Patents - Nalsar
Transcription
Patents - Nalsar
United States Code Title 35 - Patents Swapna Sundar CEO IP DOME Strategy Advisors Pvt. Ltd. No. 7/8 Flowers Road III Lane Chennai 600084 [email protected] www.ipdome.in Mobile: 09841282396 (c) Swapna Sundar, IP Dome United States Code Title 35 - Patents Kinds of patents issued by the USPTO: -UTILITY PATENTS Issued for - the invention of a new and useful process, machine, manufacture, or composition of matter, or a new and useful improvement thereof - generally permits its owner to exclude others from making, using, or selling the invention for a period of up to twenty years from the date of patent application filing - subject to the payment of maintenance fees. -DESIGN PATENTS -PLANT PATENTS -Reissue patents, defensive publication, statutory invention registration (c) Swapna Sundar, IP Dome What is patentable-(102 & 103) An invention must belong to one of these classes: a.Machine (eg. Mechanism with moving parts) b.Article of manufacture (eg. Hand tool or diagnostic kit) c.Composition of matter (eg. Drug) d.Process (eg. Of making nanotubes) e.New use or improvement of existing invention f.Modified living organism (eg. Transgenic rice) g.Isolated or purified natural materials (eg. Purified proteins) - Mathematical formulae, chemical elements, laws of nature are not patentable. City of Elizabeth V. American Nicholson Paving: Nicholson sought to patent a process for a system of pavement using wooden blocks and sued the City of Elizabeth, NJ for infringement. City claimed that he had publicly used the system for 6 years. Court found that he had been testing it in private conditions. (c) Swapna Sundar, IP Dome REQUIREMENTS FOR PATENTABILITY UTILITY New and useful – not frivolous or immoral NOVELTY Patent can be granted unless (a)the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for patent, or (b)the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of the application for patent in the United States NON-OBVIOUSNESS if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. (c) Swapna Sundar, IP Dome SOFTWARE/ ALGORITHM PATENTABILITY: patent-eligibility trilogy Gottschalk v. Benson method of programming a general-purpose digital computer using an algorithm to convert binary-coded decimals into pure binary numbers. Held the discovery was un-patentable since it was no more than abstract mathematics; granting it would preclude others from using the abstract mathematical principles. Court’s decision did not preclude patenting of software, only patentability where the only useful characteristic was an algorithm. Parker v. Flook method of calculating alarm limits by using a "smoothing algorithm" to make the system responsive to trends but not momentary fluctuations in process variables (such as temperature). Held Where a patent was sought on an implementation of a principle (the algorithm), the implementation itself must be inventive for a patent to issue. Since that was not so, the Court held unpatentable. Diamond v. Diehr A method of operating a rubber-moulding press for precision molded compounds with the aid of a digital computer. In this case the Court backed away from the analytic dissection approach, and insisted that patent-eligibility must be decided on the basis of the claim (or invention) considered as a whole, granting the patent. Court studiously avoided stating that Flook and Benson were overruled or limited. (c) Swapna Sundar, IP Dome Bilski v. Kappos - method of hedging the seasonal risks of buying energy On June 28, 2010, the Court ruled] that Bernard Bilski's patent application is an abstract idea and is therefore unpatentable. However, it also said that business methods are not inherently unpatentable, and was silent on the subject of software patents. The majority opinion also said that the Federal Circuit's "machine or transformation" test, while useful, is not an exclusive test for determining the patentability of a process. PHOSITA is a legal fiction defined in the Patent Act of the United States, based on - educational level of the inventor; - type of problems encountered in the art; - prior art solutions to those problems; - rapidity with which innovations are made; - sophistication of the technology; and -educational level of active workers in the field -KSR V. TELEFLEX: ordinary creativity and common sense – not an automaton (c) Swapna Sundar, IP Dome Teleflex, Inc. sued KSR International, claiming that KSR productsinfringed Teleflex's patent on connecting an adjustable vehicle control pedal to an electronic throttle control. KSR argued that the combination of the two elements was obvious, and the claim was therefore not patentable. The district court ruled in favour of KSR. Federal Circuit reversed in January 2005. On April 30, 2007, the Supreme Court unanimously reversed the judgment of the