Genentech v Organon (CFI, UPC_CFI_407/2025, 30 May 2025)

Dhenne Avocats · 10 October 2026

Our analysis

Summary

By order issued on 30 May 2025 in the joined proceedings UPC_CFI_407/2025 (preservation of evidence) and UPC_CFI_408/2025 (inspection), the Brussels Local Division largely granted, without hearing the defendants, the applications by Genentech and F. Hoffmann-La Roche based on EP 3 401 335 and directed at HLX11, a pertuzumab biosimilar. The measures were ordered against N.V. Organon and Organon Heist B.V. at their Oss and Heist-op-den-Berg sites and refused as regards Organon & Co. and Shanghai Henlius Biotech. The running header of the document bears the date 27 May 2025.

The order matters for pharmaceutical practice in three respects: the standard of proof applied (« highly likely »), lower than for preliminary injunctions or the merits, the acceptance of a reasoned inference for a feature not publicly shown, and leave to use the results in Dutch revocation proceedings.

Facts and procedure

The applications were filed on 6 May 2025, the very day the opt-out of the patent was withdrawn (paragraph 23). The patent had been maintained in amended form by the Opposition Division on 24 March 2025. On 7 May 2025 Organon US brought revocation proceedings before the District Court of The Hague. The applicants relied on public statements announcing a European launch of HLX11 in late 2025 or early 2026. A preliminary hearing was held by video conference on 23 May 2025, at which the applicants corrected the error in their application naming The Hague Local Division as the intended forum for the merits (paragraph 28).

The applicable law

The Court applied Art. 60(1) and (7) UPCA and Rules 192 and 194 to 199. The standard is « a certain degree of plausibility » of infringement or its threat, which the division renders as « highly likely ». It also applies to validity and is lower than in actions on the merits and for provisional measures, since otherwise the measure would lose its purpose (paragraph 37, citing the Mannheim Local Division, 3 March 2025). Jurisdiction was assessed under Rule 192.1 and Regulation (EU) No 1215/2012.

Question

Were the conditions for an order to preserve evidence and for inspection, made without hearing the defendants, met as against each company concerned, and to what extent were the requests proportionate?

Decision

The applications against Organon & Co. and Henlius were dismissed, as their registered offices and premises lie outside UPC territory (paragraphs 23 to 28). Urgency was shown by the launch expected around early 2026 (paragraph 42), and proceeding without hearing the defendants was justified by the risk of irreparable harm and of evidence being lost (paragraphs 45 and 46). Validity was presumed, the patent having been maintained in opposition with no challenge pending on the filing date (paragraph 48). Infringement was found highly likely for features (i) to (v) of claim 1, relying in particular on Chinese patent CN 111375057 A, and feature (vi) was accepted by reasoned inference from scientific publications (paragraphs 49 to 59).

On proportionality, several requests were narrowed or refused, including the FDA documentation (paragraphs 60 to 71). The bailiff may describe and photograph the equipment, take ten samples of the formulation and copy batch records and the EMA regulatory file. Two experts were appointed. Cooperation is backed by a penalty of EUR 200,000 per hour, capped at EUR 5,000,000, and enforcement is conditional on security of EUR 25,000. The results may be used in the Dutch proceedings under Rule 196.2 (paragraph 71). Costs were reserved.

Key points for practice

• Timing of the opt-out withdrawal matters: it was withdrawn on the filing date, before the applications were uploaded.
• At the preservation stage, a feature not publicly demonstrated may be established by reasoned inference from the scientific literature.
• The measures reach only companies with premises on UPC territory. The US parent and the Chinese manufacturer were beyond reach.
• Practical point: leave to use the results in parallel national proceedings must be sought expressly, the division granted it while leaving admissibility to Dutch law.

Provisions applied

Agreement on a Unified Patent Court

Arts 31, 32(1)(a), 33(1)(a), 58, 60(1) and (7) and 71

Rules of Procedure

Rules 9, 191, 192, 194, 196, 197, 198.1, 199, 220.1(c) and 224

Directive 2004/48/EC

Art. 7

Regulation (EU) No 1215/2012

Arts 4(1), 8(1) and 71b

Other instruments

Directive (EU) 2016/943, European Convention on Human Rights, Arts 6 and 8 and Art. 1 of Protocol No 1, Charter of Fundamental Rights of the European Union, Arts 17 and 47

Case law cited

Mannheim Local Division, 3 March 2025 (UPC_CFI_142/2025)

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.