Survey of the Safe Harbor in the United States and Europe Brian Coggio Ron Vogel
[email protected] [email protected] [Type here] 212-641-2336 212-641-2309 SURVEY OF THE SAFE HARBOR IN THE UNITED STATES AND EUROPE BRIAN COGGIO RON VOGEL1 On October 3, 2016, the United States Supreme Court denied Amphastar Pharmaceutical’s petition for certiorari regarding the so-called “safe harbor,” 35 U.S.C. § 271(e)(1), which shields activities done, inter alia, to secure regulatory approval of generic and biosimilar drugs (the “Safe Harbor”).2 This decision left undisturbed the Federal Circuit’s holding in Momenta Pharm., Inc. v. Teva Pharm. USA Inc. (“Momenta II”) that implemented a heightened standard of scrutiny on whether post-approval activities are covered by the Safe Harbor.3 After examining the decisions that led to Momenta II, it seems clear that a broad range of pre- and post-approval activities — including supplying active ingredients, using research tools, and stockpiling drug inventory — may be protected under the Safe Harbor as long as they are clearly linked to efforts to secure regulatory approval. Appreciating the scope of protection afforded by the Safe Harbor is vital to pharmaceutical and biotech firms. Understanding the so-called Bolar Exception and Bolar Exemption, the Canadian and European analogs of the U.S. Safe Harbor, respectively, as well as the broad research exemption that exists in Europe is critically important to allow multinational organizations to conduct their research and development efforts and take advantage of these differing, world-wide protections. We begin with the genesis of the Safe Harbor.