GlaxoSmithKline Biologicals v Moderna (CFI, 25 February 2026)

Dhenne Avocats · 10 October 2026

Our analysis

Summary

By order of 24 February 2026, the judge-rapporteur of the Hague Local Division, hearing the infringement action in GlaxoSmithKline Biologicals SA v Moderna (UPC_CFI_619/2025, EP 4 066 856 and EP 4 226 941) together with counterclaims UPC_CFI_1526/2025 and UPC_CFI_2033/2025, allowed GSK to extend its claim to the mNEXSPIKE product, dismissed Moderna’s application to strike material from the Reply and required GSK to tabulate its 51 conditional auxiliary requests. The order shows how the Division handles an extension to a product variant and 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May a claimant extend the action to a newer version of the accused product, develop its case in the Reply and maintain 51 auxiliary requests?

Decision

The Statement of Claim already covered « further versions or variants » of the products. Even if this were an amendment, Rule 263.2 is satisfied, since the EMA’s positive opinion came only in December 2025 and the earlier FDA approval is not decisive (paragraphs 9 and 10). The judge-rapporteur doubted that 51 auxiliary requests could be dealt with within the Division’s intended 14-month timeframe and ordered GSK to file, within one week, a table showing for each request the features introduced and the invalidity attacks addressed, while declining to cap them at ten (paragraphs 11 to 13). The new arguments and evidence respond to Moderna’s defence: the front-loaded procedure does not require a claimant to anticipate every defence, and Moderna can still reply, the Rule 9 application and the request to stay all deadlines were dismissed (paragraphs 14 and 15).

Key points for practice

• A claim covering « versions or variants » of the products can extend to a newer product of comparable composition, and Rule 263.2 is assessed by reference to availability in the relevant territory (paragraphs 9 and 10).
• A large number of conditional auxiliary requests calls for a table mapping them to the invalidity attacks rather than an arbitrary cap (paragraphs 11 to 13).

Provisions applied

Rules of Procedure

Rules 9, 13.1, 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 Netherlands, 10 August 2026, later procedural order in the same action.

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.