REMS Patents: Listability and Other Issues

Tom Irving, Law Clerk, Marbury Law
Stacy Lewis, Law Clerk, Finnegan
Mark Feldstein, Partner, Finnegan
Adriana Burgy, , Finnegan
Joanna Brougher, Owner & Principal, BioPharma Law Group PLLC

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.

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USA Intellectual Property Healthcare July 2023 Vol.16, No. 64, Summer 2023

Tom Irving

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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.

Stacy Lewis

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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.

Mark Feldstein

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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.

Adriana Burgy

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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.

Joanna Brougher

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BioPharma Law Group PLLC

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Finnegan

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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.

Marbury Law

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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.

USA Intellectual Property Healthcare July 2023 Vol.16, No. 64, Summer 2023