Urgency requirement

The emerging case law shows that patentees need to act promptly once they become aware of infringing activity. If a patentee does not act promptly then the preliminary measures are unlikely to be granted.

There has been some differing case law on how quickly an applicant must act in this regard. For instance, in Ortovox v Mammut (UPC_CFI_452/2023) it was held that the applicant has one month in which to act once an applicant has all the knowledge and documents that reliably enable a promising legal action. However, in Dyson v SharkNinja (UPC_CFI_443/2023) it was held that the applicant has two months in which to act. This has been confirmed in Hand held Products v Scandit, in which the court noted that, because the application for the preliminary injunction was filed on the same day that registration of unitary effect took place, it was clear that the applicant had treated the matter with the necessary urgency.

Interestingly, in Ericsson v ASUSTek, Arvato and Digital River (UPC_CFI_317/2024) it was acknowledged that the requirement of “urgency” for preliminary injunctions is not explicitly expressed in the Unified Patent Court Agreement (UPCA), but it was noted that the exceptional nature of provisional measures requires the court to be convinced of the urgency involved, and that this process is fact driven. The court stated that an applicant is expected to be diligent in seeking a remedy against an alleged infringer, and an unreasonable delay in initiating proceedings could lead to a finding that the urgency is lacking. It was held that the burden is on the applicant to show that it has not delayed unnecessarily. In particular, the applicant must provide the court with information of the moment when they became aware of the infringement. If the applicant is silent about that date and the court has no way of ascertaining it, the court may solely rely on the date of the alleged infringement for the assessment of unreasonable delay.

In this case, the court found that the applicant had failed to provide sufficient temporal elements enabling the court to assess the applicant’s diligence in initiating proceedings. Consequently, the application for provisional measures was dismissed. The court noted that the requirements for granting preliminary injunctions (validity of the patent, imminent infringement, urgency and the balance of interests) are cumulative, allowing the court not to address them all if one is not satisfied. Nevertheless, despite finding that the requirements of urgency was sufficient to dismiss the request, the court still looked at validity and infringement and held that prima facie the patent was valid and infringed.

Additionally, in Valeo v Magna (UPC_CFI_347/2024) the court discussed the one-month period of Ortovox v Mammut and held that there is “no fixed deadline” by which an applicant must submit its application for provisional measure; the question is always whether the applicant’s conduct as a whole justified the conclusion that the enforcement of its rights is not urgent.

These decisions may not mean that an application made after two months automatically fails, but it seems highly likely that persuasive reasons will be needed to show why the delay is reasonable.

Limitations on examination of validity

Emerging case law not only shows that validity may be considered in requests for preliminary measures, but that the number of validity attacks should generally be reduced to the three best arguments. Moreover, as it is the responsibility of the defendant to challenge the presumption of validity, it is therefore the defendant’s responsibility to select the three arguments (see Hand Held Products v Scandit (UPC_CFI_74/2024), which confirms the decision in Dyson v SharkNinja). Further, Hand Held Products v Scandit confirms that that there can be several realistic starting points for inventive step attacks.

The UPC seems willing to move away from the European Patent Office’s (EPO) inventive step approach of “most promising starting point”.

Additionally, the court noted in Valeo v Magna that no conclusions can be drawn from the general revocation rates of patents: only validity of the patent in suit is relevant.

Imminent infringement will be considered

Prior to Novartis and Genentech v Celltrion (UPC_CFI_166/2024) it had been unclear if the UPC was responsible for imminent infringement at all, and the defendants in this case used this point as a line of argumentation. However, this decision makes it clear that the UPC does cover it, and it sets out some useful guidelines for the pharmaceutical industry.

In this case, the defendants had developed a biosimilar and obtained a marketing authorisation for it. Back in 2022 they had publicly announced that they intended to launch the product in Europe in 2024 and, after the grant of marketing authorisation in May 2024, they issued another press release announcing their plan to rapidly expand its market share. The court stated that imminent infringement may be characterised by certain circumstances which suggest that infringement has not yet occurred, but that the potential infringer has already set the stage for it to occur. These circumstances must be assessed on a case-by-case basis with the burden lying with the applicant. The court held that the question to be answered is whether the defendant’s conduct leads to the conclusion that they are more likely than not to enter the market during the patent term. Further, the court considered that an offer is sufficient if it creates a demand for the product which the offer is likely to satisfy. This would be an advertisement in which the defendant would be able to supply a potential order, for a specific price, in compliance with regulatory measures.

