American Intellectual Property Law Association
US Federal Circuit Cases of 2012-13
March 2013
Anthony Venturino
Novak Druce Connolly Bove + Quigg LLP
Washington, DC
Laura C. Brutman
Schiff Hardin LLP
New York NY
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Prometheus - Patentable Subject Matter
Mayo v. Prometheus, 132 S.Ct. 1289 (2012)
• Involved a number of patents for a method of optimizing
therapeutic efficacy.
• At the time the discoveries embodied in the patents were made,
scientists understood the levels in a patent’s blood of certain
metabolites of thiopurine drugs correlated with the likelihood of a
particular drug dose being harmful or ineffective.
• But those in the field did not know the precise correlations
between metabolite levels and likely harm or ineffectiveness.
• The claims at issue define processes embodying researchers’
findings
identified those correlations with some precision.
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Prometheus - Patentable Subject Matter
• 35 USC 101 permits a patent to whoever invents or
discovers any new and useful: Process (process, art, or
method); Machine; Manufacture; or Composition of matter
– However, a law of nature is not-patentable.
• Laws of Nature are the basic tools of scientific work.
• Patents that tie up their use may inhibit future innovation.
• Issue –Do the patent claims add enough to their statements
of natural correlations to qualify as patent-eligible
processes that APPLY natural laws?
• Holding-No
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Prometheus - Patentable Subject Matter
• The 3 additional steps add nothing specific to the law of nature
other than what was well-understood, routine, conventional
activity, previously engaged in by those in the field; and
considering them in order adds nothing.
1. Administering a thiopurine drug to a subject –
- Identifies people, namely doctors, interested in the correlation.
2. Determining the resulting metabolite level in the blood –
- Tells doctors to engage in well understood, routine, conventional
activity previously engaged in by scientists in the field. Determining
methods were well known.
3. Wherein a metabolite level:< X indicates a need to increase the
dosage and >Y indicates a need to decrease the dosage –
- Tells
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doctor the natural law and at most suggests considering
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test results when making treatment decisions.
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Prometheus - Patentable Subject Matter
• The claimed processes are not patentable unless they have
additional features that provide practical assurance the
processes are genuine applications of those laws rather than
drafting efforts designed to monopolize the correlation.
– The claim must include an inventive concept beyond the
natural law.
• Appending conventional steps, specified at a high level of
generality, to laws of nature, natural phenomena, and abstract
ideas cannot make those laws, natural phenomena, or abstract
ideas patentable.
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Myriad - Patentable Subject Matter
Association for Molecular Pathology v. USPTO and Myriad
Genetics, Inc., 689 F.3d 1303 (Fed. Cir. 2012)
• Claims were for isolated DNA sequences related to the BRCA1
and BRCA2 genes and diagnostic methods for identifying
mutations in those DNA sequences. Certain alterations or
mutations of those genes indicated a predisposition to breast
and ovarian cancers.
• The case was before the Federal Circuit for the 2d time following
remand from the US Supreme Court for consideration in light of
its decision in Mayo v. Prometheus.
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Myriad - Patentable Subject Matter
• CAFC held:
– Composition claims covering isolated DNA sequences associated
with predisposition to breast and ovarian cancers were eligible for
patent. It was removed from its native environment and manipulated
to be significantly different from that in the body.
– Claims for complementary DNA which lacked non-coding introns in
naturally occurring chromosonal DNA, were eligible for patent.
They were the result of human intervention into nature.
– Method claims for “comparing” or “analyzing” isolated DNA
sequences were not eligible for patent. Directed to abstract mental
process, no transformative steps such as isolating genes from
blood.
– Method claim to screening potential cancer therapeutics via
changes
in growth rates of a transformed host cell was eligible for
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patent. Claim applied steps to man-made non-naturally occurring
transformed cells.
