By: Adam Sibley
Abstract
The “FDA safe harbor provision,†enacted as part of the Hatch-Waxman Act and codified at 35 U.S.C. § 271(a), excepts from infringement uses of patented inventions that are solely and reasonably related to submissions to the FDA. Over the past twenty years, the Supreme Court has broadened this safe harbor to include medical devices and upstream research, in cases such as Eli Lilly v. Medtronic, 496 U.S. 661 (1990), and Merck KGaA v. Integra Lifesciences I, 545 U.S. 193 (2005). Throughout this broadening evolution, the Supreme Court has fashioned analytical tests as well as specific definitions for various applicable terms, such as “patented invention.†However, in August 2008, the Federal Circuit brought an abrupt halt to this trend in its decision in Proveris Scientific Corp. v. Innovasystems, Inc., 536 F.3d 1256 (Fed. Cir. 2008). Although the result in Proveris might well be correct, the opinion displays obvious tensions with Supreme Court precedent and leaves many questions unanswered.