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Alexion Pharmaceuticals v Samsung Bioepis (CoA, 19 June 2025)

Date19 June 2025
CourtCoA
DivisionLuxembourg (LU)
Type of actionGeneric application
Registry referenceApp_8340/2025 · ORD_11880/2025
PartiesAlexion 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.

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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

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
Only the official text is authoritative. A machine translation is never presented as official, republishing a third-party document requires a verified basis in rights, and a link to the source is preferred.

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

No case number recorded in this record.

Parties

Exact name as it appears in the record, group affiliation only where sourced and dated.

Decisions in the same proceedings and documented appeals

No other decision in the corpus bears the same case number, and no appeal is documented in the corpus to date.

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

Related decisions cited in the analyses

Scope: Dhenne Avocats corpus. Registry-based links are marked “official number”; links derived from the analyses are marked as such. An erroneous link can be withdrawn without deleting any record.

Patents and standards

PublicationRole in the disputeFamilyStandard and declarationPoolSources
EP 3 167 888
Treatment of paroxysmal nocturnal hemoglobinuria patients by an inhibitor of complement
recorded proprietor: Alexion Pharmaceuticals Inc
Mentioned in the analysis (role not qualified)
Also mentioned in 11 other decision(s): Samsung Bioepis NL v Alexion Pharmaceuticals (CoA, 18 February 2026) · Alexion Pharmaceuticals v Samsung Bioepis NL (CFI, 1 August 2025) · Alexion Pharmaceuticals v Samsung Bioepis (CFI, 1 August 2025) · Alexion Pharmaceuticals v Amgen Technology (Ireland) Unlimited Company · Alexion Pharmaceuticals v Samsung Bioepis NL (CoA, 20 December 2024) · Alexion Pharmaceuticals v Amgen Technology (Ireland) Unlimited Company · Alexion Pharmaceuticals v Amgen Technology (Ireland) (CoA, 8 August 20 · Alexion Pharmaceuticals v Amgen Technology (Ireland) Unlimited Company
not recordednot recordednot recordedEspacenet · European Patent Register
existence and title of the publication checked on 30 October 2026 (Google Patents, Espacenet and Register links are not checked automatically)
mentioned in: Dhenne Avocats analysis
The statuses “asserted in litigation”, “declared essential”, “listed by a pool” and “essentiality examined by a court” are distinct and may coexist. Validity, infringement and technical essentiality are different questions. Scope: patents cited in the decisions of the Dhenne Avocats corpus, with no essentiality score or prediction.

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