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Myriad - Patentable Subject Matter
• The Federal Circuit stated compositions of matter claims are governed
not by Mayo but by Chakrabarty, which suggest a composition of matter
patent is patent eligible if it is markedly different than a natural product,
or if the transformation of the natural product yields a distinctive name,
character, and use. The structural differences between the natural
genes and the isolated products were the key to patent eligibility.
• Now it goes back to the US Supreme Court.
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Myriad - Patentable Subject Matter
• The Supreme Court granted certiorari on the following
question:
1. Are human genes patentable?
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Some issues could be:
– Do the claims include an inventive concept beyond natural
law?
– Does the information in the DNA represent a law of nature?
– Is the isolation of the DNA simply an isolation process already
well known and expected at the time of the invention?
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• Supreme
Court set oral arguments for April 15, 2013
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Aventis- Inequitable Conduct
Aventis Pharma S.A.v. Hospira, Inc., 675 F.3d 1324 (Fed Cir. 2012)
• The decision shows losing a claim construction argument can lead to
losing on validity, which in turn can lead to losing on inequitable
conduct.
• The district court found the '512 and ‘561 patents were invalid based on
deliberately withheld references.
• The district court found the '512 and ‘561 patents were unenforceable
for inequitable conduct.
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Aventis- Inequitable Conduct
• Claim 5 of the '561 patent recites: A “perfusion”, which contains
approximately 1 mg/ml or less of [docetaxel], and which contains less
than 35 ml/l of ethanol and less than 35 ml/l of polysorbate, wherein
said perfusion is capable of being injected without anaphylactic or
alcohol intoxication manifestations being associated therewith.
• Sanofi's counsel at oral argument conceded under the district court's
construction of "perfusion," claim 5 was obvious over the prior art (the
"GV reference" and the "Vidal reference").
• The Federal Circuit affirmed the district court's claim construction and
held claim 5 obvious.
• Also, regarding another claim interpretation issue, the Federal Circuit
affirmed the district court's claim construction for claim 7 of the ‘512
patent and held this claim obvious.
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Aventis- Inequitable Conduct
• Inequitable conduct requires materiality of the withheld reference and
applicant’s intent to deceive the PTO
• CitingTherasense, a withheld prior art reference is required to be “but
for” material and the standard for proving “but for” materiality is a
preponderance of the evidence.
• A prior art reference is “but for” material if the PTO would not have
allowed the claims had it been aware of the references.
– When a claim is properly invalidated in district court based on the
deliberately withheld reference, then that reference is necessarily
“but for material” for purposes of the inequitable conduct inquiry.
• The Federal Circuit affirmed the district court’s invalidity decision
in view of withheld references so they were “but for material”.
– Even if the withheld reference is not sufficient to invalidate the claim
in district court, it may be but for material if it would have blocked
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patent issuance under the PTO’s different evidentiary standard.
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Aventis- Inequitable Conduct
• CitingTherasense, the Federal Circuit said intent is shown by proving
"by clear and convincing evidence that the applicant knew of the
reference, knew that it was material, and made a deliberate decision to
withhold it.“
• In this case, “Intent to deceive was the single most reasonable
inference able to be drawn from the reference ....”
– Inventor disclosed prior art references discussing problem he was
trying to solve, yet withheld prior art reference revealing the solution
he chose for patents, and
– Inventor withheld another prior art reference authored by his
colleague, even though (1) he was the project leader and had to
approve the reference for publication and (2) he took steps to
ensure the reference was included in the drug’s clinical brochure six
months
before signing the patent declaration.
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Momenta-271(e)(1) safe harbor
Momenta Pharmaceuticals, Inc. v. Amphastar
Pharmaceuticals, Inc., 686 F. 3d 1348 (Fed. Cir. 2012)
• Where the scope of the 271(e)(1) safe harbor ends is significant.
– Biologics are complex molecules. Thus, analytical-method patents
may be in the patent portfolios protecting them.
