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UPC CFI 407/2025

May 6, 2025·EP3401335 · COMPOSITION COMPRISING ANTIBODY THAT BINDS TO DOMAIN II OF HER2 AND ACIDIC VARIANTS THEREOF

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Case details
Status
Case Closed
Action
Generic
Category
Evidence and inspection
Parties
Claimants
Representatives
Respondents
Representatives
Division
Brussels LD
Judges
Technology
  • Chemistry
    Biotechnology · Pharmaceuticals
Language
English
First decided
May 30, 2025
Last decision
Nov 12, 2025
EPO Opposition
  • Hexal AGWithdrawn2021-11-08
  • Pohlman, Sandra M.Admissible2022-03-22
  • Strawman LimitedWithdrawn2022-03-28
  • Abel & Imray LLPWithdrawn2022-03-30
  • European Oppositions LimitedAdmissible2022-03-30
How this compares
How long the court takes to reach a first decision.
Median days to first decision
All UPC124
Brussels LDLocked
Judge Samuel GranataLocked
Judge Petri RinkinenLocked
Judge Rute LopesLocked

At the UPC: Roche Group (29 cases)·Organon & Co (2 cases)

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Related cases
All proceedings on this patent

This dispute contains 4 other proceedings

UPC CoA 913/2025·UPC CoA 914/2025·UPC CFI 408/2025·UPC CFI 1167/2026

Start a free trial to see how each one ended.

More cases: Brussels LD·2025

Decisions
  • 2025-11-12
    Application for an Order for inspection pursuant to RoP199Public

    Summary: Review order by the Brussels Local Division following an ex parte order for preservation of evidence/inspection pursuant to Rule 197.3 RoP in Genentech/Roche v Organon proceedings. The court confirmed the inspection orders with modifications, set a deadline for expert reports, and set a 31-day (or 20 working day) term for initiating infringement proceedings after receipt of the experts' report.

    Show the legal issues (5)
    • Review of preservation of evidence order (Rule 197.3 RoP)
    • Ex parte order review
    • Scope of review
    • Duty of disclosure in ex parte proceedings (Rule 192.3 RoP)
    • Term for initiating infringement proceedings (Rule 198.1 RoP)
  • 2025-05-30
    Application for preserving evidence pursuant to RoP192Public

    Summary: The Brussels Local Division granted Genentech / Roche's ex parte applications for an order to preserve evidence (R. 192–198 RoP) and an order for inspection (R. 199 RoP) against Organon and Shanghai Henlius Biotech concerning EP 3 401 335 B1 (biological pharmaceutical patent). The orders were granted after an oral hearing on 23 May 2025. The order to preserve evidence required production of digital information; Organon NV and Organon Heist BV face a penalty of EUR 200,000 per hour for failure to cooperate. Costs are stayed pending the main proceedings.