Federal Circuit, holding that the disputed claim 4 of the patent was obvious under the requirements of 35 U.S.C. §103. Federal Circuit had rigidly applied the "teaching-suggestion-motivation" (TSM) test. Winner Int'l Royalty Corp. v. Wang, (2000), there must be a suggestion or teaching in the prior art to combine elements shown in the prior art in order to find a patent obvious. (c) Swapna Sundar, IP Dome Non-obviousness grant of patent requires more than simple novelty. Thomas Jefferson's 1813 letter: changing material to "chain, rope, or leather" was insufficient for patentability. Patent Act of 1952, in part, to reduce the impact of nonobviousness on patentability and to eliminate the flash of genius test. Graham factors Graham et al. v. John Deere Co. of Kansas City et al., (1966) The court held that obviousness should be determined by looking at the scope and content of the prior art; the level of ordinary skill in the art; the differences between the claimed invention and the prior art; and objective evidence of nonobviousness outlined by: commercial success; long-felt but unsolved needs; and failure of others. Environmental Designs, Ltd. v. Union Oil Co. of Cal., (Fed. Cir. 1983) considering skepticism or disbelief before the invention as an indicator of nonobviousness; Allen Archery, Inc. v. Browning Mfg. Co., (Fed. Cir. 1987) considering copying, praise, unexpected results, and industry acceptance indicators of nonobviousness (c) Swapna Sundar, as IP Dome Further requirements (112): Best Mode: Patent must disclose the best mode of practising the invention including preferred materials and methods. Failure may result in patent being declared ‘unenfoceable’. Duty of Candor: good faith and specifically requires that everyone involved with a patent application must disclose all publications that they know of which may adversely affect the patentability of their invention through out the pendency of the application . Within 3 months all material information must be disclosed. Oath: The inventor must swear that she understands the patent document, the duty of candour and full disclosure and that the named inventor is the true and first inventor. Inventorship The requirement that the applicant for a patent be the inventor is a characteristic of U.S. patent law. The threshold question in determining inventorship is who conceived the invention. Unless a person contributes to the conception of the invention, he is not an inventor. Swapna Sundar, IP Dome Conception of atleast one (c) claim. (112) The doctrine of equivalents: holds a party liable for patent infringement even though the infringing device or process does not fall within the literal scope of a patent claim, but nevertheless is equivalent to the claimed invention. In the US, the doctrine is applied to individual claim limitations, not to the invention as a whole and is limited by prosecution history estoppel. Warner-Jenkinson Co. v. Hilton Davis Chem. Co. (1997): the difference between the limitation in the accused device and the limitation literally recited in the patent claim may be found to be "insubstantial on the basis of the triple identity test: It performs substantially the same function In substantially the same way To yield substantially the same result Under prosecution history estoppel, if the patentee abandoned through an amendment to the patent application certain literal claim coverage (e.g., by narrowing the literal scope of the patent claim), then the patentee is estopped from later arguing that the surrendered coverage is (c) Swapna Sundar, IP Dome insubstantially different from the literally claimed limitation. Warner-Jenkinson Co. v. Hilton Davis Chem. Co. (1997): Hilton Davis Chemical Co.had developed an "ultrafiltration" process to purify dyes. By amendment he specified that a solution used in the process must have a pH level between 6.0 and 9.0, to avoid overlap with prior art which specified lower limit of 9.0; however, the plaintiff was unable to explain why the amendment stated a lower level of 6.0. The defendant had developed a process using a solution with a pH level of 5.0, which was outside the range of the plaintiff's patent. Held estopped. Festo Corporation vs. SMC: Festo was marketing a patented industrial device . SMC began marketing a device that used one two-way sealing ring and a nonmagnetizable sleeve. Festo filed suit claiming infringement under the doctrine of equivalents. Festo's claim had been amended during prosecution for statutory compliance §112 and SMC claimed that prosecution history estoppel should bar Festo . Distt. Court of Mass. held that Festo's amendments were not made to avoid prior art, and therefore the amendments were not the kind that give rise to estoppel. Affirmed by fed. Cir. The Supreme Court remanded in light of an intervening decision in