


In an attempt to curb inaccurate patent listings in the Food and Drug Administration’s “Orange Book,” a list of drugs the FDA has deemed safe and effective, the Federal Trade Commission has sent warning letters and deemed more than 300 patents unsuitable.
The disputed patents include a junk patent for Ozempic, among other drugs for COPD, diabetes, weight loss, and asthma. Ozempic has been lauded for its weight-loss effects, though some have abused the drug.
“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 Chairwoman Lina Khan said.
“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,” she added.
Companies have 30 days to withdraw, update their patent listing, or certify that their patents are legitimate “under penalty of perjury.”
“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,” FDA Commissioner Robert Califf said. “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 sent warning letters to 10 companies, including Ozempic’s Novo Nordisk.
The Washington Examiner contacted Novo Nordisk but did not receive a response.
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The crackdown on patents, which exclude pharmaceutical companies’ competition from producing similar products, will boost companies looking to produce generic drugs similar to Ozempic.
President Joe Biden’s administration has focused on bringing drug prices down with moves like this, along with letting Florida import cheaper drugs and allowing Medicare to negotiate with drugmakers.