On 16 September 2026, Teva filed an application seeking declaratory judgment of non-infringement and invalidity in relation to 14 Janssen patents asserted against Alvotech in BPCIA litigation commenced on 19 June 2026 in the US District Court for the Eastern District of Virginia. As previously reported (here), in the proceedings, Janssen is alleging that Alvotech’s AVT05, biosimilar to Janssen’s Simponi® and Simponi Aria® (golimumab), infringes those 14 patents.
Janssen is seeking preliminary and permanent injunctions against Alvotech (together with “any other persons who are in active concert or participation with them”) to prevent the manufacture and sale of AVT05, and its importation into, the US.
On the basis that Teva has the exclusive commercialisation rights for Alvotech’s biosimilar golimumab products in the US under an August 2020 strategic partnership, Teva filed a motion to intervene in the BPCIA litigation on 28 August 2026. That motion was granted by Court orders on 9 September 2026.
In its application for a declaration of non-infringement, Teva alleges that Janssen’s processes for manufacturing biosimilar golimumab, including steps in the cell culture process and the glycan content of the recombinant protein preparation, do not infringe the claims of any of the 14 patents. Teva also claims that each of the patents is invalid, for example, for lack of novelty or obviousness.
The litigation against Alvotech is the second BPCIA proceeding regarding golimumab commenced by Janssen, following a complaint filed against Bio-Thera Solutions and Accord BioPharma in March 2026. That complaint alleges that Bio-Thera/Accord’s golimumab biosimilars (Immgolis™ and Immgolis Intri™ (BAT2506)), the first and only golimumab biosimilars to have been FDA-approved (May 2026), infringe 17 Janssen patents. A preliminary injunction hearing was conducted on 1 September 2026.
Accord Biopharma, Intas and Bio-Thera have filed petitions for inter partes review (IPR) of 4 Janssen method of treatment patents related to golimumab (IPR2026-00256, IPR2026-00257, IPR2026-00258, IPR2026-00259). Those IPRs were instituted by the Patent Trial and Appeal Board on 9 September 2026.