Amgen v. Hoechst Marion Roussel: The Written Description Standard in Biotechnology Patents

Abstract

ON JANUARY 6, 2003, the Federal Circuit issued a ruling in Amgen Inc. v. Hoechst Marion Roussel, Inc., a biotechnology patent infringement suit that has been closely watched since it was first filed in 1997 (314 F.3d 1313 (Fed Cir. 2003); see 22 BLR 122 April 2003). Amgen, both the owner of numerous patents directed to the production of erythropoietin (Epo) and the manufacturer of Epogen, a highly successful commercial product covered by those patents, asserted five of its Eporelated patents against Hoechst and Transkaryotic Therapies, Inc. The district court, following a 4month trial, found each of the asserted patents enforceable. On appeal, the Court of Appeals for the Federal Circuit affirmed in part, vacated in part, and remanded the case for further proceedings. In addition to making rulings on issues of claim construction and enablement, the CAFC ruled on the written description requirement under 35 USC §112, ¶1, elaborating on the standards set out in Regents of the University of California v. Eli Lilly and Co., 119 F.3d 1559 (Fed. Cir. 1997) and Enzo Biochem, Inc. v. Gen-Probe, Inc., 296 F.3d 1316 (Fed. Cir. 2002). This article discusses the current written description standard in view of the CAFC’s ruling in Amgen. We first review the standard set forth in Eli Lilly and Enzo. We then take a look at the CAFC’s ruling on the issue in Amgen. Finally, we give some guidelines for drafting patent applications that claim genetic materials. WRITTEN DESCRIPTION REQUIREMENT ARTICULATED IN ELI LILLY AND ENZO