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The UPC's Hamburg Local Division (LD) has granted a preliminary injunction (PI) preventing Lepu Medical Technology (Beijing) Co from offering, placing on the market or using, or importing or storing for those purposes embodiments which were held likely to be infringing Occlutech GmbH's EP 2387951 protecting a medical device, within the territory covered by the EP: Germany, France, Italy, Netherlands and Ireland. Note that there was no objection to the jurisdiction of the UPC (even over Ireland which is not yet a ratified member of the UPC).
The decision provides useful guidance on how delay (or not) on the part of those seeking a PI will be interpreted, as well as the significance of CE approval and the act of publicising that approval in the interpretation of the risk of imminent infringement (Occlutech GmbH v. Lepu Medical Technology (Beijung) Co. Ltd and another UPC_CFI_553/2025).
Background
Lepu received CE-mark approval for its MemoCarna VSD and MemoCarna ASD products on 31 March – 4 April 2025 and mid-May 2025 respectively. These products were then introduced at various conferences and fairs, with schematic drawings of the ASD device shown at the Euro PCR 2025 in Paris on 20-23 May 2025 and both products showcased at the CSI Frankfurt conference on 18–21 June 2025.
These products threaten infringement of Occlutech GmbH's EP 2387951 for a braided implantable occlusion device, which was granted on 26 December 2012.
Occlutech became aware of the granting of the CE-mark approval soon after their grant in the week starting 12 May 2025, and filed its application for a PI on 18 June 2025.
CE marking as an indication of imminent infringement
The Hamburg LD referred back to the Court of Appeal (CoA) in Boehringer v Zentiva where it confirmed that obtaining a marketing authorisation, without more, was not a sign of imminent infringement. However, a situation of imminent infringement may be characterised by certain circumstances which suggest that the infringement has not yet occurred, but that the potential infringer has already set the stage for it to occur. The infringement is only a matter of starting the action. The preparations for it have been fully completed. These circumstances must be assessed on a case-by-case basis (CoA, Order of 13. August 2025, UPC_CoA_446/2025 APL_24205/2025 – Boehringer/Zentiva). In that case, the CoA decided that although, in the context of marketing of generic pharmaceuticals, the mere application for a marketing authorisation by a generics company does not amount to an imminent infringement, nor does the grant of such an authorisation create one - but, completion of the national procedures for health technology assessment, pricing and reimbursement for a generic medicine can amount to an imminent infringement. The assessment must be made with due regard to the national regulatory and legislative context and considering the circumstances of the case.
The Hamburg LD then turned to the regulatory approvals necessary for medical devices such as the one the subject of this dispute:
"Implantable medical devices, like in the case at hand, are subject to the (EU) regulation 2017/745 on medical devices (hereinafter "MDR"). According to Art. 5.1 MDR a device may be placed on the market or put into service only if it complies with this regulation, which according to Art. 5.3 MDR requires a clinical evaluation in accordance with Art. 61 MDR. Despite the fact, that their marketing is, unlike generics drugs, not reliant on a grant of a national authority, obtaining the EU certification of conformity (CE-mark) is a prerequisite for being able to legally market a medical device in (all of) the European Union, and this requires clinical evaluation.
...
Contrary to the Defendants' position the CE-mark approval does also give an indication that a market entry into Germany is to be expected in the foreseeable future, since the CE marking is required for placing a medical device in any of the EU member states, not just, but including in Germany. Also, an expected (and in fact occurred) presentation of the attacked embodiments on a trade fair in Germany is a sufficient indication that marketing the products is prepared for the German market in particular."
The court concluded that the CE-marking of allegedly infringing embodiments, which were being presented at a trade fair, amounted to sufficient evidence of imminent infringement.
Temporal urgency (or unreasonable delay)
The Hamburg LD referenced its own decision of 3 June 2024 in Ballinno/UEFA UPC_CFI_151/2024 (as well as other UPC decisions) to confirm the UPC's approach to considerations of temporal urgency sufficient to allow a PI application:
"The temporal urgency required for the ordering of provisional measures is only lacking if the infringed party has behaved in such a negligent and hesitant manner in the pursuit of its claims that, from an objective perspective, it must be concluded that the infringed party is not interested in promptly enforcing its rights, which is why it does not appear appropriate to allow it to claim provisional legal protection."
Pursuant to Rule 213.2 RoP, the court may, as part of its decision-making process, require the Applicant to submit all reasonably available evidence to ensure that it can be sufficiently certain that the Applicant is entitled to initiate proceedings under Art. 47 UPCA, that the patent in question is valid and that its right is being infringed or threatened with infringement. In urgent proceedings, the Applicant must typically respond to such an order from the court within a short period of time, which requires appropriate preparation of the proceedings. The Applicant therefore only needs to apply to the court if they have reliable knowledge of all the facts that make legal action in the proceedings for provisional measures promising and if they can substantiate these facts.
The Applicant may prepare for any possible procedural situation that may arise, based on the circumstances, in such a way that it can present the requested information and documents to the court upon such an order and successfully rebut the arguments of the Defendant's side.
In principle, the Applicant cannot be instructed to carry out any necessary subsequent investigations only during ongoing proceedings and if necessary to obtain the required documents after the fact. On the other hand, the Applicant must not delay proceedings unnecessarily. As soon as it has knowledge of the alleged infringement, it must investigate it, take the necessary measures to clarify it and obtain the documents required to support its claims. In doing so, it must diligently initiate and complete the required steps at each stage. As soon as the Applicant has all the knowledge and documents that reliably enable a promising legal action, it must file the application for the ordering of provisional measures within one month (Ballinno/UEFA).
Gaining knowledge of the CE-mark approval marks the starting point for the Applicant to investigate the situation, take the necessary measures to clarify it and obtain the documents required to support its claims, because from that moment on an infringement might be imminent. From this point the court will measure whether the matter was treated with sufficient urgency by the claimant or if there it had unreasonably delayed in bringing an action.
The Court considered that the PI application had been made "with the necessary urgency" and there was no "unreasonable delay" in seeking provisional measures. The Hamburg LD also noted that there were "special circumstances" justifying a PI, as the parties are direct competitors in occlusion devices. A PI was duly granted for imminent infringement.
Conclusions
It is clear from this judgment that any delays may weaken an applicant's position, making quick action against the threat of imminent infringement important in filing an application for provisional measures. However, the indications providing that an applicant need not have taken action before the defendant was "ready to go" in a regulatory sense will be of great assistance to those seeking PIs to enforce against imminent infringement.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
