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Update on First UPC Biosimilar Disputes (Eculizumab and Omalizumab)

Apr 24, 2024

On 24 April 2024, IAM reported that information on the first biosimilar disputes in the Unified Patents Court (UPC) has become publicly available.

The first of these disputes were filed by Alexion on 19 March 2024 at the Hamburg Local Division of the UPC against each of Samsung Bioepis (Case No. ACT_13849/2024) and Amgen (Case No. ACT_13886/2024).  Alexion is seeking provisional measures in relation to EP 3 167 888, which concerns a method of treating paroxysmal nocturnal hemoglobinuria using eculizumab, marketed by Alexion as Soliris®.

Samsung Bioepis obtained EC marketing authorisation for Epysqli® (eculizumab) on 30 May 2023 and launched it in 3 European countries in October 2023.  Amgen obtained EMA approval for Bekemv® (eculizumab) on 19 April 2023.

Alexion is also suing Samsung Bioepis in the US, asserting infringement of six US eculizumab patents and has been in dispute with Amgen in Germany, with the Munich Higher Regional Court overturning Alexion’s preliminary injunction order regarding Amgen’s off label-use of Bekemv® in February 2024.

The second set of UPC biosimilar disputes was commenced on 9 April 2024 in the Dusseldorf Local Division by Novartis and Genentech (case Numbers: ACT_18492/2024 and ACT_18551/2024) seeking provisional measures against Celltrion.  The actions relate to EP 3 805 248, regarding pharmaceutical formulations of omalizumab, marketed by Novartis and Genentech as Xolair®.  The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency adopted a positive opinion for Celltrion’s omalizumab biosimilar, Omlyclo®, on 22 March 2024.