USPTO Reviewed Janssen Golimumab Patent Challenges
The U.S. Patent and Trademark Office instituted four inter partes review proceedings on September 9, 2026.
Updated on Sept. 28, 2026 in Healthcare
On September 9, 2026, the U.S. Patent and Trademark Office issued a notice of institution for four inter partes review proceedings regarding Janssen Biotech's golimumab patents. The move follows petitions filed by Accord BioPharma, Intas Pharmaceuticals, and Bio-Thera Solutions.
Why it matters
These proceedings challenge existing methods for treating ankylosing spondylitis and psoriatic arthritis. The USPTO institution signals a reasonable likelihood that the petitioners will prevail on at least one challenged patent claim.
The USPTO instituted four inter partes review proceedings, identified as IPR2026-00256 through IPR2026-00259, after petitioners challenged patent claims. The office determined there is a reasonable likelihood that at least one challenged claim will not survive review.
The players
Janssen Biotech
This is a pharmaceutical company that holds the patents for the drug golimumab.
U.S. Patent and Trademark Office
This is the federal agency responsible for granting U.S. patents and registering trademarks.
Accord BioPharma
This entity is one of the pharmaceutical companies that filed petitions to challenge Janssen's patents.
Bio-Thera Solutions
This organization is a biotechnology company involved in the effort to challenge the validity of specific patent claims.
Intas Pharmaceuticals
This is a global pharmaceutical company that participated in filing the inter partes review petitions.
The details
The dispute centers on patents covering treatment methods for active ankylosing spondylitis and psoriatic arthritis. Janssen previously included these patents in a lawsuit filed in the District of Delaware on March 3, 2026, but the company moved to dismiss those specific counts on March 17, 2026.
Timeline
March 3, 2026: Janssen filed a lawsuit against Accord and Bio-Thera.
March 18, 2026: A judge entered the dismissal of specific patent counts.
March 20, 2026: Petitioners filed the four inter partes review petitions.
September 9, 2026: The USPTO issued the notice of institution for the IPRs.
Market Landscape
These proceedings represent the ongoing industry trend of utilizing the America Invents Act's inter partes review process to contest pharmaceutical patent exclusivity. This legal mechanism allows competitors to challenge the validity of patents outside of traditional district court litigation.
These patent challenges could eventually influence market competition and the pricing of treatments for psoriatic arthritis and ankylosing spondylitis. Patients may see broader access to generic or biosimilar alternatives if these patent claims are successfully invalidated.
The takeaway
Patent litigation remains a central component of the competition between brand-name pharmaceutical companies and generic manufacturers. Companies often use these administrative reviews to clear legal hurdles before attempting to bring biosimilar versions of complex medications to market.
Further reading
Learn more about the evolving regulatory landscape in the Healthcare section.
Source note: This article includes information reported by Big Molecule Watch.
