REMS Patents: Listability and Other Issues

Mark Feldstein, Partner, Finnegan, USA

Abstract: Are Risk Evaluation and Mitigation Strategy (REMS) patents Orange Book listable (or even should be)? A straightforward question with a lot of disagreement. This paper discusses recent litigation on Orange Book listability, including Jazz Pharmaceuticals v. Avadel CNS Pharmaceuticals, as well as current efforts of the U.S. Patent and Trademark Office (’USPTO”) and U.S. Food and Drug Administration (’FDA”) to determine what policy or rules will govern the listing of REMS patents. Outlined are considerations for patent counsel when deciding whether to list a REMS patent in the Orange Book. The paper also discusses other issues relating to REMS patents, including antitrust implications, and offers best practices for obtaining and managing REMS patents.

Stacy Lewis is called to the bar in New York and has worked as a law clerk at Finnegan since 1995. She focuses on research and writing, particularly in the life sciences. She is the coordinating editor of the books Global Patent Litigation: How and Where to Win and Design Patent Law, as well as the coursebook Chemical Patent Practice. Stacy sits on the AIPLA Quarterly Journal and IPO Law Journal editorial boards. She can be reached at stacy.lewis@finnegan.com.

Finnegan, Henderson, Farabow, Garrett & Dunner, LLP is one of the largest IP law firms in the world. From offices in Atlanta, Boston, London, Munich, Palo Alto, Reston, Seoul, Shanghai, Taipei, Tokyo, and Washington, DC, the firm practices European, German, UK, and U.S. IP law. In addition to services related to all aspects of patent, trademark, and copyright law, including counseling, prosecution, licensing, and litigation, Finnegan provides counseling and litigation services in advertising, privacy, and a wide spectrum of additional IP-adjacent commercial matters, including trade secrets, international trade, the Internet, e-commerce, government contracts, antitrust, and unfair competition.