Insulet and EOFlow clashed at the UPC over medical devices for insulin delivery, based on Insulet’s patent EP4201327. US-based Insulet developed and sold the “Omnipod 5” wearable insulin pump, while South-Korea-based EOFlow manufactured the “EOPatch” insulin pump. The Milan Central Division (CD) dismissed EOFlow’s revocation claim by default, but did not go so far as to find EOFlow infringing by default.

Since its inception in mid-2024, the case has moved from the Milan CD to the Court of Appeal (CoA) and back again, and on its way has raised interesting points on preliminary injunctions, decisions by default, and claim interpretation. Guest UPCKats John Snape and Ben Husband of Carpmaels, take IPKat readers through the twists and turns of this dispute.

Over to John and Ben:    

"Provisional measures: Milan CD refuses preliminary injunction

Insulet filed a request for provisional measures including a preliminary injunction (PI) on 3 July 2024 with the Milan CD. The case was heard by A. Postiglione (presiding and rapporteur); A. Klein (legally qualified judge); and U. Schwengelbeck (technically qualified judge).

In its Order of 22 November 2024 (UPC_CFI_380/2024), the Milan CD refused Insulet’s request for a preliminary injunction (PI), on the basis that the CD was not satisfied with a sufficient degree of certainty that the patent was valid under Rule 211.1 of the Rules of Procedure (RoP). The Milan CD held that “EOFLOW has presented two prior art documents to this Court, which in its view appear destructive in view of EP4201327 validity” (page 10).

Insulet had sought to amend the claims during the proceedings by filing auxiliary requests. These requests were rejected by the Milan CD on procedural grounds and grounds of fairness, holding that (page 10):

"… allowing the patentee to modify the patent claim in PI proceedings where there’s no risk of patent revocation, would give the party an unreasonable procedural advantage over the other party since, in the absence of any risk of a ruling on patent invalidity, the patentee would exploit the process to tailor the patent claim in the most appropriate way to address the issue of infringement."

UPC Court of Appeal overturns PI refusal

Insulet appealed, and was heard by R. Kalden (presiding); P. Rombach (rapporteur); I. Simonsson (legally qualified judge); S. Kitchen (technically qualified judge); and U. Matter (technically qualified judge).

With its Order of 30 April 2025 (UPC_CoA_768/2024), the CoA granted Insulet a preliminary injunction, finding that it “is not more likely than not that claim 1 of the patent at issue is invalid” (paragraph 58).

A key part of the CoA’s Order concerns claim interpretation. The CoA held that EOFlow had relied on the opinion of an expert regarding interpretation of the patent and prior art. However, the CoA disagreed with this approach (Headnote 1, and paragraphs 36-37):

"The interpretation of a patent claim is a matter of law. Therefore, the Court cannot leave the judicial task of interpreting the patent claim to an expert but has to construe the claim independently."

The CoA’s Order is instructive on PI requirements other than validity. The CoA assessed whether EOFlow was likely to continue infringement in the sense of Article 62(1) UPCA, given that the principal European distributor of the EOPatch (Menarini) had settled with Insulet. The CoA did not see the settlement as tipping the balance of interests against preliminary injunction (paragraphs 101, 110):

"EOFlow ships the attacked embodiment to Menarini in Italy. The fact that Menarini has entered into a settlement with Insulet does not mean that there is no risk of patent infringement with regard to EOFlow. In general, the risk of the continuation of the infringement arises from a prior infringement, if the infringer does not issue a cease-and-desist declaration with a sufficient penalty clause. EOFlow has not issued a cease and desist declaration at Insulet's request.

...Furthermore, since EOflow has not issued a cease-and-desist declaration, it cannot be ruled out in particular that EOFlow itself distributes the contested embodiments …"

Also considered was whether patients’ interests would tip the balance against preliminary injunction. The CoA considered that patients would have the opportunity to switch from the EOPatch to the Omnipod 5. Any benefits of the EOPatch over the Omnipod 5 were factors of convenience in the CoA’s view. Therefore, patients’ interests did not lead to an overall weighing of interests favouring EOFlow (paragraphs 120-123).

