By Kevin E. Noonan —
Beginning with Regents of the University of California v. Eli Lilly and Company, the Federal Circuit has applied the written description requirement stringently in many art areas as a requirement of 35 U.S.C. § 112, first paragraph, that is separate from the enablement requirement. Judge Linn, at least, believes that is a doctrinal mistake, as he expressly stated in a concurring opinion in Ariad Pharmaceuticals, Inc. v. Eli Lilly and Co. that read more like a dissent. But how Ariad attempted to avoid the strictures of the written description requirement illustrates the wisdom of the theoretical framework for written description developed in large part by Judge Lourie over the past two decades.
The claims at issue in the Ariad case include these (as the Court said in its opinion, including the limitations incorporated by independent claims):
95. [A method for reducing, in eukaryotic cells, the level of expression of genes which are activated by extracellular influences which induce NF-κB-mediated intracellular signaling, the method comprising reducing NF-κB activity in the cells such that expression of said genes is reduced], carried out on human cells.
144. [A method for reducing bacterial lipopolysaccharide-induced expression of cytokines in mammalian cells, which method comprises reducing NF-κB activity in the cells so as to reduce bacterial lipopolysaccharide-induced expression of said cytokines in the cells] wherein reducing NF-κB activity comprises reducing binding of NF-κB to NF-κB recognition sites on genes which are transcriptionally regulated by NF-κB.
145. [A method for reducing bacterial lipopolysaccharide-induced expression of cytokines in mammalian cells, which method comprises reducing NF-κB activity in the cells so as to reduce bacterial lipopolysaccharide-induced expression of said cytokines in the cells], carried out on human cells.
A careful perusal of these claims reveals that nowhere in the claims is there recited what can reduce NF-κB activity in a cell. This is in contrast to the claims in University of Rochester v. G.D. Searle & Co., which the district court and the Federal Circuit found did not satisfy either the written description or enablement requirements for failing to identify a compound useful for practicing the claimed method:
Ariad's claim format represented the strategy behind their legal arguments:
That failed:
In Rochester, we held very similar method claims invalid for lack of written description. Id. (holding patent invalid because "Rochester did not present any evidence that the ordinarily skilled artisan would be able to identify any compound based on [the specification's] vague functional description"); see also Fiers v. Revel, 984 F.2d 1164, 1170–71 (Fed. Cir. 1993) (holding a claim to a genus of DNA molecules not supported by written description of a method for obtaining the molecules); cf. Eli Lilly, 119 F.3d at 1567–68 (holding claims to a broad genus of genetic material invalid because the specification disclosed only one particular species). Ariad attempts to categorically distinguish Rochester, Fiers, and Eli Lilly, because in those cases, the claims explicitly included the non-described compositions. For example, in Rochester, the method claims recited a broad type of compound that we held was inadequately described in the specification of the patent:
Id. at 918 (emphasis added). 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, and Ariad admits that the specification suggests only the use of the three classes of molecules to achieve NF-κB reduction. Thus, to 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 so as to "satisfy the inventor's obligation to disclose the technologic knowledge upon which the patent is based, and to demonstrate that the patentee was in possession of the invention that is claimed." Capon, 418 F.3d at 1357.
