Summary of a Recent
Judicial Development in
Biotechnology

Patents Declared Void Due to Insufficient Written Descriptions

Walt McCarter
National AgLaw Center Research Associate

Summary of Decision

In Carnegie Mellon University v. Hoffmann-La Roche Inc., 541 F.3d 1115 (Fed. Cir. 2008), the United States Court of Appeals for the Federal Circuit held that a plaintiff's patents for types of recombinant DNA polymerases were void for failure to meet the written description requirement set forth in § 112 of the Patent Act, and thus affirmed summary judgment in favor of the defendant.

Background

Carnegie Mellon University brought an action against Hoffmann-La Roche, Inc., Roche Molecular Systems, Inc., Roche Diagnostic Systems, Inc., Roche Biomedical Laboratories, Inc., the Perkin Elmer Corporation, and Laboratory Corporation of America Holdings (collectively "Roche") for allegedly infringing on its patents for a type of recombinant DNA polymerases. Id. at 1119. The district court found no infringement had occurred because Carnegie Mellon had not satisfied the "written description" requirement for patents; therefore, the patents were void. Id. at 1120. Carnegie Mellon appealed. Id. at 1121.

Arguments

Carnegie Mellon argued that its patents were not invalid for lack of sufficient written description, and that the district court erred in failing to conduct a proper factual inquiry. Id. at 1122-23.

Roche argued that the district court was correct in determining that the patents were overly broad, and thus correctly found them invalid. Id. at 1123.

Analysis and Holdings

The written description requirement for patents, as set forth in 35 U.S.C. § 112, 1 of the Patent Act, provides that the specification "shall contain a written description of the invention." Id. at 1121. To satisfy the requirement, "the applicant does not have to utilize any particular form of disclosure to describe the subject matter claimed, but the description must clearly allow persons of ordinary skill in the art to recognize that he or she invented what is claimed." Id. at 1122. The court restated its prior holding that "an adequate written description of a DNA . . . requires a precise definition, such as by structure, formula, chemical name, or physical properties, not a mere wish or plan for obtaining the claimed chemical invention." Id. The appellate court found that the patents at issue were invalid for not satisfying the written description requirement, because the proffered written descriptions were overly broad and failed to disclose the nucleotide sequences and other descriptive features of the invention, and therefore affirmed the district court's grant of summary judgment. Id. at 1123-29.

The case was decided on September 8, 2008.