The Court of Appeal has set aside the Milan Central Division's order and granted a preliminary injunction across all (but Romania) 17 UPC Contracting Member States where the patent at issue, EP 4 201 327, has effect. The ruling addresses the correct approach to claim construction under the UPCA and clarifies the evidentiary and legal thresholds applicable in provisional measures proceedings under Art. 62 UPCA.
The underlying dispute concerned Insulet’s “Omnipod 5” patch pump and EOFlow’s competing “EOPatch” and “GlucoMen Day Pump” products. The Milan Central Division had previously rejected Insulet’s request for a preliminary injunction, finding that claim 1 of the patent was likely invalid for lack of novelty in view of US 2009/0124994 A1. That finding has now been reversed.
In an important clarification, the Court held that the interpretation of patent claims is a matter of law and must not be delegated to experts. While the understanding of the person skilled in the art informs the technical context, it is the Court’s role to construe the claims independently. The Court also reaffirmed that the skilled person is a legal fiction reflecting average knowledge in the relevant technical field and cannot be equated with any individual.
None of the prior art documents was found to disclose a clutch mechanism that allows the nut and leadscrew, while threadably engaged, to pass through the clutch when disengaged. The Court emphasized that the claimed device must allow such movement in its assembled state, not merely during assembly. Consequently, novelty over both documents was affirmed. The Court also found no indication in the prior art that would prompt the skilled person to modify these disclosures in the direction of the claimed invention, confirming inventive step.
The Court found it more likely than not that EOFlow’s products infringed the patent as granted. In the absence of a cease-and-desist declaration from EOFlow, the risk of continuation was deemed present.
The Court concluded that Insulet had demonstrated a credible threat of irreparable harm, including loss of market share and price erosion, particularly given the niche nature of tubeless insulin patch pumps and Insulet’s significant R&D investment. The balance of interests was held to favour Insulet, notwithstanding EOFlow’s reliance on existing patient supply and Menarini’s partial settlement. Importantly, the Court declined to limit the injunction to territories where Insulet currently markets its product.
The Court granted a preliminary injunction covering 17 CMS (i.e. all member states except of Romania), ordered EOFlow to provide information on origin and distribution channels, imposed penalty payments for non-compliance, and rejected EOFlow’s request for a security for enforcement. The Court awarded costs in full to Insulet, holding that Insulet’s partial lack of success on its information request did not justify apportionment.
