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Patent Listings in the Orange Book: FTC Guidance, Policy, and Enforcement; Practical Steps for NDA Holders and Applicants

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.

Thursday, March 21, 2024

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

or call 1-800-926-7926

This CLE webinar will guide patent counsel on patent listings in the Orange Book and the U.S. Federal Trade Commission's (FTC) recent actions. The panel will examine the FTC's policy on Orange Book listings, its recent enforcement, and the options it is considering. The panel will discuss what holders and applicants can do with both existing listings and future listings.


In September 2023, the FTC issued a policy statement "to put market participants on notice that the FTC intends to scrutinize improper Orange Book listings." The FTC evidently believes that patents that are wrongfully listed in the Orange Book will drive up drug pricing and will have a negative impact on competition. In November 2023, the FTC followed up its policy announcement by challenging over 100 patents held by companies as improperly or inaccurately listed in the Orange Book.

The FTC is targeting both existing as well as new listings, focusing on the negative impact on competition and reinforcing its concerns about anticompetitive impact. And in January 2024, Senator Klobuchar (D. Minn.) targeted specific pharmaceutical companies owning patents on the FTC's list, urging those companies to delist.

Listen as our authoritative panel of patent attorneys possessing wide experience in Orange Book listings, examines the FTC's policy on Orange Book listings, its recent enforcement, and the options it is considering. The panel will discuss what holders and applicants can do with both existing listings and with future listings in an effort to avoid receiving notices from the FTC as well as politicians.



  1. Review of Orange Book listings
  2. Improperly listed patents; delisting
  3. FTC's recent guidance, policy statements
  4. FTC enforcement
  5. Input from politicians, such as Sen. Klobuchar
  6. Practical steps for NDA holders and applicants to take with past listed Orange Book patents, as well as future listings


The panel will review these and other key issues:

  • What key considerations should pharma organizations and counsel weigh when determining whether or not to Orange Book list a patent?
  • Pros and cons of whether to list particular patents
  • Value from not listing certain patents, particularly in view of the recent Lundbeck Federal Circuit case
  • What steps could patentees have taken during prosecution or in, e.g., reissue, in the Orange Book listed patents challenged by the FTC?
  • What steps are involved in delisting a patent and what ramifications might flow therefrom?


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

Irving, Thomas
Thomas L. Irving

The Marbury Law Group

Mr. Irving has 47 years of experience in the field of IP law. His practice includes due diligence, patent prosecution,...  |  Read More

Norris, Christine C.F.
Christine C.F. Norris

The Marbury Law Group

Ms. Norris has represented a variety of clients ranging from large multinational corporations to small start-up...  |  Read More

O’Brien, Michelle
Michelle E. O'Brien

The Marbury Law Group

Ms. O’Brien has more than 20 years of experience representing domestic and foreign clients of all sizes in...  |  Read More

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