Genentech Inc. & F. Hoffmann – La Roche AG v Organon & Co, Organon Heist B.V. NV Organon & Shanghai Henlius Biotech Inc. (UPC_CFI_407/2025 and 408/2025)

Orders dated 30 May 2025 (ORD_23125/2025 and ORD_23121/2025)[1]

This concerns evidence preservation and inspection orders granted by the Brussels LD.

Background

On 6 May 2025 the Applicants, Genentech Inc. (Genentech) and F. Hoffmann – La Roche AG (“Roche”), made two applications based on EP 3401335 (“EP 355”): one for preserving evidence under Rule 192; the other for inspection in situ under Rule 199 RoP. Genentech was the original applicant for EP 355 but it has since been assigned to Roche; both companies are part of the same group.

Separately, on 7 May 2025, Organon & Co (“Organon US”) commenced invalidity proceedings in the Netherlands regarding the Dutch national part of EP 335.

Roche commercialises pertuzumab in Europe for treatment of HER2-positive breast cancer under the name Perjeta. The Applicants presented evidence of an upcoming launch of a pertuzumab biosimilar by the defendants which they considered would fall within claim 1 of EP 355. They stated that they had sufficient evidence the product would fall within features (1) to (v) of claim 1 but that there was no public evidence relating to feature (vi) which requires that “the acidic variants include a disulfide reduced variant”.

Accordingly, they sought an order: (i) authorising them through a bailiff to make a description of the product manufactured, or to be manufactured, at Organon’s premises in Belgium and the Netherlands, including taking photos and samples; (ii) authorising them through a bailiff to acquire copies of batch records, manuals, etc; (iii) appointing independent technical experts to accompany the bailiff; (iv) for the Applicants to be provided with the samples from the bailiff; (v) requiring the defendants to cooperate with the bailiff and the experts by providing unrestricted access; and (vi) for an immediate penalty for each hour of failure to cooperate. They also requested that the collected information should be directly accessible to the judge, the Applicant’s lawyers and the technical experts, subject to a confidentiality restriction. Additionally they requested permission that the information obtained could also be used in the Dutch invalidity proceedings.

The judge-rapporteur clarified some points with the Applicants at a preliminary remote hearing ex parte on 23 May 2025. In particular he asked about: the local division in which an action on the merits would be started; information why the matter was urgent or that there was a risk that evidence may be destroyed or cease to be available; and a plan for the execution at the two locations of the order sought.

Decision

As Organon & Co and Shanghai Henlius Biotech Inc have their registered offices and premises outside the territory of the UPC (US and China respectively) the judge-rapporteur declined to extend any order to those two entities.

Applications under Rules 192 and 199 RoP should be started in the local division where the applicant intends to start proceedings on the merits. The Applicants submitted that they had made a material mistake when they indicated in the applications that they intended to start proceedings in The Hague LD and in fact their intention was to start proceedings in Brussels LD. Accordingly the judge-rapporteur accepted that the location condition of Rule 192 was met.

Procedural Rules 192 to 198 RoP apply to applications for both orders for inspection and to preserve evidence. The Applicants did not argue ‘extreme urgency’ (Rule 194(4)) so the judge-rapporteur followed the default procedure for deciding the matter. He approached the matter in four steps. First, decide whether he should hear the defendants; secondly, assess the substantive matter balancing the fundamental rights of the applicants and the defendants and applying the appropriate standard of proof; thirdly, assess the actual requests and their purpose; and fourthly apply any additional conditions according to the circumstances of the case.

First step

Considering Rule 194(1) RoP the judge-rapporteur decided in his discretion that it was appropriate to decide the substantive requests without informing the defendants or summoning the defendants to an oral hearing. The Applicants had demonstrated sufficient urgency with respect to the expected launch as required by Rule 194(2)(a) RoP and had provided reasons for not hearing the defendants. They had shown that delay could cause them irreparable harm: if a competitor biosimilar were to come on the market it would have inevitable effects on the market. They had also indicated that if the court were to decide to inform the defendants they would withdraw the application.

Second step

The judge-rapporteur needed to be satisfied that the patent was valid and infringed, or that infringement was imminent. The standard of proof applied was “a certain degree of plausibility of the infringement or the threat thereof” which he understood to mean “highly likely”. He noted that this standard is lower than in infringement actions or provisional measures. When the defendants are not to be heard the Applicants are under a “duty to disclose any material facts known to them which may influence the court”, Rule 192(3).

He considered the materials submitted by the Applicants against the features of the claim and concluded that they had provided sufficient evidence that infringement was ‘highly likely’. The materials included a letter from Organon US notifying the Applicants of their launch plans which mentioned validity but did not raise the issue of non-infringement.

As to validity, he noted that a granted patent should be presumed valid; this one had been maintained in opposition proceedings; and no validity challenge had been made at the date of the applications. Further no new prior art was raised in the subsequent Dutch invalidity proceedings.

Third step

The judge-rapporteur reviewed each of the requests in detail limiting in places what he was prepared to grant. For example, he refused a request for FDA regulatory documentation as such would not be relevant to any alleged infringement in the territory of the UPC.

He allowed the gathered information to be used also for the specified Dutch proceedings on the basis that they related to the same subject matter and it would be procedurally efficient, but pointed out that this was subject to Dutch procedural law and the Dutch courts.

Fourth step

He added some specific conditions including that the gathered information should be confidential to the parties’ representatives pending a confidentiality ring, and requiring a security deposit of 25,000 euro. The orders were to be executed simultaneously at the premises in Belgium and Netherlands during normal business hours. The defendants should not communicate with each other during execution of the orders.

He noted that as the orders were made without hearing the defendants they may lodge a review within 30 days after execution, Rule 197(3).

[1] https://www.unifiedpatentcourt.org/en/node/126175