Amgen is trying to get the US Congress to enact new legislation that would dramatically alter the US biotechnology intellectual property landscape and drug-development pipeline. By prohibiting commonplace research and clinical activities on biologics conducted by biotechnology companies, the legislation could spur a flurry of big versus small biotechnology company patent infringement litigation. So far, unable to muster support from industry organizations, Amgen promises to press the issue when the 106th Congress convenes in January 1999, dragging the entire biotechnology and pharmaceutical industry into the fray. At issue is whether biologics, in addition to generics, should fall within the safe harbor of the Waxman-Hatch Act.
After an unsuccessful attempt in federal court to prevent Transkaryotic Therapies (TKT; Cambridge, MA) and partner Hoechst Marion Roussel (HMR; Kansas City, MO) from conducting clinical trials on gene-activated erythropoietin (GA-EPO) (Nat. Biotechnol. 16:404 , 1998), Amgen (Thousand Oaks, CA) moved the battleground to congress. With the 105th Congressional session nearing a close, Amgen has been unsuccessfully lobbying Congress to pass legislation that would allow patent holders to file infringement suits against companies conducting research and clinical trials on second-generation biologics prior to receiving US Food and Drug Administration (FDA; Rockville, MD) approval. Under current judicial interpretation of the safe harbor provision of the Waxman-Hatch Act, these activities are exempt from infringement.
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