Merz Therapeutics GmbH, Merz Pharmaceuticals LLC & Merz Pharma France v. Viatris Santé, UPC Paris Local Division (FR), 21 November 2025, Case No UPC_CFI_697/2025
Introduction
21 November 2025 marks the date of the first UPC decision in proceedings concerning the assertion of an SPC, in a pharmaceutical originator-generics dispute between three Merz entities (collectively “Merz”) and Viatris Santé (“Viatris”). The decision concerned Merz’s application for provisional measures (a preliminary injunction (PI)) concerning Viatris’ alleged infringement of French Supplementary Protection Certificate No. 13C0033 (“SPC 033”) following the launch of its generic fampridine. The key issue in dispute was whether Merz had filed the application quickly enough to justify the granting of the requested relief.
The Paris Local Division (“LD”) rejected Merz’s application as having been filed too late, on the basis that Viatris had competed regulatory steps for launch of the generic product, which, the court held, made entry to the market foreseeable, meaning that Merz had knowledge of imminent infringement at an earlier stage than the date it filed its PI application. The LD held that Merz should have acted with more diligence following its acquisition of EP 536 and SPC 033 from Accorda Therapeutics, Inc (“Accorda”) following Accorda’s bankruptcy.
This decision another decision in the developing guidance for UPC PI applications, despite being rather fact specific. It is a positive outcome for the generic company, highlighting the importance placed on the need for patentees to act swiftly when becoming aware of possible infringement. In the case of pharmaceutical disputes, patentees will need to ensure effective tracking is in place to monitor the timing of generic regulatory milestones.
Background
Merz markets the multiple sclerosis (“MS”) medication, fampridine, under the brand name Fampyra. Fampyra is indicated to help improve walking speeds in adult MS patients. The product is based on the dosage regime patent European Patent No. 2 377 536 (“EP 536”) which expired on 11 April 2025, and the associated SPC 033, which is due to expire on 25 July 2026.
EP 536 and SP 033 were assigned to Merz on 10 July 2024 following the bankruptcy of the original patentee, Accorda. The assignments were published in the French Official Intellectual Property Bulletin on 28 March 2025.
Viatris’ fampridine generic product, Fampridine Viatris, was launched in French market on 10 June 2025.
Merz sent a warning letter to Viatris on 18 June 2025. On 2 July 2025, Merz received a letter from Viatris informing them of their intention to launch the generic product in France. Merz subsequently filed a PI application Merz on 31 July 2025 alleging infringement of SPC 033. Viatris opposed the application, citing lack of urgency as well as challenging validity of the basic patent, EP 536, due to lack of inventive step, and invalidity of SPC 033 on the basis of prior sales of an earlier product, Pymadin (used as a type of muscle relaxant), in Poland and Bulgaria.
Unreasonably delay?
The central point of contention was whether there was any unreasonable delay in seeking provisional measures under Rule 211 of the UPC Rules of Procedure (“RoP”), and what was the correct starting date on which Merz became aware of the alleged infringement. In this case, the LD had to consider at what point the party acquiring the rights should have been aware of an event that could justify an application for provisional measures.
The decision cites previous UPC judgments on the matter of urgency in provisional measures, including Mammut Sports v Ortovox (UPC CoA ORD_44387/2024 of 25 September 2024) which indicated that delay should be calculated on the day the applicant becomes aware or should have become aware of the infringement, and Boehringer v Zentiva (UPC CoA, 446/205 of 13 August 2025) which indicated that the decisive point in time is when the applicant has (or should have), after exercising due diligence, the necessary facts and evidence within the meaning of R.206.2(d) RoP.
Merz submitted that undue delay should be assessed by reference to knowledge of the actual infringement not its imminence. As such, while Merz noted in its application that Viatris obtained a marketing authorisation (“MA”) for its product on 21 November 2021, and was granted a pricing and reimbursement rate in France in November 2024, it argued that the correct starting date should be 2 July 2025, the date on which it received the letter from Viatris indicating launch in France. Merz argued that the launch without clearing the way with a revocation action “was a surprise to them”, so this later date was when Merz supposedly first knew of the actual infringement.
