Transcript Intellectual Property Rights Associated With Financial

Recent U.S. case law on (in)validity
C5 6th International Freedom to Operate Forum
London, April 20, 2009
Daniel M. Becker
© 2009 Dechert LLP
Cases reviewed: statutory bases
35 USC …
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• § 101
utility
• § 101
statutory subject matter
Prometheus Labs. v. Mayo (Fed. Cir. 2009?)
(briefed, not yet argued)
• § 102
anticipation
In re Gleave (Fed. Cir. Mar. 26, 2009)
• § 103
obviousness
In re Kubin (Fed. Cir. April 3, 2009)
• § 112, ¶ 1
written description
Ariad v. Eli Lilly (Fed. Cir. April 3, 2009)
• § 112, ¶ 1
enablement
• § 112, ¶ 1
best mode
• § 112, ¶ 2
indefiniteness
• § 112, ¶ 4
claim dependency
• § 116
inventorship
• § 251
reissue
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Halliburton Energy v. M-I (Fed. Cir. 2008)
Cases reviewed: other, non-statutory, considerations
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obviousness-type double patenting
Pfizer v. Teva (Fed. Cir. 2008)
exhaustion
Quanta Computer v. LG (S.Ct. 2008)
inequitable conduct
Line Rothman v. Target (Fed. Cir. 2009)
Star Scientific v. RJ Reynolds (Fed. Cir. 2008)
reexamination
In re Swanson (Fed. Cir. 2008)
• § 154(b)
patent term adjustment
• § 154(d)
provisional rights
• § 156
patent term extension
• § 271(e)(1)
Hatch-Waxman safe harbor
• § 271
infringement
• § 283
injunction
• § 286
6 year time limit on damages
• 28 USC § 2201
DJ Jurisdiction
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Wyeth v. Dudas (D.D.C. 2008)
Proveris v. Innovasystems (Fed. Cir. 2008)
§ 102(b)
•
In re Gleave (Fed. Cir. March 26, 2009)
– holding: reaffirming existing case law, the Federal Circuit held that a
prior art reference does not need to disclose a utility in order to
anticipate a later claim to the prior-disclosed compound
– holding: a list of species, no matter how great the number of entries, is
a disclosure of each of the individually listed species; such list is not
properly analogized to a genus of compounds that is combinatorially
defined by a chemical framework having multiple positions that are
independently substitutable from separate lists (R1, R2, R3, . . . )
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§ 102(b)
•
In re Gleave
– appealed claim:
1. A bispecific antisense oligonucleotide, wherein substantially all of
the oligonucleotide is complementary to a portion of a gene encoding
human IGFBP-2 and substantially all of the oligodeoxynucleotide is also
complementary to a gene encoding human IGFBP-5, and wherein the
oligodeoxynucleotide is of sufficient length to act as an antisense
inhibitor of human IGFBP-2 and human IGFBP-5.
– claim construction:
claim 1 does not require antisense activity: “the claims at issue merely
require [that] the oligonucleotides . . . be ‘of sufficient length to act as an
antisense inhibitor.’”
– the prior art:
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...
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§ 102(b)
•
In re Gleave
– the doctrinal tension
• to anticipate, a prior art reference must enable one of ordinary
skill in the prior art to make and use the invention
– this requirement flows directly from the public policy that a patent cannot be
permitted to withdraw from the public that which was earlier in the public’s
possession; black letter law
– Gleave argued that the prior art fails to anticipate because it does not enable
use of the antisense oligonucleotides
• the standards for judging “enablement” of a prior art reference
differ from those required to enable a claim
– In re Hafner (CCPA 1969)
– Novo Nordisk Pharms., Inc., v. Bio-Tech Gen. Corp. (Fed. Cir. 2005)
– Rasmusson v. SmithKline Beecham Corp. (Fed. Cir. 2005) (method of
treatment!)
