Merck KGaA v. Integra Lifesciences I, LTD Uncertainty in the Scope of the Section 271(e)(1) Exemption

On June 13, 2005, the Supreme Court in <i>Merck KGaA v. Integra Lifesciences I, Ltd.</i>, 545 U.S. ___, 2005 WL 1383624 (2005) ruled that the safe-harbor infringement exemption of 35 U.S.C. '271(e)(1) may apply to non-clinical research on a patented compound as long as there is a reasonable basis to believe that the compound tested could itself be the subject of an FDA submission or that experiments with the compound will produce the kinds of information relevant to an Investigational New Drug Application ("IND") or a New Drug Application ("NDA"); the exemption may apply even though the patented compound never itself becomes the subject of an FDA submission or the experimental results arising from its use never reported in a submission. The decision reversed the holding of the Federal Circuit (331 F.3d 860 (Fed. Cir. 2003)) that the exemption applies only to research used to obtain information that is submitted to the FDA as part of an application for regulatory approval. The Court expressly refused, however, to consider whether '271(e)(1) might exempt "research tools" from infringement liability. Although the Court interpreted the reach of the '271(e)(1) exemption broadly, the issue of whether use of patented research tools falls within it remains unresolved.