Topline
The Federal Trade Commission is challenging hundreds of alleged “junk” patent listings filed by several pharmaceutical companies, which regulators claim could increase prices for medications like Novo Nordisk’s diabetes drug Ozempic by making it harder to produce generic drugs.
The “bogus” patent listings keep brand name drug prices “artificially high,” regulators said.
Key Facts
The FTC sent warning letters to 10 pharmaceutical companies—including Novo Nordisk, AstraZeneca, GlaxoSmithKline and Teva—disputing more than 300 “junk” patent listings across 20 different brand name products, the agency said Tuesday.
Some patents filed by these companies are “bogus” because they aren’t related to the drug they sell, like the injection “button” for Novo Nordisk’s diabetes drug Victoza or the “injection device with torsion spring and rotatable display” for Ozempic, according to the FTC.
If “improper or inaccurate” patents appear in the Food and Drug Administration’s Orange Book, which lists patents for brand name drugs, cheaper generic alternatives for these drugs are delayed from entering the market, the FTC said, making brand name drug prices remain “artificially high.”
Generic drugmakers can challenge Orange Book patent listings under the Hatch-Waxman Act, which grants a brief period of exclusivity to the generic manufacturer if successful, putting their product on the market before other generics.
If the brand name manufacturer defends its patent listing, regulatory approval for the generic drug could be delayed for up to 30 months.
What To Watch For
The pharmaceutical companies have 30 days to remove or amend their patent listings, or certify under penalty of perjury that the listings meet regulatory requirements.
Key Background
The FTC announced last year it would start scrutinizing “bogus” patent listings from pharmaceutical companies, which regulators argued “disincentivize” investments in developing generic drugs. The agency challenged over 100 patent listings in November, including medications for asthma and inhaler devices. Three companies—GSK, Kaleo and Impax Labs—complied with the FTC’s warnings and removed their listings with the FDA. There are no generic alternatives for Ozempic and they’re likely won’t be a generic form until at least 2031, when Novo Nordisk’s patent for semaglutide, Ozempic’s active ingredient, expires.
Contra
Five companies have rejected the FTC’s claim that alleged “junk patents” stifle competition or prevent generic drug alternatives. AstraZeneca responded to the FTC in February, arguing some of the patents challenged by the agency allowed generic drugmakers to better “understand the intellectual property landscape they will need to navigate” when creating alternative medications. The company also argued its patents were “legally compliant” and said at least one generic competitor for one of its medications had entered the market. Teva said it doesn’t use patent listings to “stifle competitions, prolong a monopoly, or price gouge patients,” adding it allows competitors to work around its patents. Teva also argued patent listings were “inherently pro-competitive” and a “critical aspect of the legal and regulatory landscape.”
Tangent
Ozempic belongs to a category of drugs called GLP-1 agonists, which have become wildly popular in recent years for weight loss, though Ozempic is only authorized for diabetes. Supplies for GLP-1 drugs like Wegovy—the weight loss medication by Novo Nordisk—have been severely limited because of increased demand, though some doses of Wegovy are back in stock in the U.S. and all three doses are listed as available by the FDA.
