Tuesday, November 13, 2012
1:00 PM - 2:00 PM ET

BLOOMBERG BNA EVENT: The “safe harbor” provision of the Patent Act (35 U.S.C. § 271(e)(1)) provides that certain activities, otherwise covered by a patent, are not infringing to the extent they reasonably relate to obtain regulatory approval to market pharmaceutical and biologic products as well as medical devices. The Supreme Court has decided two cases directed to the scope of the safe harbor provision — Eli Lilly & Co. v. Medtronic, Inc., 496 U.S. 661 (1990), and Merck KGaA v. Integra Lifesciences, Ltd., 545 U.S. 193 (2005)). In Merck, the Court reversed a Federal Circuit decision limiting section 271(e)(1)’s safe harbor protection to preclinical research ultimately included in a submission to the FDA. 545 U.S. 193, 195 (2005). Previously, in Eli Lilly & Co. v. Medtronic, Inc., the Court held that medical devices fall under safe harbor protection.
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