Key takeaways
Clarification of “Unreasonable Delay” under Rule 211.4 RoP
The LD Paris clarifies that the relevant moment for assessing delay is the point in time when the applicant knew or should have known about the upcoming infringing act – not when infringement has already occurred, thereby aligning with other UPC case law (cf. UPC CoA ORD_44387/2024, 25 September 2024, Mammut Sports v Ortovox, and UPC CoA, 446/2025, 13 August 2025, Boehringer v Zentiva).
Price and Reimbursement Approval as Trigger Event in Pharma Cases
In the pharmaceutical context, the LD Paris holds that price and reimbursement approval may already constitute the decisive trigger event for urgency. Once the pricing decision is issued, a market entry becomes foreseeable; applicants must act promptly or risk losing interim protection.
Imminent Infringement is Sufficient – Actual Launch Not Required
The LD Paris confirms that a PI application does not require an already completed infringement. However, imminent infringement must be substantiated with concrete indications.
Strict Vigilance Requirement for Patent Holders
The LD Paris highlights that rights holders must act with vigilance and proactive monitoring. Waiting for the actual launch, or for further confirmation, may be insufficient to meet the UPC’s requirements for demonstrating urgency in PI applications.
Division
Local Division Paris
UPC number
UPC CFI 697/2025
Type of proceedings
Order on provisional measures (R.206 RoP)
Parties
Applicants:
Merz Therapeutics GmbH
Merz Pharmaceuticals LLC
Merz Pharma France
Defendant:
Viatris Santé
Patent(s)
EP 2 377 536
Body of legislation / Rules
Rule 206.2 RoP, Rule 211.4 RoP
Art. 62 UPCA
