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1. Key takeaways
Broad injunctive relief covers future product variants without claim amendment (R. 263 RoP)
Following the CoA's Abbott/Sibio ruling (UPC_CoA_328/2024), a claimant requesting general injunctive relief covering patent claims can capture future product variants without amending its claim, provided the prayer for relief is drafted broadly enough, e.g., including "further versions or variants thereof."
Amendment to include a new product is admissible where EMA approval post-dates the Statement of Claim (R. 263(2) RoP)
Even treating the inclusion of a new product as a true change of claim, the amendment is admissible where the relevant regulatory event for the pertinent territory (here, EMA positive opinion) occurs after filing of the Statement of Claim. A prior approval in a different jurisdiction (here, US FDA) does not automatically trigger an obligation for the claimant to anticipate European market entry.
The defendants were not unreasonably hindered because they did not dispute that the new product is a newer version of the already-cited products with the same or similar relevant composition.
51 Auxiliary Requests raise serious concerns about feasibility in 14-month UPC proceedings (R. 30.1 RoP)
The Court questioned whether such a volume of ARs is feasible in UPC proceedings aimed at rendering decisions within 14 months. The ARs were also criticized for not being presented in an objection-related way and for lacking a tabular overview. However, the Court did not impose a hard numerical cap and dismissed the defendants' request to limit ARs to ten.
The claimant was ordered to submit a comprehensive tabular overview of its ARs for each patent within one week, clearly indicating which features are introduced with each AR and which invalidity attacks each AR addresses. Final limitation of ARs was deferred to the Interim Conference.
Front-loaded proceedings do not require anticipating every defence in the Statement of Claim (R. 9, R. 13.1(m) and (n) RoP)
The Court dismissed the defendants' application to strike allegedly late-filed submissions and evidence from the claimant's Reply. The further arguments, expert evidence, and Cryo-TEM images were considered a legitimate response to positions taken by the defendants in the Statement of Defence/Counterclaim concerning non-infringement and claim construction.
Disallowing these submissions would interfere with the claimant's fundamental right to be heard. The defendants retain sufficient opportunity to respond in one further written round and at the oral hearing.
2. Division
Local Division The Hague
3. UPC number
UPC_CFI_619/2025, UPC_CFI_1526/2025, UPC_CFI_2033/2025
4. Type of proceedings
Main infringement action (with counterclaims for revocation)
5. Parties
Claimant: GlaxoSmithKline Biologicals SA ("GSK")
Defendants: Moderna Netherlands B.V., Moderna Biotech Spain S.L., Moderna Biotech UK Limited, Moderna Biotech Distributor UK Ltd, Moderna Switzerland GmbH, Moderna Poland SP. Z.O.O., Moderna Inc., ModernaTX Inc., Moderna Belgium S.R.L., Moderna France SASU, Moderna Germany GmbH, Moderna Italy S.R.L., Moderna Portugal Unipessoal LDA, Moderna Sweden AB, Moderna Norway A/S
6. Patent(s)
EP 4 066 856, EP 4 226 941
7. Jurisdictions
UPC
8. Body of legislation / Rules
R. 263 RoP, R. 263(2) RoP, R. 30.1 RoP, R. 30.2 RoP, R. 9 RoP, R. 13.1(m) RoP, R. 13.1(n) RoP
2026-02-24_LD-DenHaag-UPC_CFI_619-2025 Download
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