Aesculap v Shanghai International Holding Corporation (Europe) (CFI, 10 July 2025)

Dhenne Avocats · 10 October 2026

Our analysis

Summary

By order of 10 July 2025 (UPC_CFI_213/2025), the Düsseldorf Local Division (Judges Thomas, Schumacher, Mlakar and Tilmann) ruled on Aesculap’s application for provisional measures under EP 2 892 442 (surgical torque-transmitting instrument) against Shanghai International Holding Corporation GmbH (Europe), the EU authorised representative, under the Medical Device Regulation 2017/745, of the Chinese manufacturer of surgical drill bits. The division stated that the application was admissible and largely well founded (paragraph 35).

Two points emerge from the parts read. A defendant that announces it will not be represented at the hearing is judged on its written submissions, and the court is not confined to a default decision. The authorised representative under the Medical Device Regulation may be liable for infringement as an intermediary. The division ordered the defendant to cease in Germany and France, to deliver the products to a bailiff, to provide information limited to origin and distribution channels and to pay EUR 33,335.70 in interim costs, without security.

Facts and procedure

Aesculap, proprietor of EP 2 892 442 in force in Germany, France and the United Kingdom, complained of the offer and distribution in Germany and France of « Bojin Medical Drill Bits (Sterile) ». The application, filed ex parte on 18 March 2025, was served on the defendant, which lodged an objection on 23 April 2025, the hearing was set for 1 July 2025 (paragraphs 28 to 31). On 12 June 2025 the defendant stated that it would not be represented and relied on its written submissions (paragraph 34).

Aesculap sought an injunction backed by penalty payments, delivery up of the products to a bailiff, information and provisional costs of EUR 33,335.70 (paragraph 12), in the alternative, it targeted the defendant’s role as authorised representative under Art. 11 of Regulation 2017/745 (paragraph 13).

The applicable law

Provisional measures are governed by Art. 62 UPCA and Rules 206 et seq. Art. 63(1) allows orders against an intermediary whose services are used to infringe. Claim interpretation follows Art. 69 EPC and its Protocol (paragraphs 55 and 64). Facts not contested are deemed admitted (Rule 171.2), and Rule 116 governs a party’s absence from the oral hearing.

Question

Can the EU authorised representative of a medical device manufacturer be subject to provisional measures, and how is a defendant that declines to appear to be dealt with?

Decision

A defendant that stays away after announcing it would not be represented is treated as relying on its written submissions, and the division decides on the merits (paragraphs 135 and 136). The feature « Zweiflach » does not require converging planes: the wedge shape is merely preferred and parallel planes are covered (paragraphs 68 to 74), so there is literal infringement (paragraphs 75 to 80). A general denial is not enough against concrete facts supported by a sample naming the defendant as authorised representative, so the allegations are deemed uncontested (paragraphs 82 to 84). In any event, the defendant is liable as an intermediary under Art. 63(1), since its appointment makes a decisive contribution to placing the product on the market (paragraphs 86 to 90).

Validity is held sufficiently secure: novelty over US 2003/0023256 because the axial locking is not disclosed (paragraphs 96 to 98), and no serious doubt on inventive step, the defendant having identified no starting point (paragraphs 99 to 101). The balance of interests favours Aesculap: it applied seven weeks after receiving a sample on 27 January 2025, and Bojin’s market entry, at about EUR 18 per drill bit against about EUR 80 for Aesculap’s, which holds over 50% of the German market with its ELAN 4 systems, threatens the status quo (paragraphs 103 to 118).

The injunction is backed by a penalty of up to EUR 5,000 per product or EUR 20,000 per day for continuing acts, and delivery up to a bailiff was ordered. Information is limited to origin and distribution channels, data mainly relevant to calculating damages being refused (paragraphs 120 to 123). Interim costs, calculated under the German statutory scale of lawyers’ fees, are reimbursed and the defendant bears all the costs, its partial success being minor (paragraphs 124 to 127). No security was required, the defendant having made little use of its opportunities to defend (paragraphs 132 to 134), and no time limit to bring proceedings on the merits was set, since an action is already pending (paragraph 137).

Key points for practice

• Announcing that one will not be represented at the hearing does not lead to a mere default procedure: the division decides on the merits on the written submissions.
• Faced with specific allegations, the defendant must say whether it disputes them. General criticism of the burden of proof counts as no challenge (Rule 171.2).
• The EU authorised representative under Regulation 2017/745 may be pursued as an intermediary under Art. 63(1) UPCA.
• Practical point: a patentee facing a manufacturer based outside the EU may act against its European authorised representative, whose appointment is a condition for placing the product on the market.

Provisions applied

Agreement on a Unified Patent Court

Arts 25, 47(1), 62, 63(1), 69 and 82

Rules of Procedure

Rules 8.5, 116, 171.2, 206, 209, 210.3, 211, 213, 352 and 354

European Patent Convention

Arts 54, 56 and 69 and Protocol on its interpretation

Regulation (EU) 2017/745

Art. 11

Case law cited

Court of Appeal: 10x Genomics v Nanostring, 26 February 2024, VusionGroup v Hanshow, 13 May 2024, Mammut v Ortovox, 25 September 2024, Biolitec v Light Guide Optics, 24 February 2025, Abbott v Sibio, 14 February 2025, Sumi Agro v Syngenta, 3 March 2025, and Insulet v EOFlow, 30 April 2025, Düsseldorf Local Division: Ortovox v Mammut, 11 December 2023 and 9 April 2024, Kaldewei v Bette, 3 July 2024, Seoul Viosys v expert e-Commerce, 10 October 2024, Magna v Valeo, 31 October 2024, Yellow Sphere v Knaus Tabbert, 10 April 2025, and Grundfos v Hefei Xinhu, 8 May 2025, Munich Local Division, Koninklijke Philips v Edrich, 13 September 2024, Hamburg Local Division, Ballinno v UEFA, 3 June 2024, The Hague Local Division, order of 23 May 2025 (UPC_CFI_191/2025 and UPC_CFI_192/2025)

Related decisions

• Aesculap AG v Shanghai International (Europe), 10 June 2025, earlier order 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.