Tuesday, September 16, 2008

URochester's patent was invalidated by "old" interpretation of written description

In the context of a discussion on the Patent Hawk blog about an article in the New York Times on the Bayh-Dole Act, one had the following commentary about University of Rochester v. Searle, 358 F.3d 916 (CAFC 2004):

The Rochester patent was invalidated (properly) in part under an interpretation of written description law not developed until long after the patent was filed. And the recent Carnegie-Mellon patent was invalidated on the same basis.

This comment evokes Charlie Gibson lecturing Sarah Palin on his view of the Bush doctrine.

This author has written on Rochester v. Searle, and posted on this blog, long ago, about Rochester v. Searle.

Recall some of the text in the CAFC decision-->

In its first argument, Rochester asserts that the district court effectively--but erroneously--held that a patent claiming a method of obtaining a biological effect in a human by administering a compound cannot, as a matter of law, satisfy the written description requirement without disclosing the identity of any such compound. Indeed, Rochester contends that "no written description requirement exists independent of enablement." In any event, Rochester argues that its patent met the requirements of ß 112 and is not invalid.

Pfizer responds to Rochester's argument by pointing out that we have "interpreted ß 112 'as requiring a "written de-scription" of an invention separate from enablement,'" (citing [**12] Enzo Biochem, Inc. v. Gen-Probe Inc., 323 F.3d 956, 963 (Fed. Cir. 2002)), and that "the many prior precedential decisions" contrary to Rochester's position "cannot be overruled except by an en banc decision." Pfizer also cites Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555 (Fed. Cir. 1991), in which we explained that "the purpose of the written description requirement is broader than to merely explain how to 'make and use' [the invention]," id. at 1563; and Reiffin v. Microsoft Corp., 214 F.3d 1342 (Fed. Cir. 2000), in which we stated that the purpose of the written description requirement is to "ensure that the scope of the right to exclude, as set forth in the claims, does not overreach the scope of the inventor's contribution to the field of art as described in the patent specification," id. at 1345. Pfizer asserts that a patent fails to satisfy the written description requirement if it claims a method of achieving a biological effect, but discloses no compounds that can accomplish that result. It main-tains that the district court correctly invalidated Rochester's '850 patent.

At this point, prior to ANY citation of the Eli Lilly case, the CAFC agreed with Pfizer (Searle): We agree with Pfizer that our precedent recognizes a written description requirement and that the '850 patent does not satisfy that requirement.
To show the presence of an independent written description requirement, the CAFC reached back to a 1971 case: those three requirements are referred to as the "written description requirement," the "enablement requirement," and the "best mode requirement," respectively. See In re Moore, 58 C.C.P.A. 1042, 439 F.2d 1232, 1235 (CCPA 1971).

Rochester's argument about Lilly is rejected at page 924: Rochester's suggestion in its brief that Lilly "compounded Ruschig's error" by "invoking the written description requirement in a case without priority issues" is similarly deficient. Neither Wm. Moore nor Sus, for example, in-volved any priority issues. Moreover, even if the court had never had occasion to apply the written description requirement to original claims prior to the 1987 Lilly decision, that requirement was nonetheless always present.

Rochester's argument about a genetic material distinction was rejected: We agree with Rochester that Fiers, Lilly, and Enzo differ from this case in that they all related to genetic material whereas this case does not, but we find that distinction to be unhelpful to Rochester's position. It is irrelevant; the statute applies to all types of inventions. We see no reason for the rule to be any different when non-genetic materials are at issue; in fact, where there might be some basis for finding a written description requirement to be satisfied in a genet-ics case based on the complementariness of a nucleic acid and, for example, a protein, that correspondence might be less clear in a non-genetic situation.

Rochester's patent claim was not an invention under the law of 2000, or of 1790:

Regardless whether a compound is claimed per se or a method is claimed that entails the use of the compound, the inventor cannot lay claim to that subject matter unless he can provide a description of the compound sufficient to distinguish infringing compounds from non-infringing compounds, or infringing methods from non-infringing methods. As the district court observed, "the claimed method depends upon finding a compound that selectively inhibits PGHS-2 activity. Without such a compound, it is impossible to practice the claimed method of treatment." (...) it is undisputed that the '850 patent does not disclose any compounds that can be used in its claimed methods.

The CAFC cited a portion of the Bayh-Dole Act:

] It is the policy and objective of the Congress to use the patent system to promote the utilization of inventions arising from federally supported research or development; to encourage maximum participation of small business firms in federally supported research and development efforts; to promote collaboration between commercial concerns and non-profit organizations, including universities; to ensure that inventions made by nonprofit organizations and small business firms are used in a manner to promote free competition and enterprise without unduly encumbering future research and discovery; to promote the commercialization and public availability of inventions made in the United States by United States industry and labor; to ensure that the Government obtains sufficient rights in federally supported inventions to meet the needs of the Government and protect the public against nonuse or unreasonable use of inventions; and to minimize the costs of administering policies in this area.

See also

Missing the point on Bayh-Dole

The reliance of the Carnegie-Mellon court on Eli Lilly


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