Alexion Pharmaceuticals v Samsung Bioepis (CoA, 19 June 2025)
| Date | 19 June 2025 |
|---|---|
| Court | CoA |
| Division | Luxembourg (LU) |
| Type of action | Generic application |
| Registry reference | App_8340/2025 · ORD_11880/2025 |
| Parties | Alexion Pharmaceuticals, Inc. |
Official decision (PDF) · UPC registry entry
Dhenne Avocats represents claimants and defendants in European patent disputes before the Unified Patent Court, including the Paris divisions.
Dhenne Avocats · 10 October 2026
Our analysis
Summary
By a decision of 19 June 2025 (UPC_CoA_402/2024), the Court of Appeal rejected Alexion Pharmaceuticals’ application for rehearing of its order of 20 December 2024, which had upheld the refusal of provisional measures against Samsung Bioepis (EP 3 167 888, treatment of paroxysmal nocturnal haemoglobinuria). Alexion argued that the Court had adopted a new approach to claim interpretation without hearing it and had relied on incorrect facts. The Court used the occasion to set out general principles on rehearing for a fundamental procedural defect: an extraordinary and narrow remedy that cannot be used to reopen the assessment of evidence or claim construction.
Facts and procedure
Alexion had sought provisional measures against Samsung Bioepis before the Hamburg Local Division. The application was dismissed because validity could not be established with sufficient certainty, and on 20 December 2024 the Court of Appeal dismissed the appeal with costs against Alexion (paragraphs 2 and 3). Alexion argued that the Court had applied an entirely new standard of claim interpretation without giving it a proper opportunity to be heard, and that the decision rested on incorrect facts. It asked for the order to be set aside and the proceedings reopened (paragraphs 4 and 5). Samsung argued that the application was inadmissible and, in the alternative, unfounded (paragraph 6).
The applicable law
Rehearing is governed by Art. 81(1) UPCA and Rules 245 to 248. Decisions of the Court of Appeal are final. Rehearing is an extraordinary remedy confined to fundamental procedural defects (paragraphs 9 to 11). The defect must have been unknown or, if known, objected to during the proceedings (Rule 248), unless that was not possible (paragraph 10). It must be so serious as to be intolerable for the legal system and to outweigh legal certainty, and the applicant must show that the same decision would not have been taken without it (paragraphs 12 and 13, referring to the CJEU’s Kamino judgment).
Question
Can a party obtain a rehearing of a Court of Appeal order by alleging an unexpected claim interpretation and an error of fact?
Decision
No. The assessment of arguments and evidence (Art. 76(3) UPCA) is not as such open to rehearing, and there is no general duty to hear experts, especially in provisional measures proceedings (paragraphs 14 to 16). Uncontested facts are held to be true (Rule 171.2), but the Court still decides whether they justify the legal consequence claimed (paragraph 17). Claim interpretation is a question of law for the Court (paragraph 18), which may take account of decisions of the EPO Boards of Appeal in related opposition proceedings as indicative of the skilled person’s view. Parties are expected to know that case law (paragraphs 19 to 21). The Court must deal with all arguments but need not address each in detail (paragraph 22). The right to be heard (Art. 76(2)) does not require advance notice of the Court’s view unless the outcome would be unforeseeable or a surprise, a standard that is less strict in provisional measures (paragraphs 23 to 25). Alexion’s complaints amounted to disagreement, not a fundamental error (paragraphs 26 to 28). The application was rejected and Alexion bears the costs of the rehearing (paragraph 29).
Key points for practice
- Rather than a third instance, rehearing is a remedy that requires a procedural defect that is intolerably serious and decisive, which the applicant must prove.
- A claim interpretation adopted by the Court of Appeal, even a new one, is no surprise where it rests on EPO case law the parties are expected to know.
- Known defects must be raised during the proceedings, failing which rehearing is unavailable.
- Practical point: in provisional measures appeals, the relevant Board of Appeal decisions and alternative claim constructions should be argued from the outset, since rehearing cannot make up for that debate.
Provisions applied
- Agreement on a Unified Patent Court
- Arts 76(2), 76(3) and 81(1)
- Rules of Procedure
- Rules 112.4, 171.2, 205.3, 207.8, 210.2, 245, 247, 248 and 350
- Case law cited
- Alexion Pharmaceuticals v Samsung Bioepis, Court of Appeal, 20 December 2024, the order under review, Fujifilm v Kodak, Court of Appeal, 17 April 2025 (UPC_CoA_312/2025), Insulet v EOFlow, Court of Appeal, 30 April 2025 (UPC_CoA_768/2024), CJEU, 3 July 2014, Kamino International Logistics and Datema Hellmann Worldwide Logistics, C-129/13 and C-130/13
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.
Going further
Lexicon: UPC Court of Appeal, Supplementary protection certificate (SPC), Biosimilar medicinal product, Launch at risk.
Dhenne Avocats blog: UPC Appeals: What the Numbers Show, Pharmaceutical patents and the UPC: is the Court hostile to them?.
Publications by Matthieu Dhenne: The Launch Letter: How Generics and Biosimilars Should Write to Avoid UPC Urgency (Kluwer Patent Blog).
Source and translations
- Official source
- Unified Patent Court registry link recorded in the record
- Original language
- not recorded
- Translation available
- no translation recorded the firm’s French record is a summary, not a translation
- Date checked
- not recorded
Follow this case
Proceedings, related decisions, appeals, parties and patents as recorded in the registry and in the Dhenne Avocats corpus. Each link states its source.
Proceedings
Parties
- claimantAlexion Pharmaceuticals, Inc.11 decisions in the corpusFollow this party
Decisions in the same proceedings and documented appeals
What the record states
- Nature of the act
- Generic application
- Outcome (Dhenne Avocats summary)
- La demande en révision d'Alexion est rejetée : aucun vice fondamental de procédure n'est établi, les griefs relevant d'un désaccord sur l'appréciation des preuves et l'interprétation des revendications.
- Appeal
- Decision of the Court of Appeal.
- Instance
- Court of Appeal decision.
Patents mentioned
EP 3 167 888mentioned in: Dhenne Avocats analysis Follow this patent
Related decisions cited in the analyses
- Fujifilm v Kodak (CoA, 17 April 2025) cited in this record
- Alexion Pharmaceuticals v Samsung Bioepis NL (CoA, 20 December 2024) cited in this record
Patents and standards
Receive an alert
Weekly summary of new records and substantive updates matching what you follow. Address confirmed by email, unsubscribe at any time, one email per week even where several of your follows match.