On July 8, 2024, Regeneron, Mylan, Celltrion, and Apotex jointly stipulated to the dismissal of CAFC Appeal Nos. 23-1395 and 23-1396, appealing the Final Written Decisions finding all challenged claims of U.S. Patent Nos. 9,254,338 and 9,669,069 unpatentable in IPR2021-00880 (IPR2022-00257 and IPR2022-00301 joined) and IPR2021-00881 (IPR2022-00258 and IPR2022-00298 joined).  The patents recite method of treatment claims for the use of a VEGF antagonist such as EYLEA^® (aflibercept) in angiogenic eye disorders.

On July 23, 2024, Regeneron requested adverse judgment after disclaiming the claims of U.S. Patent No. 11,253,572, challenged by Samsung Bioepis in IPR2023-00884 (and joined IPR2024-00260 (Celltrion) and IPR2024-00298 (Biocon)).  The patent also recited method of treatment claims using aflibercept to treat angiogenic eye disorders.

Previously, a number of other EYLEA^® patents have been invalidated in IPRs filed by biosimilar manufacturers, through Final Written Decisions and disclaimers, including U.S. Patent Nos. 10,130,681 (Final Written Decision finding all challenged claims unpatentable), 10,406,226 (disclaimed), 10,464,992 (disclaimed), 10,857,205 (disclaimed), and 10,888,601 (some claims disclaimed, some claims found unpatentable in the Final Written Decision, some claims instituted and awaiting a Final Written Decision).  To date, the validity of two EYLEA^® patents challenged in Post Grant Review proceedings have been upheld: U.S. Patent No. 10,857,231 (PGR2021-00117 by Celltrion, institution denied) and 11,253,572 (IPR2022-01524 by Apotex, institution denied).

Regeneron has prevailed in biosimilar challenges in district court, primarily on U.S. Patent No. 11,084,865 (the ’865 patent), with numerous claims being held valid and infringed by Biocon’s Yesafili™ (aflibercept-jbvf) in December 2023 (Case No. 1:24-md-03103 (N.D.W. Va.)) (previously reported Permanent Injunction Issued Preventing Launch of EYLEA^® Biosimilar Yesafili™).  Since that ruling, Regeneron has obtained preliminary injunctions based on the ’865 patent against the commercial launch of Samsung Bioepis’s Opuviz™ (aflibercept-yszy), Formycon’s Ahzantive^® (aflibercept-mrbb), Celltrion’s CT-P42 (aflibercept, aBLA pending), and awaits a decision on its motion for a preliminary injunction against Amgen’s ABP 938 (aflibercept, aBLA pending) (Case No. 1:24-md-03103 (N.D.W. Va.)) (previously reported Preliminary Injunctions Issued Preventing Launch of EYLEA^® Biosimilars).  These cases and related appeals of the preliminary injunctions are currently pending.

Regeneron reported EYLEA^® sales of $5.89 billion in 2023.

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