Obtaining and Managing REMS Patents: What Patent Prosecutors Need to Know, USPTO and FDA Policies and Rules

A live 90-minute premium CLE video webinar with interactive Q&A

This program is included with the Strafford CLE Pass. Click for more information.
This program is included with the Strafford All-Access Pass. Click for more information.

Tuesday, March 21, 2023

1:00pm-2:30pm EDT, 10:00am-11:30am PDT

Early Registration Discount Deadline, Friday, February 24, 2023

or call 1-800-926-7926

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.

Description

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.

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Outline

  1. Current FDA OB Listing Policy
  2. Future policy direction
  3. Options for REMS patent holders
  4. REMS patent litigation
  5. Issued REMS patents

Benefits

The panel will review these and other high priority issues:

  • What are the considerations for patent counsel when deciding whether to list a REMS patent in the Orange Book?
  • What is the significance of the FTC intervention in the Jazz case?
  • What best practices should counsel employ when obtaining and managing REMS patents?

Faculty

Brougher, Joanna
Joanna T. Brougher, Esq., MPH

Owner & Principal
BioPharma Law Group

Ms. Brougher is a patent attorney who focuses on all aspects of services related to patents in the areas of...  |  Read More

Feldstein, Mark
Mark J. Feldstein, Ph.D.

Partner
Finnegan Henderson Farabow Garrett & Dunner

Dr. Feldstein focuses on U.S. district court litigation, primarily concerning the enforcement of U.S. patent rights and...  |  Read More

Irving, Thomas
Thomas L. Irving

Partner
Finnegan Henderson Farabow Garrett & Dunner

Mr. Irving has 35 years of experience in the field of IP law. His practice includes due diligence, patent prosecution,...  |  Read More

Murphy, Amanda
Amanda K. Murphy, Ph.D.

Partner
Finnegan Henderson Farabow Garrett & Dunner

Dr. Murphy focuses her practice on client counseling and patent prosecution for a range of clients. She prepares new...  |  Read More

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