On December 27, 2023, Judge Thomas S. Kleeh of the United States District Court for the Northern District of West Virginia issued an order finding that Mylan (Viatris) infringed claims 4, 7, 9, 11, and 14-17 of Regeneron’s U.S. Patent No. 11,084,865[1] (“the ’865 patent”) after a nine-day bench trial held in June 2023.
This ruling is the latest update in Regeneron and Viatris’s ongoing dispute over Viatris’s proposed biosimilar of Regeneron’s Eylea (aflibercept) injection. Eylea is vascular endothelial growth factor inhibitor (anti-VEGF) treatment for retinopathy of prematurity (ROP). Eylea is administered intravitreally for treatment of wet age-related macular degeneration (wet AMD), diabetic retinopathy (DR), diabetic macular edema (DME), and macular edema following retinal vein occlusion (MEfRVO).[2]
The claims of the ’865 patent relate to formulations of a VEGF antagonist suitable for intravitreal administration. The infringed claims of the ‘865 patent recite a vial that contains an ophthalmic formulation of a VEGF antagonist, certain excipients, and which provides a specified level of stability after 2 months of storage.
The ruling also held that although Viatris’s proposed biosimilar would induce infringement of claims 6 and 25 of U.S. Patent No. 11,253,572[3] and claims 11 and 19 of U.S. Patent No. 10,888,601[4], these claims were invalid as obvious over the prior art. The ‘572 and ‘601 patents relate to methods of treating age related macular degeneration, diabetic macular edema, diabetic retinopathy, or an angiogenic eye disorder in a patient by administering aflibercept. The judge’s opinion supporting the ruling is still sealed and is not yet available to the public. Both parties have appealed to the Court of Appeals for the Federal Circuit.
