On 19 June 2025, the Unified Patent Court (UPC) Court of Appeal issued decisions refusing two rehearing applications by Alexion Pharmaceuticals in proceedings it had brought seeking preliminary injunctions against Amgen and Samsung Bioepis in relation to the sale of their eculizumab biosimilars in the EU. The result is that Amgen and Samsung Bioepis are free to continue selling their eculizumab biosimilars in the EU.
Alexion had originally filed the proceedings in the UPC against Samsung Bioepis and Amgen in March 2024, seeking preliminary injunctions for alleged infringement of EP 3 167 888 (method of treating paroxysmal nocturnal hemoglobinuria). On 20 December 2024, the UPC Court of Appeal denied Alexion preliminary injunctions, upholding the earlier decisions of the Hamburg Local Division of the UPC, delivered on 26 June 2024
The UPC Court of Appeal refused Alexion’s rehearing applications on the basis that Alexion had not established that there was a fundamental procedural defect in the earlier decisions of the Court of Appeal.
Samsung Bioepis’ Epysqli® (SB12), biosimilar to Alexion’s Soliris® (eculizumab), was approved by the European Medicines Agency (EMA) on 30 May 2023 and was launched in Europe in 2023. Amgen’s Bekemv® (eculizumab) was EMA approved in April 2023.
On 21 May 2025, Mr Justice Meade of the High Court of Justice for England and Wales delivered his decision in proceedings involving allegations of patent infringement by Alexion against each of Samsung Bioepis and Amgen, finding Alexion’s asserted patent (European Patent (UK) No. 3 167 888 B1) to be not infringed and invalid.
Samsung Bioepis and Amgen have both filed post-grant oppositions to Alexion’s EP 3 167 888. Those oppositions are ongoing.