Warner-Jenkinson v. Hilton Davis Chemical Co.. After a decision by the original panel on remand, the Fed. Cir. ordered rehearing and held that claim amendments made for statutory compliance presented a complete bar to claiming equivalents. (c) Swapna Sundar, IP Dome Plant Patent (161) A plant patent is granted by the Government to an inventor who has invented or discovered and asexually reproduced a distinct and new variety of plant, other than a tuber propagated plant or a plant found in an uncultivated state. The grant, which lasts for 20 years from the date of filing the application, protects the inventor's right to exclude others from asexually reproducing, selling, or using the plant so reproduced. Mutants, hybrids, and transformed plants are comprehended; sports or mutants may be spontaneous or induced. Hybrids may be natural, from a planned breeding program, or somatic in source. While natural plant mutants might have naturally occurred, they must have been discovered in a cultivated area. Algae and macro fungi are regarded as plants, but bacteria are not. In Pioneer Hi-bred Intl V. J.E.M. Ag Supply : Supreme Court upheld the validity of sexually reproduced plants as subject matter for patent protection. Rejecting the argument that the 1930 Plant Patent Act2 (“PPA”) and the 1970 Plant Variety Protection Act3 (“PVPA”) precluded the patenting of plants under section101 (c) Swapna Sundar, IP Dome Patenting of life: Diamond vs. Chakrabarty: Genetic engineer Ananda Mohan Chakrabarty, working for General Electric, had developed a bacterium (derived from the Pseudomonas genus) capable of breaking down crude oil, which he proposed to use in treating oil spills. The application for patent was turned down by the USPTO because the law dictated that living things were not patentable. The Board of Patent Appeals and Interferences agreed with the original decision; however, the United States Court of Customs and Patent Appeals overturned the case in Chakrabarty's favor, writing that "the fact that micro-organisms are alive is without legal significance for purposes of the patent law." Sidney A. Diamond, Commissioner of Patents and Trademarks, appealed to the Supreme Court. The Supreme Court case was argued on March 17, 1980 and decided on June 16, 1980. In a 5–4 ruling, the court ruled in favor of Chakrabarty, and upheld the patent, holding that: A live, human-made micro-organism is patentable subject matter under § 101. Respondent's micro-organism constitutes a "manufacture" or "composition of matter" within that statute. (c) Swapna Sundar, IP Dome Oncomouse A genetically modified mouse carrying an activated oncogene which increases susceptibility to cancer. Patent granted to Harvard College by USPTO in 1984 and two further patents on cell culture and testing. DuPont owns the rights to the patent and TM. The case, Madey v. Duke University (2002) involves a former Duke University professor who sued the University for patent infringement when it continued to use equipment that he had patented after he left. The university argued that it could not be liable for patent infringement because its uses were for "solely for research, academic, or experimental purposes." The Federal Circuit, reversing a lower court, made it very clear that this socalled experimental use defense does not apply to all non-profit research. In Roche Prods., Inc. v. Bolar Pharm. Co.(1984) held that scientific inquiry that has "definite, cognizable, and not insubstantial commercial purposes" did not qualify as experimental use. Bolar used ‘valium’ to test bioequivalence of its generic version. In Embrex, Inc. v. Service Engineering Corp. (2002)that the experimental use defense applied only to actions performed "for amusement, to satisfy idle curiosity, or strictly for philosophical inquiry." (c) Swapna Sundar, IP Dome AMERICA INVENTS ACT signed 16th September 2011 Changes implemented with varying dates between Sept. 2012 -13 : AFTER 2013 CURRENT 1. 2. 3. 4. 5. 6. First to invent Failure to disclose bestmode is crucial in validity and infringement Publication not necessary for first to invent Standard fees Inter partes reexamination on new questions of patentability No prioritized examination 1. 2. 3. 4. 5. 