FTC targets 'junk patents' on top drugs like Ozempic

The Federal Trade Commission (FTC) has initiated a significant challenge against over 300 patents filed with the Food and Drug Administration (FDA) aimed at maintaining market exclusivity for high-revenue drugs. These patents encompass 20 branded products, including Novo Nordisk's medications Ozempic, Saxenda, and Victoza. Companies such as AstraZeneca, Amphastar, Boehringer Ingelheim, Covis Pharma, GSK, Novartis, Teva, and two subsidiaries received warning letters from the FTC.

The FTC's main focus is on the FDA's Orange Book, which lists approved drugs along with their corresponding patents. According to the FTC, many of these patents are either improper or inaccurate, potentially obstructing the entry of affordable generic alternatives. The FTC has sent letters to ten companies, highlighting how these patents could prevent cheaper options from entering the market.

The Orange Book serves as a crucial resource for drug manufacturers because it allows them to sue generic developers seeking approval for a product with a listed patent. This legal mechanism can delay the introduction of generic medicines for up to 30 months. Additionally, pharmaceutical companies often file multiple patents for minor changes or new uses of a drug to create "patent thickets," effectively extending their market exclusivity and delaying generic competition for years.

FTC Commissioner Lina Khan has been vocal about the misuse of the Orange Book. In September, she indicated that the agency would combat companies exploiting this database. In a subsequent move less than two months later, the FTC contested patents for 17 drugs, particularly those using inhalers or injectors. Appearing on "The Daily Show with Jon Stewart," Khan highlighted the issue by mentioning how inhalers, despite being available for decades, still command high prices. Following the FTC's November action, several manufacturers removed certain patents, and three leading drugmakers announced they would cap the out-of-pocket costs for inhalers at $35.

Khan emphasized in a recent FTC release that bogus patent filings by pharmaceutical companies inflate prescription drug prices, burdening Americans financially. She stated that the FTC is committed to combating these illegal tactics to ensure timely access to both innovative and affordable medicines for Americans.

Under Khan's leadership, the FTC has adopted a more aggressive stance towards the pharmaceutical sector. This includes challenging various mergers and acquisitions. For instance, the FTC has scrutinized Amgen's acquisition of Horizon Therapeutics and Pfizer's buyout of Seagen. In December, under pressure from the FTC, Sanofi ended a licensing deal with Maze Therapeutics, which was suspected of extending Sanofi's monopoly on treating a rare disease. On the same day, Pfizer agreed to donate royalties from a cancer drug to the American Association for Cancer Research in response to FTC scrutiny.

As part of the latest challenge, the FTC has informed the FDA about the disputed patents. The FDA, in turn, will notify the manufacturers involved, who then have 30 days to either withdraw or amend their patent listings or certify that they comply with all relevant laws and regulations.