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REMS Patents: Listability and Other Issues

Abstract

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.

Authors

Portrait image of Joanna Brougher
Joanna Brougher
Owner & Principal, BioPharma Law Group PLLC, USA

Joanna is a seasoned patent attorney with deep expertise in biotechnology, pharmaceuticals, and medical devices. Her practice spans the full spectrum of patent law, from preparing and prosecuting U.S. and foreign patent applications to navigating complex proceedings such as Inter Partes Reviews (IPRs) before the Patent Trial and Appeal Board (PTAB). Joanna is dedicated to helping clients develop and protect innovative technologies, providing strategic patent portfolio management, competitive intelligence, freedom-to-operate analyses, and patentability, validity, and infringement opinions. Her work encompasses a diverse range of cutting-edge technologies, including small molecule drugs, biologics, cell-based technologies, drug formulations, delivery systems, immunotherapeutics, medical devices, diagnostic tests, and immunology applications, particularly in vaccines and antibodies. In addition to her legal practice, Joanna serves as an Adjunct Professor at Cornell Law School and the University of Pennsylvania School of Medicine, having previously taught at the Harvard School of Public Health. She frequently lectures on intellectual property topics and is a prolific author, with numerous articles on patent law and healthcare. Joanna has published two books: Intellectual Property and Health Technologies: Balancing Innovation and the Public's Health and Billion Dollar Patents: Strategies for Finding Opportunities, Generating Value, and Protecting Your Inventions. Joanna regularly speaks at domestic and international conferences, addressing critical areas of patent law, such as inventorship determinations, Orange Book listings, and strategies for building strong patent portfolios. Her thought leadership and extensive experience make her a sought-after expert in navigating the complexities of innovation and intellectual property protection in the life sciences.

Portrait image of Adriana Burgy
Adriana Burgy
, Finnegan, USA

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.

Portrait image of Mark Feldstein
Mark Feldstein
Partner, Finnegan, USA

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.

Stacy Lewis
Law Clerk, Finnegan, USA

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.

Portrait image of Tom Irving
Tom Irving
Partner, Marbury Law Group, USA

Tom Irving has some 48 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, including Obviousness-Type Double Patenting and Safe Harbor protection under 35 U.S.C. section 121.. 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.

Companies

BioPharma Law Group PLLC logo

BioPharma Law Group PLLC

BioPharma Law Group, PLLC is a boutique law firm led by Joanna T. Brougher, a seasoned patent attorney with deep expertise in biotechnology, pharmaceuticals, and medical devices. The firm provides comprehensive intellectual property services across the full spectrum of patent law, including U.S. and foreign patent prosecution, strategic portfolio management, competitive intelligence, freedom-to-operate analyses, and patentability, validity, and infringement opinions. Joanna also represents clients in complex proceedings before the Patent Trial and Appeal Board (PTAB), including Inter Partes Reviews (IPRs). The firm supports innovation in a broad range of cutting-edge technologies, from small molecules and biologics to cell-based therapies, immunotherapeutics, medical devices, diagnostics, and vaccine and antibody platforms. In addition to IP matters, BioPharma Law Group advises clients on domestic and international legal and contractual issues related to clinical trials, technology licensing, research collaborations, manufacturing, consulting, and the full suite of agreements that support life sciences R&D and commercialization.

Finnegan

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.

Finnegan

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.

Finnegan

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 Group logo

Marbury Law Group

Marbury Law Group: STRATEGIC INTELLECTUAL PROPERTY COUNSELING Marbury attorneys transform your ideas and innovations into valuable IP assets. Our attorneys manage large, medium, and small patent portfolios, and recognize your need for prompt, high quality strategic advice. We help start-up and emerging technology companies leverage their intellectual assets to achieve their business goals. In fact, many of our team members have worked at start-ups, and understand the demands facing start-up and emerging technology companies. Our attorneys work with your technical personnel to harvest potential intellectual property from your innovative development work. We have the technical skills to understand your technology and how your innovations can provide you with competitive advantages. Our diverse technical backgrounds, graduate engineering degrees, former industry, and USPTO experience allow us to quickly grasp, describe, and claim the inventions in your patent applications. Our lower overhead allows us to offer flat fees and keep our billing rates significantly lower than those of “big-law” firms, which allows us to take the time to understand the technology behind each invention and to provide cost effective answers, strategies, and patent applications. Furthering your business is our priority. Your business plan becomes the focus of our IP counseling and strategic advice. Let us put our knowledge and experience to work for you.

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