FTC Files Amicus Brief in Asthma Inhaler Patent Dispute

The Federal Trade Commission filed an amicus brief explaining that pharmaceutical maker Teva has improperly listed patents in the Food and Drug Administration’s (FDA) Orange Book and urged the court to order those listings removed. Improper Orange Book listings can harm competition by delaying the entry of cheaper generic products, according to the FTC’s brief.

The FTC’s amicus brief relates to a case brought by Teva against drugmaker Amneal after Amneal sought FDA approval to bring a generic version of asthma inhaler ProAir HFA to market.

Teva sued Amneal for patent infringement, arguing that Amneal’s patents infringe on Teva’s ProAir HFA patents. Since Teva listed those patents on its ProAir HFA inhaler in the FDA’s publication of “Approved Drug Products with Therapeutic Equivalence Evaluations,” commonly known as the “Orange Book,” Teva’s patent infringement claims triggered a statutory stay that blocks approval of Amneal’s competing drug product for up to 30 months—potentially until February 2026.

Amneal argues that Teva improperly listed its patents in the Orange Book and therefore should not be able to stay approval of Amneal’s competing generic product. Amneal further claims that Teva’s improper listing of these products harmed competition. Absent Teva’s improper Orange Book listings, Amneal claims the FDA could approve its competing product as early as April 2024.

In its amicus brief filed in Teva Branded Pharmaceutical Products R&D, et al. v. Amneal Pharmaceuticals of New York, LLC, et al., the FTC states that the court should grant Amneal’s motion for judgment to compel de-listing the patents at issue in this case. This would clear the way for swifter approval of competing generic products. 

In November, the FTC challenged over 100 patent-listings as improperly listed in the FDA’s Orange Book, including the five patents at issue in Teva’s case against Amneal, as well as 37 additional Teva patent-listings. Kaleo Inc., Impax Labs, GlaxoSmithKline, and Glaxo Group delisted patents in response to the FTC’s warning letters. AstraZeneca, Boehringer Ingelheim, and GlaxoSmithKline have all announced commitments to cap inhaler out-of-pocket costs.

The FTC’s amicus brief was filed in the U.S. District Court for the District of New Jersey. The Commission vote approving the filing of the amicus brief was 3-0.