As we previously reported, Alexion Pharmaceuticals, Inc. and Alexion Pharma International Operations Ltd. (collectively, “Alexion”) sued Samsung Bioepis Co. Ltd. (“Samsung”) in January 2024 in the U.S. District Court for the District of Delaware, alleging infringement of six patents under the BPCIA based on Samsung’s submission of its BLA for SB12, a proposed biosimilar to SOLIRIS (eculizumab).  On February 12, Alexion filed a motion for a preliminary injunction, arguing that Samsung was likely to infringe claim 1 of U.S. Patent No. 9,447,176 and claim 1 of U.S. Patent No. 10,590,189, both directed to methods of treatment using eculizumab.  On May 6, the court denied Alexion’s motion without oral argument, reasoning that there was a substantial question of validity regarding both claims.  The court held that the PTAB’s institution of an IPR for the ’189 Patent raises a substantial question of validity as to that patent, and that Samsung’s anticipation and obviousness arguments raises a substantial question of validity with respect to the ’176 patent.

Alexion appealed the court’s decision denying the motion for a preliminary injunction and, on May 17, 2024, filed an emergency motion at the district court for an injunction pending appeal of the preliminary injunction, and for a temporary restraining order pending resolution of the emergency motion.  Alexion argued that an injunction was appropriate due to the risk of irreparable harm, the balance of hardships and public interest in Alexion’s favor, and the likelihood of success on appeal.

Following submission of Samsung’s Answering Brief and Alexion’s Reply Brief (filed on May 31 and June 7, respectively), on June 14, 2024, the court denied Alexion’s emergency motion for an injunction pending appeal.  The court stated that “Alexion has failed to show that the Court clearly erred and abused its discretion” in denying the preliminary injunction, and that a “well-reasoned IPR institution decision raises a substantial question of validity” sufficient to deny a preliminary injunction.

On June 21, Alexion also filed a motion with the Federal Circuit for an injunction pending resolution of the appeal.  Samsung’s response is due on July 1, and Alexion’s reply on July 5.

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

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