PTAB Issues Final Written Decision Invalidating Regeneron's EYLEA® Patent (IPR2023-00442)

On June 14, 2024, the PTAB issued a Final Written Decision (FWD) in Samsung Bioepis's IPR2023-00442 ("the -00442 IPR) determining that the challenged claims of Regeneron's U.S. Patent No. 10,130,681 (the '681 patent) that covers EYLEA^® (aflibercept) are unpatentable. The '681 patent is directed to methods for treating angiogenic eye disorders by sequentially administering multiple doses of a vascular epithelial growth factor (VEGF) antagonist to a patient. Samsung Bioepis's Petition challenged claims 1, 3-11, 13-14, 16-24, and 26 of the '681 patent as obvious, all of which were previously found unpatentable as anticipated in Mylan Pharms. Inc. v. Regeneron Pharms., Inc., IPR2022-01225 (the "-01225 IPR"). In the -00422 IPR FWD, the Board incorporated by reference and adopted its reasoning and conclusions from the -01225 IPR FWD and Mylan's IPR2021-00881 (the "-00881 IPR") that challenged Regeneron's related U.S. Patent No. 9,254,338 (the '338 patent). The Board concluded t