Dive Brief:
- The Federal Trade Commission is challenging more than 300 patents filed with the Food and Drug Administration to protect market exclusivity for top-selling drugs.
- The patents cover 20 brand-name products, including Novo Nordisk’s medicines Ozempic, Saxenda and Victoza. AstraZeneca, Amphastar, Boehringer Ingelheim, Covis Pharma, GSK, Novartis, Teva and two subsidiaries also received warning letters on Tuesday.
- Regulators are focusing on the Food and Drug Administration’s Orange Book, which compiles approved drugs along with patent listings. Altogether, the FTC sent letters to 10 companies, alleging patents they filed are either improper or inaccurate and could block cheaper, generic competition for expensive medications.
Dive Insight:
The Orange Book is a critical tool for drugmakers because they can sue a generic developer who applies for approval of a product with a listed patent, blocking the entry of a copycat medicine for 30 months. By adding a series of patents for minor modifications or new uses, pharmaceutical companies can also craft “patent thickets” that stave off generic competition for years.
FTC Commissioner Lina Khan first put the pharmaceutical industry on notice about abuse of the Orange Book in September, saying her agency would fight companies that try to “weaponize” the database. Less than two months later, the FTC challenged patents for 17 drugs, mostly those that use inhalers or injectors.
Khan pointed to that challenge as a victory in an appearance last month on The Daily Show with Jon Stewart. Inhalers have been on the market for decades but still cost hundreds of dollars, she said. After the FTC’s November action, several manufacturers de-listed patents and three top drugmakers announced they would cap inhaler out-of-pocket costs at $35.
“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,” Khan said in the FTC’s release Tuesday. “The FTC is fighting these illegal tactics and making sure that Americans can get timely access to innovative and affordable versions of the medicines they need.”
Under Khan, the FTC has been going after the pharmaceutical industry in new, more aggressive ways. The agency has challenged several M&A deals, among them Amgen’s acquisition of Horizon Therapeutics and Pfizer’s buyout of Seagen. And in December, Sanofi terminated a licensing deal with the biotechnology company Maze Therapeutics after the agency alleged the partnership would extend Sanofi’s monopoly in treating a rare disease. The same day, FTC scrutiny prompted Pfizer to agree to donate royalties from a cancer drug to the American Association for Cancer Research.
As part of the latest challenge, the FTC notified the FDA of the disputed patents. The FDA in turn will send the disputes to manufacturers, who have 30 days to withdraw or amend the patent listing or certify that it meets with all applicable laws and regulations.