FTC targets ‘junk’ patent listings on Ozempic and other drugs
The antitrust cop says that the more than 300 patent listings stall generic competition, keeping prices high for diabetes drugs, inhalers and more.
The Federal Trade Commission is challenging hundreds of pharmaceutical patent listings in an effort to smooth the path to more affordable alternatives to brand-name drugs—including blockbusters such as Ozempic and Victoza.
The crackdown is the latest assault against what the agency regards as drugmakers’ patent ploys intended to stall generic competition.
At issue is what is called the Orange Book, a document published by the Food and Drug Administration that lists patents relevant to brand-name pharmaceuticals. Under a law meant to encourage generics, if a generics maker can successfully challenge listed patents, it can be granted a period of exclusivity before other generics are approved. But a challenge to an Orange Book patent, should a brand-name manufacturer decide to fight in court, also delays a generic’s approval for 30 months.
The FTC says that drugmakers needlessly list oodles of extra patents in the Orange Book, delaying generic alternatives and artificially keeping prices high.
“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," said FTC Chair Lina Khan. Having one generic competitor for a brand-name drug cuts prices by about 40%, the FDA has said.
The FTC issued letters to 10 companies Tuesday morning, warning them their patent listings were invalid. It also notified the FDA that it disputes the patent listings. The letters targeted what agency officials called “junk listings" on patents for 20 drug products, including diabetes drug Ozempic. Also on the list are inhalers and more diabetes treatments from AstraZeneca, Boehringer Ingelheim, Covis Pharma, GSK, Novartis Pharmaceuticals, Novo Nordisk, Teva Pharmaceutical Industries, Amphastar Pharmaceuticals and some of their subsidiaries.
The companies didn’t immediately respond to requests for comment.
Companies in the past have questioned FTC’s patent challenges, saying they listed their patents because the law requires it. They have said doing so actually helps generic companies know what patents they are up against as they strategize on when to launch products.
The targeted patents cover devices used to deliver drugs, including the “injection device with torsion spring and rotatable display" for Ozempic, or the injection “button" for Victoza, another Novo Nordisk diabetes drug.
The listings aren’t legitimate, the agency said, because the law asks drugmakers to list only patents that apply to the actual drug, such as its active ingredient or formulation or its method of use. Devices are neither, agency officials said.
Should the companies comply and the listings be removed, a generic competitor would have an easier time entering the market once the central patents expire, FTC officials said. Patients could buy a cheaper, generic form of Ozempic, for example, around 2031.
The next step would be for FDA to contact the drug manufacturers, which then have 30 days to nix or amend the listings, or certify that they are proper under penalty of perjury.
After the FTC challenged inhaler and other device patents in a similar way in November, three companies chose to comply and delist their patents with the FDA. But another five didn’t, saying they were attempting to follow the law and hadn’t received any firm guidance from federal officials indicating that they were doing so incorrectly.
“At no time did Teva use these patent listings to stifle competition, prolong a monopoly, or price gouge patients," said a letter from the drugmaker to lawmakers concerning the matter. “To the contrary, robust patent listings are inherently pro-competitive."
An FTC official declined to answer whether the agency is planning further legal action against the companies that refused to delist their patents, but said that the agency doesn’t issue empty threats.
The latest move against drugmakers represents just one salvo in what Khan regards as a continuing battle against anticompetitive healthcare practices. In her tenure the agency so far has challenged two major pharmaceutical mergers, sued a private-equity-backed company for consolidating anesthesiology practices in Texas and launched probes of drug middlemen, among other steps.
Some observers have said it is unclear whether the FTC’s scrutiny of the Orange Book will be enough to boost generic competition. Critics warn the drugmakers’ delisted patents will just make it more risky for generics to enter the market, since they might have to contend with patent litigation after they get approval, when they have already invested significant sums in getting a drug into production. Some critics blame the U.S. Patent and Trademark Office for issuing flimsy or duplicative patents in the first place.
A spokesman for the patent office said its goal is robust and reliable patents and that the office has a new fee proposal that would address concerns about drugs’ large number of patents.
The FDA has also promised new guidance this year giving companies further instructions about which patents to list in the Orange Book.
Write to Liz Essley Whyte at liz.whyte@wsj.com
