On March 20, 2026, Accord BioPharma, Inc. (“Accord”), Intas Pharmaceuticals Ltd. (“Intas”), and Bio-Thera Solutions, Ltd. (“Bio-Thera,” collectively “Petitioners”) filed four Inter Partes Review petitions (“IPRs”) challenging four patents directed to methods of treatment using golimumab. The four patents are owned by Janssen Biotech, Inc. (“Janssen”), a subsidiary of Johnson & Johnson, which markets golimumab as SIMPONI® and SIMPONI ARIA®.
Two of the IPRs, IPR2026-00256 and IPR2026-00259, challenge U.S. Patent No. 11,014,982 (the “’982 patent”) and U.S. Patent No. 12,291,566 (the “’566 patent”), respectively. Both patents are directed toward methods of treating active ankylosing spondylitis (“AS”). Petitioners argue that all 10 claims of the ’982 patent and all 7 claims of the ’566 patent are anticipated by Janssen’s clinical trial protocol NCT02186873-V24, which Petitioners assert was publicly available on ClinicalTrials.gov on October 27, 2015, or obvious over a combination of NCT02186873-V24, the labels for SIMPONI® (2015) and SIMPONI ARIA® (2013), and two publications from 2008 and 2014 describing the results of Janssen’s Phase III clinical trials investigating the use of golimumab to treat AS.
The other two IPRs, IPR2026-00257 and IPR2026-00258, challenge U.S. Patent No. 11,041,020 (the “’020 patent”) and U.S. Patent No. 12,122,824 (the “’824 patent”), respectively. Both patents are directed toward methods of treating psoriatic arthritis (“PsA”). Petitioners argue that all 10 claims of the ’020 patent and all 7 claims of the ’824 patent are anticipated by Janssen’s clinical trial protocol NCT02181673-V23, which Petitioners assert was publicly available on ClinicalTrials.gov on January 8, 2016, or obvious over a combination of NCT02181673-V23, the labels for SIMPONI® (2015) and SIMPONI ARIA® (2013), a set of reports from Janssen’s Phase III clinical trial of the use of golimumab for the treatment of PsA, and an Abbott Biotechnology Ltd. international patent publication.
All four challenged patents had issued within the last five years. Once the IPRs are accorded a notice of filing date, Janssen will have two months to submit discretionary denial briefs and three months to file preliminary responses.
On March 3, 2026, Janssen and Janssen Sciences Ireland UC filed a BPCIA complaint against Bio-Thera and Accord. The case is pending in the U.S. District Court for the District of Delaware.
Stay tuned to Big Molecule Watch for further updates on these IPRs and the associated BPCIA litigation!