On June 17, 2025, Regeneron Pharmaceuticals, Inc. (“Regeneron”) filed another complaint against Amgen Inc. (“Amgen”) under the BPCIA, alleging that Amgen’s aflibercept biosimilar, PAVBLU®, infringes U.S. Patent No. 12,331,099 (“the ’099 patent”). The ’099 patent issued on the same day, with claims generally directed to a stable liquid ophthalmic formulation with a vascular endothelial growth factor (VEGF) antagonist that does not require a buffer.
Amgen had commercially launched PAVBLU® in the United States in November 2024, after the Federal Circuit denied Regeneron’s motion for an injunction pending appeal of a district court’s denial of a preliminary injunction. In that case, the United States District Court for the Northern District of West Virginia had denied Regeneron’s motion for a preliminary injunction against Amgen in the aflibercept BPCIA litigation involving U.S. Patent No. 11,084,865 (“’865 patent”), with claims generally directed to an ophthalmic formulation with, among other elements, “a vascular endothelial growth factor (VEGF) antagonist” and a “buffer.” On March 14, 2025, the Federal Circuit affirmed that decision involving the ’865 patent.
In its new complaint asserting the newly issued patent, Regeneron seeks a judgment that Amgen has infringed the ’099 patent, damages, injunctive relief to stop further sales of PAVBLU®, and an award of attorneys’ fees.
Regeneron filed its new complaint in the United States District Court for the Central District of California. In its complaint, Regeneron stated: “Promptly upon filing of this action, Regeneron will petition the U.S. Judicial Panel on Multidistrict Litigation to transfer this action to the Northern District of West Virginia and consolidate with MDL No. 1:24-md-3103-TSK for coordinated or consolidated pretrial proceedings pursuant to 28 U.S.C. § 1407.” The aflibercept multidistrict litigation currently consists of multiple actions consolidated in the Northern District of West Virginia, with Regeneron filing suit under the BPCIA against Amgen, Mylan/Biocon, Celltrion, Formycon, Samsung Bioepis, and Sandoz.
Stay tuned to Big Molecule Watch as we continue to monitor this litigation.
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