By Kevin E. Noonan —
The American Intellectual Property Law
Association (AIPLA) has joined the chorus of patent bar groups opining on
whether there is a separate written description requirement contained in 35
U.S.C. § 112, first paragraph, in an amicus curiae brief filed in the rehearing en banc
of Ariad Pharmaceuticals, Inc. v. Eli
Lilly & Co. The AIPLA agrees with
other amici that there is such a requirement, but emphasize that properly
construed, such a requirement must be assessed in the "context" of the
entirety of 35 U.S.C. § 112 (but, in reality, that "entirety" extends
no further than the second paragraph). Similar sentiments were expressed by the Federal Circuit Bar Association
in its amicus brief, but the basis of
the argument is uniquely the AIPLA's.
The AIPLA also notes that it does not take a position on the validity of
Ariad's patent-in-suit.
The brief argues that the written description
requirement should be construed to ensure that the patent specification "advances
the well-recognized patent policies of disclosure," defining these as:
(1) particularly and
distinctly identifying the invention,
(2) putting the
invention in the hands of the public at the end of the patent term as part of
the quid pro quo bargain for exclusive rights,
(3) ensuring that the
applicant was in possession of his/her invention at the time of filing to limit
any exclusive rights to the subject matter he/she actually invented, and
(4) informing the public
of the patent scope so that potential competitors know how to avoid
infringement and can reasonably design around the claimed invention.
The brief argues that the written description
requirement, as construed as being part of § 112, first paragraph, by the Court's
jurisprudence, satisfies these different but related roles. Enablement, the amicus argues, "serves
a different and distinct purpose" — providing a disclosure that would
permit the worker of ordinary skill to practice the invention. The brief also
notes, as have others, that the requirements differ in that the enablement
inquiry includes the knowledge and skill of the worker of ordinary skill in the
art, and that these can be "very different from any invention identified
by the inventor as his/her own."
In discussing the statute at length, the brief
counsels the Court to "resist the temptation to dwell on parsing the
statutory language to the point of drawing legal conclusions based on the
placement of commas." "Instead,"
they counsel, the Court should employ an "as a whole" rationale that
would be "faithful to the statute's literal language and policy
objectives." The amicus also
asks the Court not to make a "radical departure" from precedent and reminds the Federal Circuit to
be sure to "conform to Supreme Court precedent." The brief asserts that the CAFC should
adopt a "sufficiently flexible" approach that will avoid an "unfair
standard of compliance that fails to take account of inherent differences in
technologies and claim formats."
The brief does admit that "statutory language,
legislative history and judicial precedent" — all the tools the Court
would normally employ in deciding this question — "fail to solve the
puzzle." Policy may be what
ultimately drives (or should drive) the Court's conclusions, and the policy
requires that the specification must:
1) Sufficiently
identify the invention;
2) Put the
invention in the hands of the public at the end of the patent term as part of the
quid pro quo bargain for exclusive rights;
3) Ensure that the
applicant was in possession of his/her invention at the time of filing to limit
any exclusive rights to subject matter he/she actually invented; and
4) Inform the
public of the patent scope so that potential competitors know how to avoid
infringement and can reasonably design around the claimed invention,
citing Festo
Corp. v. Shoketsu
Kinzoku Kogyo Kabushiki Co., 535 U.S. 722, 736 (2002); Bonito Boats, Inc. v. Thunder
Craft Boats, Inc., 489 U.S. 141, 150-51
(1989); McClain v. Ortmayer, 141 U.S. 419, 424 (1891); Praxair,
Inc. v. ATMl, Inc., 543 F.3d 1306, 1319 (Fed. Cir. 2008); Purdue
Pharma L.P. v. Faulding Inc., 230 F.3d 1320, 1323 (Fed. Cir. 2000); and Gentry Gallery, Inc. v. Berkline Corp., 134 F.3d 1473,
1479 (Fed. Cir. 1998).
Amicus argues
that the question before the Court can be resolved by not considering the "number
of distinct disclosure requirement[s] that must be met," but by using the totality
of the specification to determine what was disclosed. This "as a whole" approach they analogize with
various "claims as a whole" provisions such as § 103. Thus:
[F]or purposes of determining whether a patent
is invalid for failing to comply with the disclosure requirements, a
specification should be judged by the sufficiency of the disclosures in the
application as filed, taken as a whole, not by the sufficiency of the portion
of a specification deemed the "written description" or the separate
portion deemed the "enabling disclosure."
The brief then explicates further its understanding
of the totality approach, using
the equally-compelling rubric of faithfulness to the statutory scheme
taken as a whole, in the context of criticizing the panel for failing to
utilize the approach. Here,
amicus argues, the panel considered whether Ariad's specification contained an
adequate written description, concluded it did not, and ended the inquiry. The error was the belief that the
written description requirement could be "viewed in isolation from the
other requirements of Section 112." Had the Federal Circuit applied the AIPLA's "as a whole" approach, the
brief argues, it could have performed "a practical evaluation of the
sufficiency of the disclosure" as understood by one of ordinary skill in
the art, "taking into account the interaction and codependence of [all of]
the Section 112 requirements." By analogy, the brief compares (favorably!) this approach with the "common
sense" approach to obviousness imposed by the Supreme Court in KSR International Co. v. Teleflex Inc. However, the amicus argues that this "as a whole" approach "does
not relieve [the patent owner] of identifying in the patent a 'written
description' of the invention commensurate with the scope of the claims at
issue," citing Tronzo v. Biomet. Ultimately, what is required is
that the specification properly puts the public on notice "of what the
inventor contemplates as the invention encompassed by the claims at issue."
