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1. Key takeaways
Waiver of defence relating to invalidity
Unlike proceedings on the merits, where the Statement of defence shall include a Counterclaim for revocation (R. 25.1 RoP) if there is an assertion that the patent alleged to be infringed is invalid, an invalidity defence raised in proceedings for provisional measures is not a separate action. Similarly, a waiver of an invalidity defence in proceedings for provisional measures is not an application to change the claim or amend the case in the meaning of R. 263 RoP, nor is it a withdrawal in the sense of R. 265 RoP. It follows from Art. 76(2) UPCA that it is for the parties to submit grounds, facts and evidence. If a party declares that it no longer relies on arguments, facts and evidence that it has submitted, the Court can proceed based on the remaining issues in the proceedings. The Court may order the withdrawing party to compensate the costs that the other party has made in connection with the withdrawn arguments, facts and evidence (headnote).
Urgency
Prior case law according to which the application for a marketing authorization does not amount to an imminent infringement while the completion of national procedures for pricing and reimbursement for a generic medicine may do so is confirmed (sec. 53).
Publication of the information that a generics company obtained a price and reimbursement rate does nor provide sufficient certainty that the generics will be launched within six months. French regulation Art. 3 LEEM-CEPS does not on a literal reading require marketing of the generic within six months from launch. In practice, the time to launch is flexible (sec. 64 seqq.).
Necessity
Prior case law is confirmed according to which the copetitive situation, potential permanent price erosion and the interests of patients are factors that can be taken into account when weighing up the interests of the parties (sec. 87 seq.).
In the present case the court considered past product shortages, packaging problems, costs for the French health system and patients, price erosion as well as the expiry period of the SPC at issue. The court came to the conclusion that the facts presented in this regard did not rule out the grant of a provisional injunction (sec. 89 seqq.).
Grace periods
A grace period of 48 hours from service of the order of the court was granted with regard to the provisional injunction (order no. III.).
A grace period of 1 week from notification by the applicant was granted with regard to delivery up of products to the bailiff (order no. V.).
2. Division
Court of Appeal (Ingeborg Simonsson, Patricia Rombach, Bart van den Broek, Anna Hedberg, Jeroen Meewisse)
3. UPC number
UPC_CoA_917/2025
4. Type of proceedings
Appeal proceedings, proceedings on provisional measures
5. Parties
Merz Pharmaceuticals LLC, Merz Therapeutics GmbH, Merz Pharma France (all applicant);
Viatris Santé (respondent)
6. Patent(s)
EP 2 377 536; French SPC No. 13C0033
7. Body of legislation / Rules
Rule 211, Rule 206, Rule 263, Rule 222.2 RoP, Art. 76 (2), Art. 62 (2), (3), Art. 30 UPCA, Art. 3 LEEM-CEPS
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
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