Teva has until July 24 to cooperate with the FTC’s request.
An FTC spokeswoman declined to comment. Teva did not immediately respond to a request for comment.
The FTC’s investigation into Teva represents a significant escalation in Democrats’ months-long battle with the pharmaceutical industry, with lawmakers criticizing companies for making cosmetic changes to devices to extend patent protection. The agency in November 2023 called on Teva and nine other companies to voluntarily drop more than 100 patents, and in April expanded its targets to more than 300 “junk” patent lists.
Congressional Democrats have also pressured companies to voluntarily withdraw patents. Sen. Bernie Sanders (I-Vt.), chairman of the Senate Health, Education, Labor and Pensions Committee, and other lawmakers launched an investigation in January into the high price of the inhalers. While three companies dropped their inhaler patents and pledged to lower the cost of their devices, Teva refused to do so.
President Biden in April touted Democrats’ efforts to crack down on the “abusive patent list” for inhalers and other products at a White House event with FTC Chairman Lina Khan.
Drug companies “slightly changed the cap of an inhaler, and they use the new patent on that cap to block generic drug companies from being able to enter the market,” Biden said. “By playing these games with patients and prices, Big Pharma is able to charge Americans substantially higher prices and pad their profits.”
Sen. Elizabeth Warren (D-Mass.) and Rep. Rep. Pramila Jayapal (D-Wash.) last month again called on Teva and seven other companies to drop their patents.
Drug companies have generally given up on the pressure campaign, arguing that Democrats are wrongly focusing on their patents and misrepresenting the Orange Book process.
“Our decision to maintain our patent listing comes after serious and thoughtful consideration of the FTC’s allegations and our concern for Teva’s strict compliance with the law,” replied Brian Savage, Teva’s general counsel for global litigation. , Warren and Jayapal in a letter shared on June 20. with the Washington Post. “At no time did Teva use these patent listings to raise prices or stifle competition by preventing cheaper generic drugs from entering the market.”
PhRMA, the drug industry’s largest lobbying group, last week launched a campaign to defend the industry’s intellectual property protections, which include patents.
“America leads the world in medical innovation because our unique ecosystem strikes the right balance between promoting innovation and affordability,” Robert Zirkelbach, PhRMA’s chief public affairs officer and head of strategic initiatives, wrote in a blog post. “We urge policymakers to preserve strong IP protections and the long-term benefits this system provides to patients and society.”
Teva is also facing a legal challenge from Amneal Pharmaceuticals, which has sought to make a generic version of one of Teva’s inhalers. New Jersey District Judge Stanley R. Chesler, appointed by George W. Bush, last month sided with Amneal and the FTC and ordered Teva to correct or withdraw five patents in the Orange Book.