The Federal Trade Commission (FTC) has expanded its efforts to combat the improper listing of patents in the Food and Drug Administration’s Orange Book, targeting over 300 questionable listings for diabetes, weight loss, asthma, and COPD drugs. One of the drugs under scrutiny is Novo Nordisk Inc.’s popular weight-loss medication, Ozempic.
FTC Chair Lina M. Khan emphasized the negative impact of bogus patent listings on drug prices, stating, “By filing bogus patent listings, pharma companies block competition and inflate the cost of prescription drugs, forcing Americans to pay sky-high prices for medicines they rely on.”
The FTC has issued warning letters to several companies, including AstraZeneca, Novo Nordisk, Boehringer Ingelheim, Glaxo-Smith Kline, and Novartis Pharmaceuticals Corp., disputing the accuracy or relevance of the patent listings. The Commission’s actions aim to promote competition and ensure timely access to affordable generic versions of essential medications.
FDA Commissioner Robert M. Califf emphasized the importance of accurate Orange Book submissions, stating, “It is the responsibility of branded drug manufacturers to ensure that Orange Book submissions contain information only on the types of patents for which information should be submitted to FDA.”
The FTC’s recent challenges build upon previous actions taken by the Commission to address improper patent listings. In November, over 100 patent listings were disputed, leading to several companies delisting patents or committing to capping out-of-pocket costs for inhalers.
The FTC’s initiatives align with a policy statement issued in September 2023, warning against the improper submission of patents in the Orange Book. The Commission aims to prevent practices that hinder competition and delay the availability of generic alternatives.
The FTC continues to develop policies that safeguard competition and benefit consumers in the pharmaceutical industry. Consumers are advised to stay informed through the FTC’s social media channels, consumer alerts, and business blog for the latest updates on FTC initiatives.