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§ 102(b)
•
In re Gleave
– the court’s reasoning:
• the court (properly) distinguished claims drawn to compositions of
matter from those drawn to methods of use
– for method claims, “the ‘make’ requirement becomes, in effect, a ‘use’
requirement”
– for compositions of matter, “a reference satisfies the enablement requirement
of §102(b) by showing that one of skill in the art would know how to make”
• “Greave’s claims are to compositions of matter – oligonucleotides –
and therefore a reference satisfies the enablement requirement of
§102(b) by showing that one of skill in the art would know how to
make the relevant sequences disclosed in [the prior art reference].”
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§ 102(b)
•
In re Gleave
– take home lesson: in silico genomic and proteomic data that have been
accessioned into databases (“ink, formed into strings of letters, without
inventive thought and without placing the public in possession of
anything new”) (including electronically filed sequence listings) provide a
universe of potential prior art that may be useful for invalidating claims in
more recently issued patents claiming nucleic acids as compounds per
se – antisense, SiRNA, miRNA, etc.
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§ 103
•
In re Kubin (Fed. Cir. April 3, 2009) (Rader)
– holding: cloning of the protein antigen recognized by a prior art
monoclonal antibody, using art-established expression cloning
techniques and the prior art antibody itself for clone selection and
validation, where the prior art taught the importance of the antigen and
also prophetically taught that the antigen could be isolated using such
antibody and standard techniques, held obvious, notwithstanding the
fact that claims were drawn to compositions of matter with structural
limitations (sequence) that could not be predicted a priori.
– holding: continued reliance on In re Deuel (Fed. Cir. 1995) is no longer
tenable
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§ 103
•
In re Kubin
– holding: “obvious-to-try” affirmed as a viable obviousness rationale,
even in the so-called “unpredictable arts”; the “obvious-to-try” analytical
approach of In re O’Farrell (Fed. Cir. 1988) is explicitly and particularly
reaffirmed:
• “This court in O’Farrell ... observed that an obviousness finding was
appropriate where the prior art ‘contained detailed enabling methodology for
practicing the claimed invention, a suggestion to modify the prior art to
practice the claimed invention, and evidence suggesting that it would be
successful.’ Responding to concerns about uncertainty in the prior art
influencing the purported success of the claimed combination, this court
stated: ‘[o]bviousness does not require absolute predictability of success . . .
all that is required is a reasonable expectation of success.’”
(emphasis added by Kubin court)
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§ 103
•
In re Kubin
– the appealed claim:
– the structural limitation:
• Specification: “The NAIL polypeptide comprises a signal peptide (amino acids
1 – 21 of SEQ ID NO:2), and extracellular domain (amino acids 22-221 of
SEQ ID NO:2), a transmembrane domain (amino acids 222-245 of SEQ ID
NO:2), and a cytoplasmic domain (amino acids 246-365 of SEQ ID NO:2).”
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§ 103
•
In re Kubin
– the appealed claim:
– the functional “limitation”:
• court:
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§ 103
•
In re Kubin
– the prior art:
***
***
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§ 103
•
In re Kubin
– the court’s reasoning:
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§ 103
•
In re Kubin
– the court’s reasoning:
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§ 103
•
In re Kubin
– take home lesson: in assessing the obviousness of claims, it is critical
to determine, at the most abstract level, what the inventors’ real
contribution to the art was:
• “The record in this case shows that [the prior art reference] did not explicitly supply
an amino acid sequence for NAIL or a polynucleotide sequence for the NAIL gene.
