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 complaint is on RECAP. 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. No judge appears on the public docket yet. A jury is demanded.

The accused aBLA

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). Alvotech announced FDA acceptance on June 8, 2026. Counsel for Alvotech USA wrote Takeda on June 15. An earnings-call statement cited in the complaint puts expected approval in early 2027. Indications as alleged track IV Entyvio: moderately to severely active ulcerative colitis and Crohn's disease, 300 mg at weeks 0, 2, and 6, then every eight weeks.

The dance that did not start

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. Takeda says it still does not have the aBLA or manufacturing information, so there was no (l)(2) production. It sues immediately 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. Certified copies (Exhibits 1-6) are not on RECAP. 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.

What it means in practice

This is a skipped-dance BPCIA case: the artificial act is the aBLA filing plus an alleged (l)(2) refusal, not a completed patent exchange. The patents are dosing and immunogenicity method claims, not composition-of-matter claims, so induced/contributory theories and labeling will matter if the case is tried. Counsel of record is Harvey Bartle of Morgan Lewis (Princeton).

What to watch next

Judge assignment, whether Alvotech produces the aBLA under a protective order, and whether Alvotech USA or Teva is later added. The complaint's Local Rule 11.2 certification says this controversy is not the subject of another pending action.