On September 9, 2026, the U.S. Patent and Trademark Office issued a Notice of Decisions on Institution granting institution in four inter partes review proceedings challenging Janssen Biotech, Inc.’s golimumab method-of-treatment patents: IPR2026-00256, IPR2026-00257, IPR2026-00258, and IPR2026-00259. The notice states, “after review of the merits, the petitioner has shown a reasonable likelihood of prevailing with respect to at least one of the claims challenged in the petition . . . and no other non-discretionary considerations warrant denial of institution.”
As we previously reported, Accord BioPharma, Inc. (“Accord”), Intas Pharmaceuticals Ltd. (“Intas”), and Bio-Thera Solutions, Ltd. (“Bio-Thera”) filed the four petitions on March 20, 2026. IPR2026-00256 and IPR2026-00259 challenge U.S. Patent Nos. 11,014,982 and 12,291,566, respectively, both directed to methods of treating active ankylosing spondylitis. IPR2026-00257 and IPR2026-00258 challenge U.S. Patent Nos. 11,041,020 and 12,122,824, respectively, both directed to methods of treating psoriatic arthritis.
The four challenged patents were among the 17 patents Janssen asserted against Accord and Bio-Thera in Janssen Biotech, Inc. v. Accord BioPharma, Inc., No. 1:26-cv-00222 (D. Del.), filed March 3, 2026. On March 17, 2026, Janssen filed a stipulation and proposed order dismissing the method-of-treatment patent counts without prejudice, which Judge Gregory B. Williams entered the following day. Janssen’s motion for a preliminary injunction directed to the remaining asserted patents was argued on September 1, 2026, and remains pending.
Stay tuned to Big Molecule Watch for further updates on these IPRs and the associated BPCIA litigation.