Antitrust regulators at the Federal Trade Commission expanded their campaign on what they call “junk” patents, sending a new round of warning letters to drug companies about their products for obesity, diabetes, asthma, COPD and severe hypoglycemia.
The new round of letters targets 20 products and follows a push by the FTC last year to go after patents on asthma inhalers, epinephrine pens and other products. In response to last year’s campaign, many of those patents were pulled by the companies.
The latest round of letters were sent to AstraZeneca, Novo Nordisk, Boehringer Ingelheim, Covis Pharma, GSK, Novartis, Teva and Amphastar Pharmaceuticals, as well as a handful of subsidiaries.
The patents targeted by the FTC include those for Novo’s blockbuster diabetes drug Ozempic and GSK’s Ellipta asthma products, among many others. For Ozempic, the commission is going after a number of patents related to the injection pens in which the drug is contained. Those types of drug-device patents have been a frequent target for pricing critics, since they allow companies to make intellectual property protection claims based on the delivery product, rather than the underlying drug.
“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 in a press release announcing the letters. “By challenging junk patent filings, the FTC is fighting these illegal tactics and making sure that Americans can get timely access to innovative and affordable versions of the medicines they need.”
In a statement, GSK said it was reviewing the FTC action. “We take the FTC’s views seriously; however we will also do our own analysis as the law requires. Once complete, we will respond to the FDA and FTC,” the company said in an emailed statement.
A Boehringer Ingelheim spokesperson told Endpoints News that the company “has never wrongfully submitted patents for listing in the Orange Book.”
“We are confident that our patents, including the ones challenged in the meritless antitrust lawsuit filed against Boehringer, are valid, enforceable, and properly listed in the Orange Book under FDA regulations and applicable law,” the spokesperson said.
Representatives for the other drug companies didn’t immediately return request for comment on Tuesday.
The FTC said it had notified the FDA about disputes over more than 300 Orange Book patents filed by the companies. Once the FDA officially sends the dispute to the drug companies, they’ll have 30 days to respond or potentially pull the listings, according to the FTC.
Editor’s note: This story has been updated with statements from GSK and Boehringer Ingelheim. Nicole DeFeudis contributed reporting.