On 20 December 2024, the UPC Court of Appeal denied Alexion preliminary injunctions against Samsung Bioepis and Amgen in relation to the sale of biosimilars to Alexion’s Soliris® (eculizumab) 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).
In denying the preliminary injunctions, the Court of Appeal upheld the decisions of the Hamburg Local Division of the UPC, delivered on 26 June 2024, and agreed that there was an insufficient degree of certainty that the patent was valid to justify granting the preliminary relief.
Samsung Bioepis’ eculizumab biosimilar, Epysqli® (SB12) was approved by the European Medicines Agency (EMA) on 30 May 2023 and was launched in Europe in 2023 and in Korea in 2024. Amgen’s Bekemv® (eculizumab) was EMA approved in April 2023.
Samsung Bioepis and Amgen have both filed post-grant oppositions to Alexion’s EP 3 167 888. The European Patent Office has informed the parties that the nine-month opposition period expires on 3 February 2025, after which the opposition will be accelerated in light of the pending UPC revocation proceedings.
In January 2024, Alexion had also filed US BPCIA litigation against Samsung Bioepis in the US District Court for the District of Delaware, asserting infringement of six US eculizumab patents. In May 2024, the Court refused to grant Alexion preliminary injunctive relief and Alexion appealed the decision to the Court of Appeal. An emergency injunction application pending the appeal was also refused. In August 2024, Alexion and Samsung Bioepis settled the US proceedings. The terms of the settlement agreement have not been made public.
Amgen has disclosed that it is preparing to launch its US eculizumab biosimilar (Bkemv®) in Q2 2025, following a settlement agreement it entered with Alexion in May 2020.