UPC Court of Appeal clarifies claim construction, the role of party experts, and provisional measures in direct-competition cases

Background

In its order of 30 April 2025 (but for some reason not published until August 2026), the UPC Court of Appeal (CoA) set aside the CD Milan’s refusal of provisional measures and granted Insulet a provisional injunction against EOFlow based on EP 4 201 327. The patent concerns fluid delivery devices used in insulin pumps. The CoA found it more likely than not that the patent was valid and infringed by EOFlow’s EOPatch and GlucoMen Day Pump products.

The dispute arose between Insulet Corporation, a US medical device company selling a tubeless insulin patch pump, the “Omnipod 5”, and EOFlow Co., a Korean manufacturer selling the competing “EOPatch” and “GlucoMen Day Pump”, which were supplied in Europe through A. Menarini Diagnostics.

Shortly after the patent was granted on 19 June 2024, Insulet sent EOFlow a warning letter and, shortly after, applied to the CD Milan for provisional measures. A parallel application was brought against Menarini before the LD Milan Local Division. The CD Milan rejected the application against EOFlow, principally because it considered claim 1 more likely than not to lack novelty over prior art “US ’994” (CD Milan, 22 November 2024, UPC_CFI_380/2024¹). The LD Milan rejected the application for a provisional injunction against Menarini as well (LD Milan, 22 November 2024, UPC_CFI_400/2024²).

Insulet appealed. The CoA heard the EOFlow and Menarini appeals together. Insulet subsequently settled with Menarini, but no settlement was reached with EOFlow.

On appeal, the CoA reversed the Central Division’s assessment and granted provisional relief against EOFlow.

Claim construction and role of experts

The decision provides guidance on the role of expert evidence in claim construction. EOFlow argued that its expert’s interpretation should be followed because Insulet had not submitted competing expert evidence. The CoA firmly rejected this approach, holding that the interpretation of a patent claim is a matter of law, and is therefore a task for the Court which has to be carried out by the court independently.

While the claim must be interpreted from the perspective of the skilled person, the skilled person is a notional entity and cannot be equated with a party expert. It is for the Court to assess the relevant general specialist knowledge and the average knowledge, experience and abilities in the technical field. Expert evidence remains relevant insofar as it concerns facts capable of proof.

Referring to its earlier Hanshow decision (13 May 2024, UPC_CoA_1/2024³), the CoA further reiterated that claim features must be interpreted in light of the claim as a whole. Applying these principles, it disagreed with the Central Division’s construction in several respects, including by finding that claim 1 concerned the device in its assembled state.

This different claim construction was also decisive for validity: contrary to the Central Division, the CoA found it not more likely than not that claim 1 was invalid over US ’994 or WO ’504 and rejected EOFlow’s inventive-step attacks.

Provisional measures and direct competition

The decision further develops the CoA’s approach to assessment of the necessity of provisional measures under Art. 62 UPCA and R. 211 RoP.

Referring to its decisions Mammut v Ortovox (25 September 2024, UPC_CoA_182/2024, APL_21143/2024⁴) and Biolitec v Light Guide (24 February 2025, UPC_CoA_540/2024, APL_52692/2024⁵), the Court confirmed that irreparable harm is not a necessary condition for provisional relief. Rather, the Court must assess whether it is reasonable to await the decision on the merits or whether provisional measures are necessary.

Such necessity may arise from direct competition between the parties in respect of the attacked embodiment and the product of the patent holder. In that situation, provisional measures may be justified to preserve the status quo existing immediately before the alleged infringement. Referring to Sumi v Syngenta (3 March 2025, UPC_CoA_523/2024, APL_51115/2024⁶), the CoA noted that the introduction of a second competing product may lead not only to price pressure but to permanent price erosion.

In the present case, the Court considered, inter alia, evidence of price undercutting, difficulties in switching between insulin delivery systems, four-year prescription periods and repeat purchases of disposable pumps. Importantly, the relevant consideration was not merely EOFlow’s existing market presence, but the number of new patients it could supply before a decision on the merits. Insulet was not required to accept an increase in EOFlow’s market share or a further expansion of its production capacity based on profits generated through the infringement.

At the same time, the Court confirmed that an established pre-grant market position in respect of the attacked embodiment may weigh against provisional measures, because an injunction could itself alter the existing status quo. This did not benefit EOFlow, however, because its previous European sales had been limited in time and territory and substantially interrupted.

Further procedural guidance

The CoA also addressed further practically relevant procedural points:

• Risk of continued infringement: Prior infringement creates a risk of continuation where the infringer has not provided a cease-and-desist undertaking backed by a sufficient penalty clause.
• Timing of the main action: An applicant need not generally commence proceedings on the merits together with its PI application. However, where provisional proceedings take an unusually long time, failure to commence the main action may weigh against the applicant in the balance of interests.
• Territorial scope: As a rule, an injunction covers the UPC Contracting Member States in which the patent has effect, unless specific circumstances justify an exception. The absence of current sales in any individual State (in this case, Germany) is insufficient in itself to warrant an exclusion of that State from the injunction.
• Information orders: Information under Art. 67 UPCA may be ordered in provisional proceedings where there is an urgent interest and the measure is proportionate. The Court ordered disclosure of the origin and distribution channels of the infringing products, but refused disclosure of quantities and prices, which primarily concerned the calculation of damages and for which no sufficient urgency had been shown.
• Costs: Partial failure does not necessarily require a proportional allocation of costs. Where the unsuccessful part of a claim is relatively minor and has generated no additional costs, the successful party may still recover its entire reasonable and proportionate costs.

Conclusion

Insulet v EOFlow is particularly important in two respects. First, it draws a clear line between expert evidence and judicial claim construction: experts may provide evidence on relevant technical facts, but the legal interpretation of a patent claim remains for the Court.

Second, it consolidates the CoA’s developing framework for provisional measures: irreparable harm is not required, and in direct-competition cases the likely development of the market before a decision on the merits may be decisive for whether interim relief is necessary to preserve the competitive status quo.

The ruling therefore develops the CoA’s earlier jurisprudence in Hanshow, Mammut v Ortovox, Biolitec v Light Guide and Sumi v Syngenta, providing further guidance on the role of expert evidence and the circumstances in which competitive market effects may justify provisional relief.

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