Drug discovery tools and the clinical research exemption from patent infringement

摘要

Since we wrote the following article, the Court of Appeals for the Federal Circuit handed down its decision in Integra Life Sciences 1, Ltd. v, Merck KGAA, Nos. 02-1052 and 02-1065) (Fed. Cir. June 6, 2003). The Court affirmed the holding of the District Court for the Southern District of California that the clinical research exemption from patent infringement, codified in 35 USC 271 para (e) (1), does not reach the Scripps-Merck drug screening activities that infringe Integra's patent. According to the CAFC, the exemption does not "globally embrace all experimental activity that at some point, however attenuated, may lead to an FDA approval process. The safe harbor does not reach any exploratory research that may rationally form a predicate for future FDA clinical trials" (Integra, slip op. at 10). Policy considerations supporting the decision include a concern that "expansion of 271 para (e) (1) to include the Scripps-Merck [preclinical] activities would effectively vitiate the exclusive rightsof patentees owning biotechnology tool patents" (Integra, slip op. at 11). However, on the issue of damages, the CAFC reversed, on the grounds that the record evidence does not adequately support the jury's 15 million dollar "reasonable royalty" award toIntegra. On remand, the Court instructed the district court to consider various factors in arriving at a proper damage award, including the presence or absence of stacking royalties for research tools (see Integra slip op. at 17-18).