On September 1, 2026, Takeda Pharmaceuticals USA, Inc. and Takeda Pharmaceuticals International AG (collectively, “Takeda”) filed a BPCIA complaint in the U.S. District Court for the District of New Jersey against Alvotech HF (“Alvotech”), alleging that Alvotech’s proposed vedolizumab biosimilar, AVT16, will infringe six patents related to Takeda’s ENTYVIO® (vedolizumab). This is the second BPCIA case involving a vedolizumab biosimilar, following Takeda’s complaint filed last week against Polpharma Biologics in the same district.
Takeda alleges infringement of U.S. Patent Nos. 9,663,579; 10,004,808; 12,053,526; 12,171,832; 12,544,445; and 12,622,969, all generally related to methods of treatment, or methods of “achieving clinical response” or “inducing clinical remission” using a certain dosing regimen with vedolizumab. These are the same six patents asserted by Takeda against Polpharma.
Takeda alleges that Alvotech entered into license & development and product supply agreements with Teva Pharmaceuticals International GmbH (“Teva Switzerland”) in 2020, under which Alvotech would develop and manufacture AVT16. Takeda also alleges that Alvotech submitted an abbreviated Biologics License Application (“aBLA”) to market the product, and in a press release, confirmed that Alvotech would remain “responsible for development and manufacturing of AVT16,” while Teva Switzerland and its affiliates would remain “responsible for commercialization.”
According to Takeda, Alvotech “purported to provide confidential access to the Alvotech BLA,” but “conditioned providing the password [to access the BLA] on the acceptance and execution of an Offer of Confidential Access and Confidentiality Agreement (‘OCA’), the terms of which imposed obligations beyond those required by 42 U.S.C. §262(l)(1).” Therefore, according to Takeda, it has not yet received Alvotech’s aBLA or manufacturing information.
Takeda seeks declaratory judgement that Alvotech has infringed or will infringe the asserted patents, an injunction to prevent Alvotech from manufacturing, using, offering to sell, selling, distributing, and importing any current or future version of AVT16, damages, attorneys’ fees, and costs.
Stay tuned to Big Molecule Watch for further updates on this new BPCIA litigation.