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PTAB Director Institutes Four Simponi® / Simponi Aria® (golimumab) IPRs

by Robert S. Schwartz, Ph.D.
September 11, 2026

On September 9, 2026, the Director of the Patent Trial and Appeal Board (PTAB) instituted four IPRs brought by Accord and Bio-Thera against Janssen’s method of treatment patents related to Simponi® / Simponi Aria® (golimumab): IPR2026-00256 challenging U.S. Patent No. 11,014,982; IPR2026-00257 challenging U.S. Patent No. 11,041,020; IPR2026-00258 challenging U.S. Patent No. 12,122,824; and IPR2026-00259 challenging U.S. Patent No. 12,291,566 as anticipated and obvious (previously reported Accord and Bio-Thera File Four IPRs Challenging Janssen Simponi® Patents).  The institution decisions were issued as part of a bulk order without written opinions.

The FDA approved Accord and Bio-Thera’s Immgolis™ / Immgolis Intri™ (golimumab-sldi) as the first interchangeable biosimilars of Simponi® / Simponi Aria® in May 2026 (previously reported Accord’s Immgolis™ / Immgolis Intri™ (golimumab-sldi) Approved as First Simponi® / Simponi Aria® (golimumab) Interchangeable Biosimilars).

The four patents at issue in these IPRs are among 17 patents asserted by Janssen against Accord and Bio-Thera in ongoing BPCIA litigation No. 1:26-cv-00222 (D. Del.) filed in March 2026 (previously reported Janssen Files First BPCIA Suit Over Simponi® (golimumab) Biosimilar).  A preliminary injunction hearing was held in the litigation on September 1, 2026.

A second BPCIA litigation is ongoing related to Alvotech’s AVT05 (golimumab), Case No. 1:26-cv-01754 (E.D. Va.) (previously reported Janssen Files BPCIA Litigation Against Alvotech’s Proposed Simponi® / Simponi Aria® Biosimilar AVT05).  A motion for a preliminary injunction was filed in July 2026, and on September 9, 2026, the Court ordered Teva’s consent motion to intervene in the case.  Under a partnership agreement, Teva will commercialize AVT05 in the U.S. if it is approved by the FDA.

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

For more information about these and other biosimilar patent disputes, please visit BiologicsHQ.

 

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

    Methodology

    Information contained in the Venable BiologicsHQ database relates to FDA-approved drug products listed in the CDER Purple Book or on the FDA website (www.fda.gov). Information relating to FDA licensed products, FDA-approved indications, and aBLA and 505(b)(2) applications is obtained from public sources including the U.S. FDA website (www.fda.gov). Information relating to litigations is given only for cases active from January 31, 2010 onward. Information relating to foreign biosimilar / biologics follow-on products approved in Australia, Canada, the E.U., Japan and South Korea is from public sources. Statistics graphics are compiled from information contained in the Venable BiologicsHQ database.

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