2025-11-21 - LD Paris - Merz v. Viatris Sant - UPC_CFI_697/2025

ENGLISH: 1. The rules of procedure of the UPC require that applicants seeking provisional measures justify that they have been sufficiently diligent to have access to an expedited procedure before this Court (R. 211.4 RoP). Such expedited procedure implies on the one hand that the defendants defend themselves within a stringent timeframe according to the schedule drawn up by the judge-rapporteur, setting strict deadlines for the exchange of submissions (R. 209.1 RoP) and, on the other hand, that the Court deal with the case as a matter of urgency, in priority over the substantive cases brought before it.(see The Hague LD, UPC_CFI_374/2024, 29 August 2025, Cilag v Rivolution, §38) 2. The UPC has previously had to interpret what may be considered to be a lack of diligence by an applicant seeking a PI under R. 211.4 RoP. Thus, on two occasions, the UPC Court of Appeal stated that to determine the starting point of the reasonable time limit for taking action, the Court should consider the following question: “When did the applicant become aware, or should have become aware, of the infringement that would enable him, in accordance with R. 206.2 RoP, to file an Application for provisional measures with a reasonable prospect of success?” This question requires that the case in concreto be examined. (see UPC CoA ORD_44387/2024, 25 September 2024, Mammut Sports v Ortovox, and UPC CoA, 446/2025, 13 August 2025, Boehringer v Zentiva, Headnotes 1 to 3. The Court notes that Article 62.1 UPCA and Rule 211.2 RoP mention the following condition: ‘the right is infringed or such infringement is imminent’, and do not make a distinction between two separate and consecutive situations that would create two phases likely to trigger the urgency criterion. Rather, the aforementioned Article and Rule provide for two alternative situations that allow for a preliminary injunction (PI) claim to be brought before the UPC. Accordingly, establishing the existence of either situation allows for a PI action to be taken with a reasonable chance of success. 4. The criterion of imminent risk of infringement is particularly relevant in the context of a generic product being placed on the market. Indeed, the applicant need not wait for the product to be placed on the market in order to analyse it and gather sufficient evidence to demonstrate that such product infringes, at least prima facie, the claims of their title (patent or SPC). Such a product automatically falls within the scope of protection once it is classified as a generic version of the product protected by said title and declared as such.

The Paris Local Division refused provisional measures against a generic fampridine product for want of diligence under R. 211.4 RoP, without reaching infringement or validity. Two points of principle carry it. Art. 62(1) UPCA and R. 211.2 RoP set out infringement and imminent infringement as alternative bases for provisional measures, not as two consecutive phases each starting its own clock, so a proprietor cannot let the imminence pass and rely on the launch. And in the generic context imminence arises once the national pricing and reimbursement procedure is complete, because a product declared a generic of the protected reference falls within the scope of the title automatically and need not be on the market to be analysed. On the facts the Court took the date most favourable to the applicant — the day it recovered direct exploitation from its licensee — and held that from then it was or should have been aware of the imminent infringement, because on taking back exploitation it necessarily reviewed the product's status with the licensee, who had been informed through the pricing authority that the generic manufacturer intended to enter the market. It nonetheless waited five months to send a warning letter and six months to apply. The Court added that particular vigilance was called for because the title was weakened, the German national part of the patent having been revoked for lack of inventive step the previous year. The actual launch did not revive urgency, and a Court of Appeal decision handed down afterwards was an interpretation of existing rules rather than a new legal situation.