On June 25, 2025, Acting PTO Director Coke Morgan Stewart issued an opinion discretionarily denying Celltrion’s IPR2025-00456 against Regeneron’s U.S. Patent No. 11,084,865 (“the ’865 patent”).  IPR2025-00456 relates to Celltrion’s proposed EYLEA^® (aflibercept) biosimilar CT-P42.

In a single page decision, the Acting Director stated that after considering all of the parties’ arguments and evidence, discretionary denial was appropriate based on a totality of the evidence.  In particular, the substantial investment by the parties and district court in the parties’ ongoing parallel proceeding (1:24-cv-00053 (N.D.W. Va.) / MDL 1:24-md-03103 (N.D.W. Va.)) involving the ’865 patent, including briefing, discovery, and a preliminary injunction hearing and opinion issuing a preliminary injunction, favored discretionary denial.

This institution denial follows that of Samsung Bioepis’s IPR2025-00176 and Formycon’s IPR2025-00233 on the same patent earlier this month (previously reported Samsung Bioepis and Formycon’s EYLEA^® IPRs Discretionarily Denied Institution Among Wave of Fintiv Denials; Regeneron Files Second BPCIA Lawsuit Against Amgen’s Pavblu™).  In these opinions, the PTAB discussed all of the Fintiv factors and also found that they favored discretionary denial.

Regeneron reported EYLEA^® U.S. sales of $4.767 billion in FY2024.

For more information about these and other biosimilar patent disputes, please visit BiologicsHQ.

 

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The author would like to thank April Breyer Menon for her contributions to this article.