Earlier this month, a Patent Trial and Appeal Board ("PTAB") panel denied institution of two petitions that were filed separately by Samsung Bioepis (IPR2025-00176) and Formycon (IPR2025-00233) for inter partes review ("IPR") of Regeneron's U.S. Patent No. 11,084,865 (the "'865 patent"). The '865 patent issued on August 10, 2021 and is generally directed to an ophthalmic formulation with a vascular endothelial growth factor (VEGF) antagonist.
Regeneron has asserted the '865 patent in BPCIA litigations against Mylan, Samsung Bioepis, Celltrion, Formycon, and Amgen. As we previously reported, following a 9-day bench trial, the District Court for the Northern District of West Virginia issued a detailed opinion finding that Mylan infringed certain claims of the '865 patent and had not shown that those claims are invalid. The district court's judgment was appealed and later that appeal was dismissed by joint stipulation as part of an agreement between Mylan and Regeneron resolving their disputes. Additionally, the Federal Circuit affirmed the District Court for the Northern District of West Virginia's denial of a preliminary injunction against Amgen on the '865 patent, but affirmed the district court's preliminary injunctions against Celltrion, Samsung, and Formycon.
In its decisions denying institution of inter partes review, the PTAB panel exercised its discretion to deny institution of the Petitions under 35 U.S.C. § 314(a) without reaching the merits of the Petitioner's asserted grounds of unpatentability. The panel analyzed the six Fintiv factors to "balance considerations of system efficiency, fairness, and patent quality when a patent owner raises an argument for discretionary denial due to the advanced state of a parallel proceeding, such as the MDL proceeding here." In particular, the panel noted that Fintiv factor 3 (investment in the parallel proceedings) "weighs heavily in favor of discretionary denial," because the district court had already conducted "a two-week trial in the Mylan case and three other preliminary-injunction proceedings focused on validity of the '865 patent." The PTAB panel further stated that Petitioners delayed in filing their Petitions, because Petitioners were "aware of the particular claims being asserted against [them] as early as February 2024 and could have filed a Petition challenging them far earlier than [they] did." The PTAB panel concluded that "while the lack of a trial date (factor 2) weighs against denial, that single factor is solidly outweighed by the sum of the others," including the factors "which reflect the substantial investment in, and particular circumstances of, the parallel district court proceedings."
The '865 patent is also the subject of a pending petition by Celltrion for inter partes review (IPR2025-00456), filed on January 15, 2025.
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