2025-11-12 - LD Brussels - Genentech et al. v. Organon et al. - UPC_CFI_407/2025

1. A double assessment determines the scope of review proceedings in application of R. 197.3 RoP: a. First, the Court should assess whether it has “rightly” (cf. LD Munich 28 May 2025, UPC_CFI_63/2025 and LD Düsseldorf 16 April 2025, UPC_CFI_539/2024) decided to issue an “ex parte” order to preserve evidence/for inspection (R.194.1(d) RoP juncto R. 194.2 RoP). In this assessment, the Court should take into consideration the facts and evidence (i) brought forward in the application for an order to preserve evidence/inspection, and (ii) which, if not disclosed to the Court, are either public or not public, but are considered to be reasonably known to the applicant. Before assessing all the facts, the Court should consider whether failing to bring these facts and evidence to its attention could be considered a breach of the applicant's duty to disclose any material fact that might have influenced the Court's decision (R. 192.3 (second sentence) RoP). b. The Court should then assess whether the order to preserve evidence/for inspection is to be confirmed, modified or revoked. In making this assessment, facts and evidence to be taken into consideration are not limited to those that are either public or not public but reasonably known to the applicant, but should include all facts and evidence (Rule 194.3(b) RoP) presented to the Court by the parties. This assessment relates to the substantive assessment of the conditions for granting (Art. 60(1) and (3) of the UPCA), the scope and conditions set out in the order issued to preserve evidence or for inspection. 2. For both assessments (under 1.), the Court should place itself on the date of issuance of the (to be reviewed) order to preserve evidence/for inspection. It is at that date that the Court made its: a. “ex parte” assessment based on the application for an order to preserve evidence/for inspection and any additional facts and evidence brought forward by the applicant for such order (and if applicable after having heard the applicant) (first assessment), or b. could have made its assessment if the proceedings had been dealt with “inter partes” from the outset (second assessment). 3. As such, the scope of the review assessment does not pertain to the execution of the order to preserve evidence/for inspection, the outcome of such execution, or any information (evidence) gathered during execution. Any requests made by the applicant relating to the execution of the order to preserve evidence/for inspection, the alleged fact that no evidence proving the infringement was found, or the alleged fact that more was seized than was authorised, are to be dismissed in review proceedings. Such requests must be assessed in separate proceedings and/or as part of the defence after the introduction of PI proceedings and/or proceedings on the merits, which may affect the admissibility and value of such evidence. 4. The general purpose of an order to preserve evidence/for inspection is to a. Enable an applicant who has "presented reasonably available evidence to support the claim" to access additional information (evidence) that is not publicly available (and, if necessary, protected by a confidentiality order) in order to prove the infringement and/or the acts constituting infringement, and b. If granted, and based on the preserved/gathered information (evidence), enable the applicant to evaluate the reliable prospects of success in initiating subsequent infringement proceedings. More specifically, the applicant is brought in the position to evaluate whether: i. to initiate provisional measure proceedings in accordance with the "no unreasonable delay" condition set out in Rule 211.4 RoP; ii. to initiate a procedure on the merits, in accordance with R. 13.1(l)(i) RoP, which refers to an indication of the facts relied upon, particularly the "alleged or threatened infringement", iii. not to initiate proceedings where there would be insufficient evidence of infringement or threatened infringement. 5. Given the general purpose of an order to preserve evidence or for inspection, the term “about to be infringed” in Art. 60(1) UPCA and Art. 60(3) UPCA does not have the same meaning as “urgency” (in the sense of R. 194(2) RoP) nor “unreasonable delay” (in the sense of R. 211.4 RoP (cf. CoA order 15 July 2025, UPC_CoA_327/2025)), nor “threatened infringement” (in the sense of R. 13.1(l)(i) RoP). The applicable threshold is that of "about to be infringed", which must be proven by the applicant with a certain degree of plausibility. Therefore, there must be a risk of infringement and it must be apparent that it will occur in the future. The specific facts of the case will determine the duration of this period. 6. The in an order to preserve evidence/for inspection appointed experts' task is to filter (evaluate) the gathered/preserved information (evidence) and use only such information (evidence) which he/she deems necessary as possible evidence to prove or disprove the actual infringement of the patent-in-suit.

The Brussels Local Division set out the framework for reviewing an order to preserve evidence granted without hearing the defendant, and confirmed the orders under review. Review under R. 197.3 RoP is a double assessment. The Court asks first whether it rightly decided to proceed ex parte, taking into account the facts and evidence put forward in the application and those which, though not disclosed to it, were either public or reasonably known to the applicant, and considering before anything else whether the failure to bring them forward breached the duty to disclose any material fact that might have influenced the decision. It then asks whether the order is to be confirmed, modified or revoked, on all the facts and evidence the parties present, which covers the substantive conditions, the scope and the conditions attached. For both assessments the Court places itself at the date the order issued. The review does not extend to the execution of the order, its outcome, or the evidence gathered: complaints that nothing infringing was found or that more was seized than was authorised belong to separate proceedings or to the defence on the merits, and are inadmissible here. On the substance the Court held that 'about to be infringed' in Art. 60(1) and (3) UPCA is a threshold of its own, meaning neither urgency, nor unreasonable delay, nor threatened infringement, and is met where the applicant shows with a certain degree of plausibility that infringement will occur — a marketing-authorisation application that might not found provisional measures could suffice here. It also held that the risk element is not the defendant's intention but the probability of a demonstrable risk, satisfied by the prospect of material being moved elsewhere rather than destroyed, and that the scope of the order is not confined to the one claim feature the applicant still lacked evidence on, the appointed experts' filtering role being part of what keeps the measure from becoming a fishing expedition.