The US Court of Appeals for the Federal Circuit has upheld a ruling from district court that requires Teva to remove patents covering inhaler device and dose counter IP from the FDA’s Orange Book. In the decision issued on December 20, 2024, the appeals court says, “to qualify for listing, a patent must claim at least what made the product approvable as a drug in the first place—its active ingredient. In other words, Teva cannot list its patents just because they claim the dose-counter and canister parts of the ProAir® HFA.” The court also asserts that, “the fact that the FDA approved Teva’s ProAir®HFA combination product as a drug does not make the inhaler’s device parts a drug.”
Teva had filed a suit against Amneal alleging infringement of the patents after Amneal submitted an ANDA for a generic version of Teva’s ProAir HFA in July 2023. Amneal then filed a motion arguing that the patents were improperly listed in the Orange Book and should be delisted, and the US Federal Trade Commission (FTC) filed an amicus brief supporting that argument.
The FTC had issued letters to Teva and other sponsors of NDAs in November 2023 warning that patents covering inhalers without reference to the active ingredient were improperly listed in the Orange Book and should be withdrawn. A US Senate committee also notified Teva regarding improper listing of patents in the Orange Book. In the amicus brief, the FTC noted that other sponsors had voluntarily withdrawn patents in question; however, Teva refused.
Regarding the appeals court decision, FTC Director of the Office of Policy Planning Hannah Garden-Monheit commented, “We are pleased the court agreed with the FTC that these improper inhaler patent listings must be wiped from the Orange Book. Removal of junk patent listings is critical to ensuring drugmakers can fairly compete to offer generic drugs at a lower price for consumers. This decision is important not only for lowering asthma inhaler costs, it also sets the stage for removal of junk listings on a range of other critical medications where junk device listings impede competition.”
Read the FTC press release.
