On March 13, 2024, Regeneron appealed the PTAB Board’s (“the Board”) recent Final Written Decisions (“FWDs”) that found claims of two Regeneron patents related to EYLEA^® (aflibercept) unpatentable.

In CAFC 24-1564 Regeneron appeals the Board’s FWD in IPRs brought by Mylan and Biocon (IPR2022-01225) and Celltrion (IPR2023-00532, joined) that found all challenged method of treatment claims 1, 3-11, 13, 14, 16-24, and 26 in U.S. Patent No. 10,130,681 (“the ’681 patent”) unpatentable as anticipated by the prior art (the Dixon reference) that disclosed “the same molecular structure” as claimed in the ’681 patent (previously reported in “The PTAB Finds Claims of Two EYLEA^® Patents Unpatentable and Regeneron Files its Sixth Complaint Against a Proposed EYLEA^® Biosimilar”).

In CAFC 24-1567 Regeneron appeals the Board’s FWD in IPRs brought by Mylan and Biocon (IPR2022-01226), Celltrion (IPR2023-00533, joined), and Samsung Bioepis (IPR2023-00566, joined), that found all challenged method of treatment claims 1-9, 34-39, 41-43 and 45 in U.S. Patent No. 10,888,601 unpatentable as anticipated by the same prior art, and for substantially the same reasons, as in IPR2022-01225 FWD (previously reported in “The PTAB Finds Claims of Two EYLEA^® Patents Unpatentable and Regeneron Files its Sixth Complaint Against a Proposed EYLEA^® Biosimilar”).

Mylan / Biocon’s aBLA for M710 (aflibercept), Celltrion’s aBLA for CT-P42 (aflibercept), and Samsung Bioepis’s aBLA for SB15 (aflibercept) are all currently pending at the FDA.

EYLEA^®‘s U.S. sales were reported to be about $5.9 billion in 2023.

We continue to monitor these cases and will provide updates as they become available.  For more information about these and other biosimilar and biologic drug patent disputes, visit BiologicsHQ.

 

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