Number: RL33114
Title: Safe Harbor for Preclinical Use of Patented Inventions in Drug Research and Development: Merck KGaA v. Integra Lifesciences I, Ltd.
Authors: Brian T. Yeh, American Law Division 
Abstract: In Merck KGaA v. Integra Lifesciences I, Ltd., __ U.S. __, 125 S. Ct. 2372 (2005), the United States Supreme Court decided, without dissent, that the patent law's safe harbor provision exempts from infringement the preclinical use of patented inventions in drug research. Without this legal immunity, pharmaceutical companies face patent infringement liability when they conduct preclinical experiments using rival companies' patented compounds. The U.S. Court of Appeals for the Federal Circuit had earlier found that the statutory exemption applied only to clinical research activity that contributes "relatively directly" to information the Food and Drug Administration (FDA) considers in approving a drug. This narrow interpretation of the safe harbor provision had raised concerns that the patent law could significantly restrict the development and introduction of new medical treatments and generic drugs.
Pages: 11
Date: October 7, 2005