Accord and Bio-Thera File Four IPRs Challenging Janssen Simponi Patents

Accord, Intas, and Bio-Thera Solutions filed four IPR petitions challenging Janssen patents covering Simponi (golimumab) method-of-treatment claims for intravenous administration. The patents were previously asserted against Accord and Bio-Thera in Delaware federal court litigation. Petitioners argue the claims are unpatentable based on prior art clinical trials showing the dosing regimens. The challenge relates to Bio-Thera's proposed biosimilar BAT2506, with FDA aBLA accepted in July 2025. Simponi generated $1.2B in 2025 U.S. sales.