In Merck KgA v. Integra Life Sciences I, Ltd., the Supreme Court held that the safe harbor under 35 U.S.C. § 271(e)(1) extended to the use of patented compounds in pre-clinical studies, provided there is a reasonable belief that the experiments would provide information relevant for submission to the F.D.A.[1] However, the Court declined to reach the question of whether infringement of so-called “research tool” patents would also fall within this safe harbor. The Federal Circuit’s recent decision in Proveris Scientific Corp. v. InnovaSystems, Inc. suggests that life sciences companies holding research tool patents need not fear that competitors may infringe them with impunity.[2]

Please see full update for more information.