FTC targets ‘junk’ patent listings on Ozempic and other drugs

livemint.com:

The Federal Trade Commission is challenging hundreds of pharmaceutical patent listings in an effort to smooth the path to more affordable alternatives to brand-name drugs—including blockbusters such as Ozempic and Victoza. The crackdown is the latest assault against what the agency regards as drugmakers’ patent ploys intended to stall generic competition. At issue is what is called the Orange Book, a document published by the Food and Drug Administration that lists patents relevant to brand-name pharmaceuticals.

Under a law meant to encourage generics, if a generics maker can successfully challenge listed patents, it can be granted a period of exclusivity before other generics are approved. But a challenge to an Orange Book patent, should a brand-name manufacturer decide to fight in court, also delays a generic’s approval for 30 months. The FTC says that drugmakers needlessly list oodles of extra patents in the Orange Book, delaying generic alternatives and artificially keeping prices high.

“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," said FTC Chair Lina Khan. Having one generic competitor for a brand-name drug cuts prices by about 40%, the FDA has said. The FTC issued letters to 10 companies Tuesday morning, warning them their patent listings were invalid.

It also notified the FDA that it disputes the patent listings. The letters targeted what agency officials called “junk listings" on patents for 20 drug products, including diabetes drug Ozempic. Also on the list are inhalers and more diabetes treatments from AstraZeneca, Boehringer Ingelheim, Covis Pharma, GSK, Novartis