The FTC and the Orange Book: Considerations for Patent Owners

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In 2023, the Federal Trade Commission (FTC), supported by the Food and Drug Administration (FDA), issued a policy statement concerning improper listing of patents in FDA's Orange Book. The Commission took the position that listing patents in the Orange Book that do not meet the statutory listing criteria may harm competition and could be considered an unfair method of competition in violation of Section 5 of the FTC Act. That policy statement, coupled with subsequent enforcement actions, indicates that the FTC is taking an increasingly active role in scrutinizing pharmaceutical patents — and their owners.

On December 11, please join Principals Greg Booker and Karrie Wheatley for a discussion of how the FTC's recent interest in the Orange Book could affect branded pharmaceutical companies. Our hosts will discuss the following topics and more:

• What does the policy statement mean?
• What have the FTC and FDA done since issuing it?
• What can we expect going forward?

Fish & Richardson will apply for 1.0 hour of CLE credit.

If you have any questions, please contact [email protected].