6. First to file (inventor) Failure to disclose best mode no longer basis for deciding Publication necessary to bring derivation proceedings 15% increase in fees with lower fees for micro Inter partes reexamination elevated to substantial new question where party has to prove that he will prevail at least against 1 claim; institution of inter partes review within 1 year of grant after post-grant review. Prioritized examination on request within 12 months of grant of status (c) Swapna Sundar, IP Dome FDA, PATENT TERM EXTENSIONS AND THE HATCH WAXMAN ACT DRUG APPROVAL Vs. DRUG PATENTING The mission of FDA's Center for Drug Evaluation and Research (CDER) is to ensure that drugs marketed in US are safe and effective. CDER does not test drugs. It is the responsibility of the company seeking to market a drug to test it and submit evidence that it is safe and effective. Office of Testing and Research does conduct limited research in the areas of drug quality, safety, and effectiveness. A team of CDER physicians, statisticians, chemists, pharmacologists, and other scientists reviews the sponsor's NDA containing the data and proposed labelling. (c) Swapna Sundar, IP Dome • New chemical entities (NCE) • 505(b)(1) or New Drug Applications • Contains full reports of investigations of safety and effectiveness • Five year exclusivity • 505(b)(2) Application • At least some of the information required for approval comes from studies not conducted by or for the applicant (c) Swapna Sundar, IP Dome What Is a 505 (b)(2) Drug? ♦ Not a generic ♦ Not totally new ♦ Similar, but with limited differences, to previously approved drug ♦ Often an innovative variation of previously approved drug(s) containing the same active Moiety ♦ Dosage form♦ Strength♦ Delivery mechanism ♦ Different formulation – (e.g., different salt, complex, enantiomer, new combination of previously approved drugs) Hatch-Waxman: ♦ 505(b)(2) - Streamlined approval process for new products with same active moiety as previously approved drug – Reference listed drug (RLD) Must provide safety and effectiveness studies but can rely on published scientific data 3-5 year market exclusivity (c) Swapna Sundar, IP Dome New Delivery Mechanism – Canasa® (mesalamine) suppositories – Axcan – ClobexTM (clobetasol proprionate) lotion – Galderma – LuxiqTM (betamethasone valerate) foam - Connetics – TestimTM (testosterone) gel – Auxilium ♦ New Dosage Form – AltoprevTM (lovastatin) extended release tablets - Andrx – DepoDurTM (morphine Sulfate) liposomal injection – Skye Pharma – Doxil® (doxorubacin HCl) liposomal injection ♦ New Formulation – PexevaTM (paroxetine mesylate) tablets – Synthon – Stalevo® (carbidopa/levodopa/entacapone) tablets – Orion – Xopenex® (levabuterol HCl) inhalation – Sepracor ♦ New Indication – Avodart® (dutasteride) capsules – GlaxoSmithKline: urinary condition – benign prostatic hyperplasia /male patern baldness – Thalomid® (thalidomide) capsules – Celgene: for cancer (c) Swapna Sundar, IP Dome The New Drug Development Process: Steps from Test Tube to New Drug Application Review (c) Swapna Sundar, IP Dome Hatch-Waxman Act Provides three (3) bases for adjustment: USPTO failure to take certain actions within specified time frames (35 U.S.C. § 154(b)(1)(A)) USPTO failure to issue a patent within three years of the actual filing date (35 U.S.C. § 154(b)(1)(B)) Delays due to interference, secrecy order, or successful appellate review (35 U.S.C. § 154(b)(1)(C)) Provides day-for-day adjustment for each failure or delay resulting in adjustment (c) Swapna Sundar, IP Dome • Failure to take certain actions within specified time frames (14-4-4-4): l l l Failure to initially act on the application within fourteen (14) months after filing/national stage entry date Failure to act on a reply or appeal brief within four (4) months after date the reply or appeal brief is filed Failure to act on an application within four (4) months after appeal if allowable claims remain in the application • In some instances, a remand shall be considered a decision reversing an adverse patentability determination l Failure to issue the patent within four (4) months of the date the issue fee was paid and all outstanding requirements were satisfied (c) Swapna Sundar, IP Dome • USPTO failure to issue a patent within three years of the actual filing date: l l In an international (PCT) application, “actual filing date” in 35 U.S.C. § 154(b)(1)(B) means the date national stage processing commences The three-year period does not include time consumed by any of Continued examination, Secrecy order, interference, or any appellate review, or – Applicant-requested delays (c) Swapna Sundar, IP Dome • Limitations on adjustment: l No double counting of overlapping delays 16 0 l 14 38 36 No adjustment beyond any date specified in a terminal disclaimer (c) Swapna Sundar, IP Dome • Limitations on adjustment: l Reduction of adjustment for period during which applicant failed to engage in reasonable efforts to conclude processing or examination of an application l Regulations define what is a failure to engage in reasonable efforts to conclude processing or examination of an application (c) Swapna Sundar, IP Dome Judicial review of USPTO determination: l l Applicant (patentee) has 180 days from patent grant to seek judicial review of the USPTO’s adjustment determination – Judicial review is not to delay patent grant No third party challenge to USPTO determination