UPC Analytics
ENDE
Overview · Filed: Jun 19, 2025

UPC_CFI_553/2025

Braided medical device and manufacturing method therefore

Provisional measuresProvisional MeasuresHamburg LDProvisional measuresCase Closed
OverviewDecisionsReasoningCitationsDocumentsTimeline
Plain-English summary

Occlutech GmbH obtained a preliminary injunction from the Hamburg Local Division against Lepu Medical (Beijing and Europe) prohibiting the threatened infringement of EP 2 387 951 B1 (braided occlusion device for cardiac defects) across Germany, France, Italy, Netherlands, and Ireland. The court established an important principle that CE-mark approval alone signals imminent EU market entry and therefore imminent patent infringement; prior applicant knowledge of the device before CE marking is irrelevant to the urgency threshold.

Accepted arguments
What the court agreed with — by party.

  • CE-mark approval constitutes imminent infringement sufficient for PI application under R. 206.2(c) RoP regardless of prior applicant knowledge

    ClaimantLegal basis: Art. 62(2) UPCA; R. 206.2(c) RoP; Art. 5.1 Regulation (EU) 2017/745

    Note: Court held that obtaining CE-mark approval (required for legal EU market entry) signals imminent market entry and therefore imminent infringement; the applicant's prior knowledge of the device is irrelevant because the CE mark is the triggering event.

  • Hamburg Local Division has competence under Art. 33(1)(a) UPCA given imminent infringement in Germany

    ClaimantLegal basis: Art. 33(1)(a) UPCA

    Note: CE-mark approval combined with trade fair announcement and ordering information established threatened German infringement.

  • Occlutech's EP 2 387 951 is infringed by Lepu's braided occlusion device

    ClaimantLegal basis: Art. 62 UPCA

    Note: Hamburg Local Division granted the PI across Germany, France, Italy, Netherlands, and Ireland.

Rejected arguments
What the court did not agree with — and why.

  • Security/enforcement bond should be ordered against Occlutech

    RespondentLegal basis: R. 211.5 RoP

    Reason: Court found defendants did not substantiate the sales price and expected volumes needed to estimate damage, and did not show serious difficulties in recovering damages from the EU-based claimant with sufficient funds.

Key legal principles
Doctrines and rules cited in the reasoning.
CE-mark approval for a medical device signals imminent market entry across all EU member states and constitutes an indication of imminent infringement under R. 206.2(c) RoPApplicant's prior knowledge of the accused device before CE-mark approval is irrelevant to urgency; the CE mark is the relevant triggering eventCE-mark approval combined with public trade fair announcement and provision of ordering information constitutes 'setting the stage to market' for purposes of imminent infringementDefendants seeking security must substantiate potential damage with specifics including sales price and volume projections

Browse other cases on this principle.