The U.S. Federal Trade Commission on Tuesday announced it is challenging more than 300 patents held by 10 drug companies, including popular weight loss drug Ozempic.
The FTC said it sent warning letters to 10 companies and notified the U.S. Food and Drug Administration that it "disputes the accuracy or relevance" of more than 300 patents listed in the FDA's Orange Book, which lists FDA-approved drug products.
The disputed patents cover 20 different brand-name drug products. Drugmakers typically file patents for ingredients, manufacturing methods, and other intellectual property, meaning a single drug could be covered by several patents. Cheaper, generic versions of the drugs can only be made once those patens expire or are overturned in court.
FTC Chair Weighs In
“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,” FTC Chair Lina M. Khan said in a statement. “By challenging junk patent filings, 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.”
The warning letters were sent to AstraZeneca and Novo Nordisk for obesity and type-2 diabetes injectable drugs, including Novo Nordisk's Ozempic. Boehringer Ingelheim, Covis Pharma, Glaxo-Smith Kline, Novartis Pharmaceuticals Corp., Teva Pharmaceutical Industries Ltd. and some of their subsidiaries received letters related to patents for asthma and COPD inhalers. A letter was also sent to Amphastar Pharmaceuticals Inc. for a glucagon nasal spray to treat severe hypoglycemia in type-1 diabetics.
Deadline on Patent Listings
Following the FTC challenges, the FDA will send the dispute to drug manufacturers, which will have 30 days to withdraw or amend challenged patent listings, or certify under penalty of perjury that the listing complies with regulatory requirements.
“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,” said FDA Commissioner Robert M. Califf, M.D. “The FDA will continue to engage with the FTC to identify and address potential efforts to impede competition so that consumers can get access to the medicines they need.”
In November of last year, the FTC similarly challenged more than 100 patents for asthma medications and other inhaler devices, Restasis multidose bottles, and epinephrine autoinjectors. In response, Kaleo Inc., Impax Labs, GlaxoSmithKline, and Glaxo Group delisted the challenged patents. As a result, AstraZeneca, Boehringer Ingelheim, and GlaxoSmithKline then announced commitments to cap inhaler out-of-pocket costs at $35.
Story via TMX