35 USC 271(e)(1) Provides a Broad Exemption for Experimentation for FDA Purposes

Integra Lifesciences I, Ltd. v. Merck KGaA, [2002-1052, -1065](July 27, 2007)[NEWMAN, Rader, Prost] On remand from the Supreme Court, the Federal Circuit reversed the district court judgment of infringement.
BRIEF: The Federal Circuit applied the Supreme Court's interpretation of 35 USC 271(e)(1) that the FDA Exemption includes experimentation on products that are not ultimately the subject of an FDA submission. The Federal Circuit found that the exemption applies to any research, which if successful, would be appropriate for FDA submission. The experimentation is not limited to experiments conducted to show that the candidate drug can safely be administered to human subjects in clinical trials. Nor is it limited to experiments that meed the FDA's "good laboratory practice" protocols. Integra also argued that experiments should be classified as either "discovery" or "routine" and only "routine" experiments be protected by the FDA Exemption, but the Federal Circuit rejected this argument. The Federal Circuit concluded that there was not substantial evidence to support the verdict of infringement, and reversed the judgement of infringement.