Samsung Bioepis Files IPR Petition Challenging Regeneron Aflibercept Patent

On August 18, Samsung Bioepis Co., Ltd. (“Samsung Bioepis”), filed a petition for Inter Partes Review, IPR2023-01312, challenging the validity of claims 1-18 of U.S. Patent No. 10,464,992, assigned to Regeneron Pharmaceuticals, Inc. (“Regeneron”).  According to the petition, the ’992 patent claims “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.”

As we previously reported, in January 2023, Celltrion, Inc. (“Celltrion”) also filed an IPR petition challenging the claims of the ’992 patent.  The PTAB granted institution of Celltrion’s IPR petition on July 20, 2023.  With its petition filed last week, Samsung Bioepis concurrently submitted a Motion for Joinder, requesting that the IPR be instituted and joined with Celltrion’s IPR proceeding against the ’992 patent.  According to the motion, “Samsung Bioepis’s Petition is a copy of the Celltrion IPR” and “is based on grounds identical to those that formed the basis for the pending Celltrion IPR against the ’992 patent, including the same prior art combinations supported by the same evidence.”  Further, Samsung Bioepis stipulates that it “will take a limited ‘understudy’ role” so long as Celltrion remains an active party.

The PTAB also previously instituted an IPR petition filed by Chengdu Kanghong Biotechnology Co., Ltd. in January 2021, challenging the validity of the ’992 patent, but the parties voluntarily terminated the IPR proceedings 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 grounds.

Regeneron has asserted the ‘992 patent in pending BPCIA litigation against Mylan.  Specifically, Regeneron initially asserted the ’992 patent against Mylan in Regeneron Pharmaceuticals, Inc. v. Mylan Pharmaceuticals Inc., Case No. 1-22-cv-00061 (N.D.W.V), but the patent was not asserted by Regeneron in the expedited trial, held in June 2023.