Celltrion Files IPR Petition On Aflibercept Patent – Patent

Last week, Celltrion filed an IPR petition, PTAB IPR2023-00462, seeking cancellation of
claims 1-18 of U.S. Patent No. 10,464,992 (“the ‘992
patent”), assigned to Regeneron Pharmaceuticals, Inc.
According to the Petition, the challenged claims of the ‘992
patent “encompass a formulation comprising the VEGF inhibitor
protein, aflibercept, which Regeneron markets under the trade name
EYLEA®, and three excipients that are commonly used to
stabilize proteins like aflibercept: polysorbate 20, phosphate
buffer, and sucrose.” The Petition sets forth one anticipation
ground and one obviousness ground for the challenged claims.

In its Petition, Celltrion identified Regeneron
Pharmaceuticals, Inc. v. Mylan Pharmaceuticals Inc., Case No.
1-22-cv-00061 (N.D.W.V), filed on August 2, 2022, as a related
proceeding. While the ‘992 patent was included in the Complaint against Mylan, it is not one of the
narrowed six patents Regeneron indicated it
will pursue for expedited trial. The ‘992 patent was
challenged in Chengdu Kanghong Biotechnology Co., Ltd. v.
Regeneron Pharmaceuticals, Inc., IPR2021-00402 (P.T.A.B.),
which the parties voluntarily terminated on June 25, 2021. The
‘992 patent is also currently the subject of an ex
parte reexamination (Control No. 90/014,448), in which the
requestor has challenged the claims on obviousness-type
double-patenting.

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