This CLE webinar will guide patent counsel on the issues surrounding Risk Evaluation and Mitigation Strategy (REMS) patents and listing in the Orange Book. The panel will discuss REMS patents and what patent prosecutors need to know. The panel will address the current efforts of the USPTO and FDA to determine what policy or rules will govern the listing of REMS patents. The panel will also discuss other issued patents relating to REMS and will offer best practices for obtaining and managing REMS patents.
There is disagreement in the industry as to whether REMS patents are (or even should be) listable in the Orange Book. The Food and Drug Administration Amendments Act of 2007 gave the FDA the authority to require a REMS from drug manufacturers to ensure that the benefits of a drug or biological product outweigh its risks. Currently, there are 60 REMS filed with the FDA (REMS@FDA). In its Request for Comments in "Listing of Patent Information in the Orange Book; Establishment of a Public Docket" (FDA-2020-N1127), published in the Federal Register on June 1, 2020, the FDA asked questions concerning the listing of REMS patents. Then, in November 2022, the FDA requested comments on Joint USPTO-FDA Collaboration Initiatives, including what policy considerations should the USPTO and the FDA explore in relation to REMS patents. 87 Fed. Reg. 67,022 (Nov. 7, 2022).
REMS patents are currently in the spotlight as the case of Jazz Pharmaceuticals v. Avadel CNS Pharmaceuticals develops in the District of Delaware over U.S. Pat. 8,731,963, which is listed in the Orange Book and covers Jazz' product Xyrem® (1:21-CV-00691). Jazz sued Avadel for patent infringement and Avadel counterclaimed seeking a declaration ordering Jazz to remove the '963 patent from the Orange Book because it does not claim a method of using the approved drug. The Federal Trade Commission filed an amicus brief in support of Avadel, arguing that "REMS distribution patents as a category do not meet the requirements for Orange Book listing." The district court ordered Jazz to request delisting, but Jazz appealed, and the Federal Circuit granted a stay of the delisting order, pending appeal (No. 23-1186, Dec. 14, 2022).
Listen as our authoritative panel of patent attorneys discusses and examines REMS patents in the context of the Orange Book and what patent prosecutors need to know. The panel will discuss the current efforts of the USPTO and FDA to determine what policy or rules will govern the listing of REMS patents. The panel will discuss other issued patents relating to REMS and will offer best practices for obtaining and managing REMS patents.
