The Federal Trade Commission has turned up the pressure in its patent probe, officially launching a civil investigation into a group of Teva’s drug patents that the agency claims are improperly listed in an FDA database.
A Teva spokesperson confirmed to Endpoints News on Monday that the antitrust regulator has issued a civil investigative demand. The order requests internal communications and financial data related to the challenged patents, the Washington Post reported earlier based on confidential documents. Teva’s deadline to respond is July 24.
“Teva believes that its patents are properly listed in the Orange Book and continues to stand behind the company’s intellectual property,” the Teva spokesperson told Endpoints.
The investigation is a sign the FTC is ramping up its ongoing campaign against drug patents that it has described as unnecessary and anticompetitive. The FTC has challenged more than 300 listings covering treatments for asthma, diabetes, weight loss and more. In April, the latest round of warning letters targeted several patents around Teva’s AirDuo and ArmonAir inhalers.
The FTC declined to say whether it has launched similar investigations into other companies. In its April action, the agency sent challenges to GSK, AstraZeneca, Novo Nordisk, Boehringer Ingelheim, Amphastar Pharmaceuticals, Covis Pharma and Novartis. GSK told Endpoints on Monday that it has not received a civil investigative demand. The other companies didn’t respond to requests for comment.
Listing in the FDA’s database, also called the Orange Book, gives drugmakers certain advantages. For example, suing a generic competitor for infringement of a patent listed in the Orange Book “generally results in an automatic 30-month stay” of FDA approval, according to the FTC.
FTC Chair Lina Khan has argued that “bogus patent listings” in the Orange Book prevent cheaper generics from coming to market, keeping brand-name prices artificially high.
Editor’s Note: This story has been updated to include comment from GSK.