FTC launches investigation against Teva and escalates patent dispute with pharmaceutical industry

Teva has until July 24 to comply with the FTC’s request.

A spokeswoman for the FTC 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, in which lawmakers have criticized companies for making cosmetic changes to devices to extend patent protection. The agency ordered Teva and nine other companies to voluntarily withdraw more than 100 patents in November 2023 and expanded its targets in April to more than 300 “junk” patent lists.

Democrats in Congress have also put pressure on the companies to voluntarily withdraw the patents. Sen. Bernie Sanders (I-Vt.), chairman of the Senate Committee on Health, Education, Labor and Pensions, and other lawmakers launched an investigation into the high prices of the inhalers in January. While three companies withdrew their patents on their inhalers and promised to reduce the cost of their devices, Teva refused to do so.

In April, at a White House event with Federal Trade Commission (FTC) Chair Lina Khan, President Biden praised Democrats’ efforts to crack down on “abusive patent filings” for inhalers and other products.

Pharmaceutical companies “slightly modified the cap of an inhaler and are now using the new patent on that cap to prevent generic drug manufacturers from entering the market,” Biden said. “By playing games with patients and prices, the pharmaceutical industry can charge Americans significantly higher prices and increase their profits.”

Senator Elizabeth Warren (D-Massachusetts) and Representative Pramila Jayapal (D-Washington) last month again called on Teva and seven other companies to withdraw their patents.

The pharmaceutical companies generally shied away from this pressure campaign, arguing that the Democrats were wrongly focusing on their patents and misrepresenting the Orange Book process.

“Our decision to maintain our patent list follows serious and careful consideration of the FTC’s objections and our concern for Teva’s strict compliance with the law,” Brian Savage, Teva’s general counsel for global litigation, responded to Warren and Jayapal in a June 20 letter obtained by The Washington Post. “At no time has Teva used these patent lists to raise prices or suppress competition by preventing cheaper generics from entering the market.”

PhRMA, the pharmaceutical industry’s largest lobby group, launched a campaign last week to protect the industry’s intellectual property, which includes patents.

“America is a global leader in medical innovation because our unique ecosystem strikes the right balance between fostering innovation and affordability,” wrote Robert Zirkelbach, PhRMA’s chief public affairs officer and director of strategic initiatives, in a blog post. “We urge policymakers to uphold strong intellectual property protections and the long-term benefits this system provides to patients and society.”

Teva also faces a lawsuit from Amneal Pharmaceuticals, which has tried to make a generic version of one of Teva’s inhalers. New Jersey District Judge Stanley R. Chesler, appointed by George W. Bush, sided with Amneal and the FTC last month, ordering Teva to either correct or delete five patents from the Orange Book.