In that sense, Kubin and Goodwin’s disclosure represents some minor
advance in the art. But granting patent protection to advances that would occur in
the ordinary course without real innovation retards progress. Were it otherwise
patents might stifle, rather than promote, the progress of useful arts.” (quoting KSR)
– take home lesson: absent an unexpected technical challenge or
unexpected result that is clearly embodied in an affirmative claim
limitation, any claimed molecular biology “invention” that could have
been made by any of hundreds of undistinguished and undistinguishable
labs, should be vulnerable for obviousness
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§ 103
•
In re Kubin
– take home lesson: claim limitations drawn to inherent structural
features, such as (i) nucleic acid or protein sequences, (ii)
bioinformatically-predicted protein domains (intracellular domain,
transmembrane domain, extracellular domain, hydrophilic domains,
dimerization domains, etc.), (iii) amino acid sequences of antibody V
regions or CDRs, should be viewed critically, and can at times be
discounted as adding little, if anything, to the nonobviousness of
the claims, even if those inherent structures could not have been
predicted a priori
– take home lesson: beware the tendency to reduce case law precedent
to short sound bites, believing the holding somehow to be immutable (In
re Deuel; In re Bell)
– take home lesson: Judge Rader is among the most biotech- and
patent-friendly of the Federal Circuit judges; this decision is unlikely to
be an outlier.
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§ 112, ¶ 1, written description
•
Ariad Pharms., Inc. v. Eli Lilly & Co. (Fed. Cir. April 3, 2009)
– holding: the specification must describe compounds suitable for
performing claimed methods, even when the claims do not themselves
explicitly recite use of a compound
– holding: reaffirming existing case law, the Federal Circuit held that the
adequacy of written description is determined as of the effective filing
date accorded to the claim (i.e., as of “the filing date sought” by the
patentee)
– holding: reaffirming existing case law, the Federal Circuit reaffirmed that
the written description must be commensurate in scope with the
invention claimed: claims must not “overreach the scope of the inventor’s
contribution to the field of art as described in the patent specification.”
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§ 112, ¶ 1, written description
•
Ariad v. Eli Lilly
Ariad claim:
Univ. of Rochester claim*:
*
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Univ. of Rochester v. G.D. Searle & Co. (Fed. Cir. 2004)
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§ 112, ¶ 1, written description
•
Ariad v. Eli Lilly
– court’s reasoning: “Ariad attempts to categorically distinguish
Rochester, Fiers, and [Regents of UC v.] Eli Lilly, because in those
cases, the claims explicitly included the non-described compositions ....
Ariad’s attempt to distinguish these cases is unavailing. Regardless of
whether the asserted claims recite a compound, Ariad still must describe
some way of performing the claimed methods.... [T]o satisfy the written
description requirement for the asserted claims, the specification must
demonstrate that Ariad possessed the claimed methods by sufficiently
disclosing molecules capable of reducing NF-κB activity....”
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§ 112, ¶ 1, written description
•
Ariad v. Eli Lilly
– effect of “(in)effective” filing date
• Because Ariad had sought the earliest possible effective filing date to avoid
express and inherent anticipation, and written description “is determined as of
the filing date – April 21, 1989 in this case – evidence of what one of ordinary
skill in the art knew in 1990 or 1991 cannot provide substantial evidence to
the jury that the asserted claims were supported by adequate written
description.”
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§ 112, ¶ 1, written description
•
Ariad v. Eli Lilly
– take home lesson: do not reflexively assume that invalidity contentions
are best served by denying the patentee its earliest claimed filing date
– take home lesson: critically assess the timewise relevance of any
evidence that the patentee proffered during prosecution to support
adequacy of written description
– take home lesson: in assessing the adequacy of written description,
assess at the most abstract level what the inventors’ real contribution to
the art was, because “the scope of the right to exclude must not
overreach the scope of the inventor’s contribution to the field of art as
described in the patent specification”
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§ 112, ¶ 2
•
Halliburton Energy Svcs. v. M-I LLC (Fed. Cir. 2008)
– holding: even when the patentee can articulate a definition supported by
the specification, claims are indefinite if the scope of the claim varies
depending on factors external to claim
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§ 112, ¶ 2
•
Halliburton Energy
– claim:
1.
