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GlaxoSmithKline Biologicals v Moderna Netherlands (CFI, 14 September 2026)

Date14 September 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., Moderna Biotech Spain, S.L., Moderna Biotech UK Limited, Moderna Biotech Distribut…

Official decision (PDF) · UPC registry entry

Case timeline

Dhenne Avocats represents claimants and defendants in European patent disputes before the Unified Patent Court, including the Paris divisions.

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Dhenne Avocats · 10 October 2026

Our analysis

Summary

By order of 11 September 2026, the panel of the Hague Local Division hearing GlaxoSmithKline Biologicals SA v Moderna (EP 2 590 626) revoked, after the oral hearing of 1 September 2026, the judge-rapporteur’s order excluding GSK’s new cryo-TEM imaging reports as late-filed. The reports are admitted, with a written explanation from GSK and a written response from Moderna. The order shows that a ruling excluding evidence can be revisited even during the oral phase where the hearing reveals that the evidence is central.

Question

May the panel, after the oral hearing, revoke a Rule 105.5 order excluding late-filed evidence, and on what conditions?

Decision

The original exclusion was justified, but the hearing showed that the location of the mRNA within the particles, the presence of water and the nature of the aqueous core are decisive for infringement, so fairness required admitting the reports (paragraph 7). The evidence is limited, already known to the parties and concerns Moderna’s own products (paragraph 8). Moderna’s procedural objection was dismissed: Rules 334 and 335, together with Rule 331.3, allow a case management order to be varied or revoked at any stage, including the oral phase (paragraph 10). The right to be heard under Article 76(2) UPCA is secured by word-limited written submissions (paragraph 11), and the target date for the decision is unaffected (paragraph 12).

Key points for practice

Provisions applied

Agreement on a Unified Patent Court
Art. 76(2)
Rules of Procedure
Rules 105.5, 114, 118.6, 331.3, 334, 335 and 337
Other provisions
European Convention on Human Rights, Art. 6, Charter of Fundamental Rights of the European Union, Arts 41(2) and 47

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: 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: 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.

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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

    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…

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

What the record states

Nature of the act
Infringement Action
Outcome (Dhenne Avocats summary)
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.
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 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 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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