FTC targets 300 Big Pharma 'junk patents,' sends warning letters to top drugmakers

The Federal Trade Commission is stepping up its crackdown on so-called “junk patents,” which it contends are ploys intended to delay generic competition. “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,” FTC Chair Lina Khan said.

The agency sent letters to 10 companies, warning that their patent listings were invalid. It also notified the Food and Drug Administration that it disputes the accuracy and relevance of more than 300 Orange Book 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 additional diabetes treatments from AstraZeneca, Boehringer Ingelheim, Covis Pharma, GSK, Novartis Pharmaceuticals, Novo Nordisk, Teva Pharmaceutical Industries, Amphastar Pharmaceuticals and some of their subsidiaries.

The challenges are based on the FDA’s Orange Book, which lists patents relevant to brand-name pharmaceuticals. The FTC says drugmakers needlessly list extra patents, delaying generic alternatives and artificially keeping prices high. If a generics maker successfully challenges listed patents, it can be granted a period of exclusivity before other generics are approved. However, if a brand-name manufacturer decides to fight a challenge in court, it delays a generic’s approval for 30 months.

The targeted patents cover devices used to deliver drugs, such as the “injection device with torsion spring and rotatable display” for Ozempic and the injection “button” for Victoza, another Novo Nordisk diabetes drug. The listings are not legitimate, the agency said, because the law asks drugmakers to list only patents that apply to the actual drug, such as its active ingredient formulation or method of use.

Drugmakers Novo Nordisk and GSK told The Wall Street Journal that the companies are reviewing the FTC’s letters. Boehringer Ingelheim 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,” a spokesperson said.

Related: Boehringer Ingelheim sued for allegedly using expired patents to control inhaler market

Companies in the past have questioned the FTC’s challenges, saying they listed their patents because the law requires it and that doing so actually helps generic companies determine when to launch products. If the companies comply and the listings are removed, a generic competitor would have an easier time entering the market after the central patents expire.

This action represents the latest front in what Khan regards as a continuing battle against anticompetitive health-care practices. So far in her tenure, the agency 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.