"FTC Opens Investigation Into Teva, Escalating Patent Fight With Pharma; Democrats Have Accused Drug Companies Of "Junk Patent Listings," Arguing That The Industry Is Blocking Generic Competition And Inflating Patients' Costs" - Washington Post

https://www.washingtonpost.com/health/2024/07/01/teva-patent-pharma-generic-inhaler/

The Federal Trade Commission has opened an investigation into Teva Pharmaceuticals, citing the company's refusal to take down about two dozen patents for its asthma and COPD inhalers, according to confidential agency documents reviewed by The Washington Post.

The FTC last week sent a civil investigative demand — effectively a subpoena — ordering Teva to provide internal communications, analysis and financial data related to the contested patents listed in a federal registry known as the Orange Book. The agency has argued that pharma companies such as Teva have wrongly made minor tweaks to their products to keep patents in the Orange Book and fend off generic competition. Teva charges hundreds of dollars for inhalers in the United States that the company sells for a fraction of the price overseas.

Teva has until July 24 to cooperate with the FTC's demand.

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 of Democrats' months-long fight with the pharmaceutical industry, with lawmakers criticizing companies for making cosmetic changes to devices to extend patent protections. The agency in November 2023 called on Teva and nine other companies to voluntarily take down more than 100 patents, and in April expanded its targets to more than 300 "junk" patent listings.

Congressional Democrats also have pressured the companies to voluntarily withdraw the patents. Sen. Bernie Sanders (I-Vt.), chairman of the Senate's health committee, and other lawmakers opened an investigation in January into the high price of inhalers. While three companies took down 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 "abusive patent listings" for inhalers and other products at a White House event with FTC Chair 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. "Playing these games with patients and pricing, Big Pharma is able to charge Americans significantly higher prices and pad their profits."

Sen. Elizabeth Warren (D-Mass.) and Rep. Pramila Jayapal (D-Wash.) last month called again on Teva and seven other companies to take down their patents.

Drug companies have generally balked at 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 following serious and thoughtful consideration of the FTC's contentions and our concern for Teva's strict compliance with law," Brian Savage, Teva's general counsel for global litigation, responded to Warren and Jayapal in a June 20 letter shared 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 also is 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, a George W. Bush appointee, last month sided with Amneal and FTC and ordered Teva to either correct or take down five patents in the Orange Book.