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ARTICLE · 17 SEPTEMBER 2024

Alexion And Samsung Settle Eculizumab BPCIA Case

Goodwin Procter LLP
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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...

United StatesIntellectual Property
Seth Manilove
Seth Manilove

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.

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