US accuses GSK, 9 others of blocking cheaper drugs with patents

The US Federal Trade Commission has accused 10 multinational pharmaceutical manufacturers, including GSK, of blocking the market entry of cheaper generic drugs with inaccurate patent listings.

To promote competition, the commission said it is disputing these patent listings because they can delay cheaper generic alternatives from entering the market, keeping brand-name drug prices artificially high.

It issued warning letters on Tuesday to Glaxo-Smith Kline (GSK), Boehringer Ingelheim, Covis Pharma, Novartis Pharmaceuticals Corp., Teva Pharmaceutical Industries Ltd., and some of their subsidiaries over asthma and COPD inhaler devices.

It also served AstraZeneca and Novo Nordisk warnings over their obesity and type-2 diabetes injectable drugs.

…as patients suffer high drug costs

Amphastar Pharmaceuticals Inc. was served a warning over a glucagon nasal spray to treat severe hypoglycemia in type-1 diabetics.

“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,” Lina Khan, FTC Chair said.
“By challenging junk patent filings, the FTC is fighting these illegal tactics and ensuring that Americans can get timely access to innovative and affordable versions of the medicines they need.”

The FTC added that the accuracy of more than 300 patent listings across 20 different brand name products has been recently disputed.

These patent listings are currently listed in the FDA’s publication of “Approved Drug Products with Therapeutic Equivalence Evaluations,” commonly known as the Orange Book, which lists drug products approved as safe and effective.

It found that certain patent listings for diabetes, weight loss, asthma, and COPD drugs, including Novo Nordisk Inc.’s bestseller weight-loss drug, Ozempic were junk.

When a patent is disputed under FDA regulations, the FDA sends the dispute to the branded drug manufacturer who will then have 30 days to withdraw or amend the listing or certify under penalty of perjury that the listing complies with applicable statutory and 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,” Robert Califf, said FDA commissioner.

“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.”

The FTC’s latest patent listing dispute filings come after the Commission challenged over 100 patent listings in November for medications specific to asthma and other inhaler devices.

The challenges led to Kaleo Inc., Impax Labs, GlaxoSmithKline, and Glaxo Group delisting patents in response to the FTC’s warning letters.

Subsequently, AstraZeneca, Boehringer Ingelheim, and GlaxoSmithKline all announced commitments to cap inhaler out-of-pocket costs at $35.

In September 2023, the FTC issued a policy statement that warned that the agency would be scrutinising the improper submission of patents for listing in the Orange Book.

According to the policy statement, costs associated with challenging improperly listed patents can disincentivise investments in developing generic drugs, which risks delaying or thwarting competitive generic alternatives.

The Federal Trade Commission develops policy initiatives on issues that affect competition, consumers, and the U.S. economy.