Federal Circuit Heightens Written Description Requirement for Patents on Genetic Material

By Mr Joshua Krumholz and Ms Patrea L. Pabst

On April 2, 2002, the Federal Circuit issued an opinion in Enzo Biochem, Inc. v. Gen-Probe Inc., No. 01-1230 (Fed. Cir. Apr. 2, 2002), that is important to both emerging biotechnology companies and investors in those companies. In that opinion, the Federal Circuit, the court responsible for maintaining uniformity of the laws governing patents, affirmed and expanded upon an increasingly strict standard for the written description requirement for patents covering genetic materials. Based on this opinion, a patent that does not describe the nucleotide sequence of the claimed genetic material may be held invalid, even where (1) someone ordinarily skilled in the art would fully understand the claimed invention, and (2) the description is supported by a deposit of the nucleic acid molecule in issue.

The Written Description Requirement

To receive a United States patent, an inventor must provide a specification that contains "a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise and exact terms as to enable any person skilled in the art to which it pertains or with which it is most nearly connected, to make and use the same." 35 U.S.C. 112, 1. Courts had held that the analysis of this requirement involves fact-specific, case-by-case consideration of the invention in light of the relevant art.

In Regents of the University of California v. Eli Lilly & Co., 119 F.3d 1559 (Fed. Cir. 1997), the Federal Circuit suggested that this requirement might apply more stringently in cases involving genetic material. In that case, the patent described the nucleotide sequence of cDNA encoding rat insulin and a method of obtaining cDNA encoding for other vertebrate insulins, including human insulin, but failed to describe the nucleotide sequence of cDNA encoding human or other vertebrate insulin. The claims of the patent pertaining to human and other vertebrate insulins were found invalid on the basis that they did not satisfy the written description requirement.

The decision was subject to extensive criticism, much of it centered on the fact that, for those skilled in the art, the disclosure of the patent made it routine to derive the human and other vertebrate cDNA. The disclosure of the patent appeared to be comparable in specificity and detail to written descriptions found to be adequate in other technologies. Many hoped that the case would be...