Short Summary
This is a confidentiality order (R.262A) issued by the Local Division The Hague of the Unified Patent Court in patent infringement proceedings (UPC_CFI_191/2025) concerning EP2279254, owned by Arbutus Biopharma Corporation. The order, based on an agreement reached between the parties, establishes a confidentiality regime and confidentiality club to protect certain information Moderna wishes to submit regarding the composition and manufacturing process of its Spikevax® and mRESVIA® products.
Detailed Summary
This order was issued by the Court of First Instance of the Unified Patent Court, Local Division The Hague, on 4 August 2025, in proceedings concerning European Patent No. EP2279254, owned by Arbutus Biopharma Corporation. The proceedings were initiated on 3 March 2025 when Arbutus Biopharma Corporation and Genevant Sciences GmbH (the Claimants) brought patent infringement actions against multiple Moderna entities (the Applicants/Defendants), alleging infringement of EP254 (proceedings no. ACT_10280/2025, UPC_CFI_191/2025). Moderna filed counterclaims for revocation.
On 8 July 2025, Moderna filed its statement of defence and counterclaim for revocation in both unredacted and redacted versions. Moderna then filed two identical R.262A applications (App_32589/2025 for the claim and App_32590/2025 for the counterclaim) requesting the court to order that certain information highlighted in grey in the unredacted versions of its submission be treated as confidential, with access restricted to a defined confidentiality club.
The Claimants were given the opportunity to respond, and the parties were requested to discuss and reach agreement on the members of the confidentiality club and the terms of the R.262A order. The parties reached such an agreement, submitted by the Claimants on 24 July 2025 as exhibit G122. Although the submitted agreement was not signed, the consent of the Applicants was assumed under R.284 RoP.
The court confirmed the agreed confidentiality regime, which defines 'Confidential Information' as all non-public, proprietary, or trade secret information filed by Moderna in the Proceedings relating to the composition and/or manufacturing process of the Spikevax® and mRESVIA® products and designated as confidential by Moderna upon filing. The regime restricts use of such information solely to the Proceedings and prohibits disclosure outside them, subject to certain exceptions (e.g., information obtained on a non-confidential basis from another source not bound by confidentiality).
The order imposes obligations on the Claimants to take organizational and technical precautions to prevent unauthorized disclosure, to notify Moderna within three calendar days of any inadvertent disclosure, to use best efforts to retrieve unauthorized copies, and to inform unauthorized recipients of the Court's R.262A order. The regime also addresses legally required disclosures, requiring the Claimants to notify Moderna and cooperate in seeking protective orders.
The Confidentiality Club was defined to consist of: (a) specified persons within Arbutus or Genevant; (b) outside counsel from specified firms (Brinkhof, Simmons & Simmons, Stibbe, Rentsch Partner, and Pestalozzi for UPC proceedings, and Williams & Connolly for US proceedings); and (c) experts to be identified in person appointed by the Claimants. The obligations of confidentiality continue to apply after termination of the Proceedings.
The Registry was instructed to continue granting the UPC representative of the respondents access to the unredacted documents submitted by Applicants in workflows ACT_10280/2025 and CC_32138/2025. The order was issued under Order no. ORD_32975/2025 by Judge-Rapporteur Margot Elsa Kokke.
Practitioner Note
This case demonstrates the evidentiary and procedural standards applied in patent matters before The Hague (NL) Local Division. Understanding the court's reasoning in Moderna, Inc. et al. vs Arbutus Biopharma Corporation & Genevant Sciences GmbH is valuable context for structuring arguments or assessing risk in similar proceedings.
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