Eculizumab (Soliris) biosimilars: the UPC's first pharma injunction decisions went to the biosimilars

What was decided

Alexion holds European Patent 3 167 888, a method-of-treatment patent in the eculizumab family (Soliris, for paroxysmal nocturnal haemoglobinuria). In March 2024 it asked the Unified Patent Court’s Hamburg Local Division for preliminary injunctions against Amgen’s and Samsung Bioepis’s biosimilars across the UPC countries at once.

Hamburg refused on 26 June 2024. It thought infringement was sufficiently likely, but could not be satisfied to the required degree that the patent was valid, and a preliminary injunction needs both. The Court of Appeal dismissed Alexion’s appeals on 20 December 2024, for a different reason: on the correct reading of the claim, which turned on whether an apparent error in the claim could be corrected by interpretation, the case for an injunction was not made out. In June 2025 the Court of Appeal refused Alexion a rehearing. Both biosimilars remain on sale in the EU. A US court had also refused Alexion an injunction against Samsung Bioepis in May 2024.

Timeline

Date	Event
19 March 2024	Alexion files PI applications in Hamburg
26 June 2024	Hamburg Local Division refuses both injunctions
20 December 2024	UPC Court of Appeal dismisses Alexion’s appeals
19 June 2025	Court of Appeal refuses a rehearing

What it means if you are…

A buyer or tender organiser. Biosimilar eculizumab is available across the UPC countries without an injunction hanging over it, and the patentee’s attempts to remove it have run out of road at the UPC. For tender planning that is the difference between a biosimilar price you can rely on and one that might vanish mid-contract.

A biosimilar or generics planner. The UPC will not grant a Europe-wide preliminary injunction on a patent whose validity it doubts, even where infringement looks likely. That makes a credible validity attack, filed early and in the right form (a protective letter helps), the main defence against a multi-country injunction. The flip side is that a patent the court thinks is probably valid will be enforced in seventeen countries in one order.

A parallel trader. Biologics move less in parallel trade than small molecules, but the principle carries: the UPC decides once for most of the EU, so the country-by-country patchwork that makes parallel trade possible is thinner for UPC-litigated patents than for national ones. The UK is outside the UPC and is decided separately.

Status and what to watch

The preliminary injunction route is closed to Alexion. Oppositions against the patent at the European Patent Office and any main action on the merits continue. More generally, watch how the UPC Court of Appeal’s approach to validity in PI cases develops; it has since granted injunctions in other pharmaceutical cases where validity looked stronger.