FTC weighs in on Teva's inhaler litigation against Amneal amid far-reaching patent crackdown

When it comes to questioning drug patents, the U.S. Federal Trade Commission (FTC) isn’t backing down.

After filing a challenge in November against more than 100 patents in the FDA’s Orange Book—and persuading several drugmakers to retract their intellectual property (IP) protections in the process—the antitrust agency is now calling out uncooperative companies in court.

Late last week, the FTC filed an amicus brief in New Jersey federal court, arguing that Teva “improperly listed” patents on its asthma inhaler ProAir HFA in the Orange Book. Teva used those patents to block Amneal Pharmaceuticals’ approval bid for a generic version of the inhaler, the FTC contends.

In turn, the agency thinks the court should order Teva to retract the five patents at the center of the lawsuit.

The FDA Orange Book is a catalog of branded drug patents that serves as a key source of information for generic drug developers. Bunk patents registered in the Orange Book have the potential to harm competition by stalling the entry of more affordable generic drugs, the FTC argues.

In the case of Teva’s Amneal lawsuit, the company’s patent infringement claims successfully triggered a statutory stay that blocked approval of Amneal’s generic ProAir inhaler for up to 30 months—meaning the drug might not be approved until February 2026.

Amneal, like the FTC, has called out Teva for its “improper Orange Book listings." The company figures the allegedly shaky nature of the patents should have prevented Teva from winning a stay of approval. Had Teva not challenged Amneal on the basis of its five ProAir HFA patents, Amneal argues that the FDA could have approved its generic asthma med as early as April 2024, according to the FTC.

Now, the FTC is pushing the court for a judgment to compel delisting on the five ProAir patents in question, which would “clear the way for swifter approval of competing generic products.”

Teva, for its part, did not immediately respond to Fierce Pharma’s request for comment on the situation.

The FTC is pressing its position in the legal arena after striking out against more than 100 Orange Book patents back in early November. Aside from Teva, the agency also called out pharma majors such as AstraZeneca, Boehringer Ingelheim and GSK. The patents targeted by the agency mainly revolve around drug products paired with special delivery devices, such as inhalers and autoinjectors.

At the time the FTC issued its challenge, the agency gave implicated companies 30 days to either withdraw or amend their patent listings or to “certify under penalty of perjury” that the patents were appropriate.

By December, at least three companies—GSK, Amneal’s Impax Laboratories and Kaleo—had moved ahead with delisting certain patents.

Teva, however, did not delist or amend any of the 42 patents challenged by the FTC, including those at the center of its Amneal lawsuit, the FTC said in its amicus brief. The patents in question concern device or device components, the agency added. The patent covering ProAir HFA’s active ingredient, albuterol sulfate, expired all the way back in 1989.

The FDA’s admonition against Teva comes as several other inhaler makers have moved to lower costs and improve access to their products.

Boehringer Ingelheim kicked off the trend in early March when it said it would cap patients’ out-of-pocket costs at $35 per month for all of its inhaler products, including Atrovent, Combivent, Striverdi, Stiolto and its Sprivia line, many of which use the company’s Respimat inhaler device.

AstraZeneca followed suit about a week-and-a-half later when it revealed it was expanding a savings program across its entire U.S. respiratory portfolio that’s also designed to cap monthly out-of-pocket inhaler costs at $35.

GSK last week made the same move, again setting a $35-per-month cost ceiling for its portfolio of asthma and chronic obstructive pulmonary disease (COPD) meds.