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On June 19, 2026, Janssen Biotech, Inc. and Janssen Sciences Ireland UC (collectively, “Janssen”) filed a BPCIA Complaint in the U.S. District Court for the Eastern District of Virginia against Alvotech hf. and Alvotech USA Inc. (collectively, “Alvotech”) for patent infringement related to Alvotech’s proposed golimumab biosimilars (AVT05 SC and AVT05 IV) to Janssen’s SIMPONI and SIMPONI ARIA products.
Janssen asserts a total of 14 patents (“Janssen Patents”), including patents generally directed to cell culture processes, tangential flow filtration, and chromatography column qualification techniques. The Complaint brings 28 counts in total—for each patent, a count of infringement under 35 U.S.C. § 271(e)(2)(C) and a count seeking declaratory judgment of infringement.
Janssen seeks, among other relief: a judgment that Alvotech has infringed the Janssen Patents under 35 U.S.C. § 271(e)(2)(C) by filing its aBLAs for AVT05 SC and AVT05 IV; an order that the effective date of approval for AVT05 SC and AVT05 IV be no earlier than the expiration of the infringed patents pursuant to 35 U.S.C. § 271(e)(4)(A); a declaration that making, using, offering to sell, selling, or importing AVT05 SC and AVT05 IV would infringe the Janssen Patents; a preliminary and permanent injunction enjoining Alvotech and its commercialization partner, Teva Pharmaceuticals, Inc., from making, using, offering to sell, selling, or importing AVT05 in the United States; a determination that Alvotech’s infringement has been willful and that the case is exceptional; an award of costs and attorneys’ fees; and available damages pursuant to 35 U.S.C. § 284 and 35 U.S.C. § 271(e)(4)(C).
This is the second BPCIA case that Janssen has filed relating to a golimumab biosimilar. Janssen’s case against Accord and Bio-Thera remains pending in the U.S. District Court for the District of Delaware. A hearing is scheduled for September 1, 2026, on Janssen’s motion for a preliminary injunction against Accord/Bio-Thera.
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