Celltrion and Samsung recently filed IPR petitions challenging claims of Regeneron patents directed to treating angiogenic eye disorders with aflibercept.  Specifically, Celltrion and Samsung have each filed petitions challenging U.S. Patent No. 10,130,681: IPR2023-00442 (Samsung), IPR2023-00532 (Celltrion), and U.S. Patent No. 10,888,601: IPR2023-00566 (Samsung), IPR2023-00533 (Celltrion).

As we previously reported, Mylan previously filed IPR petitions challenging the ’681 and ’601 patents, and the PTAB granted institution of these petitions on January 11, 2023.  In particular, the PTAB concluded that there is a reasonable likelihood that at least challenged claim 1 of the ’681 patent (IPR2022-01225) and at least challenged claim 34 of the ’601 patent (IPR2022-01226) are unpatentable as being anticipated by the same prior art publication.

Celltrion and Samsung both filed motions for joinder with Mylan’s IPR on the ’601 patent (IPR2022-01226).  Like Mylan’s IPR2022-01226, Celltrion and Samsung’s petitions challenging the ’601 patent seek cancellation of challenged claims 1-9, 34-39, 41-43, and 45.  The petitions set forth four anticipation grounds and one obviousness ground for all challenged claims as well as two obviousness grounds for claims 9 and 36.

Samsung’s IPR2023-00442 seeks cancellation of claims 1, 3–11, 13–14, 16–24, and 26 of the ‘681 patent, and the petition sets forth one obviousness ground for the challenged claims.  Mylan’s (and Celltrion’s) IPR on the ’681 patent seeks cancellation of claims 1, 3-11, 13-14, 16-24, and 26, and the petition sets forth three anticipation grounds and three obviousness grounds for the challenged claims.  Celltrion also filed a motion for joinder with Mylan’s IPR on the ’681 patent (IPR2022-01225).

The ’601 patent is one of six narrowed patents that Regeneron is asserting in the first phase of the BPCIA litigation between Regeneron and Mylan concerning Mylan’s aBLA for a biosimilar version of aflibercept.  In other IPRs filed by Mylan, the PTAB previously issued final written decisions invalidating the claims of two other patents related to aflibercept.  Regeneron has appealed those decisions to the Federal Circuit.

Stay tuned to Big Molecule Watch for further updates on these IPRs and pending litigation related to aflibercept.

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