Occlutech v Lepu Medical Technology (Beijing) (CFI, 21 October 2025)

Dhenne Avocats · 10 October 2026

Our analysis

Summary

By order of 21 October 2025 (UPC_CFI_553/2025), the Hamburg Local Division granted Occlutech’s application for provisional measures against Lepu Medical Technology (Beijing) and Lepu Medical (Europe) Cooperatief, prohibiting them from offering, placing on the market, using, importing or stocking in Germany, France, Italy, the Netherlands and Ireland the MemoCarna ASD and VSD occlusion devices embodying claim 1 of EP 2 387 951. The order found threatened infringement in Germany on the basis of CE marking and a trade presentation in Frankfurt, and refused any security.

Facts and procedure

The application was filed on 18 June 2025, the defendants responded on 15 July 2025 and the oral hearing took place on 26 September 2025. The patent concerns a braided implantable occlusion device. The opt-out was withdrawn in May 2025. The products had CE marking and had been presented at EuroPCR, in Dubai and at the CSI trade fair in Frankfurt (18 to 21 June 2025), with ordering information. The header date is 21 October 2025, while the signatures are dated 20 October 2025.

The applicable law

Provisional measures fall under Art. 62 UPCA and Rules 206 et seq. RoP, the division having to be satisfied with a sufficient degree of certainty of validity and infringement (Rule 211.2 RoP). Competence rests on Art. 33(1)(a) UPCA and Art. 7(2) and 71b(2) of Regulation 1215/2012, construction follows Art. 69 EPC. CE marking is assessed in the light of the Medical Devices Regulation (EU) 2017/745.

Question

Are CE marking and a trade fair presentation in Germany enough to show threatened infringement justifying a provisional injunction in five States, and is the validity of the patent sufficiently certain?

Decision

Yes. CE marking, a precondition for lawful marketing in the EU, signals market entry, including in Germany, and the CSI presentation with ordering information prepares marketing. Threatened infringement in Germany is established (paragraphs 38 to 46). Urgency runs from knowledge of the CE marking, earlier access to the catalogue and the Dubai presentation being irrelevant. Occlutech acted without undue delay (paragraphs 47 to 54). The ‘centre point’ may cover a crossing region close to the centre, and claim 1 requires a closed distal end (paragraphs 76 to 87). Validity is more likely than not: no added matter, novelty over DN1 and DN2 (paragraphs 88 to 112). Both products literally embody claim 1 (paragraphs 113 to 127). Direct competition and the risk of price erosion tip the balance in the patentee’s favour (paragraphs 130 to 138). The defendants did not substantiate their potential loss, reputational harm is not enough and the applicant is a solvent EU company: no security is required (paragraphs 139 to 143). The injunction carries a penalty of up to EUR 250,000 per breach, the value is set at EUR 1 million and costs are borne by the defendants.

Key points for practice

• CE marking of a medical device, combined with a trade presentation, may be enough to show threatened infringement within a local division’s territory.
• For medical devices, urgency may run from knowledge of the CE marking rather than from earlier presentations abroad.
• A defendant seeking security must quantify and substantiate its loss. Reputational harm is not enough.
• Practical point: a patentee monitoring a competitor should track CE marking databases, which may trigger the urgency period.

Provisions applied

Agreement on a Unified Patent Court

Art. 25, 31, 32(1), 33(1)(a), 34, 62, 73(2)(a) and 82(2)

Rules of Procedure

Rules 206.2(c), 209, 211.2 to 211.5, 213, 220.1(c), 224.2(b) and 354.3

European Patent Convention

Art. 69, Art. 138(1)(c)

Directive 2004/48/EC

Art. 9(3)

Regulation (EU) No 1215/2012

Art. 7(2) and 71b(2)

Case law cited

Court of Appeal: Aylo v Dish, 3 September 2024 (UPC_CoA_188/2024), Boehringer Ingelheim v Zentiva, 13 August 2025 (UPC_CoA_446/2025), Biolitec v Light Guide Optics, 24 February 2025 (UPC_CoA_540/2024), Sumi Agro v Syngenta, 3 March 2025 (UPC_CoA_523/2024), Hamburg Local Division: Dyson v Dreame, 14 August 2025 (UPC_CFI_387/2025), Ballinno v UEFA, 3 June 2024 (UPC_CFI_151/2024), Munich Local Division: Hand Held Products v Scandit, 27 August 2024 (UPC_CFI_74/2024), Düsseldorf Local Division: Valeo v Magna, 31 October 2024 (UPC_CFI_347/2024)

Related decisions

• Occlutech v Lepu Medical (Europe) Cooperatief, 20 May 2026, later decision of the Hamburg division in the same proceedings.

Prepared by Dhenne Avocats from the official decision, consulted on 10 October 2026. The database is updated every week, on Friday. Only the official text is authoritative.