FTC Challenges Drug Makers' Patents, Including Ozempic's


A box of Ozempic and its contents on a table in Dudley, North Tyneside, Britain, on October 31, 2023.

Lee Smith | Reuters

The Federal Trade Commission said Tuesday it is challenging hundreds of alleged “junk” patents held by pharmaceutical companies for 20 brand-name drugs, including Nordisk blockbuster medications Ozempic, Saxenda and Victoza.

The FTC sent letters to 10 companies, warning them that certain drug patents were listed incorrectly. These companies include Novo Nordisk, AstraZenecaBoehringer Ingelheim, Covis Pharma, GlaxoSmithKline, Novartis, Teva Pharmaceuticals and Amphastar Pharmaceuticalsas well as some of its subsidiaries.

Many of the drug patents are for type 2 diabetes, along with asthma and inhalers for chronic obstructive pulmonary disease, or COPD.

Most best-selling drugs are protected by dozens of patents covering various ingredients, manufacturing processes and intellectual property. Generic drug makers can only release cheaper versions of a brand-name drug if the patents have expired or have been successfully challenged in court.

“By filing false patent listings, pharmaceutical companies block competition and inflate the cost of prescription drugs, forcing Americans to pay sky-high prices for the medications they depend on,” said FTC Chair Lina Khan. it's a statement. “By challenging junk patent applications, the FTC is fighting these illegal tactics and ensuring that Americans can get timely access to innovative, affordable versions of the medicines they need.”

The FTC also notified the Food and Drug Administration about the challenges. The FDA manages patent lists of approved drugs in a document called the Orange Book.

The FTC first challenged dozens of brand-name drug patents last fall, prompting three drugmakers to comply and withdraw their patents from the FDA. Five other companies did not do so.

Tuesday's announcement expands the Biden administration's efforts to crack down on alleged patent abuses by the pharmaceutical industry. The FTC has argued that drug makers are unnecessarily listing dozens of additional patents for brand-name drugs to keep their drug prices high and prevent generic competitors from entering the U.S. market.

The patent disputes add to a broader effort by the Biden administration to make health care more affordable for Americans, a key pillar of President Joe Biden's 2024 re-election campaign.

“We applaud the FTC's work with the FDA to end Big Pharma's patent gaming and reduce the costs of prescription drugs, including weight loss and diabetes drugs,” said Jon Donenberg, deputy director of the Council. National Economic Commission, in a statement to CNBC.

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