May 1, 2024
(press release)
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The Federal Trade Commission sent letters to 10 drugmakers April 30 warning them that hundreds of patent listings for 20 drugs are invalid. The agency said "junk" listings keep drug prices high by stalling generic competition. The agency is disputing the accuracy of more than 300 patent listings in the Orange Book, an FDA document of patents for brand name products. The FTC says drugmakers list dozens of unnecessary patents in the book, which ultimately can delay cheaper alternatives from entering the market. The letters targeted 20 brand name products, including Novo Nordisk's Ozempic. The patents being challenged are related to the devices used to deliver drugs, including the "injection device with torsion spring and rotatable display" for Ozempic, according to The Wall Street Journal. These types of patents are invalid, per the FTC, because they relate to the devices, rather than the actual product itself. "By filing bogus patient listings, pharma companies block competition and inflate the cost of prescription drugs, forcing Ameicans to pay sky-high prices for medicines they rely on," Lina Khan, chair of the FTC, said in a news release. Novo Nordisk and GSK told the Journal the companies are reviewing the FTC's letters. A spokesperson for Boehringer said it has never wrongfully submitted patents to the Orange Book, and several other companies didn't respond to the publication's comment requests. The FDA will now contact the drugmakers regarding the disputes. The companies will then have 30 days to withdraw or amend the listings, or certify that the listings comply "with applicable statutory and regulatory requirements," under the penalty of perjury.
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