On August 30, 2024, Alexion Pharmaceuticals, Inc. and Alexion Pharma International Operations Ltd. (collectively, “Alexion”) and Samsung Bioepis Co. Ltd. (“Samsung Bioepis”) settled their BPCIA dispute related to Samsung Bioepis’s biosimilar EPYSQLI® (eculizumab-aagh). Alexion had sued Samsung Bioepis in January 2024 in the U.S. District Court for the District of Delaware for infringement of six patents under the BPCIA based on Samsung Bioepis’s submission of its BLA for EPYSQLI®.
Samsung Bioepis’s biosimilar EPYSQLI® (eculizumab-aagh) was approved by the FDA on July 22, 2024. Alexion had sought a preliminary injunction to prevent the launch of EPYSQLI®, but the Delaware court denied the motion on May 6, 2024, stating that Alexion failed to demonstrate a likelihood of success on the merits due to doubts about the validity of the asserted patent claims. Alexion had appealed the Court’s decision denying a preliminary injunction to the Federal Circuit.
Samsung had also filed five petitions for inter partes review (IPR) for five of the six Alexion patents at issue in the district court litigation: IPR2023-00933 (U.S. Patent No. 9,732,149), IPR2023-00998 (U.S. Patent No. 9,718,880), IPR2023-00999 (U.S. Patent No. 9,725,504), IPR2023-01069 (U.S. Patent No. 10,590,189), and IPR2023-01070 (U.S. Patent No. 10,703,809). Each of the IPRs had been instituted in December 2023.
In view of the parties’ settlement, the district court case and Alexion’s appeal to the Federal Circuit have been dismissed. The parties also filed a joint motion to terminate each of the pending IPRs, and the PTAB granted the motion on September 4, 2024.
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