The brief emphasizes that the approach must be
employed with sufficient flexibility to be able to adapt to different
technologies. This, the brief
asserts, is the flaw in the argument that the enablement requirement is sufficient — there will be some instances where enablement simultaneously satisfies the
written description requirement, and other instances (and technologies) when this
will not be the case. A particular
example cited in the brief is genus/species claims, where it can certainly be
the case that the specification enables making and using species within a
claimed genus, but does not provide a written description "for a claim
covering . . . a particular species." On this point the brief concludes:
In the end, it is
the dynamic interaction of the Section 112 requirements that produce the kind
of disclosures necessary to advance the policies recited above. Whatever the answer on the sufficiency
of the written description or enabling disclosure in the case, the proposal here
would not allow the court to simply stop the analysis after examining only one
of the requirements in isolation, and to ignore the others. It would
rather permit a party to point the court to the disclosure as a whole, which
would be evaluated in light of the patent policies.
The "as a
whole" approach to assessing the sufficiency of disclosure in a
specification proposed by AIPLA's brief is consistent with the statute, because
the requirement for a written description, an enabling disclosure and a claim
that "particularly points out and distinctly claims the subject matter the
applicant regards as his invention" must be considered together, amicus
argues. Amicus ignores the best
mode requirement (understandably, perhaps) but builds its "as a whole" argument
by combining two of the requirements from the first paragraph of Section 112
with the "claims" requirement from the second paragraph of Section
112. While this has been done by
other amici, its consequence is to expand the scope of § 112, 2d ¶, from its
traditional role of providing a statutory basis for the peripheral claiming
requirement to being part of the sufficiency of disclosure requirement of § 112, 1st ¶. The brief supports this interpretation
of the statute by arguing, first, "there is no requirement that the
written description of the invention be in a separately designated section of
the specification, nor that the enablement be in a separately designated
section," further saying that
both requirements are "intertwined" in some specifications. Second, the requirements of §112, 1st ¶, must be
evaluated in the context of what is claimed according to §112, 2d ¶, saying
that this has "always" been the requirement for enablement, citing Christianson v. Colt Indus. Operating Corp., 870
F.2d 1292, 1299 (1989). "Taking ¶
1 and ¶ 2
together, it is not the written description requirement but the claim,
interpreted in light of the specification and the patent file-history, that
identifies the invention," amicus asserts. Third, a claim can and will very often identify the
invention without 'describing' it," says this amicus, citing Koito Mfg. Co. v. Turn-Key-Tech,
LLC, 381 F.3d 1142,
1154 (Fed. Cir. 2004). This
argument relates to the "legal" wording of a claim, in contrast to
the language used in a specification (which the brief contends is directed not at a lawyer
but a person of ordinary skill in the art). This argument appears to envision a "translation"
function of the written description requirement, between the legal wording of
the claim and the technical wording of the specification. Finally, the brief appeals to the
"inherent circularity" of the analysis, which they argue "points
to the necessity for an 'as a whole' analysis," wherein the specification
must be assessed in light of the "invention" and the claimed
invention must be assessed in view of the description in the
specification.
Adopting this
approach would not change the "content" of each individual
requirement, the brief argues, but rather would affect "only the ultimate
determination of the sufficiency of the disclosure." Using the approach advocated by this
amicus would require establishing the "context" of the "invention"
in terms of the circularly-dependent claims and specification, and ultimately
resulting in an approach that may make up in "common sense" what it
seems to lack in analytical vigor. Its greatest advantage may be that it is more consistent with the
Supreme Court's "totality of the circumstances" approach to patent
jurisprudence than the traditional efforts by the Federal Circuit to bring
clarity to the application of U.S. patent law.
For additional information regarding this topic, please see:
• "Amicus Briefs in Ariad v. Lilly: Federal Circuit Bar Association," November 29, 2009
• "Amicus Briefs for Ariad v. Lilly: Intellectual Property Owners Association," November 25, 2009
• "Amicus Briefs in Ariad v. Lilly: GlaxoSmithKline," November 24, 2009
• "Amicus Briefs in Ariad v. Lilly: United States," November 23, 2009
• "Amicus Briefs in Ariad v. Lilly: Google, Verzion Communications Inc. and Cisco Systems, Inc.," November 22, 2009
• "Amicus Briefs in Ariad v. Lilly: Professor Christopher Holman," November 19, 2009
• "Lilly Files Principal Brief for Ariad v. Lilly Rehearing En Banc," November 16, 2009
• "Next Up: Ariad v. Lilly Rehearing En Banc," November 10, 2009
• "Federal Circuit Grants En Banc Review in Ariad v. Lilly," August 21, 2009
• "Ariad Files Petition for Rhearing in Ariad v. Lilly," June 3, 2009
• "Ariad Decision Voids Attempt to Use Broad Claiming to Avoid the Written Description Requirement," April 14, 2009
• "Ariad Pharmaceuticals, Inc. v. Eli Lilly and Co. (Fed. Cir. 2009)," April 6, 2009
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