Astellas Institute for Regenerative Medicine v Healios K.K. (CFI, 17 November 2023)

Dhenne Avocats · 10 October 2026

Our analysis

Summary

By an order of 17 November 2023 (UPC_CFI_80/2023, ACT_465342/2023, App_584332/2023), the judge-rapporteur of panel 1 of the Munich Central Division (A. Kupecz) ruled on the request of Astellas Institute for Regenerative Medicine, claimant in the revocation action against EP 3 056 564, to protect a confidential annex on the launch timeline of its product, filed in response to the stay request of Healios K.K. and Osaka University. Access is restricted to the defendants’ representatives and three named natural persons. Leave to appeal was granted, the order being one of the first UPC orders on Rule 262A RoP.

Question

Do the defendants need unrestricted access to a highly confidential exhibit to understand the claimant’s position on the stay, and how many natural persons must be given access?

Decision

The parties agree that the annex is highly confidential within Art. 58 UPCA. The defendants do not need unrestricted access: the claimant’s legal position is set out in pleadings not marked confidential, and its interest in confidentiality prevails. Under Rule 262A.6 RoP, the circle must be no larger than necessary but must include at least one natural person per party, in addition to the representatives. Osaka University, though it proposed no one, is entitled to one natural person, who need not be an employee: access is given to two Healios in-house lawyers and one external Japanese patent attorney, without other management or business staff. The annex, kept strictly confidential even after the proceedings, is also withheld from third-party access (Rule 262.2 RoP), the claimant must file a redacted version within seven days.

Key points for practice

• Practical point: the natural person allowed access under Rule 262A.6 RoP may be an external adviser. The party seeking confidentiality should file a redacted version from the outset.

Provisions applied

Agreement on a Unified Patent Court

Art. 58 and Art. 73(2)(b)(ii)

Rules of Procedure

Preamble point 8, Rules 9, 220.2, 224.1(b), 262.2 and 262A

Directive (EU) 2016/943

Art. 9(1) and (2)(a)

Case law cited

Avago Technologies International Sales v Tesla, Hamburg Local Division, 4 October 2023, Avago Technologies International Sales v Tesla Germany, Hamburg Local Division, 3 November 2023

Related decisions

• Astellas v Healios, 20 November 2023, order rejecting the stay request in support of which the annex was filed.

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.