Patents - Nalsar

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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
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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.
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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.
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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
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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.
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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
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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.
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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.
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• 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
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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
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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
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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
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• 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
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• 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
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• 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
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• 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
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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
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•
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
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•
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
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• 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
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•
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
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Orange Book
Lists Product Name
Patent Number
Patent Expiration Date
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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
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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
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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
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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.
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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
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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
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• 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
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• 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
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• 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
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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
•
•
•
•
•
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180 days Market Exclusivity
•
•
•
•
•
Section 505(j)(5)(B)(IV)
First to file
When does it start
Judgment trigger
Commercial marketing trigger
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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
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• 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
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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
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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
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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.
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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.
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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
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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”
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Thank you for your attention!
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IP Strategy Advisors
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Chennai 600084
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