prior to patent grant (c) Swapna Sundar, IP Dome • Conditions for extension: 1) The patent had not expired before an application was filed 2) The patent has never been extended under 35 USC 156(e)(1) 3) The application for extension is submitted within 60 days of FDA approval of the product 4) The product has been subject to a regulatory review before its commercial marketing or use 5) The approval is the first permitted commercial marketing or use of the product (with some exceptions) FDA decides regulatory delay and PTO decides term extension. Patent Term Restoration- maximum five years Total extension (Patent term remaining upon approval + restoration) =14 years or less.Sundar, IP Dome (c) Swapna • “Product” means: – The active ingredient of a new human/animal drug, antibiotic drug, or human/vet. biological product • Any medical device, food additive or color additive subject to regulation under the Federal Food, Drug and Cosmetic Act • A patent is considered to claim the product if a. the patent claims the active ingredient per se, or b. claims a composition or formulation which contains the active ingredient(s) and the claim covers the composition or formulation approved for commercial marketing or use c. if any one active ingredient has not been previously approved, it can form the basis of an extension of patent term provided the patent claims that ingredient (c) Swapna Sundar, IP Dome • A new animal drug or veterinary biological product may be extended based on a second or subsequent approval of the active ingredient provided: 1) The patent claims the drug or product 2) The drug or product is not covered in another patent that has been extended 3) The patent term was not extended on the basis of the regulatory review period for use in non-food producing animals 4) The second or subsequent approval was the first permitted commercial marketing or use of the drug or product for administration to a food-producing animal (c) Swapna Sundar, IP Dome • Patent Linkage:Generic Marketing Approval is “Linked” to the Expiration of the Pioneer Drug Patent • If a patent exists, marketing approval will not be granted to a generic until the patent has expired or is found to be invalid. • Orange Book patent listings: New Drug Application (NDA) must include patent information and the FDA considers the existence of patents as part of the approval process for certain drug applications (c) Swapna Sundar, IP Dome • Orange Book 1) Lists: 1) Approved Drugs, 2) Discontinued Drugs 3) Provides Patent and Exclusivity Information 2) Published annually with monthly cumulative supplements • Electronic Orange Book also availableOpportunity for generic drug companies to inform FDA that it does not believe a particular listed patent does covers the FDA-approved drug product • FDA requests evaluation of complaint by innovator company • Innovator company can request de-listing or respond with good-faith belief that listing is proper (c) Swapna Sundar, IP Dome Orange Book Lists Product Name Patent Number Patent Expiration Date (c) Swapna Sundar, IP Dome Exclusivity Information • Under 505 (b) and (c) of the Food, Drug and Cosmetics Act, patent information covering the drug granted approval must be submitted within 30 days of approval of NDA / supplement or within 30 days of grant of patent – US FDA Requires Applicant to list patents that cover the drug as part of NDA filing – Applicant Must submit signed declaration – FDA relies on innovator drug company’s assertion – Patent information published in Orange Book (c) Swapna Sundar, IP Dome Abuse of listing provision • Listing irrelevant patents • The '84 Act does not prevent an NDA holder from listing a newly acquired patent • This further delays generic competition • Only one thirty month stay proposed • Shared Exclusivity (c) Swapna Sundar, IP Dome Infringement (the Bolar exception) • Roche Products V. Bolar Pharmaceutical Co. (Fed. Cir. 1984) • Roche was the assignee of the rights, expiring in 1984 in prescription sleeping pill "Dalmane”. • In early 1983, Bolar decided to market a generic drug equivalent to Dalmane after patent expiry. • Bolar immediately began its effort to obtain federal approval and to prove bio-availability. Took steps to acquire flurezepam HCl for studies on stability etc. required for ANDA filing. • Roche complained before Distt. Ct. that testing 6 m before expiry constituted infringement. Held: Tests, demonstrations, and experiments which are in keeping with the legitimate business of the alleged infringer are infringements for which experimental use is not a defense (c) Swapna Sundar, IP Dome Patent challenges and generic exclusivity Overview of the legal process- ANDA Requirements: • Information to show that that the listed drug is approved; • That the listed drug has the same active ingredient as the new drug; • That