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.  Alexion’s complaint alleged 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 preliminary injunction, arguing that Samsung is likely to infringe two method-of-treatment claims: claim 1 of U.S. Patent No. 9,447,176 (“the ’176 Patent”) and claim 1 of U.S. Patent No. 10,590,189 (“the ’189 Patent”).  On May 6, the court issued a sealed order denying Alexion’s motion without oral argument.  The court’s order was unsealed on May 10.

The court held that there was a substantial question of validity regarding both claims.   On December 20, 2023, the PTAB had instituted IPR on the ’189 Patent (IPR 2023-01069), in response to a petition filed by Samsung.  The court held that the PTAB’s institution of an IPR raises a substantial question of validity as to the ’189 Patent.  With respect to the ’176 patent, the court held that Samsung’s anticipation and obviousness arguments raised a substantial question of validity.  Accordingly, the court denied Alexion’s motion for PI because it had not shown that it was likely to succeed on the merits with respect to the validity of the claims.

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

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