Washington, D.C. – The Federal Trade Commission (FTC) has launched an investigation into Teva Pharmaceuticals over the company’s refusal to remove nearly two dozen patents for its asthma and COPD inhalers, as per confidential documents acquired by The Washington Post.

Last week, the FTC issued a civil investigative demand to Teva, requesting internal communications, analysis, and financial data related to the disputed patents listed in the federal registry known as the Orange Book. The agency argues that pharmaceutical companies like Teva have exploited minor modifications to their products to maintain patents in the Orange Book and block generic competition. Teva sells its inhalers for hundreds of dollars in the U.S., while the same products are sold for much less overseas.

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

The investigation into Teva by the FTC signifies a significant escalation in the ongoing battle between Democrats and the pharmaceutical industry. Lawmakers have been critical of companies for manipulating devices to extend patent protections. In November 2023, the agency urged Teva and nine other companies to voluntarily remove over 100 patents, later expanding its focus to more than 300 questionable patent listings by April.

Democratic lawmakers, including Sen. Bernie Sanders and others, have been pressuring companies to withdraw patents voluntarily. While some companies have taken down inhaler patents and promised to reduce prices, Teva has refused to do so.

President Biden commended Democrats’ efforts in April to combat “abusive patent listings” during an event at the White House with FTC Chair Lina Khan.

Sen. Elizabeth Warren and Rep. Pramila Jayapal have recently called on Teva and seven other companies to remove their patents. Warren praised the FTC’s decision to investigate Teva, stating that companies must be held responsible for manipulating patent laws to increase medication prices.

The pharmaceutical industry, however, has pushed back against the scrutiny, claiming that Democrats are misrepresenting the patent process in the Orange Book. Teva’s general counsel for global litigation, Brian Savage, defended the company’s decision to maintain its patent listings, denying any wrongdoing related to pricing or competition stifling.

Additionally, Teva is currently facing a legal challenge from Amneal Pharmaceuticals, seeking to produce a generic version of one of Teva’s inhalers. A district judge recently ruled in favor of Amneal and the FTC, ordering Teva to rectify or remove five patents from the Orange Book.

Experts predict that more pressure will be exerted on the pharmaceutical industry in the future, with potential legal action looming due to improper patent listings. William Feldman, a Harvard physician and researcher, has highlighted the FTC’s groundwork for potential lawsuits against pharmaceutical firms engaging in such practices, suggesting that Orange Book reform is still in its early stages.