• Momenta is the assignee of US 7,575,886, which relates to methods for
analyzing sulfated polysaccharides, e.g. heparin and LMWH [low
molecular weight heparin, e.g., enoxaparin]." Enoxaprin is a generic for
the brand name drug LOVENOX for preventing blood clots.
• Momental asserted Amphastar infringed by testing enoxaprin
manufactured for sale after approval.
– Momenta asserted Amphastar was "manufacturing generic
enoxaparin for commercial sale" and performing "in their process for
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manufacturing
infringes the '886 patent.
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Momenta-271(e)(1) safe harbor
• 35 USC 271(e)(1) states:
– (e)(1) It shall not be an act of infringement to make, use, offer to sell,
or sell within the United States or import into the United States a
patented invention ... solely for uses reasonably related to the
development and submission of information under a Federal law
which regulates the manufacture, use, or sale of drugs or veterinary
biological products.
• Due to the molecular complexity of enoxaprin, the FDA required generic
drug makers to submit results of specific testing to obtain approval and
to conduct tests and maintain records after approcval.
• The Federal Circuit held 35 USC 271(e)(1) safe harbor applies to certain
post-approval activities and shields Amphastar from infringement.
• Amphastar’s post-approval drug testing was required by the FDA. Thus,
it was Firm
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information under a Federal law which regulates the manufacture, use,
or sale of drugs.
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Momenta-271(e)(1) safe harbor
• To arrive at his decision the panel had to distinguish over Classen v.
Biogen IDEC, 659 F.3d 1057 (Fed. Cir. 2011).
• Classen alleged the defendants' post-approval studies of vaccines
infringed. The defendants argued participation in the vaccine studies was
reasonably related to the FDA requirement to report adverse events to
FDA, and thus within the safe harbor.
– In a 2-1 decision, the Federal Circuit found in favor of Classen, holding
271(e)(1) "does not apply to information that may be routinely reported
to the FDA, long after marketing approval has been obtained."
• The Momenta majority distinguished Classen:
– Here, the submissions are not "routine submissions" to the FDA, but
instead are submissions that are required to maintain FDA approval....
Unlike Classen, where the allegedly infringing activity "may" have
eventually led to an FDA submission, there is no dispute in this case
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Amphastar's
allegedly infringing activities are carried out to "satisfy
FDA's requirements.”
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Thank you for your attention! Questions?
Anthony Venturino
Partner
Novak Druce Connolly Bove
+ Quigg LLP
1875 Eye Street
Washington, DC 20006
+1-202-659-0100 (phone)
anthony.venturino@novakdruce.com
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Intervening Rights
Marine Polymer Tech. v. Hemcon, 672 F.3d 1350 (Fed. Cir.
2012)
• Doctrine of Intervening Rights forecloses recovery of prereexamination infringement if the resulting claims were in
“amended form” and not “substantially identical” to the
original claims. 35 U.S.C. §§252 and 307(b)
• In this case, the claim scope had been arguably changed
based upon arguments made during a reexamination, but
the text of the claims had not been amended.
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Intervening Rights
• Federal Circuit held that pursuant to the plain language of
the statute, intervening rights defense arises following
reexamination only when the patent holder has amended
claims or added new claims.
• Practice Tips for Patent Holder
– During reexamination, only when arguments alone will fail should
claim amendments be made to overcome prior art.
– During original prosecution, embodiments of different scope should
be covered by separate independent claims (rather than by an
independent and dependent claim). During reexamination, patent
holder can simply cancel the broader independent claim to
overcome
prior art. Amendments are therefore not made to the less
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broad independent claim and would not provide third party
intervening rights.
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Different Results: Reexamination and Litigation
In re Baxter International Inc., 673 F.3d 1357 (Fed. Cir. 2012)
• Federal Circuit held that a prior decision in a patent
infringement suit did not preclude a different outcome on
reexamination.
– Federal Circuit upheld the USPTO’s Ex Parte Reexamination
decision that Baxter’s claims were unpatentable as obvious. In re
Baxter International, Inc., No. 11-1073 (Fed. Cir. May 17, 2012).
