On September 30, 2026, the U.S. District Court for the District of Delaware issued an order granting Janssen Biotech, Inc. and Janssen Sciences Ireland UC’s (collectively, “Janssen”) motion for a preliminary injunction in Janssen Biotech, Inc. v. Accord BioPharma, Inc., No. 1:26-cv-00222 (D. Del.). The order enjoins defendants Accord BioPharma, Inc. and Bio-Thera Solutions, Ltd. from manufacturing or using their golimumab biosimilar, BAT2506, in commercial quantities, offering to sell or selling it within the United States, or importing it into the United States for commercial purposes. The order requires Janssen to post a $98.8 million bond. The accompanying memorandum opinion was filed under seal, pending redaction.
As we previously reported, Janssen asserted 17 patents against Accord and Bio-Thera in a complaint filed on March 3, 2026. On September 9, 2026, the U.S. Patent and Trademark Office granted institution in four inter partes review proceedings by Accord and Bio-Thera challenging Janssen Biotech, Inc.’s golimumab method-of-treatment patents.
Stay tuned to Big Molecule Watch for further updates on Janssen’s BPCIA litigation and related IPRs.