the route of administration, the dosage forms, the strength of new drug etc are the same as the listed drug; • That the new drug is bio-equivalent to the listed drug. (c) Swapna Sundar, IP Dome Section 505(j)(2)(A)(vii) • Generic Drug Company must certify when filing Abbreviated New Drug Application (ANDA) 1) 2) 3) 4) That the drug has not been patented; That the patent has already expired; The date on which the patent will expire, and the generic drug will not go on the market until that date passes; or That the patent is not infringed or is invalid Referred to as paragraphs I, II, III and IV certifications (c) Swapna Sundar, IP Dome Para I to IV • If the applicant makes a certification under paragraphs I or II, the statute provides that the FDA may approve the ANDA effective immediately • If the applicant makes a certification under paragraph III, the FDA may approve the ANDA effective on the date that the applicant certifies that the patent will expire (c) Swapna Sundar, IP Dome • Paragraph I, II, III certifications relatively straightforward – Existence of ANDA normally a secret until approval date • Paragraph IV certification more complicated to administer – ANDA applicant must notify innovator company of its filing; must describe reasons patent will not be infringed, is invalid, or unenforceable (c) Swapna Sundar, IP Dome • Paragraph IV Certification – Innovator has 45-days after receipt of notice to file an infringement suit; the submission to FDA of paragraph IV certification in an ANDA creates infringement for purposes of federal court jurisdiction – If lawsuit filed FDA approval is stayed for 30months; at end of period FDA issues tentative approval – Most ANDA applicants await resolution of the litigation before going to market to avoid liability for damages (c) Swapna Sundar, IP Dome • Provision that is intended to allow the patent-holder time to vindicate its patent in court • If the court finds that the patent is invalid or is not infringed, the FDA's approval becomes effective as of the date of that ruling • BASIS FOR NON-INFRINGEMENT – All Elements Rule • Pennwalts case: fruit sorter with position detection. V. Microsizer. Unmistakable surrender (by amendment or argument) – Estoppel • Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., Ltd., 234 F.3d 558, 56 U.S.P.Q.2d 1865 (Fed. Cir. 2000) • DESIGN AROUND: State Indus. Inc. V. A.O. Smith (c) Swapna Sundar, IP Dome Basis for invalidity Anticipation Obviousness Prior art date to be kept in mind Combining two references-motivation to combine When a reference cannot be used as prior art against the challenged patent • Species and genus situations • Obviousness type double patenting • • • • • (c) Swapna Sundar, IP Dome 180 days Market Exclusivity • • • • • Section 505(j)(5)(B)(IV) First to file When does it start Judgment trigger Commercial marketing trigger (c) Swapna Sundar, IP Dome Mova v Shalala & the successful defense requirement • FDA approved an application by a drug manufacturer, Mylan Pharmaceuticals, Inc. to market a generic version of micronized glyburide, a drug used to treat diabetes • Mova Pharmaceutical Corp.had filed an earlier application to market a generic version of the same drug • Mova's application had not yet been approved, because of a patent infringement suit brought by Pharmacia & Upjohn Company • Upjohn claimed that Mova's product infringed a patent belonging to Upjohn (c) Swapna Sundar, IP Dome • Mova argued that it was entitled to 180-day market exclusivity period running from the date Mova won its suit or began marketing its product, and the FDA was barred from approving Mylan's similar application until after the end of that 180-day period • In response, the FDA cited a regulation- The successful defense requirement • FDA’s interpretation was that the first Paragraph IV applicant was required to have “successfully defended against a suit for patent infringement” before the applicant is eligible for the 180day marketing exclusivity period. Court refused to accept FDA reading. • If the first applicant is never sued, the FDA claims, then the court-decision trigger will never be satisfied • Later ANDA applicants will be unable to market their products until the first applicant decides to put its product on the market (c) Swapna Sundar, IP Dome First applicant loses its suit • If the first applicant loses its infringement suit, the first applicant would then be able to satisfy neither the court-decision trigger nor the commercial-marketing trigger • Thus, the FDA claims, no generic drugs could enter the market until after the pioneer company's patent expired (c) Swapna Sundar, IP Dome First applicants who enter into an agreement with the NDA holder • First ANDA applicant to file a patent challenge may never trigger the start of the 180-day period, thereby blocking