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