"The Federal Trade Commission (FTC) 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 (FDA) 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, 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.
Several companies didn't respond to requests for comment. Spokespeople for Novo Nordisk and GSK said the companies are reviewing the FTC's letters. A spokesman for Boehringer said the company has never wrongfully submitted patents to the Orange Book.
"Drug-and-device combination products are complex and costly to develop and manufacture, and we file patents to protect our investment in innovations like these that benefit people and improve their lives," the Boehringer spokesman said.
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 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 the FDA to contact the drug manufacturers, which then have 30 days to reject 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 an additional 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." [1]
1. FTC Targets Drug Patent Listings --- Regulator says Orange Book files keep prices high on Ozempic, others. Whyte, Liz Essley. Wall Street Journal, Eastern edition; New York, N.Y.. 01 May 2024: B.1.
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