Genentech v Organon Heist (CFI, UPC_CFI_407/2025, 12 November 2025)

Dhenne Avocats · 10 October 2026

Our analysis

Summary

By an order of 12 November 2025, given in proceedings UPC_CFI_407/2025 (preservation of evidence) and UPC_CFI_408/2025 (inspection), the Brussels Local Division largely dismissed the request for review filed by Organon Heist and N.V. Organon against the orders granted without hearing the defendants on 30 May 2025 in favour of Genentech and F. Hoffmann-La Roche (EP 3 401 335, anti-HER2 antibody formulation). The division confirmed the measures, held the complaints about their execution inadmissible and set the next procedural steps.

The order clarifies three points: the two-stage method of review, the fact that urgency is not a mandatory condition for ex parte measures, and the autonomous reading of the requirement that the patent be « about to be infringed » under Art. 60 UPCA, applied to a biosimilar awaiting marketing authorisation.

Facts and procedure

Genentech and Roche filed their applications on 6 May 2025, after an ex parte hearing on 23 May, the division issued two orders on 30 May 2025, which were executed on 27 June 2025 at Organon’s sites in Heist-op-den-Berg (Belgium) and Oss (the Netherlands) (paragraphs 1 to 6). They concerned HLX11, described as a biosimilar of Perjeta (pertuzumab). The applications against Organon & Co. and Shanghai Henlius Biotech had been dismissed, with no appeal. Organon Heist and N.V. Organon requested review on 25 July 2025, the hearing took place on 21 October 2025 (paragraphs 7 to 13).

The applicable law

Art. 60 UPCA allows measures to preserve evidence and inspection orders on the basis of reasonably available evidence making it plausible that the patent has been or is about to be infringed (paragraphs 1 and 3), where appropriate without hearing the defendant (paragraph 5). Rule 194 governs that choice, Rule 192.3 imposes on the applicant a duty to disclose material facts, and Rule 197.3 allows the defendant to request a review.

Question

Were the ex parte orders justified as to the choice of that route, the requirement of imminent infringement and their scope, and do complaints about their execution fall within the review?

Decision

Review involves two assessments made as of the date of the orders: the first asks whether the ex parte route was justified on the facts disclosed or reasonably known to the applicant, the second asks what the division would have decided had the matter been heard inter partes from the outset (paragraphs 39 to 41). Requests concerning the execution or outcome of the seizure fall outside the review and are inadmissible (paragraphs 42 and 53).

No breach of the duty of disclosure was found: Organon’s disagreement concerned the reading of the facts, not their concealment (paragraph 55). Urgency, which the UPCA does not define, is not a mandatory condition. It was nonetheless shown by the plausible timeline for authorisation in early 2026, statements by Organon’s CEO, its letter of 28 April 2025 and the Dutch nullity action (paragraphs 57 to 61). The test is the probability of a risk to the evidence, not the defendant’s intent: destruction was unlikely, but relocation making the material unavailable was probable (paragraphs 62 to 67).

The « about to be infringed » requirement is autonomous: distinct from urgency and from threatened infringement, it requires a risk of future infringement shown with a certain degree of plausibility (paragraphs 48 to 50 and 70). The marketing authorisation application, together with the other evidence, was sufficient here, even though it might not suffice for provisional measures (paragraph 71). The measures did not have to be confined to feature (vi), since the appointed experts filter the material gathered (paragraphs 74 to 78), and the option to call representatives without delaying execution was upheld (paragraphs 79 to 82). The order sets a timetable for written submissions, stays the confidentiality applications and the experts’ work, regulates the filing of their report and the Rule 198.1 time limit, and reserves costs.

Key points for practice

• Review is not the forum to challenge how the seizure was executed: such complaints belong in separate proceedings or in the defence on the merits.
• A defendant alleging non-disclosure must point to a concealed fact. A different reading of the facts presented is not enough.
• In biosimilar disputes, a marketing authorisation application combined with signs of a launch may make imminent infringement plausible for the purposes of Art. 60.
• Practical point: since urgency is not a mandatory condition for ex parte measures, applicants should document precisely the risk of evidence being moved between the defendant’s sites.

Provisions applied

Agreement on a Unified Patent Court

Arts 25 and 58, Art. 60(1), (3) and (5) and Art. 73(2)(a)

Rules of Procedure

Rules 9, 192.3, 194, 196.1, 197, 198.1, 199, 220.1 and 262A

Directive 2004/48/EC

Art. 7

Case law cited

Progress Maschinen & Automation v AWM, Court of Appeal, 23 July 2024, Court of Appeal, 15 July 2025 (UPC_CoA_327/2025), Court of Appeal, 13 August 2025 (UPC_CoA_446/2025), Munich Local Division, 28 May 2025 (UPC_CFI_63/2025), Düsseldorf Local Division, 16 April 2025 (UPC_CFI_539/2024), Mannheim Local Division, 3 March 2025 (UPC_CFI_142/2025)

Related decisions

• Genentech v Organon, 30 May 2025, ex parte order to preserve evidence under review.

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.