ONWARD Medical v Niche Biomedical (CFI, 17 October 2025)

Dhenne Avocats · 10 October 2026

Our analysis

Summary

By order of 17 October 2025 (UPC_CFI_693/2025, proceedings in German), the Munich Local Division dismissed ONWARD Medical’s application for provisional measures against Niche Biomedical (ANEUVO), based on EP 3 421 081 concerning a neuromodulation system and directed at the ExaStim stimulation system in Germany and France. The division had serious doubts about the novelty of claim 1 as granted and declined to rule on the amended versions put forward in the alternative. The order sets a clear rule for patentees: provisional measures cannot rest on an amended claim.

Facts and procedure

The application, dated 30 July 2025, had been preceded by a protective letter from Niche Biomedical of 25 July 2025 alleging lack of novelty over three US documents, including US 2016/0263376 (Yoo). On 29 August 2025 ONWARD filed eight auxiliary requests amending the claims. The oral hearing took place on 24 September 2025. The order has no numbered paragraphs. It is structured in sections A to C.

The applicable law

Provisional measures fall under Art. 62 UPCA and Rule 211.2 RoP, which requires the court to be satisfied with a sufficient degree of certainty that the patent is valid. The scope of the claims is assessed under Art. 69 EPC and its Protocol, novelty under Art. 54 EPC, changes of claim fall under Rule 263 RoP and amendment of the patent under Rule 30 RoP.

Question

Is the validity of the patent as granted sufficiently certain, and may provisional measures be granted on the basis of claims amended in the alternative?

Decision

No on both counts. The skilled person is a team of a medical technology specialist and an engineer experienced in active implants (section A.I). The claim covers invasive, epidural and transcutaneous systems, with stimulation patterns pre-programmed and stored (sections A.II to A.IV). Yoo discloses the spatial and temporal components of stimulation patterns and time-varying parameters, which raises serious doubts as to the novelty of claim 1 (section A.V.2). Amendment requests are admissible in principle in urgent proceedings under Rule 263 RoP (section B.I), but a patentee who considers an amendment necessary accepts that the granted patent is likely invalid. Provisional measures cannot rest on a defective claim, and the validity of amended versions is not examined in these proceedings, their correction being a matter for the main action (section B.II). ONWARD bears the costs, including those of the protective letter. Niche Biomedical’s request for an interim costs award of EUR 168,000 was rejected for lack of substantiation and because the figures varied without explanation (section C).

Key points for practice

• Provisional measures cannot be based on an amended version of the claims where the granted version is likely invalid.
• A protective letter allows the defendant to put the decisive prior art before the panel at the outset, and its costs are recoverable.
• An application for an interim costs award must be quantified and substantiated consistently, or it will fail.
• Practical point: a patentee should test the validity of the granted claim before seeking provisional measures, any amendment being a matter for the merits.

Provisions applied

Agreement on a Unified Patent Court

Art. 62, 69, 73(2)(a) and 82

Statute of the Court

Art. 37(2)

Rules of Procedure

Rules 30, 118.8, 151, 152.1, 158.2, 211, 220.1(c), 224.1(b), 263, 354 and 355.4

European Patent Convention

Art. 54, Art. 69

Case law cited

Court of Appeal, UPC_CoA_335/2023 and UPC_CoA_182/2024, Munich Local Division, 10 October 2023 (UPC_CFI_17/2023)

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.