UPC_CFI_380/2024

FLUID DELIVERY DEVICE WITH TRANSCUTANEOUS ACCESS TOOL, INSERTION MECHANISM AND BLOOD GLUCOSE MONITORING FOR USE THEREWITH

Provisional measuresProvisional MeasuresMilan CDProvisional measuresCase Closed

Overview Decisions Reasoning Citations Documents Timeline

Plain-English summary

Insulet Corporation (US), maker of OmniPod insulin pumps, applied for a preliminary injunction against EOFLOW Co. Ltd (South Korea) based on EP 4 201 327 (a patent for a fluid delivery device used in insulin pumps). The Milan Central Division denied the PI, finding that prior art US'994 disclosed all features of claim 1 with sufficient certainty to cast serious doubt on the patent's validity. Insulet's auxiliary request to amend the patent in PI proceedings was held inadmissible, and Insulet was ordered to bear costs.

Accepted arguments

What the court agreed with — by party.

Patent EP 4 201 327 claim 1 is likely not novel in view of prior art US'994
RespondentLegal basis: Art. 54 EPC
Note: Court found that US'994 discloses all features of claim 1 of the patent at issue (fluid delivery device with rotating nut/clutch mechanism), negating validity with sufficient certainty to deny the PI.
Auxiliary request to amend patent under R. 30.2 RoP is inadmissible in provisional measures proceedings
RespondentLegal basis: R. 30.2 RoP; R. 263.2 RoP
Note: Court held that the expedient nature of PI proceedings, combined with adversarial principle and right of defence, makes patent amendments under R. 30 inadmissible; 'amend its case' in R. 263.2 refers only to pleadings, not patent claims.

Rejected arguments

What the court did not agree with — and why.

US'994 contains unworkable embodiments and should not be read to disclose all features of claim 1
ClaimantLegal basis: Art. 54 EPC; general principles of claim interpretation
Reason: Court applied the principle that patent descriptions must be interpreted to make the invention workable; US'994 Fig. 4 and Fig. 5 disclose two distinct workable embodiments, and the keyhole feature does not render the device non-functional.
Court should permit patent amendment as auxiliary request to cure any validity defect
ClaimantLegal basis: R. 30.2 RoP; R. 263.2 RoP
Reason: Patent amendment under R. 30.2 RoP is inadmissible in PI proceedings; R. 263.2 RoP's 'amend its case' refers only to pleadings amendments.

Key legal principles

Doctrines and rules cited in the reasoning.

PI applicant must cumulatively prove entitlement, validity, and infringement to sufficient degree of certainty (R. 211.2 RoP)Patent amendment under R. 30.2 RoP is inadmissible in provisional measures proceedings due to expediency requirement and adversarial principle R. 263.2 RoP 'amend its case' means pleadings amendment only, not amendment of patent claims Patent descriptions must be interpreted to make the invention workable rather than unworkable Insufficient validity showing is grounds for denial of PI even without deciding infringement

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Prior art relied on

References cited and the role they played.

US'994 (US patent cited as prior art against EP 4 201 327 claim 1)Novelty-destroying

Claim construction notes

The court construed claim 1 of EP 4 201 327 as covering a fluid delivery device with a drive mechanism comprising a drive wheel, lead screw, plunger, threadable nut, and clutch configured to allow the nut to pass through when disengaged and grip the nut when engaged so the drive wheel rotates the nut to advance the plunger. The court found US'994 discloses two embodiments (Figs. 4 and 5) that between them cover all these features.