BioMarin Pharmaceutical v Ascendis Pharma (CFI, 2 April 2025)

Date	2 April 2025
Court	CFI
Division	Munich (DE) Local Division
Type of action	Preliminary objection
Registry reference	App_13067/2025 · ORD_15496/2025
Parties	Ascendis Pharma Growth Disorders A/S, Ascendis Pharma A/S v. BioMarin Pharmaceutical 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 order of 2 April 2025 (UPC_CFI_18/2025), the judge-rapporteur of the Munich Local Division rejected the preliminary objection of Ascendis, sued by BioMarin for infringement of EP 3 175 863 (variants of C-type natriuretic peptide) in respect of its product TransCon CNP, still in clinical trials. The withdrawal of the opt-out was held valid and the acts of infringement sufficiently alleged.

Question

Is the withdrawal of an opt-out that lists States in which the patent is not in force valid, and is the characterisation of clinical trial acts a matter for a preliminary objection?

Decision

The withdrawal identifies the patent and mentions Member States only in connection with the proprietor, without limiting its scope. Latvia and Slovakia were correctly included, since they are designated in the decision to grant under Article 97(1) EPC (point 1).

The statement of claim sets out the contested embodiment and the acts complained of, including manufacture in Germany, which suffices to establish the Munich division’s competence. Whether those acts, linked to clinical trials, amount to infringement is a substantive question outside the Rule 19 RoP examination (point 2). The auxiliary request for correction under Rule 13.1(l) RoP was dismissed (point 3). An appeal lies only together with the final decision or with leave.

Key points for practice

Practical point: an apparent error in the list of States in an opt-out withdrawal does not affect its validity where the patent is identified, substantive defences such as the experimental use exception are argued on the merits, not by preliminary objection.

Provisions applied

Agreement on a Unified Patent Court: Art. 73(2)(b)
Rules of Procedure: Rules 13.1(l), 19, 21.1, 220.2 and 224.1(b)
European Patent Convention: Art. 97(1)
Case law cited: Munich Local Division, 18 March 2025 (UPC_CFI_339/2024 and UPC_CFI_235/2024), Aylo Freesites v DISH, Court of Appeal, 3 September 2024 (UPC_CoA_188/2024)

Related decisions

BioMarin v Ascendis, 2 June 2025, procedural order on the counterclaim and the timetable.

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: Local and central divisions (UPC), Supplementary protection certificate (SPC), Biosimilar medicinal product, Launch at risk.

Dhenne Avocats blog: The Transitional Period and the UPC: Coordinating Two Judicial Orders, Pharmaceutical patents and the UPC: is the Court hostile to them?.

Publications by Matthieu Dhenne: Pleading the Long Arm: What a UPC Statement of Claim Must Carry Beyond Jurisdiction, Valeo v. Bosch and the Redistribution of Cases Within the UPC (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

defendantBioMarin Pharmaceutical Inc.2 decisions in the corpus Follow this party
claimantAscendis Pharma A/S2 decisions in the corpus Follow this party
claimantAscendis Pharma Growth Disorders A/S2 decisions in the corpus Follow this party

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: Preliminary objection
Outcome (Dhenne Avocats summary): L'exception préliminaire d'Ascendis est rejetée : le retrait de l'opt-out est valable et les actes allégués, dont la fabrication en Allemagne, fondent la compétence de la division de Munich.
Appeal: No appeal documented in the corpus, this does not mean that no appeal was lodged.
Instance: First-instance decision, whether it has become final is not recorded.

Patents mentioned

EP 3 175 863 mentioned in: Dhenne Avocats analysis Follow this patent

Related decisions cited in the analyses

BioMarin Pharmaceutical v Ascendis Pharma (CFI, 2 June 2025) cited in this record
AYLO Premium v DISH Technologies (CoA, 3 September 2024) cited in this record
Dolby International v Epson France (CFI, 27 May 2025) cites this decision

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

Publication	Role in the dispute	Family	Standard and declaration	Pool	Sources
`EP 3 175 863`	Mentioned in the analysis (role not qualified) Also mentioned in 1 other decision(s): BioMarin Pharmaceutical v Ascendis Pharma (CFI, 2 June 2025)	not recorded	not recorded	not recorded	Espacenet links not checked 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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