Patent Cases at the
Supreme Court and Federal Circuit:
Significant Cases in 2013
Presentation to University of Massachusetts
Commercial Ventures and Intellectual Property
Case Managers’ Meeting
January 21, 2014
Jay DeYoung, Principal
Tiffany Reiter, Associate
Ian Lodovice, Associate
J. Peter Fasse, Principal
Significant Cases In 2013
1. Allergan v. Sandoz, 726 F.3d 1286 (Fed. Cir. 2013) (obviousness)
2. Galderma Laboratories v. Tolmar, Inc., 2013 U.S. App. LEXIS 24573 (Fed. Cir. Dec. 11,
2013) (obviousness)
3. Teva v. Sandoz, 723 F.3d 1363 (Fed. Cir. 2013) (indefiniteness)
4. Biosig/Nautilus, 715 F.3d 891 (Fed. Cir. 2013) (indefiniteness)
5. Novozymes A/S v. DuPont Nutrition Biosciences APS, 723 F.3d 1336 (Fed. Cir. 2013)
(written description)
6. Pronova Biopharma Norge AS v. Teva Pharmaceuticals USA, Inc., 2013 WL 5202779 (Fed.
Cir. Sep. 12, 2013) (anticipation)
7. Association for Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct. 2107 (2013)
(patent eligible subject matter)
8. CLS Bank Int’l. v. Alice Corporation, Ltd. 717 F.3d 1269 (Fed. Cir. 2013, en banc)(patent
eligible subject matter)
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Allergan v. Sandoz
• Allergan’s Combigan® (glaucoma medication)
• Claim 1 of the ’463 patent:
 1. A composition comprising about 0.2% timolol by weight and
about 0.5% brimonidine by weight as the sole active agents, in a
single composition.
• Claim 4 of the ’149 patent
 4. A method of reducing the number of daily topical ophthalmic
doses of brimondine [sic] administered topically to an eye of a
person in need thereof for the treatment of glaucoma or ocular
hypertension from 3 to 2 times a day without loss of efficacy,
wherein the concentration of brimonidine is 0.2% by weight, said
method comprising administering said 0.2% brimonidine by weight
and 0.5% timolol by weight in a single composition.
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Allergan v. Sandoz
• Prior Art: U.S. Patent No. 5,502,052 (DeSantis)
 “Fixed combinations of alpha2-agonists and beta-blockers [timolol]
for the treatment of glaucoma”
 Incorporated reference that lists alpha2-agonists including
brimonidine
 “Administration of two or more medications in separate, spaced
dosages, several times a day often resulted in poor patient
compliance”
• Prior Art: Larsson
 topical administration of 0.2% brimonidine with 0.5% timolol in
combination—spaced five minutes apart
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Allergan v. Sandoz
• Brimonidine was one of only three alpha2-agonists known
for treating glaucoma, and both it and timolol were known
and used in the claimed concentrations
• Prior art establishes a motivation and reasonable
expectation of success in combining brimonidine and
timolol into a fixed combination product
• In finding the composition claims obvious, the Federal
Circuit did not accept the District Court’s findings on longfelt need and an unexpected result of avoiding an
“afternoon trough” effect from prior attempts at 2/day
dosing of brimonidine
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Allergan v. Sandoz
• Method claim 4 is similar to the claims of the ’463 patent
with the exception that it contains the additional limitation
that the daily number of doses of brimonidine be reduced
from 3 to 2 times a day without loss of efficacy.”
