The Federal Trade Commission (FTC) is taking action against numerous pharmaceutical companies, including Novo Nordisk, AstraZeneca, GlaxoSmithKline, and Teva, for allegedly filing hundreds of “junk” patent listings. These questionable patents, such as the injection “button” for Novo Nordisk’s diabetes drug Victoza or the “injection device with torsion spring and rotatable display” for Ozempic, are not directly related to the drugs they are supposed to protect. The FTC claims that these improper patents can delay the entry of generic alternatives into the market, keeping brand-name drug prices artificially high.
The FTC has sent warning letters to these pharmaceutical companies disputing over 300 patent listings across 20 different brand name products. According to the agency, if inaccurate patents appear in the FDA’s Orange Book, which lists patents for brand-name drugs, it can delay the availability of cheaper generic alternatives. Generic drugmakers have the ability to challenge these listings under the Hatch-Waxman Act, which could grant them exclusivity for a brief period and allow their product to enter the market before other generics.
Pharmaceutical companies have 30 days to remove or amend their patent listings or certify that they meet regulatory requirements under penalty of perjury. Last year, the FTC announced its intention to crack down on bogus patent listings from pharmaceutical companies, claiming that they disincentivize investments in developing generic drugs. While some companies, such as GSK, Kaleo, and Impax Labs, complied with the FTC’s warnings and removed their patent listings, others have rejected the claim that these listings stifle competition or prevent generic alternatives.
Novo Nordisk’s diabetes drug Ozempic, which belongs to a class of drugs called GLP-1 agonists, has become popular not only for its diabetes properties but also for its weight loss benefits. However, supplies of GLP-1 drugs have been limited due to increased demand. Despite the ongoing debate over patent listings and their impact on drug prices and competition, pharmaceutical companies continue to defend their practices, arguing that the patents are legally compliant and essential for protecting their intellectual property rights in the highly competitive pharmaceutical industry.