Decision by default: Milan CD dismisses revocation claim by default

In the meantime, the case on the merits proceeded, with EOFlow filing a revocation action on 14 October 2024, and Insulet filing an infringement counterclaim on 10 December 2024. On the basis that EOFlow’s financial position had deteriorated due to cross-border litigation over a corresponding US patent, Insulet applied to obtain security for legal costs from EOFlow.

The Milan CD (sitting in the same composition as for the provisional measures action) granted Insulet’s request on 11 April 2025, and ordered EOFlow to pay a security deposit of €500,000 by 2 May 2025. However, at the interim conference on 13 May 2025, EOFlow’s representative indicated that the deposit had not been paid and EOFlow was unwilling to proceed with any payment (page 5).

Consequently, in its Order of 22 July 2025 (UPC_CFI_597/2024), the Milan CD dismissed EOFlow’s revocation action by default, finding that the two requirements in Rule 355 RoP for a decision by default were met: EOFlow had not complied with a legally issued order, and Insulet had requested a decision by default (page 8). EOFlow was ordered to bear the costs of the revocation action dismissed by default.

Claim interpretation: Milan CD hears infringement counterclaim, interprets “nut”

Although the Milan CD had dismissed EOFlow’s revocation action by default, the Milan CD considered it necessary to assess the merits of Insulet’s infringement counterclaim, as opposed to finding EOFlow infringing by default (pages 7-8):

"The goal of expeditious proceedings must be balanced against the principles of proportionality and fairness. Whether the relief sought is a declaration of infringement or revocation of a patent, a decision cannot be issued 'by default' solely on the grounds of the defendant’s failure to take a step.

Consequently, Rule 355.2 must be interpreted in light of the burden of proof principle set out in Rules 171.1 and 172.1, which reflects the front-loaded nature of UPC proceedings. This implies that the rules of procedure provide for acknowledgement of the claim, even in a decision by default, only if the facts behind the claim are sufficiently substantiated.

For this reason, the Court decides that it would be pointless to issue a decision by default on the counterclaim for infringement. In any event, although EOFLOW failed to fulfil its obligation to pay the security, the panel would still be required to assess, albeit summarily, the merits of the case.

The Court therefore concluded that holding an oral hearing would enable a more solid assessment of the evidence to be made, and thus allow a decision on the counterclaim for infringement to be reached with greater legal certainty for both parties."

So, the Milan CD assessed Insulet’s infringement counterclaim, and found infringement by EOFlow. Part of the infringement decision concerns interpretation of the term “nut”. EOFlow argued for a narrow interpretation of “nut”, being only the “threaded part of the leadscrew” (page 13). However, the Milan CD considered that Figure 12 of the patent showed a nut that “is clearly a tube nut and the threaded part is only a part of the nut” (page 14). In addition to consideration of the description and drawings, the Milan CD turned to EOFlow’s expert exhibit. The CD considered that the exhibit “flatly contradicted” EOFlow’s interpretation, by displaying “nuts” that were partially threadless inside (page 14). Therefore, the Milan CD adopted a broader interpretation of “nut” as encompassing “… a tube nut partially threaded in its interior …” (page 15).

Insulet in full flow

The case between Insulet and EOFlow gives guidance on the UPC approach to preliminary injunctions, decisions by default, and claim interpretation. Insulet has succeeded at first instance and no evidence of an appeal filing against the Milan CD judgment was identified at the time of writing, although proceedings between these parties remain ongoing: Insulet’s patent has been opposed at the EPO by EOFlow and two other anonymous opponents, and at least one divisional application is undergoing examination at the EPO."

Source: https://ipkitten.blogspot.com/2025/09/upckat-lessons-from-ebb-and-flow-of.html