• “Sandoz has failed to point to evidence in the prior art that
would allow us to conclude that the addition of timolol to
brimonidine dosed twice per day would eliminate the
afternoon trough issue” even though it was known to dose
twice per day
• Thus, Sandoz failed to prove claim 4 would have been
obvious
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Allergan v. Sandoz
• Takeaways & Implications
 When drafting claims, consider including language that
describes an unexpected aspect of your invention – but only
if you have adequate proof
 When arguing secondary considerations, be sure your
arguments match the scope of your claims
 This decision provides a prime example of why method
claims can be very valuable
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Galderma Laboratories v. Tolmar
2013 U.S. App. LEXIS 24573 (Fed. Cir. Dec. 11, 2013)
• Background & Procedural Posture
 Appeal from the US District Court for the District of DE
 Hatch-Waxman litigation
o Tolmar filed an ANDA seeking approval to market a generic version of
Differin® Gel , 0.3%
o Differin® Gel , 0.3% is a topical medication for treatment of acne
 January 2010: Galderma sued Tolmar in D. Del.
o Galderma alleged Tolmar’s ANDA infringed various patents
o Judge Stark ruled against Tolmar on several issues at a bench trial
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Galderma Laboratories v. Tolmar
• Asserted claims:
 Claims require an aqueous gel or cream that includes 0.3% by weight
of adapalene
 Recite one or more inactive excipients included in the gel or cream
• Issue on appeal
 Tolmar appealed Judge Stark’s finding that the asserted claims were
not invalid as obvious under 35 U.S.C. § 103
 Sole issue on appeal is whether it was obvious to use a 0.3%
adapalene composition for the treatment of acne
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Galderma Laboratories v. Tolmar
• Tolmar’s obviousness argument
 The ’720 patent specifically discloses and claims adapalene along
with other inventive compounds
 Claim 4 of the ’440 Reissue patent recites a preferred range of
0.01% to 1% for cosmetic compositions in which adapalene is the
active ingredient
 Prior to their expiration, the ’440 and ’720 patents were listed in
the FDA's Orange Book as covering Galderma’s prior art Differin®
0.1% Gel as well as Differin® Gel, 0.3%
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Galderma Laboratories v. Tolmar
• Galderma’s arguments against obviousness
 Prior art taught away from a 0.3% concentration because of a dosedependent increase in the side effects of the drug
 Prior art taught the optimal concentration of adapalene for the
treatment of acne was 0.1%
 Secondary considerations – unexpected results and commercial
success showed the claims were not obvious
o Comparable tolerability of 0.1% and 0.3% adapalene was unexpected
o Differin® 0.3%, quickly gained and maintained market share
o Tolmar sought to enter the market precisely because Differin® 0.3%
has been commercially successful
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Galderma Laboratories v. Tolmar
• Federal Circuit reversed lower court decision and
found the asserted claims were invalid as obvious
 Prior art did not teach away from a 0.3% concentration of
adapalene
 Secondary considerations were not sufficient to support a finding
of non-obviousness
o Unexpected results that are probative of non-obviousness are those
that are “different in kind and not merely in degree from the results of
the prior art” Id. at 17.
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Galderma Laboratories v. Tolmar
• Judge Newman Dissent
 Majority ignored several district court findings of fact
o Lower court had determined that the evidence as a whole had taught
away from increasing the concentration of adapalene above 0.1%
 Secondary considerations were sufficient
o District Court found the unexpected results were “different in kind”
o Differin® 0.3% gel quickly gained market share, despite the fact that
the overall market was declining
o “In refusing to credit any of the demonstrated ‘secondary
considerations’ my colleagues foreclose patentability to a vast body of
improvement patents” Id. at 24.
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Galderma Laboratories v. Tolmar
• Takeaways & Implications
 Teaching Away & Secondary Considerations
o Prior art does not teach away by expressing a “general preference for
an alternative invention but does not criticize, discredit, or otherwise
discourage investigation into the invention claimed” Id. at 14.
o “The mere fact that generic pharmaceutical companies seek approval
to market a generic version of a drug, without more, is not evidence of
commercial success” Id. at 20.
o Unexpected results must be “different in kind and not merely in
degree” Id. at 17.
o Absence of an expected effect is only a “difference in degree” Id. at 18.
o District Court footnote 14 pointed out that “cases finding mere
differences in degree have generally involved situations in which the
claimed invention was merely a continuation of a trend previously
disclosed in the prior art” Id. at 88.
