ONWARD Medical v Niche Biomedical (CoA, 27 March 2026)

Dhenne Avocats · 10 October 2026

Our analysis

Summary

By order of 27 March 2026 (UPC_CoA_898/2025), the UPC Court of Appeal (Judges Voß, presiding and judge rapporteur, van den Broek, Sabotier, and technically qualified Judges Elmeros and Schenkl) dismissed ONWARD Medical’s appeal against the Munich Local Division’s refusal of provisional measures of 17 October 2025 in its dispute with Niche Biomedical over EP 3 421 081 (neuromodulation system). It nevertheless rejected the principle applied at first instance: relying on an unregistered version of a claim in provisional proceedings is not excluded as a matter of principle. The application failed because infringement was not sufficiently certain.

Facts and procedure

ONWARD complained of the offer in Germany and France of Niche Biomedical’s ExaStim transcutaneous spinal cord stimulation system and its ReCure electrode pads. The Local Division had found the novelty of granted claim 1 seriously doubtful over Yoo and rejected the eight auxiliary requests, holding that provisional measures cannot rest on an amended claim (paragraphs 14 to 16). On appeal, at the hearing of 5 March 2026, ONWARD withdrew its main request based on claim 1 and pursued unconditionally its auxiliary request combining claim 1 with features of claims 7 and 9 (paragraphs 18 to 20).

The applicable law

The Court applies Articles 25, 26, 62, 69, 73 and 76 UPCA, Rules 150.2, 211.2, 222.2, 263 and 265 RoP, and Articles 69 and 70 EPC.

Question

May the proprietor base an application for provisional measures on an unregistered version of the claim, may such a request be made for the first time on appeal, and is the intended use required by Article 26 UPCA established?

Decision

Turning the auxiliary request into the main request is admissible. Niche has no legitimate interest in a decision on the withdrawn request, since the provisional order does not bind the court on the merits (paragraph 38). Rule 211.2 RoP refers to the « patent in question », not the patent « as granted » (paragraphs 41 to 43). The summary nature of the proceedings does not require excluding an unregistered version as a matter of principle. Admissibility depends on the circumstances, and an undue curtailment of the defendant’s rights may lead to rejection in the balancing of interests (paragraphs 44 to 47). The applicant need not first seek limitation at the EPO, and the CJEU’s Phoenix Contact case law does not stand in the way (paragraphs 49 and 50). Late auxiliary requests fall under Rule 263.2 RoP and, as a rule, only a small number is acceptable (paragraphs 55 to 58), on appeal, their admission falls under Rule 222.2 RoP and calls for restraint (paragraph 61). The request, new on appeal, is admitted: rewording the German translation does not change the claim, construed in the language of the proceedings, and Niche was able to respond fully (paragraphs 62 to 69).

On the merits, the Court construes the features: several distinct pre-programmed patterns, at least two stimulation sites, stages not necessarily sequential (paragraphs 104 to 146). Direct infringement is not established, as the system is delivered unprogrammed and programmed afterwards by medical staff (paragraphs 151 to 157). The objective requirements of indirect infringement are met, including for the ReCure pads, but not the subjective one: intended use may be inferred from objective circumstances, such as a manual recommending the patented use or a means tailored exclusively to it, but the German manual describes no programming meeting feature 8 and non-infringing use remains possible (paragraphs 168 to 179). The Spanish manual, filed on appeal without justification, is disregarded (paragraph 172).

The operative part dismisses the appeal, orders ONWARD to bear the costs of the appeal and to pay Niche an interim award of EUR 56,000, half the EUR 112,000 ceiling applicable to a value of EUR 1,000,000 (paragraphs 183 to 186).

Key points for practice

• An unregistered version of a claim may support an application for provisional measures. The court decides case by case, taking account of the summary nature of the proceedings (paragraphs 40 and 46).
• The number of auxiliary requests must remain limited in provisional proceedings, and new ones on appeal call for restraint (paragraphs 58 and 61).
• The intended use required by Article 26 UPCA may be inferred from objective circumstances, but a manual describing general programming functions is not enough (paragraphs 170 and 173).
• Practical point: against a medical device programmed by the user, the applicant must show a concrete case of use within the claim or a specific instruction to that effect in the manual.

Provisions applied

Agreement on a Unified Patent Court

Arts. 25, 26, 62, 69(1), 73 and 76(1)

Rules of Procedure

Rules 150.2, 211.2, 222.2, 263 and 265

European Patent Convention

Art. 69, Art. 70

Case law cited

NanoString v 10x Genomics, UPC Court of Appeal, 26 February 2024, VusionGroup v Hanshow, UPC Court of Appeal, 13 May 2024, Mammut v Ortovox, UPC Court of Appeal, 25 September 2024, SharkNinja v Dyson, UPC Court of Appeal, 3 December 2024, Abbott v Sibio, UPC Court of Appeal, 14 February 2025, Sumi Agro v Syngenta, UPC Court of Appeal, 3 March 2025, Boehringer Ingelheim v Zentiva, UPC Court of Appeal, 13 August 2025, Meril v Edwards, UPC Court of Appeal, 25 November 2025

Related decisions

• ONWARD Medical v Niche Biomedical, 17 October 2025, Munich Local Division order under appeal.
• Niche Biomedical v ONWARD Medical, 27 April 2026, withdrawal of an application for costs before the Court of Appeal.
• Niche Biomedical v ONWARD Medical, 6 August 2026, costs of the provisional measures proceedings.

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.