Occlutech GmbH v. Lepu Medcial Technology (Bejing) Co., Ltd. and Lepu Medical (Europe) Cooperatief U.A., Order of the CFI UPC Hamburg Local Division, 21 October 2025, Case no. UPC_CFI_553/2025
Imminent infringement. Medical device. Consequences of the recent obtained CE-mark-approval for territorial jurisdiction and assessment of imminent infringement
HEADNOTES:
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.
The Order can be read here.
