Occlutech v Lepu Medical & Anor (UPC_CFI_553/2025)
Decision date:
21 October 2025
Osborne Clarke summary
- Occlutech applied to the Hamburg LD for provisional measures (preliminary injunction) against Chinese company Lepu Medical and its Dutch subsidiary. Occlutech alleged that the Lepu companies directly infringed, or the infringement was imminent, its patent relating to a braided occlusion device with their "MemoCarna ASD" and "MemoCarna VSD" medical implantable occlusion devices. The attacked embodiments had recently received CE-mark approvals and had been exhibited at trade shows in Europe and Asia.
- The Lepu companies did not object to the UPC's international jurisdiction over the dispute, accepting that the Dutch subsidiary acted as an anchor defendant for Chinese company under Article 31 UPCA, in conjunction with Articles 7(2) and 71b(2) of the recast Brussels Regulation. However, the Lepu companies did challenge the Hamburg LD's competence to hear the matter, arguing that there was no special connection or targeted marketing to Germany and no "imminent infringement".
- The court rejected this argument holding that it had competence under Article 33(1)(a) UPCA, as it was the LD hosted by the UPC state where the actual or threatened infringement has or may occur. There must be at least a plausible allegation of infringing acts by that party in the country in origin or a situation of imminent infringement (as recently explained by the Court of Appeal in Boehringer v Zentiva).
- The Hamburg LD drew an analogy with the Court of Appeal's reasoning in Boehringer v Zentiva, noting that the Court of Appeal had decided in the context of marketing generics that the mere application for a marketing authorisation did not amount to an imminent infringement but completion of national procedures for health and technology assessment, pricing and reimbursement could amount to an imminent infringement. In this case, implantable medical devices are subject to the Medical Devices Regulation, which stipulates that devices can only be put on the market or put into service if they comply with the Regulation and have undergone clinical evaluation. Obtaining an EU CE-mark is a prerequisite to putting a medical device on the market in the EU and that requires clinical evaluation.
- Accordingly, obtaining and announcing CE-marks for both attacked embodiments was held to indicate an expected market entry in any of the EU Member States in the foreseeable future, including Germany. Plus, the presentation of the attacked embodiments at a trade fair in Germany was a sufficient indication that marketing was directed at the German market. Due to the imminent infringement finding, the court left open the question whether the presentation of the devices at the trade fair turned an imminent infringement into an actual infringement under Article 25 UPCA.
- The defendants challenged the urgency with which Occlutech had acted in bringing the provisional measures proceedings. The defendants pointed to Occlutech's earlier knowledge of the alleged infringing devices from catalogues from 2023 and a Dubai conference. The court held that the applicant had treated the matter with the necessary urgency. It was not relevant at which point the applicant gained general knowledge of the infringing devices as long as their marketing in the EU could not have been considered imminent due to the lack of a CE-mark. Any knowledge prior to the CE-marks being granted was deemed irrelevant. It was acknowledged that the defendants announced their CE-mark approvals in April and May 2025, with Occlutech finding out about it later. Occlutech filed its application in June 2025 and the court found that it acted without undue delayed as it demonstrated that it investigated the defendants' activities in Europe/Germany, even though it was difficult to obtain information on the specific products as they are sold through direct sales channels or tenders with hospitals.
- The defendants also challenged the validity of the patent, alleging added matter and lack of novelty. The court found these attacks unconvincing and held that the patent was more likely than not valid. The attacked embodiments were also held to make literal use of claim 1 of the patent.
- The court weighed the parties' interests, finding that there were special circumstances justifying an injunction – namely, the parties were direct competitors and there was a likelihood that the launch of the attacked embodiments would result in lost sales for Occlutech due to the assumed lower price of the defendants' products. A preliminary injunction was granted, prohibiting the defendants from offering, placing on the market, using, importing and storing for those purposes the infringing products in Germany, France, Italy, the Netherlands and Ireland (the court noted that because of the imminent infringement finding an injunction covering all UPCA countries could have been granted under Article 34 UPCA, but this is not what Occlutech had requested).
- The defendants had sought security for costs from Occlutech, but the court dismissed the request. It stated that it was contradictory for the defendants to deny imminent entry into the market with the attacked embodiments, while at the same time requesting security. The information provided by the defendants did not allow the court to assess any possible damage if the provisional measures were later revoked.
- The court set a penalty payment of up to €250,000 for each case of non-compliance with the preliminary injunction.
Issue
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