GlaxoSmithKline Biologicals v C.P. Pharmaceuticals International C.V. (CFI, 21 August 2026)

Dhenne Avocats · 10 October 2026

Our analysis

Summary

In an order of 21 August 2026 issued in the joined files UPC_CFI_620/2025, UPC_CFI_1509/2025 and UPC_CFI_1511/2025, the judge-rapporteur of The Hague Local Division prepared the oral hearing of 3 September 2026 in the dispute between GlaxoSmithKline Biologicals SA and the Pfizer and BioNTech group companies over EP 2 590 626. She admitted three exhibits filed after the close of the written procedure, declined to treat an overview document as an amendment of the patent, and fixed the invalidity attacks and auxiliary requests to be argued. The order shows how the division reconciles front-loaded proceedings with the occasional admission of new material.

Question

On what conditions may new exhibits be admitted after the written procedure has closed, and how may the judge-rapporteur confine the issues for the oral hearing?

Decision

The bar for late documents is high, but the Cayman 2024 Report was admitted: GSK had commissioned it, it uses the same test set-up as the Cayman 2025 Report and the new information is limited to a single pKa value for the lipid ALC-0315 (paragraphs 5 to 7). GSK’s Rule 36 application was inadmissible as a further written pleading, but Annex I (archived 2021 pages of the BioNTech website) was admitted under Rule 9.1, since GSK could not have filed it earlier (paragraphs 13 and 14). Amending the patent requires an application under Rule 263 (paragraph 9). The three inventive step attacks were clarified (paragraph 10), GSK is held to its ten auxiliary requests (paragraph 11), and each may be attacked on one or at most two grounds (paragraph 12).

Key points for practice

• A late exhibit stands a better chance of admission where the opposing party already knows it and the new information is narrowly confined (paragraph 7).
• Even an unconditional limitation of the patent requires an application for leave under Rule 263, not an overview document (paragraph 9).

Provisions applied

Rules of Procedure

Rules 9.1, 36, 105.5, 263.1 and 263.3

Case law cited

Court of Appeal, Kodak v Fujifilm, 2 June 2026

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.