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Teva Pharmaceuticals v. Sandoz, et. al.
723 F.3d 1363 (Fed. Cir. 2013)
• Background & Procedural Posture
 Consolidated appeal from the US District Court for the Southern
District of NY
 Hatch-Waxman Litigation
o Appellants filed an ANDA seeking approval to market generic versions of
Copaxone, a drug used to treat multiple sclerosis
o Teva sued Appellants for patent infringement
• District Court decision
 After a bench trial, the court held that the asserted claims are not
invalid for indefiniteness, obviousness or lack of enablement, and
that the Appellants infringe all of the asserted claims
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Teva Pharmaceuticals v. Sandoz
• The Patents-in-Suit
 Copolymer–1 molecules, like other polymers, have a distribution of
molecular weight values, as opposed to a singular molecular weight
 The claims of the patent-in-suit used two different approaches to
determine the molecular weight distribution of copolymer-1
o Group I Claims : Claim a range of average molecular weight values for
copolymer-1 molecules using statistical methods Mn, Mw and Mp to
calculate the average values
-
Mp = molecular weight of the most abundant molecule in the sample
Mn, Mw = average molecular weight values that are calculated by using
different methods (these values often differ)
o Group 2 Claims: Describe what percentage of molecules in a given
sample has molecular weights that fall within a defined range
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Teva Pharmaceuticals v. Sandoz
• Indefiniteness
 Appellant’s argument:
o Term “molecular weight” is not specifically defined and is a value
obtained from one of Mn, Mw or Mp methods
o Because each of the three terms would result in different scopes of the
patent claims, both Group I and Group II claims are invalid
 Teva’s argument:
o Prosecution history of the patents and the usage of Size-Exclusion
Chromatography (SEC) method (cited in the specification as the
measurement method) make it clear that the term molecular weight
refers to Mp values
o Group II claims are not indefinite because they refer to the exact
molecular weight values, not the statistical average molecular weight
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Teva Pharmaceuticals v. Sandoz
• Federal Circuit Decision:
 Upheld District Court’s decision regarding the validity and
infringement of Group II claims
 Reversed District Court’s finding that Group I claims were not invalid
as indefinite
o Court noted that Teva gave two contradictory statements during
prosecution concerning whether the term “molecular weight” refers to
Mw or Mp
o Term “molecular weight” would have been susceptible to multiple
interpretations because several statistical methods could be used to
calculate the molecular weight of copolymer-1
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Teva Pharmaceuticals v. Sandoz
• Takeaways & Implications
 Claim terms with several possible interpretations can be invalidated
for being indefinite
o Specification was unhelpful to Teva because it did not specify which
measurement method was to be used
 Prosecution history was dispositive
o Harmed Teva in this case because Teva’s contradictory statements
regarding molecular weight contributed to finding the term indefinite
o “Teva's attempt to resolve this ambiguity hinges in part on the
prosecution history. But two of its prosecution statements directly
contradict each other and render the ambiguity insoluble.” 723 F.3d at
1369.
