GlaxoSmithKline Biologicals v Moderna Netherlands (CFI, 14 September 2026)
| Date | 14 September 2026 |
|---|---|
| Court | CFI |
| Division | The Hague (NL) Local Division |
| Type of action | Infringement Action |
| Case number(s) | UPC_CFI_616/2025 |
| Registry reference | UPC_CFI_616/2025 |
| Parties | GlaxoSmithKline 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
- 18 February 2026 : GlaxoSmithKline Biologicals v Moderna (CFI, 18 February 2026) UPC_CFI_616/2025
- 7 May 2026 : GlaxoSmithKline Biologicals v Moderna Netherlands (CFI, UPC_CFI_616/2025, 7 May 2026) UPC_CFI_616/2025
- 12 June 2026 : GlaxoSmithKline Biologicals v Moderna Netherlands (CFI, UPC_CFI_616/2025, 12 June 2026) UPC_CFI_616/2025
Dhenne Avocats represents claimants and defendants in European patent disputes before the Unified Patent Court, including the Paris divisions.
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
- Evidence excluded as late-filed may be readmitted after the hearing if the debate shows it to be decisive, provided both sides can comment in writing (paragraphs 7 to 11).
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
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.
Parties
- defendantModerna Netherlands B.V.5 decisions in the corpusFollow this party
- claimantGlaxoSmithKline Biologicals SA16 decisions in the corpusFollow this party
- defendantModerna Biotech Spain, S.L2 decisions in the corpusFollow this party
- defendantModerna Biotech UK Limited5 decisions in the corpusFollow this party
- defendantModerna Biotech Distribut2 decisions in the corpusFollow this party
Decisions in the same proceedings and documented appeals
- 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.
- 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.
- 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…
- 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
EP 2 590 626mentioned in: Dhenne Avocats analysis Follow this patent
Related decisions cited in the analyses
- GlaxoSmithKline Biologicals v Moderna Netherlands (CFI, UPC_CFI_616/2025, 12 June 2026) cited in this record
- GlaxoSmithKline Biologicals v Moderna Netherlands (CFI, UPC_CFI_616/2025, 7 May 2026) cited in this record
- GlaxoSmithKline Biologicals v Moderna (CFI, 18 February 2026) cited in this record
Patents and standards
| Publication | Role in the dispute | Family | Standard and declaration | Pool | Sources |
|---|---|---|---|---|---|
EP 2 590 626Liposomes 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 recorded | not recorded | not recorded | Espacenet · 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 |
Receive an alert
Weekly summary of new records and substantive updates matching what you follow. Address confirmed by email, unsubscribe at any time, one email per week even where several of your follows match.