In a procedural order, the judge-rapporteur of the Hague Local Division dealt with three procedural points in a pharma dispute: (i) GSK’s attempt under Rule 263 RoP to add Moderna’s updated vaccine product mNEXSPIKE to the definition of the alleged infringing products, (ii) Moderna’s Rule 9 RoP application seeking to strike allegedly late-filed evidence and claim-construction/infringement argumentation, and (iii) the reasonableness of GSK’s 40 conditional auxiliary requests filed with its Rule 30.1 RoP amendment application.
GSK sought leave to amend its infringement case to expressly include mNEXSPIKE, pointing to the EMA’s positive opinion of 11 December 2025 and arguing that mNEXSPIKE was essentially an upgrade with the same relevant lipid composition as the previously identified products. Moderna opposed the amendment, relying inter alia on earlier public information in the US.
The Court granted the Rule 263 application. It stressed, first, that there is generally no need to limit an injunction request to specific product names: following the Court of Appeal’s guidance (Abbott v Sibio), relief need not be tied to a closed list of “infringing products”. On the wording of GSK’s statement of claim, the requested injunction already covered “further versions or variants”. Accordingly, the express addition of mNEXSPIKE was not strictly necessary.
However, even if treated as an amendment of the case, the requirements of Rule 263.2 RoP were met. The Court accepted that GSK could not, with reasonable diligence, have been expected to plead a Europe-relevant product launch before the EMA’s December 2025 step, and it found no unreasonable hindrance to Moderna’s defence given the asserted continuity with the already pleaded products.
With its reply/defence to the counterclaim, GSK filed 40 conditional auxiliary requests. Moderna argued that the number was excessive, non-convergent and potentially even higher if combinations were allowed, and it sought a restriction to 10 and/or dismissal of requests en bloc.
The Court was “not convinced” (at that stage) that 40 auxiliary requests (introducing at least 18 new features) were reasonable. However, rather than imposing a numerical cap or striking requests en bloc, the Court ordered GSK to file within one week a comprehensive table identifying, for each auxiliary request, the introduced feature combination and the invalidity attack(s) addressed. Any further combinations would require approval under Rule 30.2 RoP.
Moderna sought (or alternatively requested the Court to disregard) various parts of GSK’s reply, including Cryo-TEM images, related expert analysis, and extensive claim-construction/infringement sections said to go beyond a proper reply.
The Court dismissed the Rule 9 application. It held that the contested material was, in the circumstances, a permissible response to Moderna’s non-infringement and claim-construction positions and largely expanded on points already made in the statement of claim. The front-loaded nature of UPC proceedings does not require claimants to anticipate every defence at the outset. Excluding the material would, on the facts, interfere with GSK’s right to be heard, and Moderna still had sufficient opportunity to respond in a further written round and at the oral hearing. Moderna’s request to stay deadlines pending the Rule 9 decision was also dismissed.
