FTC IDs 300+ 'Junk Patents' Among Drugmakers

The warning letters don't specify how the drugmakers are flouting patent regulations, or what criteria the FTC uses to make that determination.

The Federal Trade Commission on Tuesday challenged the legitimacy of more than 300 "junk patents" for drugs treating a range of conditions from diabetes to COPD and including Novo Nordisk Inc.'s weight-loss drug Ozempic.

In warning letters to 10 pharmaceutical companies, the FTC disputes the accuracy or relevance of the patent listings across 20 brand name products, as listed in the FDA's "Approved Drug Products with Therapeutic Equivalence Evaluations," a.k.a. the Orange Book.

None of the warning letters specify how the drugmakers are flouting patent regulations, or what criteria the FTC uses to make that determination.

"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 says. "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.
   
• Boehringer Ingelheim, Covis Pharma, Glaxo-Smith Kline, Novartis Pharmaceuticals Corp., Teva Pharmaceutical Industries Ltd. and some of their subsidiaries for asthma and COPD inhalers.
   
• Amphastar Pharmaceuticals Inc. for a glucagon nasal spray to treat severe hypoglycemia in type-1 diabetics.

The drug makers will have 30 days to withdraw or amend the listing or certify – under penalty of perjury -- that the patent is legitimate and complies with regulations.

"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," says FDA Commissioner Robert M. Califf, MD. "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, the FTC challenged more than 100 patent listings for medications specific to asthma and other inhaler devices, Restasis multidose bottles, and epinephrine autoinjectors.

Those challenges led to Kaleo Inc., Impax Labs, GlaxoSmithKline, and Glaxo Group delisting patents. In addition, AstraZeneca, Boehringer Ingelheim, and GlaxoSmithKline capped inhaler out-of-pocket costs at $35, the FTC says.

These recent actions follow a September 2023 FTC policy statement that warned drugmakers that the commission would be scrutinizing the improper patents in the Orange Book. The FTC says junk patents can lead to costly legal battles over patent rights that disincentivize investments in alternative and cheaper generics. 

In a response to a query from HealthLeaders, Novo Nordisk acknowledged that it had "received the letter from the FTC and are currently reviewing it."