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Biosig Instruments v. Nautilus
715 F.3d 891 (Fed. Cir. 2013)
• Background & Procedural Posture
 Appeal from Southern District of NY
 Biosig sued Nautilus alleging that Nautilus infringed claims 1 and 11
of the ’753 patent
 During litigation, Nautilus twice sought ex parte reexamination of the
’753 patent from the USPTO
 After the reexamination proceeding, Biosig re-instituted patent
infringement action against Nautilus in 2010
 After claim construction, Nautilus moved for summary judgment on
infringement and invalidity for indefiniteness
o District Court denied Nautilus’ motion for summary judgment on noninfringement as premature
o District Court granted Nautilus’ motion on invalidity, holding that the
’753 patent’s “spaced relationship” term as recited in claim 1 was
indefinite as a matter of law
20
Biosig Instruments v. Nautilus
• The ’753 Patent
 Directed to a heart rate monitor that effectively eliminates noise
signals (EMG signals) while detecting a user’s heart rate
 Claim 1 excerpt:
o A heart rate monitor for use by a user in association with exercise
apparatus and/or exercise procedures, comprising:
-
an elongate member;
electronic circuitry including a difference amplifier having a first input
terminal of a first polarity and a second input terminal of a second polarity
opposite to said first polarity;
said elongate member comprising a first half and a second half;
a first live electrode and a first common electrode mounted on said first half
in spaced relationship with each other;
a second live electrode and a second common electrode mounted on said
second half in spaced relationship with each other…
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Biosig Instruments v. Nautilus
• Issue on appeal:
 Whether “spaced relationship” was distinctly and particularly claimed
in the patent
• Biosig’s argument
 The term “spaced relationship” is not indefinite
 The patent’s claim language, specification, and the figures illustrating
the “spaced relationship” provide sufficient clarity
o The functionality of the claimed heart monitor that provided the basis for
overcoming the PTO’s office action rejections also gives meaning to the
term “spaced relationship”
o The specification describes the electrodes’ “spaced relationship” in terms
of their corresponding function of detecting distinct electrical signals
 Skilled artisans could apply a test and determine the “spaced
relationship” as pertaining to the function of removing EMG signals
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Biosig Instruments v. Nautilus
• Nautilus’ argument
 The term “spaced relationship” is indefinite because Biosig did not
articulate with specificity the dimensions or other parameters
characterizing the space between the electrodes
 No evidence as to how a skilled artisan would have determined the
appropriate parameters yielding the necessary “spaced relationship”
• Federal Circuit reversed District Court’s grant of summary
judgment of invalidity as indefinite
 Held that the term “spaced relationship” was not indefinite
 The claims provide inherent parameters sufficient for a skilled artisan
to understand the bounds of “spaced relationship”
 A skilled artisan could apply a test and determine the "spaced
relationship" as pertaining to the function of removing EMG signals
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Biosig Instruments v. Nautilus
• Takeaways & Implications
 Standard for indefiniteness:
o “If the meaning of the claim is discernible, even though the task may be
formidable and the conclusion may be one over which reasonable
persons will disagree, we have held the claim sufficiently clear to avoid
invalidity on indefiniteness grounds.” 715 F.3d at 901-902.
o “[T]he fact that some experimentation may be necessary to determine
the scope of the claims does not render the claims indefinite.” Id. at 902.
 Functional Language
o “[T]his court's jurisprudence does not proscribe drafting or defining
claims in relation to their functions” Id. at 903.
-
Claims are not necessarily indefinite for using functional language
Functional language may be used to limit the claims without having the
means-plus-function format
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Biosig Instruments v. Nautilus
• SCOTUS granted certiorari on two questions:
 1) Whether the Federal Circuit’s acceptance of ambiguous patent
claims with multiple reasonable interpretations – so long as the
ambiguity is not “insoluble” by a court – defeats the statutory
requirement of particular and distinct patent claiming
 (2) Whether the presumption of validity dilutes the requirement of
particular and distinct patent claiming
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Novozymes A/S v. DuPont Nutrition Biosciences APS
• Novozymes owned a patent claiming mutant alpha-amylase
enzymes that have improved acid and thermal stability
• DuPont, through its own research, developed a specific
alpha-amylase enzyme, which it then patented
• Novozymes filed a continuation to cover DuPont’s mutant
