UPC Weekly - Undue delay in requesting preliminary injunction – how long is too long?

2025 Week 36

As a patentee, how fast do you need to move to obtain an inter partes preliminary injunction (PI) at the UPC against an infringer?  The UPC Local Division The Hague gave their view in a complex commercial setting in Cilag v. Rivolution in a decision dated 29 August 2025.

The background

Cilag is part of the J&J group.  EP 3689262 B1 was granted on 8 November 2023.  Unitary effect was registered on 15 April 2024, by way of a request for re-establishment of rights which was needed due to the initial deadline being missed.  The European patent was granted to Ethicon.  The Unitary patent was assigned to Cilag on 5 April 2025 and this was then recorded by the EPO on 15 April 2025.

Amongst many products, the J&J group sells surgical staplers as well as refill cartridges for the staplers.

Two Chinese manufacturers also appear in the story.  They are Bluesail and David Medical.  Bluesail’s relevant product is the  ESI EndoFlex Gen III cartridge.  David Medical’s product is the EnDrive Beluga cartridge.

Rivolution is a German distributor and has sold these Bluesail and David Medical products in both Germany and Austria.

The German national preliminary injunctions

Ex parte PIs were granted by the German national court against Bluesail and David Medical for the products mentioned above. These injunctions were based on EP 2621360 B1, which is the parent of divisional EP 3689262 B1. These PIs were obtained on 14 November 2023 and 12 November 2024.

The PI application to UPC LD The Hague

Cilag filed the UPC PI application on 29 April 2025, naming both Cilag and Ethicon as the applicants.

The PI application to UPC LD Munich

Cilag had also filed an application for a UPC PI against Rivolution based on another patent: EP 2515768 B1. This PI application was filed at the Munich Local Division also on 29 April 2025. In that case, the claims define a surgical instrument (a stapler) rather than the cartridges.

By order of 6 August 2025, the LD Munich awarded a PI to Cilag against Rivolution in respect of the relevant staplers, but without (at that time) setting out the reasons for its decision. Rivolution filed an appeal against that order, and requested that suspensive effect for the appeal, but this request was  refused by the UPC Court of Appeal (CoA) on 15 August 2025. The actual merits of the appeal against the PI will need to await the written reasoning of the LD Munich.

The decision of UPC LD The Hague

Despite the fact that there is a German national PI against the Chinese manufacturers, and the fact that the LD Munich has granted a PI in relation to the stapling devices against Rivolution, The Hague Local Division decided to refuse a PI against Rivolution in relation to the cartridges.

The conclusion of the LD was that Cilag had delayed for too long before filing the PI application in respect of the cartridges.  We look into the specific reasons for this below.

The awareness and action timeline

Clearly, based on the German national PIs, Cilag were aware of the Bluesail and David Medical products in November 2024.  Additionally, on 7 and 8 November 2024, Cilag learned at a Frankfurt meeting relating to bariatric surgery that Rivolution was proposing a Bariatric Study that would cover 2000 patients and would use these cartridges.

On 6 February 2025, Cilag sent a cease-and-desist letter to Rivolution, based on the parent patent (EP 2621360 B1) and setting out a feature-by-feature infringement analysis of claim 1 of the parent patent, and asking for reply by 20 February 2025.

On 20 February 2025, Rivolution duly replied, saying that the parent patent (EP 2621360 B1) would be invalid in view of the fate of its Chinese equivalent.

With a further letter on 26 March 2025, Cilag responded, pushing back on the allegation of invalidity of the parent patent (EP 2621360 B1) and further asserting infringement of various other patents, including divisional EP 3689262 B1.

At the beginning April 2025, Cilag learned that the Rivolution Bariatric Study will be bigger than previously thought, including some J&J customers, leading to additional concern about irreparable harm caused by the alleged infringement.

Grounds for a UPC PI

To grant an inter partes PI, the UPC LD needs to be satisfied that:

• the party requesting the PI is (probably) entitled
• the patent is (probably) valid
• the relevant product (probably) does infringe the patent
• there is an infringing act, or infringement is imminent
• the patentee has acted without undue delay
• the PI is necessary
• the balance of interests favours the PI being granted

Rivolution defended against the PI on essentially all of these headings.

Entitlement

The court noted that Ethicon had assigned all of its rights to Cilag, and was therefore not entitled to request a PI.  But Cilag was entitled to request the PI.

Undue delay

In many PI decisions, we see references to urgency.  But there can be confusion about the use of this word.  Sometimes it refers to the applicant’s apparent urgency in identifying the infringement, building their case and filing the PI application.  The LD here refers to this as “temporal urgency”.  The LD contrasted this with “objective urgency” or “necessity” to grant the PI, for example where a PI is needed to prevent irreversible harm in the market caused by the launch of an alleged infringement.

In this case we are talking about the “temporal urgency” type.  We will refer to this here as “delay”.

In its reasoning, the court accepted that a party must be given time to consider the potential infringement, obtain evidence to credibly substantiate the facts and prepare the PI application, including making preparations for responding to the defendant’s likely arguments in reply.  However, if there is an unreasonable delay, this should be fatal to the PI application.  The court explained the reasons for this:

… an applicant whose conduct already indicates that it is not in a hurry, cannot expect assistance in the form of an order for provisional measures. In other words, given that the main proceedings at the UPC are (to be) concluded within a (little over a) year, a patent holder who acts with unreasonable delay, shall not be allowed to jump the queue.

The court criticized Cilag for taking 3 months to send a letter to Rivolution to complain about the infringement, even though enough information about the infringements was known in November 2024 to obtain a German ex parte PI based on the parent patent.

Cilag attempted to address these concerns by pointing to an increase in intensity of infringing activity by Rivolution during April 2025, this causing a “revival of urgency”.  But the court held against them:

… Cilag could and should have realised the true extent of the potential infringement, and the related possible market share loss and price erosion at a much earlier stage. The facts were there already; that Cilag apparently only studied these facts properly in April 2025 and subsequently realised this, cannot create urgency.

Focus on wrong patent?

Part of Cilag’s explanation related to their complex patent portfolio.  They argued that the focus for the cease-and-desist letter to Rivolution had been on the parent patent (EP 2621360 B1).  Only when Rivolution pushed back on the validity of this patent did Cilag carry out formal assessment of infringement of the divisional patent (EP 3689262 B1).

The court was keen to distinguish the facts of this case from the PI awarded by the LD Munich for the staplers.  The court pointed to the fact that Cilag had already assessed the cartridges when seeking the German national PIs.  It was true that these PIs were based on a different patent.  But the court noticed that claim 1 of each patent was very similar, the only substantive difference being in the final bold features of the claim:

The court said:

… unlike in the parallel Munich proceedings, it is unlikely that much time was needed to assess that the cartridges infringe the patent asserted here, which is a divisional of EP 360. Claim 1 of the patent is very similar to that of its parent EP 360 … It is not plausible that much time (more than a month) was needed to establish infringement of EP 262 with the infringing products.

Outcome

As a result the PI was refused and Cilag were ordered to pay costs. Clearly the facts of the case are highly specific, but the key is that the court looked into the timeline in detail and into what (in their view) Cilag should have known and should have acted upon with more speed.