Over the past several years, the Federal Trade Commission (FTC) has persistently been challenging what it deems to be improper patent listings for pharmaceuticals. For example, and as previously reported by Buchanan, FTC has filed patent listing dispute notifications with the U.S. Food and Drug Administration (FDA) and has even issued notice lettersto pharmaceutical companies challenging a total of more than 100 device-based patent listings as being improperly or inaccurately listed in FDA's Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the Orange Book).
On May 21, 2025, in continuing its efforts to promote competition and lower drug prices, FTC renewed its challenges against numerous improperly listed patents that protect brand-name asthma, diabetes, epinephrine autoinjector, and COPD medications from generic competition. FTC states these "improper patent listings can delay generic alternatives from entering the market, keeping drug prices artificially high and preventing patients from accessing lower cost drugs."
As part of these challenges, FTC again issued warning letters to several companies and notified FDA that it is contesting over 200 patent listings in the FDA's Orange Book related to 17 brand-name products. Specifically, FTC disputes these patent listings as they do not meet the statutory criteria for listing in the Orange Book, as confirmed by a recent ruling in the U.S. Court of Appeals for the Federal Circuit. Upon receiving the FTC's disputes, FDA will also notify the relevant drug manufacturers, who will have 30 days to amend or withdraw the listings or certify their compliance under penalty of perjury.
FTC remains committed to challenging what it deems to be improper patent listings and practices that harm consumers through higher prices. Buchanan's Life Sciences Industry Group is poised to assist companies better understand the impacts of FTC's actions in this arena and develop strategies to ensure compliance and mitigate risk.
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