UPC CFI, LD Hamburg, 21 October 2025: Imminent of infringement with medical device by obtaining CE-mark approval and announcement
23-12-2025 Print this page
Preliminary injunction granted (Article 62(1) UPCA).
Sufficient proof of threat of imminent infringement with medical device (R. 206.2(c) RoP): by obtaining (and publicly announcing) CE-mark approval for the attacked embodiments after the necessary clinical evaluation, providing “ordering information” and announcing to show-case their products on a trade fair (“device parade”) the Defendants have set the stage to market these products.
Applicant has treated the matter with the necessary urgency. It is not relevant at which point the Applicant gained general knowledge of the attacked embodiments and their appearance as long as their marketing in the European Union could not have been considered imminent due to lacking the EU certification of conformity (CE-mark).
As this CE-mark approval is, as stated above, a prerequisite for legally marketing a medical device in the European Union, any knowledge of the Applicant regarding the attacked embodiments prior to this date is not relevant.
Unfounded request for security for costs (R. 352.1 RoP). The information provided by the Defendants does not enable the Court to assess any possible damage, which the Applicant may be liable to bear in the event that the Court revokes the order for provisional measures.
