Teva Pharmaceuticals and Amneal Pharmaceuticals have concluded their legal dispute concerning the listing of patents for Teva’s ProAir HFA inhaler in the U.S. Food and Drug Administration’s (FDA) Orange Book. This resolution follows a series of judicial decisions that questioned the appropriateness of including certain device-related patents in the Orange Book, a resource that catalogs approved drug products and their associated patents.
The litigation began when Teva initiated a patent infringement lawsuit against Amneal after the latter sought FDA approval to market a generic version of the ProAir HFA inhaler. Teva’s claims were based on five patents related to the inhaler’s device components, specifically its metered dose inhaler dose counters. Amneal countered by challenging the validity of these patents’ inclusion in the Orange Book, arguing that they did not pertain to the drug’s active ingredient, albuterol sulfate, but solely to the inhaler device itself.
In June 2024, U.S. District Judge Stanley Chesler ruled in favor of Amneal, determining that the patents in question were improperly listed in the Orange Book. The court found that these patents did not claim the drug or its active ingredient but were directed solely to components of the inhaler device. Consequently, Teva was ordered to delist these patents from the Orange Book. This decision was subsequently upheld by the U.S. Court of Appeals for the Federal Circuit in December 2024, affirming that for a patent to be properly listed in the Orange Book, it must claim the drug for which the application was submitted, including its active ingredient.
The Federal Trade Commission (FTC) played a significant role in this case, supporting Amneal’s position. The FTC argued that improper patent listings in the Orange Book could delay the entry of more affordable generic drugs into the market, thereby harming competition and consumers. The agency’s involvement underscores its broader initiative to scrutinize and challenge questionable patent listings that may impede generic drug competition.
This case highlights the critical importance of accurately listing patents in the Orange Book. It serves as a reminder to pharmaceutical companies to ensure that only patents directly claiming the drug or its approved uses are included, thereby maintaining the integrity of the patent listing process and fostering a competitive market environment.