Insulet v A. Menarini Diagnostics (CFI, 22 November 2024)

Dhenne Avocats · 10 October 2026

Our analysis

Summary

By order of 22 November 2024 (UPC_CFI_400/2024, App_40442/2024), made after the hearing of 15 October 2024, the Milan Local Division (panel presided over by P. Perrotti) dismissed Insulet Corporation’s application for provisional measures against A. Menarini Diagnostics, distributor of the EOPatch insulin pump, based on the unitary patent EP 4 201 327. It found it more likely than not that claim 1 as granted lacks novelty over US 2009/0124994. The auxiliary requests to amend the patent and the limitation of the claim under Rule 263.3 were held inadmissible in provisional proceedings. Issued on the same day as the Milan Central Division’s order in the parallel proceedings against the manufacturer EOFLOW, it reaches the same outcome.

Facts and procedure

Insulet filed its application on 8 July 2024, proposing a value of EUR 2,500,000, the court declined to rule ex parte and set a hearing. Menarini challenged novelty and inventive step, infringement, urgency and the balance of interests. Insulet filed four auxiliary requests to amend on 26 August 2024 and, on 30 September 2024, an application under Rule 263.3 to limit its claim to former auxiliary request 1. EOFLOW, the manufacturer of the pump, applied to intervene on 16 September 2024, it has brought a revocation action before the Milan Central Division, which Menarini drew to the panel’s attention on 14 October 2024.

The applicable law

The requirements for provisional measures (Art. 62 UPCA, Rules 209 and 211 RoP) are cumulative: the absence of any one of them is enough for dismissal (section 1). A sufficient degree of certainty requires it to be more likely than not that the patent is valid (section 3.1). Novelty is assessed under Art. 54(2) EPC, and the claim is construed under Art. 69 EPC and its Protocol. Amendment of the patent falls under Rules 30.2 and 50.2, read with Art. 138 EPC.

Question

May the proprietor defend its patent in provisional proceedings through auxiliary requests or a limitation of the claim, and is a likely lack of novelty enough to refuse measures without examining the other requirements?

Decision

On validity, the division construed in particular the terms « device », « nut », « clutch mechanism » and « to pass through », and concluded that the subject matter of claim 1 as granted appears to lack novelty over US 994 (section 3.4), the very filing of auxiliary requests reflected, in its view, legal caution (section 3.1). As the requirements are cumulative, infringement, urgency and the balance of interests were not examined.

Auxiliary requests are not admissible in provisional measures proceedings, amendment of the patent being available only in the main proceedings (section 4.1), and the Rule 263.3 application is inadmissible (section 5). Menarini’s request for security for costs (EUR 200,000) was refused: the mere practical difficulty of enforcing a costs order outside the UPC territory is not enough (section 6.2). Insulet was ordered to pay an interim award of costs of EUR 117,465, an undisputed amount (section 7), and the value in dispute was set at EUR 2,500,000.

Key points for practice

• The requirements for provisional measures are cumulative: sufficient doubt on novelty makes it unnecessary to examine infringement, urgency and the balance of interests.
• The Milan Local Division confines amendment of the patent to the main proceedings and will not allow a Rule 263.3 limitation of the claim to take its place.
• The difficulty of enforcing a costs order outside the UPC territory does not by itself justify security for costs.
• Practical point: a proprietor seeking provisional measures against both manufacturer and distributor before two divisions should expect a consistent assessment of validity and be ready to defend the patent as granted.

Provisions applied

Agreement on a Unified Patent Court

Arts. 47, 62(4), 69(4) and 73

Rules of Procedure

Rules 30.2, 50.2, 158, 209, 211, 263.3 and 313

European Patent Convention

Art. 54(2), Art. 69, Art. 138

Case law cited

NanoString v 10x Genomics, Court of Appeal, 26 February 2024, Mammut Sports Group v Ortovox Sportartikel, Court of Appeal, 25 September 2024, Mammut Sports Group v Ortovox Sportartikel, Düsseldorf Local Division, 9 April 2024, and ten further first-instance decisions and orders (Lisbon, Düsseldorf, Munich, Paris, Nordic-Baltic Regional Division)

Related decisions

• Insulet v EOFLOW, 22 November 2024, Milan Central Division order in the parallel proceedings against the manufacturer.

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.