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In a decision likely to shape not only future biosimilar litigation but the biosimilar industry generally, the U.S. Supreme Court on June 12, 2017 handed down its much-anticipated ruling in Amgen v. Sandoz.
In the first case interpreting the Biologics Price Competition and Innovation Act (BPCIA), the Court (J. Thomas) unanimously reversed the Court of Appeals for the Federal Circuit, holding that biosimilar makers need not wait for FDA approval before providing the reference product sponsor with 180-day notice of commercial marketing. The Court also held that the statute does not provide a federal injunctive cause of action to force biosimilar applicants to provide their FDA application to the reference sponsor, but remanded to the Federal Circuit to determine whether injunctive relief might be available to reference sponsors under state law. The decision raises intriguing questions of statutory construction and policy and is expected to speed market entry of biosimilars and increase competition.The Federalist Society’s uniquely qualified, expert panel discussed the decision and its implications for the industry and patent rights generally.
- Prof. Gregory Dolin, Co-Director, Center for Medicine and Law, University of Baltimore School of Law
- Prof. Erika Lietzan, Associate Professor of Law, University of Missouri School of Law