On March 20, 2026, Accord, Intas, and Bio-Thera Solutions filed four petitions for inter partes review (“IPR”) challenging Janssen patents related to Simponi^® (golimumab). The petitions are IPR2026-00256 (U.S. Patent No. 11,014,982 (“the ’982 patent”)), IPR2026-00257 (U.S. Patent No. 11,041,020 (“the ’020 patent”)), IPR2026-00258 (U.S. Patent No. 12,122,824 (“the ’824 patent”)), and IPR2026-00259 (U.S. Patent No. 12,291,566 (“the ’566 patent”)).

The challenged patents were previously asserted by Janssen against Accord and Bio-Thera in pending litigation in the District of Delaware, No. 1:26-cv-00222 (D. Del.) (previously reported Janssen Files First BPCIA Suit Over Simponi^® (golimumab) Biosimilar).

Each petition targets method-of-treatment claims directed to intravenous administration of golimumab at a 2 mg/kg dose at weeks 0 and 4, followed by maintenance dosing every eight weeks. The petitions seek cancellation of claims 1–10 of the ’982 and ’020 patents and claims 1–7 of the ’824 and ’566 patents.

Accord and Bio-Thera assert that the challenged claims are unpatentable under 35 U.S.C. §§ 102 and 103 based on prior art, including clinical trials evaluating intravenous dosing regimen of golimumab in patients with active ankylosing spondylitis (“AS”) and active psoriatic arthritis (“PsA”). The petitions contend that these references disclose or render obvious the claimed treatment methods, including the claimed route of administration, dosing schedules and efficacy requirements in patients with AS and PsA. The petitions contend that the claimed efficacy requirements “merely describe the results Janssen obtained when it treated” AS and PsA patients with the methods disclosed in the prior art clinical trials.

Accord and Bio-Thera’s aBLA for BAT2506, a proposed Simponi^® biosimilar, was accepted by the FDA in July 2025 (previously reported Bio-Thera Submits aBLA for Simponi^® (golimumab) Biosimilar BAT2506).

Johnson & Johnson reported U.S. sales of $1.2B for Simponi^® / Simponi Aria^® in 2025.

For more information about these and other biosimilars, please visit BiologicsHQ.

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The authors would like to thank April Breyer Menon for her contributions to this article.