A method for conducting a drilling operation in a subterranean
formation using a fragile gel drilling fluid comprising:
(a) an invert emulsion base;
(b) one or more thinners;
(c) one or more emulsifiers; and
(d) one or more weighting agents, wherein said operation includes
running casing in a borehole.
– patentee’s proffered construction of “fragile gel”:
(i) easily transitions to a liquid state upon introduction of force; and
(ii) at rest, is capable of suspending drill cuttings and weighting materials; and
(iii) contains no organophilic clay . . . .
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§ 112, ¶ 2
•
Halliburton Energy
– the court’s reasoning: “[U]nder Halliburton’s proposed construction in
this case, an artisan would not know from one well to the next whether a
certain drilling fluid was within the scope of the claims because a wide
variety of factors could affect adequacy (formation geology, wellbore
size, depth, angle, etc.). In other words, a given fluid might be adequate
to suspend drill cuttings in some formations and/or well configurations,
whereas in others it would not be.
When a proposed construction requires that an artisan make a
separate infringement determination for every set of circumstances
in which the composition may be used, and when such
determinations are likely to result in differing outcomes (sometimes
infringing and sometimes not), that construction is likely to be
indefinite.”
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§ 112, ¶ 2
•
Halliburton Energy
– the decision explicitly reaffirms Geneva Pharms. v.
GlaxoSmithKline (Fed. Cir. 2003)
• claims to synergistically effective amount in the combination of
amoxicillin and clavulanic acid (Augmentin) held indefinite because
“a given embodiment would simultaneously infringe and not infringe
the claims, depending on the particular bacteria chosen for
analysis.”
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§ 112, ¶ 2
•
Halliburton Energy
– take home lesson: long considered an unlikely basis for invalidating
claims, given the requirement that a claim be “insolubly ambiguous” and
“not amenable to construction” to be held to be indefinite, the Federal
Circuit has recently reinvigorated this basis for challenging claim validity
– take home lesson: look for express or implied reference to conditions
and events external to the claim; if the same embodiment would both fall
within the scope and infringe, and outside the scope and not infringe,
depending on externalities, claims may be indefinite
– take home lesson: analogously, look for a test or measurement
required by the claim (e.g., “binds to the same antigenic epitope”),
without the specification setting forth a single defining assay
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Obviousness-type double patenting
•
Pfizer, Inc. v. Teva Pharmaceuticals USA, Inc. (Fed. Cir. 2008)
– holding: the protection against obviousness-type double patenting
provided by 35 USC § 121 applies only to patents that later-issue from
true divisional applications, i.e, applications filed in response to, and
consonant with, a restriction requirement; section 121 does not apply to
shield continuations-in-part (CIPs)
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Obviousness-type double patenting
•
Pfizer v. Teva
– background
• obviousness-type double patenting is a judicially-created doctrine designed to
prevent unjustified time-wise extension of right to exclude
• the doctrine prohibits a patentee “from obtaining an extension of the right to
exclude through claims in a later patent that are not patentably distinct from
claims in a commonly owned earlier patent”
• compare the claims of the later-issued patent to the claims of the earlierissued patent
– later claims are not patentably distinct if:
» later claims anticipated by the claims of the prior-issued patent
» later claims obvious over the claims of the prior-issued patent
» later claimed subject matter overlaps prior claims, with both earlier
and later claims reading on the preferred embodiment (Schnellertype)
» later patent separately claims the earlier claimed invention’s utility
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Obviousness-type double patenting
•
Pfizer v. Teva
– background
• obviousness-type double patenting can be cured by disclaiming the terminal
portion of the term of the second patent that extends beyond that of the first
• and there is a “safe harbor”: 35 U.S.C. § 121 fully protects a later issued
patent from obviousness-type double patenting where the later claims issue
from a divisional application “filed as a result of,” and with claims fully
consonant with, a restriction requirement that was applied in the prosecution
of the earlier-issued patent
– the Federal Circuit has construed Section 121 broadly to provide a safe
harbor for later-issued patents over earlier-issued patents if the two
“patents [are] similarly derived from the same restriction requirement.”
