2025-10-21 - LD Hamburg - Occlutech v. Lepu Medical - UPC_CFI_553/2025
- Aktenzeichen:
- UPC_CFI_553/2025
- Datum:
- Spruchkörper:
- Court of First Instance - Hamburg (DE) Local Division
- Art:
- Decision
- Parteien:
- Occlutech GmbH v. Lepu Medical (Europe) Cooperatief U.A. a.o.
Kernaussage: 1.
2025-10-21 - LD Hamburg - Occlutech
v.
Lepu Medical - UPC_CFI_553/2025
1. Since a CE marking is required for placing a medical device in any of the EU member states, obtaining such a CE-mark approval gives an indication of an expected market entry of the device in any of the EU member states including in Germany in the foreseeable future (Art. 5.1 regulation (EU) 2017/745 on medical devices, Art. 33 (1) lit. a UPCA).
2. By obtaining (and publicly announcing) CE-mark approval for the attacked (implantable) medical devices, providing “ordering information” and announcing to show-case their products on a trade fair, the Defendants have set the stage to market these products, R. 206.2 lit. c) RoP.
3. As CE-mark approval is a prerequisite for being able to legally market a medical device in the European Union, any knowledge of the Applicant regarding the attacked embodiments prior to this date is not relevant.
notable
The Hamburg LD granted a preliminary injunction against Lepu Medical for imminent infringement of Occlutech's braided occlusion device patent. In a significant extension of the CoA's Boehringer/Zentiva framework from pharmaceuticals to medical devices, the court held that CE-mark approval combined with trade fair participation and online ordering information constitutes 'setting the stage' for imminent infringement. The court established that prior knowledge of attacked embodiments before CE-mark approval is irrelevant for urgency, since CE marking is a prerequisite for legally marketing medical devices in the EU. On claim construction, 'crossing at the centre point' was interpreted to include crossings in a region close to the centre point, supported by the patent's functional teaching and the desirability of avoiding protrusions. All validity defences (added matter, novelty over two prior art documents) were rejected.
Stichwörter
Preliminary injunction; Art. 62(2) UPCA; Imminent infringement, R. 206.2 lit. c) RoP; Competence, Art. 33 (1) lit. a UPCA; Medical devices, regulation (EU) 2017/745 on medical devices; CE-mark approval.
Nichtigkeitsgründe
vorläufig ·Art. 138 EPCNovelty
Preliminarily survivedArt. 54 EPC · Art. 138(1)(a) EPC
“Novelty over DN1 (WO 2008/040555) and DN2 (WO 1996/01591) maintained.”
Added Matter
Preliminarily survivedArt. 123(2) EPC · Art. 138(1)(c) EPC
“Feature 1.2.1.4 was limitation not extension. Supported by original disclosure.”