On 12 May 2025, 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®, biosimilar to Alexion’s Soliris® (eculizumab), until 15 March 2027. The decision is based on the Court’s finding that claims 1 and 2 of Alexion’s Canadian patent no. 2645810 (which encompass eculizumab) are valid and infringed by Bkemv®.
Subject to any appeal, the injunction will remain in force until 15 March 2027, the date on which Alexion’s ‘810 patent expires. The Court also ordered Amgen to deliver up to Alexion or destroy (at Alexion’s election) all eculizumab product (including any intermediates) that would breach the injunction.
The Canadian decision comes a month after a class action complaint was filed in the US by EmblemHealth, alleging that Alexion unlawfully delayed the introduction of biosimilar competition to Soliris® by misusing its patents. That lawsuit followed the launch of two eculizumab biosimilars in the US: Teva/Samsung Bioepis’ Epysqli® in April 2025 and Amgen’s Bkemv® in March 2025. Both Samsung Bioepis (in September 2024) and Amgen (in May 2020) reached settlements with Alexion in relation to their US eculizumab biosimilars.