enzyme and sued when the patent issued
• Jury held patent valid and infringed and awarded $18 million
• District Court held patent invalid for lack of written
description (JMOL)
• Federal Circuit affirmed, because the application contains no
disclosure of the species covered by the issued claims
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Novozymes A/S v. DuPont Nutrition Biosciences APS
• Novozyme’s patent disclosed seven enzymes that could be
mutated, 33 amino acid positions that should give thermal
stability, data with respect to 16 of these locations, and
stated one or more of these locations could be altered
• No indication which locations or types of mutations would
be preferred
• DuPont made and tested 1500 mutants to come up with a
commercial product, which contained a mutation in one of
the 33 locations noted in Novozymes’ patent, but DuPont’s
specific mutation was not listed in the patent
27
Novozymes A/S v. DuPont Nutrition Biosciences APS
• DuPont proved that 13 of 19 substitutions (including
Novozymes’ example) at that location did not work
• Novozymes’ claims require three characteristics that were
individually supported in the patent, but not described or
even “highlighted” in combination
• Novozymes’ application provided a roadmap, but left the
actual inventive work to industry to finish an unfinished
invention
• Nothing in the patent indicates that Novozymes possessed
at the original filing date what it is now claiming, and thus
patent is invalid for lack of written description under §112,
first paragraph
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Novozymes A/S v. DuPont Nutrition Biosciences APS
• Takeaways & Implications
 The US Courts seem to be approaching the EPO’s approach
on support issues
 Consider continuation claims very carefully, both for support
issues, and to ensure that your application will be treated
under pre-AIA patent laws, if that is desired
 Draft applications to describe many different combinations
and subcombinations, which is useful for both US and EP
practice
29
Pronova Biopharma Norge AS v. Teva Pharma
• Plaintiff Pronova owns a patent covering its Lovaza® FDAapproved, prescription fish-oil product
• Teva and Par each filed Abbreviated New Drug Applications
(ANDA) to market their generic versions, and made Para. IV
assertions alleging invalidity or non-infringement
• Pronova filed suit and the District Court held that the
patent was not invalid and would be infringed
• The infringers appealed asserting anticipation by public use
based on Pronova’s predecessor company’s submission of
samples that met all claim limitations to a third party
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Pronova Biopharma Norge AS v. Teva Pharma
• The District Court held that all prior uses were
experimental, and stated that any barring “public use” had
to be of the purpose identified in the patent
• A bar under §102(b) exists where before the critical date
the invention is in public use (by public access or
commercial exploitation) and ready for patenting
• Here, invention was ready for patenting and sending
samples to third party with no confidentiality or other
restrictions put the invention into public use
• All aspects of the claimed invention must be disclosed,
which occurred here (detailed analysis was provided with
samples), thus the patent was invalid under § 102(b)
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Pronova Biopharma Norge AS v. Teva Pharma
• Takeaways & Implications
 Be very careful with any submissions of your invention to third
parties and maintain confidentiality and control
 For clinical trials, make sure that the clinical trial administrators are
under confidentiality, and that the patients do not know the full
details of the invention if they are not also under confidentiality
 Under the AIA, while the USPTO view is that secret prior uses and
sales are not barring events, we have yet to hear the courts’ view
on this issue
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Assoc. of Molecular Pathology v. Myriad Genetics
• Plaintiffs challenged patent claims covering isolated DNA
and cDNA representing the BRCA1 and BRCA2 genes
• Myriad discovered that mutations in these DNA sequences
were associated with breast and ovarian cancers
• Legal issue: Are claims to naturally occurring DNA and
cDNA eligible for patent protection?
• District Court – No – isolated DNA and cDNA are both
products of nature
• Federal Circuit - Yes – both DNA and cDNA are patent
eligible, Supreme Court vacated and remanded, Fed. Cir.
again held DNA and cDNA patent eligible
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Assoc. of Molecular Pathology v. Myriad Genetics
• Supreme Court - “[W]e hold that a naturally occurring DNA
segment is a product of nature and not patent eligible
merely because it has been isolated, but that cDNA is
patent eligible because it is not naturally occurring.”
• “except insofar as very short series of DNA may have no
intervening introns to remove when creating cDNA. In that
situation, a short strand of cDNA may be indistinguishable
from natural DNA.”
