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

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.