Insulet v EOFLOW (CFI, 22 November 2024)

Dhenne Avocats · 10 October 2026

Our analysis

Summary

By order of 22 November 2024 (UPC_CFI_380/2024), made after the hearing of 16 October 2024, the Milan Central Division (panel presided over by A. Postiglione) dismissed Insulet Corporation’s application for provisional measures against EOFLOW Co., Ltd. based on the unitary patent EP 4 201 327 (fluid delivery device, insulin pump). The division addressed validity first and found it unlikely that claim 1 is novel over US 2009/0124994, that doubt was enough to refuse the measure, without any examination of infringement. The order also refused to admit, in provisional proceedings, late auxiliary requests amending the claims.

Facts and procedure

Insulet, the proprietor (a divisional in the WO 2013/149186 family, grant published on 19 June 2024), targets EOFLOW’s EOPatch pump, distributed in Europe by Menarini. Its ex parte application, filed on 3 July 2024, was refused on 8 July 2024, and the proceedings continued inter partes. Joinder with the parallel proceedings against Menarini before the Milan Local Division was refused on 4 September 2024, and Menarini’s application to intervene was rejected on 1 October 2024. EOFLOW argued lack of novelty and inventive step over US 2009/0124994 (Roe) and WO 2010/055504 (Yodfat) and brought a revocation action before the same division. Insulet filed four auxiliary requests on 27 August and 16 September 2024.

The applicable law

Provisional measures fall under Art. 62 UPCA and Rule 211 RoP: under Rule 211.2, a sufficient degree of certainty is lacking if it is more likely than not that the patent is invalid. The claim is construed under Art. 69 EPC and its Protocol, the claim being the starting point and the description and drawings explanatory aids (Court of Appeal, 26 February and 13 May 2024). Amendment of the patent falls under Rule 30, amendment of pleadings under Rule 263.

Question

May the proprietor defend its patent in provisional proceedings with late auxiliary requests, and do serious doubts on novelty stand in the way of provisional measures without any examination of infringement?

Decision

On the auxiliary requests, Rule 263 concerns pleadings only. Substantial changes to the claims fall under Rule 30. Even treated as amendments of pleadings, they could have been made earlier with reasonable diligence, having been formalised some three weeks after being raised informally. The division added that admitting patent amendments in provisional proceedings would give the proprietor an unreasonable procedural advantage and turn the summary procedure into a condensed version of the merits.

On validity, feature 4.5.1 does not require the nut to pass entirely through the clutch. Mapping claim 1 onto the figures of Roe, the division rejected Insulet’s objection that the disclosure was unworkable: the shaft is supported only in the operational phase, and the keyhole relates almost exclusively to another embodiment. Claim 1 is therefore unlikely to be novel. Given the harm an injunction would cause the defendant and the revocation action already pending, the doubts on validity prevent the measure. The application and ancillary requests were dismissed. Insulet bears the costs (Art. 69 UPCA, Rule 118.5), the value in dispute was set at EUR 2,500,000 and the ceiling for recoverable representation costs at EUR 400,000.

Key points for practice

• In provisional proceedings, the Milan Central Division may address validity first and dismiss the application on that ground alone.
• Auxiliary requests amending the claims fall under Rule 30 and are viewed with caution in provisional proceedings, particularly when late.
• An objection that a prior art document is unworkable requires each element to be tied to the relevant embodiment.
• Practical point: a proprietor contemplating provisional measures should settle its validity defence, auxiliary requests included, at the outset, rather than relying on amendments in the course of the proceedings.

Provisions applied

Agreement on a Unified Patent Court

Arts. 47, 62 and 69

Rules of Procedure

Rules 30, 118.5, 206, 211, 263 and 333

European Patent Convention

Art. 69 and its Protocol, Art. 123

Case law cited

NanoString v 10x Genomics, Court of Appeal, 26 February 2024, Court of Appeal, 13 May 2024 (UPC_CoA_1/2024), first-instance orders UPC_CFI_15/2023, UPC_CFI_114/2024 and UPC_CFI_452/2023

Related decisions

• Insulet v A. Menarini Diagnostics, 22 November 2024, parallel provisional measures proceedings before the Milan Local Division against the distributor.

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.