34
Assoc. of Molecular Pathology v. Myriad Genetics
• The Court gave no deference to the USPTO policy of
issuing such patents for three decades (the US
government actually argued against patent eligibility)
• The Court clearly stated the decision does not apply
to:




other claims in Myriad’s patents
method claims
applications of natural laws or products of nature
DNA in which the order of the nucleotides is altered
• Thus, all was not lost for Myriad, which has since filed
several suits on other claims in the same patents
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Assoc. of Molecular Pathology v. Myriad Genetics
• Takeaways & Implications
 What impact will this decision have on other “naturally
occurring” chemicals such as antibodies, hormones, and
other proteins, therapeutic RNA, cells, microorganisms,
and other biological molecules?
 Has Myriad opened the flood gates? Several suits have been
filed, e.g., to invalidate claims to stem cells
 Draft applications to describe many variations on how new
isolated nucleic acids can be used and modified
 Include claims to, e.g., cells and vectors, that contain nucleic
acids that they would not normally contain in nature
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CLS Bank, Int'l v Alice Corp.
• Alice owned four patents covering a computerized trading
platform for exchanging obligations in which a trusted third
party settles obligations between a first and second party
so as to eliminate “settlement risk” (the risk that one party
will not pay) - the third party either exchanges both parties’
obligations or none to eliminate this risk
• CLS sought a declaration of invalidity; Alice counterclaimed
infringement and the district court ruled in favor of CLS,
holding that each asserted claim of the four patents is
invalid under 35 U.S.C. §101 for covering an “abstract idea”
37
CLS Bank, Int'l v Alice Corp.
• In 2012, the Federal Circuit reversed, finding the system,
method, and media claims were directed to practical
applications of invention falling within the categories of
patent eligible subject matter defined by § 101
• The panel held (2 to 1) that computer-implemented
inventions are patent-eligible under § 101 unless it is
“manifestly evident” that the claims cover only an abstract
idea; i.e., “the single most reasonable understanding is that
a claim is directed to nothing more than a fundamental
truth or disembodied concept, with no limitations in the
claim attaching that idea to a specific application.”
• CLS requested reconsideration en banc
38
CLS Bank, Int'l v Alice Corp.
• En banc, a majority of a fractured court (10 judges, 7 opinions) affirmed
the district court’s holding that none of the system, method, and
computer-readable media claims are directed to eligible subject matter
• The analysis (according to 5 judges) involves four questions:
 (1) does invention fits within : process, machine, manufacture, or
composition of matter?
 (2) does claim pose a risk of "preempting an abstract idea“?
 (3) what is the idea at risk of preemption? (define "whatever
fundamental concept appears wrapped up in the claim“)
 (4) is there a “human contribution” (“inventive concept”) to the
claimed subject matter, i.e., does the claim contain “additional
substantive limitations that narrow, confine, or otherwise tie down the
claim so that, in practical terms, it does not cover the full abstract idea
itself“? (need to consider “whether steps combined with a natural law
or abstract idea are so insignificant, conventional, or routine as to yield
a claim that effectively covers the natural law or abstract idea itself“?
• Here, the court held all of the claims preempted an abstract idea
39
CLS Bank, Int'l v Alice Corp.
• Five of the judges would have held at least the system
claims valid (but majority held all claims stand or fall
together)
• Four judges cautioned, "if all of these claims, including the
system claims, are not patent-eligible, this case is the death
of hundreds of thousands of patents, including all business
method, financial system, and software patents as well as
many computer implemented and telecommunications
patents.“
• The Supreme Court has granted cert. and will hear the case
on March 31, 2014
40
CLS Bank, Int'l v Alice Corp.
• Takeaways & Implications
 For now, we need to wait and see what the Supreme
Court decides
 All patent claims to methods, and computerimplemented methods, must include specific steps to
tie the invention to a specific application
 These steps must be more than
o a field-of-use limitation
o an insignificant post-solution step
o well-understood, routine, or conventional steps
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Questions?
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Thank You!
J. Peter Fasse
Principal
(617) 521-7802
PeterFasse@fr.com
Jay DeYoung
Principal
(617) 956-5985
Deyoung@fr.com
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Ian Lodovice
Associate
(617) 956-5972
ilodovice@fr.com
Tiffany Reiter
Associate
(617) 956-5937
reiter@fr.com
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