Genentech & F. Hoffmann-La Roche v Organon Heist & Ors (UPC_CFI_407/2025, UPC_CFI_408/2025)
Decision date:
12 November 2025
Osborne Clarke summary
- This decision concerned an application for review of an ex parte order for inspection and preservation of evidence. The request for the inspection and preservation of evidence was brought by Genentech and Roche against the defendants in relation to the alleged imminent infringement of Genentech's patent concerning an HER2 antibody composition by the upcoming launch by Organon of a pertuzumab biosimilar.
- The court had dismissed the applications in relation the first defendant (Organon US, a US pharmaceutical company and parent company to Organon BE and Organon NL, the second and third defendants respectively) and the fourth defendant (Henlius, a Chinese biopharmaceutical company focused on biosimilars). No appeal was introduced regarding this dismissal. However, the applications were ordered with respect to Organon BE and Organon NL (collectively referred to as Organon).
- In its application for review, Organon requested that the court's order be set aside entirely and any documents returned to it and copies destroyed or, alternatively, that the order be modified such that the bailiff be ordered to immediately return or destroy all copies obtained illegitimately or those deemed irrelevant by the court in establishing the alleged imminent infringement. Organon also requested that the costs of responding to Genentech and Roche's application be borne by Genentech and Roche.
- The Brussels LD laid out some general guidelines on the assessment of applications to preserve evidence or for inspection of premises. The general purpose of an evidence preservation/inspection application is to enable to the applicant to access additional information that is not publicly available in order to prove infringement, provided "reasonably available evidence" has been provided to support its claim. If granted, and based on the preserved/gathered evidence, the applicant should be enabled to evaluate the "reliable prospects of success" in bringing infringement proceedings.
- In the orders, the court had detailed four steps to be taken in the assessment of an application to preserve evidence/for inspection. First, the court considered whether or not to hear the defendants, with the court having the discretion set out in Rule 194.1 RoP . When exercising this discretion, the court shall consider the elements in Rule 194.2 RoP – a) the urgency of the action, b) whether the reasons for not hearing the defendant are well-founded, c) the probability that evidence may be destroyed or become unavailable. Applying this rule requires the court to undertake a balancing assessment, weighing these elements separately, meaning that no one element should be considered absolute. When an applicant requests measures without the defendant being heard, the court should not be misled by the applicant (Rule 192.3).
- The second step was the court's substantive assessment of whether to grant the requested measures. The requirements regarding an order to preserve evidence are set out in Article 60(1) and (3) UPCA . The court had to assess whether the patent had been infringed or was about to be infringed. In the order, the court was clear that the standard is "a certain degree of plausibility of the patent being infringed or about to be infringed" and that this standard of proof is lower than that required for infringement actions (on the merits) and preliminary measures actions. The burden of proof lies with the applicant – in this case Genentech and Roche. There was disagreement between the parties on the interpretation of "about to be". Organon argued that it should be read as "imminent" and therefore closely related to the urgency assessment in Rule 194.2 RoP. As such, it said that the orders were "premature". The court disagreed with this interpretation, noting that 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 the period.
- The third step, if the order is granted, was the court assessing whether the actual requests covered the purpose for which the application was made. This also involved balancing the rights of the parties. Organon argued that the earlier assessment by the court was flawed.
- In the fourth step, additional conditions relating to the execution of the order may be ordered by the court based on the circumstances of the case. Organon did not question any of the additional conditions set by the court, except for its argument based on "procedural impropriety".
- The Brussels LD carried out a review of these four steps undertaken by the court in coming to grant the orders.
- Firstly, in not hearing the defendant, Organon argued that the court was misled by Genentech and Roche regarding the urgency element and the probability that the evidence may be destroyed or cease to be available. Upon review, the court held that Genentech and Roche had disclosed all material facts known to them when applying for the orders. Moreover, it stated that the timeline for Organon's biosimilar launch put forward by Genentech and Roche was accurate and created urgency in the sense of Rule 194.2(a) RoP.
- Likewise, on review the court found that the standard for probability that evidence may be destroyed or cease to exist had been met by Genentech and Roche. The court held that the threshold for assessing the probability of evidence ceasing to be available is not the intention of the entity, but the probability of a demonstrable risk of evidence being destroyed or ceasing to be available. It was found that there was a probable risk that the materials would be moved from the Belgium and Netherlands locations to elsewhere, meaning that the materials would cease to be available. Thus, the court was said to have rightfully decided the issue on an ex parte basis.
- Secondly, the Brussels LD stated that its review of the court's substantive assessment of the applications was limited to the wording "about to be infringed". Applying the standard of "a certain degree of plausibility", the court found that Genentech and Roche had sufficiently proven that its patent was about to be infringed. The court specifically referred to Organons's application for a marketing authorisation. Although a marketing authorisation application might not constitute a threat of infringement in a provisional measures application, it was sufficient to prove with a certain degree of plausibility that the patent was about to be infringed for the purposes of this application.
- In reviewing the third step (assessment of the scope of the orders), the court held that the granted orders were justified, "rightly balanced" to prevent misuse of the legal tool as a "fishing expedition" and were not overly broad, as Organon had argued.
- Finally, the court reviewed the additional conditions imposed in the orders. The order had permitted Organon to contact its legal representative and/or technical representative to participate in the execution of the order but that could not delay execution. The Brussels LD noted that the presence of a legal or technical representative is not a prerequisite for executing the order and securing their presence should not be used to delay the carrying out of the order in any way. As such, Organon's request to alter these additional conditions was rejected.
- Overall, the court dismissed Organon's application for review and confirmed the orders for inspection and preservation of evidence.
- The court provided important guidance on the scope of review proceedings under Rule 197.3 RoP, establishing a double assessment framework. First, whether the court rightly decided to issue the ex parte order; and second, whether the order should be confirmed, modified or revoked based on all facts and evidence presented by both parties. For both assessments, the court should place itself on the date of issuance of the order to preserve evidence/for inspection.
- The court held that the scope of review proceedings does not pertain to the execution of the order, the outcome of such execution, or any information gathered during execution. Such requests must be assessed in separate proceedings and/or as part of the defence in provisional measures or proceedings on the merits.
- The court further detailed practical steps to be taken by the experts gathering and preserving the evidence. The court held that the appointed experts' task is to filter (evaluate) the gathered/preserved information and use only such information that they deem necessary as possible evidence to prove or disprove the actual infringement of the patent.
- The court indicated that a decision on the costs would be assessed either in infringement proceedings (if brought by Genentech and Roche) or in a separate application.
Issue
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