REMS Patents: Listability and Other Issues

July 4, 2023

International In-House Counsel Journal

By Mark J. Feldstein, Ph.D.; Adriana L. Burgy; Tom Irving, Partner, Marbury Law, USA; Joanna Brougher, Owner and Principal, BioPharma Law Group PLLC, USA; *Stacy Lewis

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.

To read the full paper, click here.

*Stacy Lewis is a Law Clerk at Finnegan.

Originally printed in the International In-House Counsel Journal on July 4, 2023. This article is for informational purposes, is not intended to constitute legal advice, and may be considered advertising under applicable state laws. This article is only the opinion of the authors and is not attributable to Finnegan, Henderson, Farabow, Garrett & Dunner, LLP, or the firm’s clients.