The US Federal Trade Commission (FTC) recently filed an amicus brief in a patent infringement case filed by Teva against Amneal after Amneal submitted an ANDA for a generic version of Teva’s ProAir HFA albuterol MDI in July 2023. In the brief, the FTC contends that the court should grant Amneal’s motion to force device and dose counter patents asserted by Teva to be delisted from the Orange Book, “clearing the way for Americans to access less expensive asthma inhalers.”
In November 2023, the commission issued warning letters to sponsors of NDAs challenging patents listed for numerous inhalers, including more than 40 patents listed for Teva inhalers. Earlier this year, a US Senate committee launched an investigation of inhaler prices and also sent a letter to Teva citing improper listing of patents in the Orange Book as an anticompetitive practice.
According to the brief, “In the FTC’s view, device patents that do not mention any drug in their claims do not meet the statutory criteria for Orange Book listing, and a device patent that is improperly listed in the Orange Book must be delisted.” The brief points out that Teva has listed one of the patents in question (US Patent No. 10,561,808) in relation to 4 APIs, 6 NDAs, and 21 different products, meaning that the patent is clearly not related to a specific drug.
The amicus brief points out that other companies that received warning letters, including GSK, Boehringer Ingelheim, Impax, and AstraZeneca have delisted patents and/or capped out-of-pocket costs for inhalers, while Teva instead defied the commission by re-certifying all 42 of the patents cited by the FTC as improperly listed.
Read the Federal Trade Commission press release.
