UPC_CFI_697/2025 – Merz v Viatris
- Court
- Local Division Paris
- Date
- Outcome
- Denied
- Sector
- Pharma/Bio
- Decision Type
- PROCEDURAL
Expert Commentary
Urgency (unreasonable delay) Facts 1. On 31 July 2025, Merz filed for a preliminary injunction against Viatris' generic product. This product was introduced on 10 June 2025 based on a marketing authorization dated 28 November 2021. 2. Viatris argues that the patent is invalid and that Merz lacks an urgent interest. 3. Merz became the patent owner on 23 August 2024 (by means of an assignment). The Court 1. The period for calculation of unreasonable delay starts on the day on which the applicant became aware or should have become aware, of the infringement that would enable them to start PI proceedings with a reasonable prospect of success. Reference is made to case law of the Court of Appeal. 2. The Court decides that – for generic products – the starting point is the moment there is imminent infringement: the originator can obtain a PI from that moment on. 3. On 22 November 2024, Viatris' product was included in the list of reimbursable products with a price and its reimbursement rate. 4. Merz obtained after the assignment direct exploitation rights on 2 January 2025. Merz should have been aware of Viatris' imminent infringement from that moment on. 5. Merz acted with a unreasonable delay of more than 6 months. 6. Application rejected. Comment 1. Merz and their representatives should have been more vigilant. They should have realized that urgency in the UPC is a serious requirement for PI’s (in contrast to many national systems such as France where the representatives of Merz practice). It is a serious requirement because in proceedings on the merit you can obtain a decision in 12-14 months. 2. Having said that, I think that – in this particular case – the Court has given a rather inflexible interpretation of the Court of Appeal decision. One should always consider all the circumstances of the case; these are rather special in this particular case. I mention: a. Merz obtained the SPC and exploitation right unusually late in January 2025; b. although Viatris had the possibility to come to the market as of 22 November 2024, they did not do so. This is quite unusual; c. Merz could therefore have been under the impression that Viatris was not interested. In particular because the SPC would expire in July 2026. Why take action under that assumption?; d. when Viatris entered the market 7 months after they had the possibility to enter the market Merz immediately take action; e. the SPC expired in July 2026. Refusing the PI meant that Merz would, in fact, get no protection until the end of the SPC; f. The Board of Appeal of the EPO had maintained the patent. So this was a prima facie case of infringement. 3. Conclusion: a. A strong warning for pharma companies and their representatives to act against a generic as soon as the generics is able to start selling their product somewhere in the UPC territory! b. My advise to the Local Division is to be a bit flexible, assuming the circumstances of the case and justice requires it. I think this case could have done with some more flexibility. In my view, it is not acceptable that Viatris can simply continue infringing until the end of the SPC - even if the Court may have a point in saying that Merz and their representatives could have avoided it by being more vigilant. Indeed why did Merz not write a letter to Viatris in January asking to confirm that they would not come on the market until the end of the SPC? After not having received a positive confirmation they should have filed the PI.
Full Decision Text
Key Holdings
- The Court rejected a preliminary injunction application due to unreasonable delay, finding that the applicant (Merz) should have been aware of imminent infringement more than six months before filing.
- For generic products, the urgency period for a PI starts when the originator becomes aware, or should have become aware, of imminent infringement (e.g., when the product is listed as reimbursable).
- The decision highlights the strict application of the urgency requirement for preliminary injunctions in the UPC, emphasizing the need for patent owners to act swiftly.
Tags
- Delay
- Infringement
- Pharma
- Preliminary Injunction
- Urgency