REMS Patents: Listability and Other Issues

Tom Irving, Partner, Marbury Law, 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.

Tom Irving has some 45 years of experience in intellectual property law. His U.S. pharma practice includes America Invents Act (AIA) post-grant proceedings, due diligence, counseling, patent prosecution, reissue, and reexamination. In addition to advising on procuring strong U.S. patents, Tom counsels clients on a wide range of mainly pharmaceutical matters, including pre-litigation, Orange Book listings of patents covering FDA-approved drugs, infringement issues, enforceability, supplemental examination, and validity analysis. He has served as lead counsel in numerous patent interferences, reissues, and reexaminations; as lead counsel in numerous AIA post-grant proceedings; and as an expert witness in patent litigation and patent procurement.

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.