FTC Renews Challenge of More Than 200 Improper Patent Listings

Continuing its efforts to promote competition and lower drug prices, today the Federal Trade Commission renewed its challenges against dozens of improperly listed device patents that shield brand-name asthma, diabetes, epinephrine autoinjector, and COPD drugs from prompt generic competition. Improper patent listings can delay generic alternatives from entering the market, keeping drug prices artificially high and preventing patients from accessing lower cost drugs.

The FTC sent warning letters to Novartis, Amphastar Pharmaceuticals, Mylan Specialty, Covis Pharma, and three Teva entities, and notified the Food and Drug Administration (FDA) that it disputes the appropriateness of more than 200 patent listings in the FDA’s Orange Book across 17 different brand-name products. These patent listings, which the FTC has previously disputed, continue to be maintained in the FDA’s publication of “Approved Drug Products with Therapeutic Equivalence Evaluations,” commonly known as the Orange Book. However, these patents 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.

“The American people voted for transparent, competitive, and fair healthcare markets and President Trump is taking action. The FTC is doing its part,” said FTC Chairman Andrew N. Ferguson. “When firms use improper methods to limit competition in the market, it’s everyday Americans who are harmed by higher prices and less access. The FTC will continue to vigorously pursue firms using practices that harm competition.”

The FTC previously challenged the accuracy or relevance of these patent listings via warning letters to companies and notifying the FDA in November 2023 and April 2024. That activity led to the delisting of patents across 22 different brand-name products.

The FTC’s renewed challenges come after the U.S. Court of Appeals for the Federal Circuit upheld a District Court’s order to pharmaceutical maker Teva to delist several asthma inhaler patents from the FDA’s Orange Book. The Federal Circuit affirmed a finding that the patents were improperly listed, consistent with an amicus brief filed by the FTC. The FTC previously challenged the Teva asthma inhaler patents at issue in that case via the FDA’s Orange Book dispute process. The Federal Circuit ruling confirmed the basis underlying the FTC’s prior Orange Book disputes.

The FTC’s renewed warning letters sent today target patent listings that remain listed on the FDA’s Orange Book despite the FTC’s previous challenges and the Federal Circuit’s recent ruling.

Upon receipt of the FTC’s patent listing disputes, the FDA will forward those disputes to the respective branded drug manufacturer, which will have 30 days to withdraw or amend the listing or certify under penalty of perjury that the listing complies with applicable statutory and regulatory requirements.