In contrast, Viatris alleged the starting point should be assessed by the imminence of the alleged infringement. It said that the starting date should be 22 November 2024, which is when the price of Fampridine was published in France. At this point, Merz should have been aware of the imminent infringement about to take place and therefore able to apply any provisional remedies.
The LD dismissed the PI application, finding that Merz had not acted with the required urgency. It held that awareness of imminent infringement and awareness of actual infringement are alternative triggers for a PI application, not successive points in time. Actual infringement is no more important than imminent infringement in the context of seeking provisional measures; either of these could provide sufficient evidence for a patentee to commence a PI application, and if there is a case for imminent infringement, the clock for urgency cannot be restarted once actual infringement takes place. One the patentee is aware of either situation, they should be diligent in taking steps to seek redress.
On the facts therefore, the LD agreed with Viatris that the starting point to be considered should be 22 November 2024 as this is the date the administrative procedures (in particular the setting of the pricing and reimbursement rate) required for Fampridine to be marketed in France were finalised. This made the entry of the generic product foreseeable, and Merz should have known of the imminent infringement.
The LD also highlighted that Viatris had informed the French Health Products Economic Committee (“CEPS”) on 3 October 2024 that it intended to market its generic product within six months, i.e. before the expiry of the SPC. At that time, Biogen, as the licensee, was responsible for marketing Fampyra in France. It had been notified of Viatris’ intention, and had informed Merz of the potential of imminent infringement. The LD held that Merz should have undertaken due diligence of the rights it intended to acquire. It also noted that Merz did not send the warning letter to Viatris until 18 June 2025, which was five months after it regained direct exploitation rights from Biogen (on 2 January 2025). Further, Merz did not commence the PI application until 31 July 2025, which was a number of months after it should have been aware of Viatris’ intention to launch and the imminent infringement.
The LD also noted that Merz should have been more vigilant in the view that the validity of its patent was weakened by a revocation action in Germany.
The LD went on to say that the first act of actual infringement on the French market took place on 10 June 2025. This could not be considered a new starting point which would create urgency and justify the filing of the provisional measures.
Thus, the LD concluded that Merz had unreasonably delayed in seeking provisional measures, and rejected the PI application. The LD did not comment on infringement or validity of the SPC, with such issues remaining open for future proceedings.
Merz was ordered to pay 56,000 Euros to Viatris for the interim costs of proceedings.
Key takeaways & practical implications
Imminent infringement is particularly relevant to disputes concerning generic and biosimilar medicines, and this decision provides important guidance to both patentees and generic manufacturers as to when a patentee should issue an application for provision measures in the context of competing administrative steps for launch of a generic product, and the standard to which they may be held in demonstrating diligence, particularly when acquiring rights, in seeking such relief.
More generally, there is still no fixed deadline on which to file for provisional measures at the UPC, and so this date will still depend on the unique fact patterns of each case. A “safe harbour” of two months has been accepted by the Munich LD in a number of UPC decisions, however this is not yet universally accepted, and the Court of Appeal is yet to rule definitively on this issue. However, there are always exceptions to any general rule. For example, in Amycel v Szymon Spyro The Hague LD accepted Amycel’s arguments that a 12-month delay in bringing its application for provisional measures application was justifiable as it had to obtain evidence on the specific strains of mushrooms to anticipate the arguments Szymon Spyro would make, which was a time-consuming process.
However, in relation to all scenarios which may lead to an application for provisional measures, it is clear that an applicant should document the precise dates on which they became aware of the infringement and try to pull together accurate timelines of information including investigations of infringing products as depending on the facts of the case, this could potentially be a time-consuming process. We expect to see the UPCs approach to the subject evolve as further cases are decided.
The order can be read here.
