 1960s through ‘90s, we have learned the value of “strategic alliances” in pursuing corporate earnings. Now, the small company with patents can deal equally with the big corporation who has all the resources to exploit the intellectual property. A common bond has been found. Only one of many examples of technological September 2014 226 New Age Intellectual Property progress can be found in farming. In 1900 in the United States, 35 percent of the population (of 75 million) worked on farms or in the transportation of agricultural products. In 2013 with a U.S. population of 330 million, it is 2 percent who were producing more crops because of revolutionary technology; from bio-engineering to the tractors that are locked into satellites that provide a myriad of information for greater crop yield and production methods. We now have what is called “Precision Farming” born from the new technologies that progress and invention has created. American farms and ranches produce (at retail) $547 billion to the economy. In 1900 the average citizen could expect to live to about 50 years. Today that has changed to 84 years and rising. Since 1950, more financial wealth has been generated in the U.S. than was created in all the rest of the world since time had begun. In 1900 there were approximately 5,000 millionaires in America. Today it is estimated there are over five million. We are a Nation of creators and doers that never learned about limitations. We each can personally think of those inventions 227 les Nouvelles and improvements that have had a major positive effect on our own lives. Not only from our health and the medicines that keep us well, but the diagnostic equipment to quickly analyze what is wrong and how to cure it. Just think back to our grandparents and the life that they took for granted, and compare it to today. Now project your thoughts into the future, where our grandchildren will be so much better off because of what we are inventing and discovering in labs and research centers throughout the world. One thing is for sure, the creation of intellectual property will continue on an accelerated basis, with increased demands by industry and the consumer. IP is a whole new business that is not only changing the world today, but will continue for centuries to come. When technological progress ceases, then so will mankind. So in summation, the obvious is that intellectual property is an unlimited and inexhaustible resource that is changing the course of destiny on an almost daily basis. Tomorrow is the future that we are creating today. ■ LES International Officers President President-Elect Past-President Vice-President ® Vice-President Vice-President Vice-President Secretary Treasurer Counsel Counsel Arnaud Michel Jim Sobieraj Yvonne Chua Omer Hiziroglu Mark Horsburgh Fiona Nicolson John Paul François Painchaud Eduardo de Souza Michael Lechter Junichi Yamazaki les Nouvelles Editorial Review Board Chair: Rodney DeBoos, Melbourne, Australia Lex van Wijk, Amersfoort, Netherlands Heinz Goddar, Munich, Germany Norm Jacobs, Boca Raton, Florida, U.S.A. Sun-Ryung Kim, Seoul, Korea Masato Kobayashi, Tokyo, Japan Kenneth D. McKay, Toronto, Canada Thomas Bereuter, Vienna, Austria Eduardo C.A. de Mello e Souza, Rio de Janeiro, Brazil Larry Plonsker, Editor 10580 Northgreen Dr., Wellington, FL 33449 Tel: +1-561-432-8814 E-mail: [email protected] Carla J. Blackman, Design Interface Inc. Design & Production les Nouvelles Volume XLIX Number 3 (ISSN 0270-174X) les Nouvelles is published quarterly by the Licensing Executives Society International (LESI). LESI is an association of 32 National and Regional Societies, each composed of individual members who are engaged in the profession of licensing and other aspects of transferring or profiting from intellectual property. Subscription to the journal is included in the membership dues paid by all members. Subscription for the print publication is available to nonmembers for US$200/year. Please contact the Editor for further details. The articles published in les Nouvelles reflect the views of the authors and not of the Society as an association or its officers. Material printed in the journal is covered by copyright. No parts of this publication may be reproduced, displayed or transmitted in any form, without prior permission from the Editor or Board of LESI. A peer review and evaluation system is used to maintain the scholarly nature of the material published in this journal. All articles submitted for publication are reviewed and evaluated by members of the Editorial Review Board (ERB). The ERB members are chosen for their expertise in the fields of licensing and intellectual property. All evaluations are reviewed in a double-blind fashion to remove any bias in the results. The final decision on publication rests with the editor. A guideline for authors can be found on our Web site at the following address: www.lesi.org/lesnouvelles/advertise. asp#submission Copyright ©2014 Licensing Executives Society International. 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JOURNAL OF THE LICENSING EXECUTIVES SOCIETY INTERNATIONAL WASHINGTON, DC LES NOUVELLES SEPTEMBER 17, 2014 les Nouvelles JOURNAL OF THE LICENSING EXECUTIVES SOCIETY INTERNATIONAL Volume XLIX No. 3 September 2014 Advancing the Business of Intellectual Property Globally Determining An Appropriate Royalty Rate For Reasonable Royalty Trademark Damages—A Modified Georgia-Pacific Framework DAVID DREWS — Page 150 Advanced Citation Analysis Can Help Identify Licensing Candidates MIKE LLOYD — Page 156 Customs Value, Licensing And Royalties—The Russian Perspective SERGEY MEDVEDEV — Page 166 Radioisotope Pharmaceutical Licensing PAUL R. BETTEN — Page 172 How Does Europe Deal With The Question Of How To Transfer Rights From The Author To The Exploiter?—The European Perspective On The Work Made For Hire Doctrine JULIAN KLAGGE AND CHRISTIAN CZYCHOWSKI — Page 178 The Unitary Patent And The Unified Patent Court CHRISTOPH CORDES — Page 184 Protecting Traditional Knowledge As Cardinal Technology In The Philippines ROBERT NEREO B. SAMSON AND GONZALO D.V. GO III — Page 192 The Impact Of Australian Goods And Services Tax On Assignments And Licences Of Intellectual Property STEPHEN ADRIAN — Page 202 EU State Aid Policy: A Model To Assess Intellectual Property Rights And Knowledge Dissemination In R&D Cooperation—Part II MARIO CISNEROS — Page 206 UniLink: A New Model For Increasing Academic And Industry Partnerships HESTER TAK AND BOB SMAILES — Page 215 New Age Intellectual Property: Emerging Global Benefits LAWRENCE J. UDELL — Page 224