Context:
- First approved by the U.S. Food and Drug Administration (FDA) in 2009, Janssen’s SIMPONI and SIMPONI ARIA are drugs used to treat chronic inflammation, including for patients who have rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and ulcerative colitis. The products’ active ingredient is golimumab, an antibody that blocks the inflammatory molecule called tumor necrosis factor alpha, and in 2024 alone, their sales in the U.S. exceeded $1 billion. In submitting an abbreviated Biologics License Application, Accord BioPharma and Bio-Thera Solutions plan to sell BAT2506 – a biosimilar copy of SIMPONI and SIMPONI ARIA. Accord is a subsidiary of Intas Pharmaceuticals, while Bio-Thera has a licensing partnership with Intas.
- In March, Janssen sued Accord and Bio-Thera over the alleged infringement of 17 of its patents related to golimumab in the United States District Court for the District of Delaware, seeking preliminary and permanent injunctive relief against them (copy of complaint below box). Later that month, Accord filed petitions for inter partes review (IPR) over four of Janssen’s asserted patents in the U.S. Patent and Trademark Office (USPTO). The District of Delaware case was meanwhile assigned to Judge Gregory B. Williams, and, on September 9, 2026, the USPTO granted institution in the four IPR proceedings.
What’s new: Janssen has won a preliminary injunction against Accord and Bio-Thera, becoming the first company ever to reportedly win a biosimilar preliminary injunction in the District of Delaware. The order enjoins the defendants from manufacturing or using their golimumab biosimilar, BAT2506, in commercial quantities, offering to sell or selling it within the U.S., or importing it into the country for commercial purposes. The accompanying memorandum opinion, which was filed under seal pending redaction, also requires Janssen to post a $98.8 million bond.
Direct impact: Accord BioPharma and Bio-Thera have already filed an appeal against the decision. And given the USPTO has granted IPRs of four of the asserted patents,Â
Wider ramifications: The decision was positive for Janssen, which is also facing litigation brought by 2seventy Bio in the UPC’s Brussels Local Division (LD) over the alleged infringement of one of its myeloma treatment-related patents. Last month, the Brussels LD ruled against treating The National Institute of Health as a co-claimant in the case, permitting only supportive intervention (September 24, 2026 ip fray article). The company celebrated a major win in Canada earlier this year, when the Supreme Court dismissed a six-year case seeking to invalidate one of its patents related to an antipsychotic drug by Pharmascience (July 24, 2026 ip fray article).
This is a copy of the decision, issued on September 30, 2026:
The patents-in-suit
- U.S. Patent No. 8,017,325 (“Selection of high-producing cell lines”)
- U.S. Patent No. 8,586,356 (“Gal α1-3gal-containing N-glycans in glycoprotein products derived from CHO cells”)
- U.S. Patent No. 8,852,889 (“Cell culture process”)
- U.S. Patent No. 8,956,830 (“Methods of cell culture”)
- U.S. Patent No. 9,170,249 (“N-acetylhexosamine-containing N-glycans in glycoprotein products”)
- U.S. Patent No. 9,217,168 (“Methods of cell culture”)
- U.S. Patent No. 9,475,858 (“Cell culture process”)
- U.S. Patent No. 9,487,810 (“Methods of cell culture”)
- U.S. Patent No. 9,663,810 (“Methods of cell culture”)
- U.S. Patent No. 9,890,410 (“N-acetylhexosamine-containing N-glycans in glycoprotein products”)
- U.S. Patent No. 11,014,982 (“Anti-TNF antibodies, compositions, and methods for the treatment of active ankylosing spondylitis”)
- U.S. Patent No. 11,041,020 (“Methods for the treatment of active Psoriatic Arthritis”)
- U.S. Patent No. 12,122,824 (“Anti-TNF antibodies, compositions, and methods for the treatment of active ankylosing spondylitis”)
- U.S. Patent No. 12,129,292 (“Anti-tumor necrosis factor (TNF) antibodies and compositions thereof”)
- U.S. Patent No. 12,139,735 (“Cell culture process”)
- U.S. Patent No. 12,180,271 (“Manufacturing methods for producing anti-TNF antibody compositions”)
- U.S. Patent No. 12,291,566 (“Anti-TNF antibodies, compositions, and methods for the treatment of active Ankylosing Spondylitis”)
Accord is challenging four of the above patents:
- 12,122,824
- 12,291,566
- 11,041,020
- 11,014,982
This is a copy of the redacted complaint, filed on March 11, 2026:
Counsel
Janssen is being represented by McCarter & English’s Daniel M. Silver and Alexandra M. Joyce, as well as a team at Latham & Watkins: David P. Frazier, Drew W. Roberts, Michael R. Seringhaus, Roger J. Chin, and Sarah Propst.
Meanwhile, Accord BioPharma and Bio-Thera Solutions are being represented by Young, Conaway, Stargatt & Taylor’s Anne Shea Gaza, Daniel G. Mackrides, and Robert M. Vrana, as well as Gemini Law’s Brigid Morris, Heather M. Schneider, Michael Cottler, Michael Johnson, and Robert V. Cerwinski.