the FDA from granting approval to any generic product. • First generic challenger will enter into a lucrative cash settlement with the patent owner that results in a judgment in favor of the patent (c) Swapna Sundar, IP Dome Hoechst-Roussel v Andrx : H-R, the patentee reached a settled with Andrx in respect of once-daily diltiazem product developed by Andrx allegedly infringing upon a formulation patent for Hoechst Marion Roussel's Cardizem CD a once-daily medication for the treatment of hypertension and angina. Andrx developed a second formulation that did not infringe on the Hoechst Marion Roussel patent. Andrx has agreed to market this second formulation and to not market the first. Andrx delayed marketing the formulation until the suit was settled. Hoechst Marion Roussel agreed to compensate Andrx for that delay and will make a final lost-profit payment of approximately $50 million to Andrx. (June 1999) Pfizer V. Apotex (TorPharm): In respect of Amlodipine Besylate ‘Norvasc’, for hypertension and angina, the patent was held invalid as court held that it was found during ‘routine…testing’ to optimise selection of known pharma compounds. (c) Swapna Sundar, IP Dome TOTAL No. OF LAW SUITS AGAINST INNOVATORS: 749 INVOLVING :243 brand-name drugs. 72% of Para IV challenges result in litigation Generic challenger wins: 42% Average loss for innovator companies: 12% Average life of patents shortened by: 4 years Between 2008-2009, after 58 ANDA filings, Indian generic maker Orchid Chemicals & Pharmaceuticals Ltd has received approvals from the US Food and Drug Administration (US FDA) for its antibiotic combination piperacillin and tazobactam for injection, with 180-day exclusivity to market the products in US. Dr. Reddy’s marketed generic versions of Omeprazole, and Prozac with 180 day exclusivity. With 27 pending ANDAs, Ranbaxy won this month to sell generic Lipitor, and will share the exclusivity with Israeli generic Teva. (c) Swapna Sundar, IP Dome 2000 -June 2008: 200 Originator – generic settlement agreements to resolve patent disputes or opposition procedures covering 49 medicines, of which 63% were best-selling medicines that lost exclusivity between 2000 and 2007. In 48% of cases, the generic company's ability to market its medicine was restricted. In addition to the restriction in many cases - a value transfer from the originator to the generic company in the form of a direct payment, a license, a distribution agreement or a "side-deal". Direct payments to generic companies in more than 20 settlement agreements for a total amount exceeding € 200 million From: http://ec.europa.eu/competition/sectors/pharmaceuticals/inquiry/2_Originator_Generic_competition.pdf (c) Swapna Sundar, IP Dome Most generics interact closely with originator drug manufacturers – sometimes with respect to specific drugs, and at others on more general drug development Sandoz--Novartis Sandoz (c) Swapna Sundar, IP Dome 1. Teva 2. Mylan 3. Sandoz 4. Watson 5. Greenstone 6. Pan Pharma 7. Hospira 8. Apotex 9. Mallincrodt (covidien) 10. Dr. Reddy’s ANDAs are filed by generics that have an agreement with originator not to be sued, but to be supplied with generic copy of drug Both generic and originator benefit without competition or fear of litigation a long term relationship develops between originator and generic Pfizer licensed the product to its own Greenstone subsidiary for generic Gabapentin (Neurontin). Examples of this relationship include: Paxil (Paroxetine) - licensed by GSK to Par Prozac (Fluoxetine) - licensed by Lilly to Barr Augmentin (Co-Amoxiclav) licensed by GSK to IVAX In February this year Dr. Reddy's announced a similar deal with Merck & Co. for two products Proscar (Finasteride) and Zocor (Simvastatin). (c) Swapna Sundar, IP Dome COUNTER GENERIC STRATEGY AstraZeneca received FDA approval to market Omeprazole (exp. In 2001) in US in 1989, as Prilosec®. By 1999, AstraZeneca’s product became one of the most widely prescribed drugs of any kind in the world, with sales of some $6.1 billion annually. In 1999 AstraZeneca commenced suit against four generic pharmaceutical manufacturers after ANDA filing and in 2000 against 4 more. In 1995, the company decided to create a strategy to overcome losses due to patent expiry. What would the outcome be? How can this strategy work? (c) Swapna Sundar, IP Dome US Patent 4255431 on omeprazole racemic mixture Evergreening WO patent 94/27988 on esomeprazole – senantiomer Purple as symbolics of dependable magic Distress resolution, fear reduction “the purple pill” (c) Swapna Sundar, IP Dome Thank you for your attention! Please let us have your feedback at: [email protected] IP Strategy Advisors Contact us at: No. 7/8 Flowers Road III Lane, Chennai 600084 www.ipdome.in our seminars are available at youtube/ipdome seminars: (c) Swapna Sundar, IP Dome