Celltrion Files IPR Petition on Aflibercept 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.

Stay tuned to BMW for further developments on this IPR, and check out our PTAB Tracker for information on pending and concluded IPRs on aflibercept and other biosimilar products.