The court stated that imminent infringement may be characterised by certain circumstances which suggest that infringement has not yet occurred, but that the potential infringer has already set the stage for it to occur. These circumstances must be assessed on a case-by-case basis with the burden lying with the applicant. The court held that the question to be answered is whether the defendant’s conduct leads to the conclusion that they are more likely than not to enter the market during the patent term. Further, the court considered that an offer is sufficient if it creates a demand for the product which the offer is likely to satisfy. This would be an advertisement in which the defendant would be able to supply a potential order, for a specific price, in compliance with regulatory measures.

The court held that customers familiar with the practices of the pharmaceutical industry are likely to regard statements about future market entry as “vague announcements” when regulatory measures, pricing and reimbursement conditions have not been finalised. In order for an infringement to be imminent, all pre-launch preparations must be completed such that an offer can be made at any time. As the advertisement did not show any specific timeline, and there was no information about price negotiations or reimbursements, nor were samples presented to potential customer, the court held that it could not find the defendants had completed all pre-launch preparation. Therefore, the application for provisional measures was rejected. The court additionally held that, due to the lack of infringement, it did not have to decide on the likelihood of validity.

Protective letters & ex parte hearings

Protective letters are effectively a pre-emptive statement of defence: they may set out why a product or process does not infringe a patent, and/or contain arguments as to why the patent is invalid, and set out the reasons why any future application by the patentee for provisional measure should be rejected by the UPC. Protective letters may be filed with the UPC at any time, by any person, for a small fee (currently €200). The protective letter has effect for a period of six months, which is extendible upon payment of a fee (currently €100). Protective letters are not made public, so a patentee would not be aware of one until they make an application for a preliminary injunction.

In myStomer v Revolt (UPC_CFI_177/2023) the patentee applied for an ex parte preliminary injunction the day after a trade fair in which Revolt had exhibited its bike and provided an order form. Revolt had already filed a protective letter a few days before the trade fair. In the protective letter Revolt argued exhaustion and denied infringement. However, as noted by the court, there were no invalidity arguments in the letter. The court dismissed the exhaustion arguments as they had already been considered and dismissed by the Swiss Court. The court further considered that Revolt had not significantly denied infringement. Therefore, the court considered it appropriate and justified to grant the preliminary injunction on the same day of the request without summoning that parties to an oral hearing.

It seems that if a court does not find a protective letter persuasive, it may exercise its discretion and order a preliminary injunction without hearing the alleged infringer.

Key takeaways

The UPC is a proving to be a popular venue for preliminary injunctions. While case law is still developing, a key emerging trend is the need for patentees to act urgently when requesting a preliminary injunction.

The UPC has shown that it is willing to consider validity in requests for preliminary injunctions, but it seems the number of attacks generally should be limited to the best three. Further, there may be several realistic starting points for inventive step attacks.

There has been less case law relating to protective letters, nevertheless, it seems that courts may still be willing to carry out ex parte hearings if they find a protective letter unpersuasive.

Useful links

• UPC_CFI_452/2023, 11 December 2023 (PDF): dycip.com/upc-cfi-452-2023
• UPC_CFI_443/2023, 21 May 2024 (PDF): dycip.com/upc-cfi-443-2023
• UPC_CFI_74/2024, 27 August 2024 (PDF): dycip.com/upc-cfi-74-2024
• UPC_CFI_317/2024, 15 October 2024 (PDF): dycip.com/upc-cfi-317-2024
• UPC_CFI_347/2024, 31 October 2024 (PDF): dycip.com/upc-cfi-347-2024
• UPC_CFI_166/2024, 06 September 2024 (PDF): dycip.com/upc-cfi-166-2024
• UPC_CFI_177/2023, 18 October 2023 (PDF): dycip.com/upc-177-2023