Irides: Weekly global patent litigation update

This edition features updates from: The Unified Patent Court (UPC) and Japan.

The Irides Weekly Update is our round-up of patent litigation news highlights from around the world.
 

UPC

Brussels Local Division Upholds Evidence Preservation Order in Biosimilar Action.
[UPC_CFI_407-408/2025]

On 30 May 2025, the Brussels Local Division (LD) granted a request from Roche and Genentech under Art. 60 UPCA and r. 197.1 RoP for an Order to preserve evidence on an ex parte basis. The Order allowed Roche and Genentech to obtain information from Organon regarding its biosimilar pertuzumab product at its manufacturing sites in Belgium and the Netherlands. The Order was executed on 27 June 2025, and Organon issued an application for review under r. 197.3 on 25 July 2025. In this this application for review, decided on 12 November 2025, the LD refused Organon's application.

A review of such an ex parte Order is a two-step process. For both steps the Court should place itself on the date of issuance of the ex parte Order. First, the Court must assess whether it rightly decided to issue the ex parte Order. And second, the Court must assess whether the Order should be confirmed, modified or revoked.

In the first step, the Court will consider the facts and evidence which were presented in the original application, and any additional evidence which should have reasonably been known to the applicants (Genentech and Roche) when making the application. An essential part of this test is whether the applicants had breached their duty of full disclosure to the Court.

In relation to the first step, Organon argued that Roche and Genentech misled the Court on the question of urgency and the probability of evidence being destroyed or made otherwise unavailable (see r. 194(2)). Urgency related to the timeline to product launch; Organon argued that Genentech and Roche had presented too fast a timeline to MA grant, but the Court found that there was nothing inaccurate in the timeline, and in any event Organon's own announcements on launch timing aligned with that timeline. Organon did persuade the Court that it was improbable that it would destroy evidence due to regulatory requirements, but not that it wouldn't move evidence between sites so as to avoid the effect of the Order. Therefore, the Court decided it had been right to issue the ex parte Order.

In relation to the second step, the Court can consider any evidence presented by either party save that it cannot have been obtained as a result of executing the Order (which is to be assessed in any resulting PI or merits proceedings).

Unlike the first step, which requires urgency due to its ex parte aspect, this second step is instead concerned with whether the patent is infringed or "about to be infringed" (Art. 60(1)). The parties debated the meaning of "about to be infringed"; Organon submitted that it was akin to urgency but the Court rejected this holding instead that it means simply that it is apparent that there is a risk of infringement which will occur in the future. How far into the future depends on the facts of the case. Here the possible imminent MA grant and launch timing announcements indicated that the patent was "about to be infringed".

Having confirmed that the Order should have been made, the Court then reviewed its scope. The Court considered the balance of interest between the parties; for example, Organon had been entitled to contact a lawyer to participate in the execution of the Order, but could not delay matters waiting for their arrival. The Court considered an adequate balance had been struck in the terms of the Order and so Organon's application failed and the Order was left unaltered.
 

UPC

Düsseldorf Local Division rules on what steps are sufficient to constitute proper service.
[UPC_CFI_515/2025]

On 11 November 2025, an Order was given by the Düsseldorf Local Division (LD) which considered whether the attempts to effect service of a Preliminary Injunction (PI) application on a Chinese-based defendant were sufficient to constitute good service pursuant to r. 275.2 RoP.

The PI application was filed on 13 June 2025 and 5 days later, service was initiated in accordance with the Hague Convention via the official online portal of the Central Authority of China. The Chinese authorities subsequently forwarded the documents to the Supreme People’s Court of China on 19 June 2025. However, no further processing took place. A subsequent request for the Defendant to accept service voluntarily had also failed. Finally, in late October and early November, the LD sent inquiries to the Chinese Authorities about the status of service but these were not answered. 

