South Korean medical device manufacturer Eoflow receives sales ban in UPC territory

The UPC Court of Appeal has overturned the first-instance decision in Insulet vs Eoflow, taking a fundamentally different view on the role of expert opinions in PI proceedings. It is currently unclear whether the main proceedings will continue. In the meantime, Insulet reached a settlement with second defendant Menarini.

Insulet has filed suits against Eoflow and Menarini over infringement of EP4 201 327, which protects insulin patch pumps. The European patent has unitary effect which can only be asserted before the UPC.

Now, the Court of Appeal has ruled Eoflow must cease distribution and advertising of its insulin patch pumps in the UPC territory (case ID: UPC_CoA_768/2024, APL_64374/2024). The plaintiff can enforce the preliminary injunction without providing security. This is unusual, but the court ruled that no other judgment was likely in the main proceedings.

Menarini and Insulet reach settlement

The division, presided over by judge Rian Kalden, heard the proceedings against Eoflow and Menarini together. At the oral hearing, judge Kalden gave the parties two weeks to reach a settlement. Menarini subsequently settled with Insulet. According to JUVE Patent sources, the settlement includes a phase-out provision allowing patients to plan an orderly transition of their insulin supply.

Previously, both the local and central divisions in Milan had rejected Insulet’s PI applications, citing doubts about the validity of the patent-in-suit (case IDs: ACT_40442/2024, UPC_CFI_400/2024). The two defendants had jointly submitted an expert opinion in the first instance to substantiate their doubts about both legal validity and infringement. While the court of first instance largely followed this reasoning, the court of second instance took a fundamentally different view.

Role of expert opinions in UPC PIs

In the headnotes to its decision, the Court of Appeal criticised the assessment of the expert in the court of first instance. The division headed by Rian Kalden made clear that only the court can interpret the patent and that this cannot be left to an expert opinion. The judgment stated, “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 second headnote explained in detail that it is the court’s task to decide what can be expected of a skilled person and that this decision cannot rely too heavily on an expert opinion.

The UPC has thus clarified its position. Such expert opinions are mandatory in Italian infringement proceedings and common in Dutch proceedings, but play a lesser role in German Federal Court of Justice proceedings.

Battle in US

The dispute is part of international litigation and several long-standing patent proceedings in Europe. Insulet has already seen success against competitor Medtrum at the Regional and Higher Regional Courts in Düsseldorf, as well as in damages proceedings.

Eoflow and Insulet also litigated in the US. After judges ordered Eoflow to pay damages to Insulet in a misappropriated trade secrets dispute, the parties dropped parallel patent proceedings, according to JUVE Patent sources.

Judges have scheduled an interim conference in the main proceedings for the middle of next week. The main hearing will take place on 15 July, but Eoflow has not yet provided security for the costs of the proceedings.