On September 1, 2026, Takeda Pharmaceuticals USA, Inc. and Takeda Pharmaceuticals International AG sued Alvotech hf. in the District of New Jersey, No. 2:26-cv-11301. The only named defendant is the Iceland parent. Alvotech USA (the aBLA applicant), Teva affiliates, and a subcutaneous candidate called AVT80 are discussed but not sued here. A jury is demanded.
The accused aBLA
According to the complaint, the product is AVT16, aBLA No. 761544: vedolizumab injection for intravenous use in 300 mg single-use vials, proposed as an interchangeable biosimilar to Entyvio (BLA 125476). The pleading cites a June 8, 2026 announcement of FDA acceptance and a June 15 letter from counsel for Alvotech USA. It also cites an earnings-call statement anticipating approval in early 2027. The proposed indications and dosing described in the complaint track IV Entyvio: moderately to severely active ulcerative colitis and Crohn's disease, with 300 mg at weeks 0, 2, and 6, then every eight weeks.
The dispute over application disclosure
The June 15 letter purported to give confidential access under 42 U.S.C. 262(l)(1) but, as pleaded, withheld the aBLA password and conditioned access on extra Offer of Confidential Access terms. In the September 1 complaint, Takeda alleges it had not received the aBLA or manufacturing information and that no (l)(2) production had occurred. It brings claims under 35 U.S.C. 271(e)(2)(C)(ii) and 42 U.S.C. 262(l)(9)(C). No (l)(3)(A) or (l)(3)(B) exchange is alleged. No notice of commercial marketing is alleged. Takeda also pleads that Alvotech hf. is a "submitter" even though Alvotech USA filed the aBLA.
The six patents
All six numbers are in the complaint body. The docket lists certified patent copies as separate Exhibits 1-6. They are method patents on vedolizumab dosing and response: 9,663,579 (May 30, 2017); 10,004,808 (June 26, 2018); 12,053,526 (August 6, 2024); 12,171,832 (December 24, 2024); 12,544,445 (February 10, 2026); and 12,622,969 (May 12, 2026). Each patent has a 271(e)(2) count and a declaratory-judgment count. The prayer seeks an injunction against current or future versions of the aBLA product, damages, and exceptional-case fees.
The theory pleaded
Takeda alleges that the aBLA submission and failure to provide the information required by section 262(l)(2) permit this suit under the cited BPCIA provisions. Those are Takeda's allegations and legal theories; the complaint is not a ruling on them. The asserted patents concern dosing and immunogenicity methods. Harvey Bartle of Morgan Lewis signed the complaint.
Scope of this summary
This page summarizes the September 1 complaint, including Takeda's allegations about access to the aBLA. It does not report a later disclosure, addition of a party, or ruling. The complaint's Local Rule 11.2 certification states that the controversy was not the subject of another pending action.