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GlaxoSmithKline Biologicals v Moderna Netherlands (CFI, UPC_CFI_616/2025, 12 June 2026)

Date12 June 2026
CourtCFI
DivisionThe Hague (NL) Local Division
Type of actionInfringement Action
Case number(s)UPC_CFI_616/2025
Registry referenceUPC_CFI_616/2025
PartiesGlaxoSmithKline Biologicals SA v. Moderna Netherlands B.V. et. al

Official decision (PDF) · UPC registry entry

Case timeline

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Dhenne Avocats · 10 October 2026

Our analysis

Summary

In the joined proceedings UPC_CFI_616/2025 (infringement) and UPC_CFI_1439/2025 (counterclaim for revocation) between GlaxoSmithKline Biologicals SA and Moderna Netherlands B.V. and fourteen other Moderna companies concerning EP 2 590 626, the judge-rapporteur of The Hague Local Division records the decisions taken at the interim conference of 11 June 2026, whose recording failed. The order is of practical interest for its preliminary views and its method of narrowing the case.

Question

How should the hearing be prepared in a case with many invalidity attacks and auxiliary requests, and how should late-filed material be dealt with?

Decision

Provisionally, feature 1.3 does not appear to be literally infringed, which puts equivalence at the centre of the debate. The added matter and insufficiency attacks seem unconvincing, and several auxiliary requests may not comply with Rule 30.1(b) RoP, narrowing the attacks now does not prevent the others from being raised on appeal (paragraph 4). Moderna must select its strongest invalidity attacks, five at most according to the conference, and GSK must link each auxiliary request to a specific attack. Moderna’s objection to GSK’s new material is partly upheld as regards infringement: cryo-TEM data, part of an expert declaration and material on an additional accused product are excluded. Experts are heard on specific disputed facts (Rule 112.2(b)), without general cross-examination (paragraph 7). The judge-rapporteur’s provisional view is that the conditional nature of the counterclaim should not prevent the related costs from being taken into account (paragraph 5). Each value is set at EUR 50,000,001 and the ceiling for recoverable costs at EUR 2,000,000.

Key points for practice

Provisions applied

Rules of Procedure
Rules 9, 30.1, 36, 105.5, 106, 112.2, 176, 181.2 and 333
Case law cited
Centripedal v Keysight, Mannheim Local Division, 5 December 2025, UPC_CFI_414/2024, Emboline v AorticLab, Munich Local Division, 13 January 2026, UPC_CFI_628/2024, BFexaQC v Nvidia, Munich Local Division, 11 March 2026

Related decisions

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.


Decisions in the same proceedings

Going further

Lexicon: Patent infringement action, Supplementary protection certificate (SPC), Biosimilar medicinal product, Launch at risk.

Dhenne Avocats blog: Pharmaceutical patents and the UPC: is the Court hostile to them?.

Publications by Matthieu Dhenne: Pleading the Long Arm: What a UPC Statement of Claim Must Carry Beyond Jurisdiction, The Launch Letter: How Generics and Biosimilars Should Write to Avoid UPC Urgency (Kluwer Patent Blog).

Source and translations

Official source
Unified Patent Court registry link recorded in the record
Original language
not recorded
Translation available
no translation recorded the firm’s French record is a summary, not a translation
Date checked
not recorded
Only the official text is authoritative. A machine translation is never presented as official, republishing a third-party document requires a verified basis in rights, and a link to the source is preferred.

Follow this case

Proceedings, related decisions, appeals, parties and patents as recorded in the registry and in the Dhenne Avocats corpus. Each link states its source.

Proceedings

  • UPC_CFI_616/2025 official number

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Parties

Exact name as it appears in the record, group affiliation only where sourced and dated.

Decisions in the same proceedings and documented appeals

  1. 18 February 2026 GlaxoSmithKline Biologicals v Moderna (CFI, 18 February 2026) Infringement Action · UPC_CFI_616/2025

    Le juge rapporteur autorise l'extension de la demande au produit mNEXSPIKE, rejette la demande de la règle 9 et la demande de suspension des délais, et ordonne à GSK de présenter un tableau de ses 40 requêtes subsidiaires.

  2. 7 May 2026 GlaxoSmithKline Biologicals v Moderna Netherlands (CFI, UPC_CFI_616/2025, 7 May 2026) Infringement Action · UPC_CFI_616/2025

    Le juge rapporteur rejette la demande d'audition en personne des experts, faute d'indication des faits à confirmer, et la demande de prorogation de la duplique, faute de circonstances exceptionnelles.

  3. 12 June 2026 GlaxoSmithKline Biologicals v Moderna Netherlands (CFI, UPC_CFI_616/2025, 12 June 2026) Infringement Action · UPC_CFI_616/2025
  4. 14 September 2026 GlaxoSmithKline Biologicals v Moderna Netherlands (CFI, 14 September 2026) Infringement Action · UPC_CFI_616/2025

    La division locale de La Haye rapporte l'ordonnance du 12 juin 2026 qui écartait les nouveaux rapports cryo-TEM de GSK et les admet après l'audience, avec un échange écrit limité.

What the record states

Nature of the act
Infringement Action
Outcome (Dhenne Avocats summary)
Le juge rapporteur fixe la valeur du litige, impose le choix des moyens de nullité et des requêtes subsidiaires, écarte des éléments nouveaux tardifs de la titulaire, refuse un contre-interrogatoire général des experts et organise l'audience du 1er septembre 2026, en livrant des avis préliminaires sur la contrefaçon et la validité.
Appeal
No appeal documented in the corpus, this does not mean that no appeal was lodged.
Instance
First-instance decision, whether it has become final is not recorded.

Patents mentioned

Related decisions cited in the analyses

Scope: Dhenne Avocats corpus. Registry-based links are marked “official number”; links derived from the analyses are marked as such. An erroneous link can be withdrawn without deleting any record.

Patents and standards

PublicationRole in the disputeFamilyStandard and declarationPoolSources
EP 2 590 626
Liposomes with lipids having an advantageous pKa-value for RNA delivery
recorded proprietor: GlaxoSmithKline Biologicals SA
Mentioned in the analysis (role not qualified)
Also mentioned in 6 other decision(s): GlaxoSmithKline Biologicals v Moderna Netherlands (CFI, 14 September 2 · GlaxoSmithKline Biologicals v C.P. Pharmaceuticals International C.V. · GlaxoSmithKline Biologicals v C.P. Pharmaceuticals International C.V. · GlaxoSmithKline Biologicals v Moderna Netherlands (CFI, UPC_CFI_616/20 · GlaxoSmithKline Biologicals v Pfizer (CFI, 25 February 2026) · GlaxoSmithKline Biologicals v Moderna (CFI, 18 February 2026)
not recordednot recordednot recordedEspacenet · European Patent Register
existence and title of the publication checked on 30 October 2026 (Google Patents, Espacenet and Register links are not checked automatically)
mentioned in: Dhenne Avocats analysis
The statuses “asserted in litigation”, “declared essential”, “listed by a pool” and “essentiality examined by a court” are distinct and may coexist. Validity, infringement and technical essentiality are different questions. Scope: patents cited in the decisions of the Dhenne Avocats corpus, with no essentiality score or prediction.

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