This strategy, of drafting broader claims to avoid a determination of invalidity, is reminiscent of the strategy Genetics Institute attempted to employ regarding its erythropoietin composition claims in Amgen Inc. v. Chugai Pharmaceutical Co. Genetics Institute asserted the following claim against Amgen in the first litigation (Amgen I):
(U.S. Patent No. 4,677,195)
This claim was upheld at trial but invalidated by the Federal Circuit (in Amgen II) for non-enablement:
Faced with this decision, Genetics Institute returned to the Patent Office and obtained the following claim (which, lacking the activity limitation was broader than the claim invalidated by the Federal Circuit):
(U.S. Patent No. 5,322,837)
Genetics Institute then sued Amgen on this patent. On summary judgment, Judge Young concluded:
From this conclusion, the ineluctable logic of the doctrine of claim preclusion compels a declaration that Genetics may not invoke the spectre of the '837 patent against Amgen and its privies. Whether under the name claim preclusion or res judicata, the principle and its elements are familiar: a claim is precluded where there is (1) a final judgment on the merits in an earlier action; (2) an identity of the cause of action in both the earlier and present suits; and (3) an identity of parties or privies in the two suits. Kale v. Combined Ins. Co. of America, 924 F.2d 1161, 1165 (1st Cir.), cert. denied, 502 U.S. 816, 116 L. Ed. 2d 44, 112 S. Ct. 69 (1991); Hartley v. Mentor Corp., 869 F.2d 1469, 1471 n.1 (Fed. Cir. 1989) (applying regional circuit law of res judicata to patent dispute).
The Court then supplied the doctrinal rationale for the importance of a full and complete disclosure of a claimed invention:
United States v. Dubilier Condenser Corp., 289 U.S. 178, 186-87, 77 L. Ed. 1114, 53 S. Ct. 554 (1933) (citations omitted); see also O'Reilly v. Morse, 56 U.S. 62, 119-20, 14 L. Ed. 601, (15 How. 62, 127-28) (1853) (Taney, C.J.) (one skilled in the art must be able to produce precisely the described result by using the means specified by the inventor); Grant v. Raymond, 31 U.S. 217, 247 (31 Peters 141, 160) (1832) (Marshal
l, C.J.) (correct specification is a prerequisite to obtaining a patent in order to give the public "the advantage for which the privilege is allowed, and is the foundation of the power to issue the patent."). When a putative inventor fails or refuses to fulfill the obligation to teach precisely what is claimed, the inventor is not entitled to the protections of the patent law. See, e.g., Morton Int'l, Inc. v. Cardinal Chem. Co., 5 F.3d 1464, 1469-70 (Fed. Cir. 1993) (affirming determination of lack of enablement where fifty examples in specification "obviously teach something," but not what was defined in the claims).
The Federal Circuit agreed, and granted Amgen its costs of responding to Genetic Institute’s appeal.
These decisions illustrate why Judge Linn's position fails to account for the strong policy considerations behind a separate written description requirement. Judge Linn (at right) argues that the claims have primacy in defining an invention, and that concentrating on a separate written description requirement obscures the question (in Ariad) of whether the claims are enabled. In addition, citing In re Hyatt, he suggests that Ariad's claims are "single means claims" that encompass unknown methods that cannot be enabled.
While it is certainly true that the Court's application of the written description requirement has occasionally "created mischief" (for example, in Enzo v. Genprobe I), it has also served a legitimate purpose. It is certainly the case that it provides a bright line rule for determining what an applicant has invented at the time the application was filed. It avoids the effects of improving technology, wherein an applicant can enable production of additional species (for example, of cDNA species encoding orthologs) that an applicant has not obtained. It has also beneficially prevented applicants, including the Rochester and Ariad inventors, from foreclosing the future with broad claims to all compounds or all methods for achieving a particular result. While Judge Linn may be correct that in certain circumstances an applicant will fail to satisfy both the written description and enablement requirements (as in Rochester), in others this may not always be the case (for example, isolation of a cDNA encoding one ortholog of a mammalian protein might enable the skilled worker to isolate orthologs from all other mammalian species); under these circumstances a separate written description requirement precludes overclaiming and rewarding an applicant with claims supported by a specification that does not satisfy the patent quid pro quo. If for no other reason, these situations implicate the Constitutional requirement that patents be granted only that "promote the progress" of the useful arts. That, alone, provides ample justification for the Federal Circuit's separate consideration of the written description and enablement requirements when determining whether claims are supported by a specification that adequately satisfies 35 U.S.C. § 112, first paragraph.
Patent Docs 
Leave a reply to SK Cancel reply