US agency warns 10 pharma companies of filing ‘bogus’ patents

AstraZeneca, GSK and Teva among manufacturers accused of “improper” submission of patents | More than 300 patents targeted in second wave of challenges by Federal Trade Commission | ‘Junk patents’ block competition and ramp up prices unfairly, says FTC chair.

The Federal Trade Commission (FTC) has expanded its fight against “illegal tactics” by pharmaceutical manufacturers by challenging “improper or inaccurate” listing of patents in the Food and Drug Administration’s (FDA) Orange Book.

Targeting more than 300 patent listings across 20 different brand name products, the FTC has sent warning letters to 10 pharma companies for filing what it calls “junk” patent listings.

The move, announced on Tuesday, April 30, is an expansion of the FTC’s campaign against pharmaceutical manufacturers, the commission said in a press release.

Among the accused listings are major blockbuster drugs such as Novo Nordisk’s diabetes drugs Ozempic and Victoza; and its weight-loss drug Saxenda.

Other disputed patents cover asthma and COPD drugs.

FTC chair Lina Khan stated: “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.

“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.”

Responding to Khan’s X post on the FTC’s action, one follower said: “Go get 'em, @linakhanFTC. Profiteering off sick people is despicable.”

Prior warning

Less than six months has passed since the FTC published a policy statement that warned that the agency would be scrutinising the “improper” submission of patents for listing in the Orange Book, which lists drug products that it approves as safe and effective.

By November 2023 the commission had challenged 100 patents owned by nine companies including AbbVie, Impax Laboratories, Kaleo and Mylan. The patents described medications specific to asthma and other inhaler devices, Restasis multidose bottles, and epinephrine autoinjectors.

AstraZeneca, Boehringer Ingelheim, Glaxo-Smith Kline (GSK) and Teva were among the accused both then and now.

In response to the FTC’s November challenges, Kaleo, Impax Labs, GSK delisted patents, and AstraZeneca, Boehringer Ingelheim, and GSK all announced commitments to cap inhaler out-of-pocket costs at $35.

This second round of warning letters were sent to:

● AstraZeneca and Novo Nordisk for obesity and type-2 diabetes injectable drugs;

● Boehringer Ingelheim, Covis Pharma, GSK, Novartis, Teva and some of their subsidiaries for asthma and COPD inhalers; and

● Amphastar Pharmaceuticals for a glucagon nasal spray to treat severe hypoglycemia in type-1 diabetics.

The drug manufacturers have 30 days after receiving the warning letter to withdraw or amend their listings, or certify under penalty of perjury that the listing complies with applicable statutory and regulatory requirements, said the FTC.

“Improper” listings in the Orange Book (the FDA’s publication of Approved Drug Products with Therapeutic Equivalence Evaluations), can delay cheaper generic alternatives from entering the market, keeping brand name drug prices artificially high, the FTC explained.

Did you enjoy reading this story?  Sign up to our free daily newsletters and get stories sent like this straight to your inbox