UPC: CE marking for a medical device as a trigger for “imminent infringement”, refining the standard on imminence, urgency, and territorial scope

Background

The UPC Court of Appeal, has already decided that the completion of national pricing and reimbursement and health technology assessment procedures for pharmaceuticals may, depending on the national context and facts, constitute an imminent infringement justifying provisional measures (see our article on the Boehringer/Zentiva case here). In the present case, the Hamburg Local Division of the UPC (the Hamburg LD) had to assess whether the CE marking of medical devices, coupled with public launch signals, also constituted a threat of imminent infringement that could lead to the granting of a preliminary injunction. 

German company, Occlutech, is the owner of EP 2 387 951 pertaining to a medical implantable braided occlusion device and manufacturing methods, for cardiovascular use (the Patent). The Patent was initially opted out of the UPC, but the opt-out was subsequently withdrawn. 

Lepidu Medical Technology (Beijing) and its Dutch subsidiary, Lepidu Medical (Europe) (the Defendants) advertised the attacked products, two braided occlusion devices, in a product catalogue in 2023. They demonstrated them at a trade fair in Dubai in May 2025 and obtained a CE marking for each device in April and mid-May 2025 respectively. This was announced in social media posts and the products were advertised on their website. Significantly, the Defendants announced that they were sponsoring a cardiovascular conference in Frankfurt (CSI Frankfurt) starting on June 18 2025 and would participate in a device parade to present their products. Occlutech filed an application for provisional measures on June 18 2025, the opening day of the CSI Frankfurt, the Defendants had not presented products in Europe before that date. 

The Hamburg LD decision

The Hamburg LD first assessed whether there was a threat of imminent infringement in Germany and then whether the urgency and balance of interests justified a preliminary injunction in the jurisdictions covered by the Patent.

1. Imminent Infringement 

The Hamburg LD considered that, while a CE marking is a prerequisite to marketing medical devices in Europe, it is not, in itself, sufficient to demonstrate a threat of imminent infringement. In this case, in addition to obtaining (and publicly announcing) the CE-mark approval, the Defendants also provided “ordering information” on their website and announced the showcasing of their products at a trade fair. This combination set the stage for marketing the products and indicated a threat of imminent infringement. 

2. Urgency 

The Hamburg LD concluded that Occlutech had acted diligently for the following reasons:

• It had filed the application for a preliminary injunction on June 18 2025, the opening day of the CSI Frankfurt. 
• The Defendants had announced the CE marking in April and May 2025. There had been no presentation of the devices in Europe before June 18 2025. 
• The date of CE marking was the starting point for obtaining knowledge of an infringement and for carrying out preparatory acts to file for a preliminary injunction. It was irrelevant that the Defendants participated in fairs and conferences outside of Europe as was the possibility of Occlutech assessing product features in a 2023 product catalogue. Because CE mark approval is a prerequisite for marketing a medical device in the EU, any knowledge of the attacked embodiments prior to that date cannot be relevant.
• In total, about a month had elapsed between becoming aware of the CE‑mark approval (May 12 2025) and filing the application (June 18 2025).

3. Validity 

The Patent was more likely than not novel and valid, even in view of the Defendants’ claims regarding prior art and added matter.

4. Balance of interests

A few days before this decision, the UPC Local Division of the Hague had ruled that a CE marking was a relevant factor in assessing the necessity and proportionality of a preliminary injunction for medical devices. The Hamburg LD applied a similar reasoning, looking at both the CE marking and other factors when balancing the interests of the parties. These included: 

• The parties are direct competitors.
• A CE-marking is a preparatory step required by the European Medical Devices Regulation to market a medical device in Europe and “sets the stage” for the introduction of the products in Germany, where the threat of infringement was raised. 
• The Defendants increased their market activities by participating in trade fairs and conferences in Europe.
• The introduction of the Defendants’ products could affect Occlutech’s sales in a market characterized by long-term relationships. 
• The Defendants’ products are offered at significantly lower prices than Occlutech’s products on the Italian market. 

Based on these findings, and after weighing the various interests of the parties, the Hamburg LD issued a preliminary injunction against the Defendants without security. 

Related UPC development

A parallel dispute between the same parties but involving a different patent emphasized that CE-marking is also relevant from the perspective of liability for a patent infringement. The Düsseldorf Local Division of the UPC reminded the parties that the affixing of a CE-marking by a company that acts as a European representative for medical devices in Europe may give rise to its liability as an intermediary (however, in this case, the patent was not considered infringed), as previously stated by the Düsseldorf Local Division in a decision dated July 10 2025. However, it confirmed that affixing a CE-marking is not, in itself, sufficient to constitute an infringement.

Key takeaways

• The Hamburg LD applied the Court of Appeal’s Boehringer/Zentiva framework to implantable medical devices by treating EU‑wide CE-marking as a practical prerequisite for market entry. However, imminent infringement is not triggered by CE approval alone. Additional concrete, public launch signals, such as publication of ordering information or announcements of trade‑fair presentations are needed to evidence a risk of imminent commercialization and future infringement.  
• The regulatory step involved in the assessment of imminent infringement is different for pharmaceuticals and medical devices. A CE-mark is required for medical devices to enter the European market but that CE marking alone may suffice to enter the cash-pay market, where patients self-fund their purchase (as noted by the UPC Local Division of the Hague). By contrast, pharmaceuticals need to obtain marketing authorization, but there a further regulatory steps setting the stage to enter the market such as completion of a procedure fixing the conditions under which public entities may purchase the medicine. 
• The obtaining of a CE marking is also the trigger for: (i) the patent-holder to start investigating a potential infringement and (ii) the court to establish whether an application is brought without unreasonable delay (i.e. urgency). 
• Interestingly, the Hamburg Local Division’s preliminary injunction extends to Ireland, which is not yet a UPC Contracting State. Occlutech had requested a preliminary injunction covering the UPC Contracting States (Germany, France, Italy, and the Netherlands) and also Ireland. The defendants did not challenge the Hamburg LD international jurisdiction. While this appears to be in line with the CJEU’s Electrolux/BSH decision and with UPC long arm jurisdiction decisions, the Hamburg Local Division did not substantiate its long arm jurisdiction over Ireland or the Chinese entity. It suggests that the UPC is prepared to accept jurisdiction over EP countries outside the UPC—and over foreign defendants—when its jurisdiction is not challenged.