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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.

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Author

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.

Company

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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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