The Federal Trade Commission (FTC) is taking decisive action to promote competition in the pharmaceutical market by renewing its challenges against more than 200 improperly listed device patents. These patents, associated with brand-name drugs for asthma, diabetes, epinephrine autoinjectors, and COPD, are believed to delay the entry of generic alternatives, thereby keeping drug prices artificially high and limiting patient access to affordable medications.

In a recent move, the FTC issued warning letters to several pharmaceutical companies, including Novartis, Amphastar Pharmaceuticals, Mylan Specialty, Covis Pharma, and three entities of Teva. The agency has also notified the Food and Drug Administration (FDA) about its disputes regarding the appropriateness of these patent listings in the FDA’s Orange Book, which lists approved drug products. The FTC argues that these patents do not meet the necessary statutory criteria for inclusion in the Orange Book, a position supported by a recent ruling from the U.S. Court of Appeals for the Federal Circuit.

FTC Chairman Andrew N. Ferguson emphasized the importance of transparent and competitive healthcare markets, stating that improper practices by firms harm everyday Americans by leading to higher prices and reduced access to medications. The FTC is committed to pursuing companies that engage in such anti-competitive practices.

This renewed challenge follows previous actions taken by the FTC, which included warning letters sent in November 2023 and April 2024, resulting in the delisting of patents for 22 different brand-name products. The recent ruling by the Federal Circuit, which upheld a District Court’s order for Teva to delist several asthma inhaler patents, further validates the FTC's stance on these patent listings.

Upon receiving the FTC's disputes regarding patent listings, the FDA will forward these concerns to the respective branded drug manufacturers. These companies will then have 30 days to either withdraw or amend the listings or certify under penalty of perjury that the listings comply with all applicable statutory and regulatory requirements.