Alexion Pharmaceuticals v Samsung Bioepis NL (CFI, 26 June 2024)

Dhenne Avocats · 10 October 2026

Our analysis

Summary

By an order of 26 June 2024 (UPC_CFI_123/2024, ORD_38059/2024, ACT_13849/2024), following an oral hearing on 25 June 2024, the Hamburg Local Division (S. Klepsch, presiding and judge-rapporteur, S. Schilling, A. Zana, R. Goedeweeck, technically qualified judge) dismissed Alexion Pharmaceuticals, Inc.’s application for provisional measures against Samsung Bioepis NL B.V. based on EP 3 167 888 B1, which concerns an anti-C5 antibody, and directed at Epysqli®, a biosimilar of Soliris® (eculizumab). An order of the same day rules to similar effect on the parallel application against the Amgen companies (UPC_CFI_124/2024).

The order finds literal infringement of claim 2 on summary examination, but refuses relief because validity is not established with sufficient certainty, revocation by the EPO in the pending opposition appearing reasonably likely. It shows the weight given, in interim proceedings, to a pending opposition.

Facts and procedure

The patent stems from a chain of divisional applications from WO 2007/106585. It was granted following a decision of Technical Board of Appeal 3.3.04 of 21 September 2023, on the basis of an auxiliary request corresponding to claim 2 as asserted. The application for provisional measures was entered on 19 March 2024, an opposition was filed at the EPO on 2 May 2024. Alexion sought, among other things, an injunction backed by penalty payments. The defendants sought dismissal.

The applicable law

The registered proprietor has standing (Art. 47(2) UPCA, Rule 8.5 RoP). Provisional measures fall under Art. 62 UPCA and Rules 205 et seq. RoP, the court must be satisfied with a sufficient degree of certainty that the applicant is entitled to commence proceedings, that the patent is valid and that it is infringed (Art. 62(4) UPCA, Rule 211.2 RoP). The pending opposition requires an assessment of the likelihood of revocation by the EPO (Art. 33(10) UPCA, Rule 209.2(a) RoP). Interpretation follows Art. 69 EPC and its Protocol. Insufficiency falls under Art. 83 EPC.

Question

Does claim 2, directed to a pharmaceutical composition comprising an antibody defined by SEQ ID NO: 2 and SEQ ID NO: 4, cover the biosimilar’s eculizumab, and is the patent’s validity sufficiently certain despite the pending opposition?

Decision

On infringement, the panel reads SEQ ID NO: 4 as the light chain without its first 22 amino acids, which form a signal peptide. The skilled person is led there by the therapeutic purpose of a « pharmaceutical composition », by the C5 binding function, by the unusual length of the sequence and by the features of its N-terminus, as confirmed by the CAS registry entry for eculizumab and the SignalP tool. Neither the claim wording nor the grant history precludes this reading, since the Board of Appeal ruled on a different factual record. Literal infringement of claim 2 is found on summary examination.

On validity, sufficient certainty is lacking if the court considers it more likely than not that the patent is not valid. The standard of proof must be neither too high, in light of the Court of Justice’s Phoenix Contact judgment, nor too low, given the harm the defendant would suffer if the measure were later revoked. The Board of Appeal allowed only the antibody with the 22 additional residues, whereas Alexion itself argues that such an antibody is non-functional and cannot be formulated as a medicine. There is no assurance that the EPO will share the panel’s interpretation, as the Board refused corrections under Rule 139 EPC and rejected the claim sets covering eculizumab. The third-party observations do not address the central arguments. Revocation for insufficiency appears reasonably likely: validity cannot be established with the necessary certainty. The application is dismissed, Alexion bears the costs and the value in dispute is set at EUR 100,000,000.

Key points for practice

• An interpretation that supports infringement can turn against the patentee where it departs from the subject matter allowed by the Board of Appeal and exposes a risk of insufficiency.
• Where an opposition is pending, the UPC assesses the likelihood of revocation by the EPO, including the Office’s likely position on interpretation.
• Sufficient certainty as to validity is lacking once invalidity appears more likely than not.
• Practical point: in biosimilar cases, the patentee should check that its positions on the scope of the sequences are consistent with the grant history before seeking provisional measures.

Provisions applied

Agreement on a Unified Patent Court

Arts. 25(a), 33(10), 47(2), 54, 60, 62, 63, 64, 65(1), 68 and 73(2)(a)

Rules of Procedure

Rules 8.5, 13.1, 25.1, 44, 69, 118.7, 205, 209.2, 210.3, 211.2, 211.5, 213.1, 220.1 and 224.2

European Patent Convention

Art. 69 and Protocol on its interpretation, Art. 83, Rule 139

Other provisions

Directive 2004/48/EC, Art. 9

Case law cited

VusionGroup v Hanshow, Court of Appeal, 13 May 2024, 10x Genomics v NanoString, Court of Appeal, 26 February 2024, Düsseldorf Local Division, 9 April 2024, UPC_CFI_452/2023, CJEU, 28 April 2022, Phoenix Contact, C-44/21

Prepared by Dhenne Avocats from the official decision, consulted on 10 October 2026. The database is updated every week, on Friday. Only the official text is authoritative.