US challenges ‘fake’ patents on Ozempic and other drugs in bid to stoke competition

WASHINGTON — Federal regulators are challenging patents on 20 brand-name drugs, including the blockbuster weight-loss injection Ozempic, in the latest action by the Biden administration targeting industry practices that drive up pharmaceutical prices.

The Federal Trade Commission on Tuesday sent warning letters to 10 drugmakers, criticizing patents on popular drugs for weight loss, diabetes, asthma and other recovery conditions. The letters allege that certain patents filed by Novo Nordisk, GlaxoSmithKline, AstraZeneca and seven other companies are false or misleading.

Manufacturers of brand-name drugs use patents to protect their drugs and prevent cheaper, generic drugs. Most blockbuster drugs are protected by dozens of patents covering various ingredients, manufacturing processes and intellectual property. Generic drug manufacturers can only market their own, cheaper versions once the patents have expired or have been successfully challenged in court.

“By filing false patent citations, pharmaceutical companies block competition and drive up the cost of prescription drugs, forcing Americans to pay sky-high prices for the drugs they depend on,” FTC Chair Lina Khan said in a statement.

Ozempic is part of a class of drugs originally developed to treat diabetes but recently approved for the treatment of obesity, increasing the number of prescription medications. Medicare spending on these drugs has also increased sharply in recent years.

The drug’s manufacturer, Novo Nordisk, declined to comment.

The FTC’s latest announcement follows a similar action in September, when regulators challenged more than 100 patents from drugmakers including Abbvie, AstraZeneca and Boehringer Ingelheim.

Companies that receive the letters have 30 days to revoke or update their patent lists or declare “under penalty of perjury” that they are legitimate, according to the FTC. The patents are registered with the Food and Drug Administration, which reviews and approves new drugs.

The patent challenges are part of a strategy by President Joe Biden to drive down drug prices, including by letting Medicare negotiate with drugmakers and allowing states like Florida to import cheaper drugs from other countries.