FTC Challenges to Orange Book Listings: Considerations for Patent Holders

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On November 7, 2023, the Federal Trade Commission announced that it is challenging more than 100 patents held by 10 branded drug companies as improperly or inaccurately listed in the Food and Drug Administration's Orange Book. The Commission has notified FDA that it disputes the accuracy or relevance of the listed information for the targeted patents. Once FDA receives the dispute notice, it will send the statement of dispute to the New Drug Application holder, who will then have 30 days to withdraw or amend the listings or certify under penalty of perjury that the listings comply with the applicable statutory and regulatory requirements.

Please join attorneys Gwilym Attwell, Martina Hufnal, and Tina Murphy on December 14 as they discuss these recent developments. Bringing a diverse range of perspectives in patent prosecution, regulation, and litigation, our hosts will cover:

• A timeline of recent FTC filings
• The legal grounds underlying the challenges
• What to consider during the pre-listing process
• Diligence in reviewing existing Orange Book listings
• Litigation issues​

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