In reaching its conclusion, the Court noted that even though r. 275.2 RoP concerns service of the statement of claim, it must also apply to PI proceedings given their urgent nature. All available means for formal service had been exhausted and service under the Hague Convention was regarded as having definitely failed. The applicant had comprehensively shown that the address provided for service was correct. 

Taking into account the time period and the unsuccessful attempts to contact the Defendant and the authorities, the Court considered it was justified to deem the steps taken as adequate for proper service. The Court also noted that its decision was not contrary to the provisions of The Hague Convention. Applying the requirement to let a six-month period pass cannot apply without restriction to PI applications as it risks the applicant’s legal protection becoming ineffective. Further, any additional delay would be incompatible with the urgent nature of PI proceedings.

The Court therefore ordered that the steps already taken constituted good service, that service was deemed effective as of the date of the Order and that the Order should be published on the Court’s website. 
 

UPC

Munich Local Division Refuses Preliminary Injunction Due to Considerable Doubts about Validity and Rejects Request for the Application to be Based on Auxiliary Requests.
[UPC_CFI_693/2025]

On 17 October 2025, the Munich Local Division (LD) dismissed Onward Medical N.V.’s application for a Preliminary Injunction (PI) against Niche Biomedical Inc. (trading as ANEUVO). The application was based on EP 3 421 081 B1, concerning neuromodulation treatment systems. The Court assessed both the likelihood of the patent being upheld in light of cited prior art and the patentee’s attempt to rely on auxiliary claim amendments.

Background

The Applicant sought a PI in Germany and France in relation to the Defendant’s “ExaStim” neurostimulation system. The original PI request relied on Claim 1 as granted. In response to the Defendant’s protective letter, the Applicant requested that, if the Court considered the granted claims to be invalid, it be allowed to amend its PI application to rely upon an auxiliary request. In its protective letter and its response to the PI application, the Defendant asserted that the patent was not new in light of three prior-art citations.

The application was rejected by the Court.

Prior art

The Court had considerable doubts as to the novelty of granted Claim 1 under Art. 54 EPC. In particular, it relied on the prior-art document known as “Yoo,” which disclosed the combination of features forming Claim 1. Yoo was held to describe all relevant elements of the claimed neuromodulation system, including pre-programmed stimulation patterns with both spatial and temporal elements, and time-varying stimulation parameters. Therefore, applying the principles from the Court of Appeal’s decision in 10x Genomic v NanoString (UPC_CoA_335/203), it was predominantly probably that the patent as granted was valid.

Auxiliary Requests

While auxiliary requests may generally be admissible in interim-relief proceedings (UPC_CoA_182/2024), provisional measures under Art. 62 UPCA will not be granted if the patent must be amended to be considered valid. As such, the auxiliary requests must be rejected. This rule applies both to auxiliary requests filed with the original PI application, as well as those submitted later in response to validity challenges. Therefore, as a rule, applications for PIs must be rejected if they are based on an alternative version of the claim. If the patentee considers amendment necessary, the patent as granted is likely invalid. Interim measures cannot be granted if the patent is recognisably defective in its granted form and the Court cannot consider application to amend the patent under r. 30 RoP in the proceedings for interim measures.

Costs

As the PI application failed, the Applicant was ordered to bear the costs of the proceedings. However, the Defendant’s claim for provisional reimbursement was rejected because the information provided in the incurred costs was not even remotely comprehensible or verifiable.
 

US

FDA announce new draft guidance to accelerate biosimilar approval.

The FDA has announced new draft guidance, the aim of which is to make it faster and less expensive in certain circumstances for companies to develop biosimilar therapeutic protein medicines. The proposal is to reduce the occasions when developers need to carry out Comparative Efficacy Studies (CES), in essence full clinical trials designed to prove equivalent effectiveness. The FDA noted that these studies often have lower sensitivity than other comparative analytical assessments and that more modern, advanced analytical technologies (to be carried out alongside pharmacokinetic and immunogenicity assessments) are often better at detecting subtle, clinically meaningful differences between a proposed biosimilar and its reference product.
 

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