– In contrast, in a previous patent infringement suit, Federal Circuit
upheld a District Court decision that Baxter’s claims were not invalid
as obvious. Fresenius USA, Inc. v. Baxter Int'l, Inc., 582 F.3d 1288
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(Fed.
Cir. 2009).
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Different Results: Reexamination and Litigation
• USPTO and District Courts “take different approaches in
determining validity and on the same evidence could quite
correctly come to different conclusions.”
– A challenger that attacks the validity of a patent in civil litigation has a
statutory burden to prove invalidity by clear and convincing evidence.
– In contrast, in USPTO reexaminations, the standard of proof is
preponderance of evidence, which is substantially lower than in a civil
litigation. Also, in USPTO reexaminations there is no presumption of
validity.
• Future of parallel litigation and reexamination
– Decrease due to AIA replacing Inter Partes Reexamination with Inter Partes
Review, which has restrictions on parallel proceedings.
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– Could still arise from Ex Parte Reexamination proceedings, which are not
subject to the same restrictions.
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Preliminary Injunction Requires Causal Nexus
Apple Inc. v. Samsung Electronics Co., 695 F.3d 1370 (Fed.
Cir. 2012)
• Federal Circuit overturned district court’s Preliminary
Injunction against Samsung that would have prevented
Samsung from selling its Galaxy Nexus smartphone in the
US.
• Facts
– Apple’s patent claim was for a “unified search” apparatus that
allowed a user to search a device’s memory and the Internet with a
single search query.
– Apple alleged that the “Quick Search Box” (QSB), a unified search
feature embodied in the Galaxy Nexus, infringed the claim.
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Preliminary Injunction Requires Causal Nexus
• Federal Circuit held that to show irreparable harm
necessary to support a preliminary injunction, patentee
must establish a “sufficiently strong casual nexus” between
the alleged infringement and the alleged harm (e.g., loss of
sales).
• In applying the sufficient causal nexus doctrine, the patent
holder must show that “the infringing feature drives
consumer demand for the accused product.”
– Apple presented no evidence that consumers bought the Galaxy
Nexus because it was equipped with the QSB.
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Preliminary Injunction Requires Causal Nexus
• Practice Tips for Patent Holder
– In establishing irreparable harm necessary to support a preliminary
injunction, the evidence should:
• show that the patented feature is THE driver of consumer
demand for a product (merely establishing that sales or market
share would be lost is not sufficient);
• show how the patented feature drives demand for the
defendant’s product (as opposed to the patent holder’s product);
and
• pertain to the exact feature claimed in the patent.
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Patent Eligibility for Computer-Implemented Claims?
CLS Bank International v. Alice Corp. Pty Ltd. No. 11-1301
(Fed. Cir. 2012)
• Federal Circuit vacated its panel decision that Alice claimed
patent-eligible subject matter, and ordered rehearing en
banc.
• Alice’s patent claims were directed to a computerized
trading platform that enables a trusted third party to settle
obligations between two parties in a manner that eliminates
“settlement risk.”
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Patent Eligibility for Computer-Implemented Claims?
• For the rehearing en banc, the court requested the parties
address the following:
– (1) what test should be adopted to determine whether a computerimplemented invention is an “abstract idea”;
– (2) when, if ever, does the presence of a computer in a claim lend
patent eligibility to an otherwise patent-ineligible idea;
– (3) should it matter to patent eligibility that the computerimplemented invention is claimed as a method, system, or storage
medium; and
– (4) should such claims be considered equivalent for determining
patent-eligibility?
• Oral argument held February 8, 2013. Decision not
expected
for months.
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• Stay tuned!
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Thank you for your attention! Questions?
Laura C. Brutman
Schiff Hardin LLP
666 Fifth Avenue
Suite 1700
New York, NY 10103
+1-212-745-0848
lbrutman@schiffhardin.com
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