As we have previously reported, in November 2023 Regeneron Pharmaceuticals, Inc. (“Regeneron”) filed complaints against Celltrion,  Samsung Bioepis and Formycon (collectively, “the Defendants”) in the U.S. District Court for the Northern District of West Virginia, alleging patent infringement under the Biologics Price Competition and Innovation Act (“BPCIA”) based on the Defendants’ submission of aBLAs for their proposed biosimilars of EYLEA (aflibercept).   Regeneron seeks a judgment that the Defendants have infringed the asserted patents, monetary damages, fees and costs, a declaration that the case is exceptional, a judgment of willful infringement and enhanced damages, an award for an accounting of damages, and equitable relief including a preliminary and permanent injunction.

Last week, a status conference was held regarding Regeneron’s emergency request for a briefing schedule for its forthcoming motion for preliminary injunction.

On December 22, 2023 Regeneron had moved for authorization of alternative service to enable Regeneron to serve the Defendants via e-mail, alleging that the Defendants had engaged in willful delays in order to limit Regeneron’s ability to seek preliminary injunction within the 180-day window provided under the BPCIA after notice of commercial marketing is given.  On January 4, 2024 Celltrion, Samsung Bioepis, and Formycon filed oppositions to Regeneron’s motion for alternative service, each disputing any intent to delay and indicating that each planned to file motions to dismiss due to lack of personal jurisdiction that would render Regeneron’s motion for authorization of alternative service moot.  That same day , Samsung Bioepis filed its motions to dismiss the first and second BPCIA suits against it for lack of personal jurisdiction.  Formycon and Celltrion’s oppositions to Regeneron’s motion each indicated that they plan to file their motions to dismiss by January 17.

Stay tuned to Big Molecule Watch for more updates on this litigation.

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