Locke Lord QuickStudy: The FTC Strikes Again – Challenging the Listing of 300+ Patents in FDA’s Orange Book

Locke Lord LLP
May 2, 2024

On April 30, 2024, the FTC issued a press release[1] and warning letters to ten pharmaceutical companies notifying them that the FTC had “availed [themselves] of the FDA’s regulatory process and submitted patent listing dispute communications to the FDA” identifying patents believed to be improperly listed in the FDA’s “Approved Drug Products with Therapeutic Equivalence Evaluations,” known as the “Orange Book.” The warning letters stated that the identified patents were not necessarily an exhaustive list and stressed the companies’ burden to ensure patents in the Orange Book are listed “accurately and in accordance with all relevant statutory and regulatory requirements.” The warning letters left open the FTC’s rights to address the improper listings using other available avenues, including “investigating this conduct as an unfair method of competition under Section 5 of the FTC Act.”

In the warning letters, the FTC identified over 300 patents listed for twenty drug products, including treatments for diabetes, asthma, COPD, and weight loss.

As we previously reported, the FTC has recently begun investigating improperly listed patents. The FTC issued a policy statement on September 14, 2023 and subsequently sent notice letters to ten companies on November 7, 2023 challenging the listing of more than 100 patents in the Orange Book. In the April 30, 2024 press release, the FTC states that its November 2023 challenges led to companies delisting patents and to announce “commitments to cap inhaler out-of-pocket costs at $35.”

Under the FDA’s regulatory dispute process, 21 C.F.R. § 314.53(f)(1), the FDA will notify the New Drug Application holders of FTC’s challenge, and the companies will then have 30 days to withdraw the patents, amend the listing, or certify that the patents are properly listed.

For more information regarding FTC enforcement mechanisms and requirements for listing patents in the Orange Book, please see our prior publication "FTC Challenges 100+ Patents, Bringing ‎Attention to Orange Book Patent Listing Requirements." We will continue to monitor the FTC’s actions.


[1] FTC Expands Patent Listing Challenges, Targeting More Than 300 Junk Listings for Diabetes, Weight Loss, Asthma and COPD Drugs | Federal Trade Commission