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Obviousness-type double patenting
•
Pfizer v. Teva
– holding: Pfizer’s later Celebrex patent, which issued from a CIP of an
application in which the restriction requirement was made, is not entitled
to protection under § 121
• “We conclude that the protection afforded by section 121 to applications (or
patents issued therefrom) filed as a result of a restriction requirement is
limited to divisional applications. . . . Here, the [later-issued] . . patent, was
filed as a CIP and not a divisional application. We hold that section 121 does
not apply. . . . “
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Obviousness-type double patenting
•
Pfizer v. Teva
– take home lesson: U.S. patents identified as an FTO concern should
not be assessed in isolation, but rather in the context of their respective
families; the family relationships should be critically assessed by detailed
de novo review of the file wrappers to determine the actual genealogical
relationships
– take home lesson: obviousness-type double patenting is a cognizable
basis for ex parte and inter partes reexamination, In re Lonardo (Fed.
Cir. 1997) (basis for the Cabilly II reexam); although the defect is curable
by the patentee’s filing of a terminal disclaimer, the filing of a TD may
be all that is needed to clear FTO; example…
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Obviousness-type double patenting
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Reexam
•
In re Swanson (Fed. Cir. 2008)
– holding: a substantial new question of patentability (“SNQ”) sufficient to
support a request for reexamination can be presented by a reference
that was previously considered and applied in a rejection during
prosecution, if the “particular question of patentability presented by the
reference” in the reexam request differs from that the question of
patentability presented during prosecution
– holding: a substantial new question of patentability (“SNQ”) sufficient to
support a request for reexamination can be presented by a reference
that was previously considered by a district court during infringement
litigation
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Reexam
•
In re Swanson
– background: 2002 amendment to 35 U.S.C. § 303 explicitly overturned
the Federal Circuit’s earlier holding in In re Portola Packaging (Fed. Cir.
1997), that the presumption of administrative correctness precludes the
finding of an SNQ over art cited during prosecution:
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Reexam
•
In re Swanson
– case facts: the particular reference at issue, Deutsch, was considered
during initial examination, where it was applied as a secondary reference
for rejecting various claims as obvious. In the reexam request, the
reference was asserted to anticipate various of the claims.
– court’s reasoning: “In light of the extremely limited purpose for which
the examiner considered Deutsch in the initial examination, the Board is
correct that the issue of whether Deutsch anticipates the method
disclosed in claims 22, 23, and 25 was a substantial new question of
patentability, never before addressed by the PTO.”
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Reexam
•
In re Swanson
– case facts: the particular reference at issue, Deutsch, was considered
during infringement litigation, at the end of which the jury returned a
verdict that the patentee had failed to prove by clear and convincing
evidence that the claims were anticipated, obvious, or otherwise invalid.
The Federal Circuit affirmed that judgment in a first appeal.
– court’s reasoning: two differences in standards as between
proceedings in district court and in the USPTO permit the same art to
present a substantial new question of patentability, even though
unsuccessfully asserted during prior litigation: (i) in district court, the
statutory presumption of validity applies, requiring that the defendant
prove invalidity by clear and convincing evidence, whereas in
administrative proceedings, a lower preponderance standard
applies; and (ii) in the USPTO, claims are given their broadest
reasonable interpretation consistent with the specification, whereas
during litigation, the court construes the claims to ascertain their
objective scope
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Reexam
•
In re Swanson
– take home lesson: in assessing whether reexam is available as an
option to clear FTO (either to be threatened during license negotiations
with the patentee, and/or to be undertaken to invalidate relevant claims),
it is critical during review of the prosecution history to identify with
particularity the exact nature of the rejections levied during prosecution,
and to assess whether those rejections were the best possible rejections
to be made over the art of record
– take home lesson: do not discount the usefulness in invalidity
challenges of art made of record during prosecution
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