GlaxoSmithKline Biologicals v Moderna (CFI, 18 February 2026)

Dhenne Avocats · 10 October 2026

Our analysis

Summary

By order of 18 February 2026 in proceedings UPC_CFI_616/2025 and UPC_CFI_1439/2025 (EP 2 590 626), the judge-rapporteur of the Hague Local Division allowed GSK to extend its action against Moderna to the mNEXSPIKE product, dismissed Moderna’s application to strike material from the Reply and ordered GSK to file, within one week, a table of its 40 conditional auxiliary requests. The order shows how the Division deals with a product variant that emerges during the proceedings and with a heavy set of auxiliary requests.

Question

May a claimant extend the action to a newer version of the accused product, develop its case in the Reply and maintain 40 auxiliary requests?

Decision

The claim already covered the products « and/or further versions or variants thereof », so mNEXSPIKE was within it from the outset (paragraph 10), even if this were an amendment, Rule 263.2 is met, since the EMA’s positive opinion came only in December 2025 and the earlier FDA approval did not show that EU availability was imminent (paragraph 11). The limited invalidity attacks do not justify 40 requests filed without a table or a link to the objections, and it was doubtful they could be handled within the UPC’s target of about 14 months (paragraph 13). A table was ordered, any limitation being left to the interim conference, and Moderna’s requests for dismissal en bloc or a cap of ten were rejected (paragraph 14). The new material responds to Moderna’s defence, and the front-loaded procedure does not require a claimant to anticipate every defence: the Rule 9 application and the request to stay all deadlines were dismissed (paragraphs 15 and 16).

Key points for practice

• Pleading « versions or variants » of the products in the Statement of Claim allows a newer product of comparable composition to be brought in later (paragraphs 10 and 11).
• Numerous auxiliary requests should be mapped, in a table, to the invalidity attacks they address (paragraphs 13 and 14).

Provisions applied

Rules of Procedure

Rules 9, 30.1, 30.2 and 263

Case law cited

Abbott Diabetes Care v Sibio, Court of Appeal, 14 February 2025

Related decisions

• GlaxoSmithKline Biologicals SA v Moderna, 24 February 2026, comparable order in the parallel action on two other patents.
• GlaxoSmithKline Biologicals SA v Moderna Netherlands, 12 June 2026, order following the interim conference.
• GlaxoSmithKline Biologicals SA v Moderna Netherlands, 14 September 2026, post-hearing order on late-filed evidence.

Prepared by Dhenne Avocats from the official decision, consulted on 10 October 2026. The database is updated every week, on Friday. Only the official text is authoritative.