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 to be not infringed and invalid.
Alexion alleged that Samsung Bioepis’ Epysqli® and Amgen’s Bekemv®, biosimilars to Alexion’s Soliris® (eculizumab), infringed European Patent (UK) No. 3 167 888 B1, granted on 1 May 2024. The Court held there was no infringement on the basis that the relevant claims of the patent claimed a light chain antibody sequence which had 22 amino acids (a leader sequence) not present in eculizumab. The Court further held that Alexion’s patent was invalid for obviousness/lack of inventive step. It is not yet known whether Alexion will appeal the decision.
The UK judgment follows decisions of the UPC (June 2024) and the UPC Court of Appeal (December 2024), refusing to grant preliminary injunctions against Amgen and Samsung Bioepis in relation to the sale of their eculizumab biosimilars in the EU.
In contrast to the decision in the UK and Europe, less than two weeks ago, the Canadian Federal Court published a decision (issued on 28 April 2025 on a confidential basis) granting Alexion an injunction preventing the Canadian launch of Amgen’s Bkemv® until 15 March 2027. This decision was based on the Court’s finding that claims 1 and 2 of Alexion’s Canadian patent no. 2645810 are valid and infringed by Amgen.
In the US, a class action complaint was filed in April 2025 by EmblemHealth, alleging that Alexion unlawfully delayed the introduction of biosimilar competition to Soliris® by misusing its patents. That lawsuit followed the launch of Teva/Samsung Bioepis’ Epysqli® in April 2025 and Amgen’s Bkemv® in March 2025. Both Samsung Bioepis (in August 2024) and Amgen (in May 2020) reached settlements with Alexion in relation to their US eculizumab biosimilars.