United States: Federal Circuit Declines en banc Review of Written Description Requirement

The U.S. Court of Appeals for the Federal Circuit declined a request by the University of Rochester for an en banc rehearing of the Court’s holding in University of Rochester v. G.D. Searle & Co., Inc. The Court held that the University of Rochester’s patent is invalid for failing to comply with the written description requirement of 35 U.S.C. §112, 1 because the patent specification failed to specifically disclose non-steroidal compounds that could inhibit the activity of the PGHS-2 gene product as required by the claims and there was no evidence that knowledge of such compounds would have been known to those having ordinary skill in the art. University of Rochester v. G.D. Searle & Co., Inc., Case No. 03-1304 (Fed. Cir. July 2, 2004) (Newman, J., dissenting) (Rader, J., dissenting) (Linn, J., dissenting) (Dyk, J., concurring) (Lourie, J., concurring).

In 1997, the Federal Circuit, in Reagents of the Univ. of Cal. v. Eli Lilly & Co., held that the written description requirement of §112, 1 is a separate requirement from the enablement and best mode requirements and held a biotech patent invalid because the written description did not provide adequate support for the claimed subject matter. This holding created a stir in the patent community because the demarcation between enablement and written description requirements had become somewhat unclear. In 2002, the Court made what some regard as a flip-flop when it issued its decision in Enzo Biochem, Inc. v. Gen Probe, Inc. The first panel in the Enzo Biochem case followed Eli Lilly and held the patent invalid but on rehearing, the panel reversed itself. The second Enzo Biochem decision added to the confusion surrounding the "new written description invalidity doctrine" created by Eli Lilly.

The issues presented have generated diverse opinions among the judges on the Federal Circuit. In the University of Rochester case, Judges Newman, Rader and Linn wrote separate dissenting opinions. Judges Dyk and Lourie wrote concurring opinions.

Judges Lourie, who authored the panel decision in the University of Rochester case, wrote a concurring opinion in support of the denial of rehearing stating that "there is and always has been a separate written description requirement in the patent law" and that "Section 282 of the Patent Act lists as [an invalidity] defense to an infringement action...arising from a failure to comply with a requirement of section 112 of the Act, which includes written description." Judge Rader disagreed and argued (in a dissenting opinion) that prior to the Court’s decision in Eli Lilly there were only two requirements, enablement and best mode, and prior to that time the function of the written description was only to ensure the inventor had possession of the claimed subject matter as of the filing date of the application relied upon. Judge Linn (in a dissenting opinion) stated: "Reading into paragraph 1 of section 112, an independent written description requirement, divorced from enablement, sets up an inevitable clash between the claims and the written description as the focus of the scope of coverage. This is ill-advised. Surely there is no principle more firmly established in patent law than the primacy of the claims in establishing the bounds of the right to exclude."

The University of Rochester case, like the Eli Lilly case, involved biotechnology patents. The concurring and dissenting opinions demonstrate a diversity of opinion in the Federal Court as to whether the written description should be considered a separate requirement for determining validity only of biotech patents. Judge Rader (in a concurring opinion) stated that the written description requirement "is the same for all types of inventions, although it may be applied differently, based on the technology and what is known by one of ordinary skill in the art at the time an invention was made." Judge Dyk (also in concurring opinion) indicated that he does not endorse the existing "written description jurisprudence" and that the Court has yet to "articulate satisfactory standard that can be applied to all technologies." However, Judge Dyk did not regard the University of Rochester case as the "right case, in which to consider those difficult questions."

The district courts and patent bar will have to wait for another case (or for a successful petition for cert to the U.S. Supreme Court in this case) to resolve the written description issues created by the Eli Lilly and Enzo Biochem decisions. In the meantime, practitioners, especially those in the biotechnology arts, are well advised to ensure that the written description in the patent specification sets forth "a precise definition, such as by structure, formula, chemical name or physical properties" of any claimed element.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.