    Show the legal issues (4)
    • Order to preserve evidence (R. 192–198 RoP)
    • Order for inspection (R. 199 RoP)
    • Penalty for non-compliance
    • Ex parte proceedings
Documents
Document titleDatePublic
Publication of order2026-06-09Not public
Publication of order2026-06-09Not public
Publication of order2026-06-09Not public
Publication of order2026-06-09Not public
Case closed2026-02-25Not public
Order2026-02-12Not public
Order2026-02-12Public
Receipt2026-02-11Not public
Cover sheet2026-02-11Not public
Exhibit Claimant2026-02-11Not public
Application document Claimant2026-02-11Not public
Decision2026-02-04Not public
Decision2026-02-04Public
Receipt2026-01-30Not public
Cover sheet2026-01-30Not public
Exhibit document Claimant2026-01-30Not public
Application document Claimant2026-01-30Not public
Communication2026-01-11Not public
Communication2026-01-02Not public
Cover sheet2025-12-10Not public
Other document Defendant2025-12-10Not public
Receipt2025-12-10Not public
Communication2025-12-07Not public
Communication2025-12-05Not public
Cover sheet2025-12-04Not public
Receipt2025-12-04Not public
Cover sheet2025-12-01Not public
Further pleadings2025-12-01Not public
Receipt2025-12-01Not public
Cover sheet2025-11-26Not public
Receipt2025-11-26Not public
Cover sheet2025-11-19Not public
Receipt2025-11-19Not public
Decision2025-11-12Not public
Final Order2025-11-12Public
Communication2025-11-10Not public
Order2025-10-17Not public
Order2025-10-17Public
Interim procedure opened2025-10-14Not public
Order2025-10-14Not public
Order2025-10-14Public
R. 262 RoP2025-09-18Not public
R. 9 RoP2025-09-18Not public
Receipt2025-09-18Not public
2025.09.17 - conf. request Organon R.9 Applications (R. 262(2) R. 262A(1))(signed)2025-09-17Not public
2025.09.17 - conf. request Organon R.9 Applications (R. 262(2) R. 262A(1))(signed)2025-09-17Not public
Receipt2025-09-17Not public
Exhibit PM-004 - Document 2 - Confidential (R.262A.1 RoP)2025-09-17Not public
2025.09.17 - Application destruction seized evidence (R. 9 RoP)(CONFIDENTIAL - signed)2025-09-17Not public
Exhibit PM-002 - NL bailiff report (NL and EN) Confidential (R.262A.1)2025-09-17Not public
Exhibit PM-005 - Document 3 - Confidential (R. 262A.1 RoP)2025-09-17Not public
Exhibit PM-001 - BE bailiff report (NL and EN) Confidential (R.262A.1)2025-09-17Not public
Exhibit PM-003 - Document 1 - Confidential (R.262A.1 RoP)2025-09-17Not public
Hearing-Dates2025-09-02Not public
R. 197 (4) RoP2025-09-02Not public
Letter to the registry on confirmation of closing paths2025-09-01Not public
Letter to the registry on confirmation of closing paths2025-09-01Not public
Letter to the registry on confirmation of closing paths2025-09-01Not public
Letter to the Registry on confirmation of closing paths2025-09-01Not public
Letter to the Registry on confirmation of closing paths2025-09-01Not public
Letter to the Registry on confirmation of closing paths2025-09-01Not public
Letter to the Registry on confirmation of closing paths2025-09-01Not public
Letter to the Registry on confirmation of closing paths2025-09-01Not public
Roche Genentech - Further Written Comments in Review Request2025-08-29Not public
Roche Genentech - Further Written Comments in Review Request2025-08-29Not public
Brief re Preference Hearing Dates2025-08-27Not public
Brief re Preference Hearing Dates2025-08-27Not public
Rule 9 Order2025-08-25Public
Receipt2025-08-21Not public
2025.08.21 - confidentiality request Organon re. comments (Art. 58 R. 262(2) and R. 262A(1)) (signed)2025-08-21Not public
2025.08.21 - confidentiality request Organon re. comments (Art. 58 R. 262(2) and R. 262A(1)) (signed)2025-08-21Not public
2025.08.2020 - Roche Genentech Comments to Application (Redacted Version)2025-08-20Not public
2025.08.2020 - Roche Genentech Comments to Application (Unredacted Version)2025-08-20Not public
2025.08.2020 - Roche Genentech Comments to Application (Redacted Version)2025-08-20Not public
2025.08.2020 - Roche Genentech Comments to Application (Unredacted Version)2025-08-20Not public
2025.08.20 - Organon further written comments Request for review (CONFIDENTIAL - SIGNED)2025-08-20Not public
2025.08.20 - Annex 1 - Witness statement Erik Ceresa (CONFIDENTIAL)2025-08-20Not public
2025.08.20 - Annex 1 - Witness statement Erik Ceresa (CONFIDENTIAL)2025-08-20Not public
2025.08.20 - Organon further written comments Request for review (CONFIDENTIAL - SIGNED)2025-08-20Not public
2025.08.20 - Annex 1 - Witness statement Erik Ceresa (CONFIDENTIAL)2025-08-20Not public
2025.08.20 - Organon further written comments Request for review (CONFIDENTIAL - SIGNED)2025-08-20Not public
2025.08.20 - Organon further written comments Request for review (CONFIDENTIAL - SIGNED)2025-08-20Not public
2025.08.20 - Annex 1 - Witness statement Erik Ceresa (CONFIDENTIAL)2025-08-20Not public
2025.08.20 - Organon further written comments Request for review (CONFIDENTIAL - SIGNED)2025-08-20Not public
2025.08.20 - Annex 1 - Witness statement Erik Ceresa (CONFIDENTIAL)2025-08-20Not public
2025.08.20 - Annex 1 - Witness statement Erik Ceresa (CONFIDENTIAL)2025-08-20Not public
2025.08.20 - Organon further written comments Request for review (CONFIDENTIAL - SIGNED)2025-08-20Not public
2025.08.12 - Comments Organon in App_33913-2025 and 33918-2025 (signed)2025-08-12Not public
2025.08.12 - Comments Organon in App_33913-2025 and 33918-2025 (signed)2025-08-12Not public
R. 262A2025-08-11Not public
Receipt2025-08-08Not public
2025.08.08 - Application for confidentiality of R.9 RoP application and exhibits (signed)2025-08-08Not public
Exhibit PM-003 - Document 1 - Confidential (R.262A.1 RoP)2025-08-08Not public
2025.08.06 - Confidentiality request Organon (Art. 58 - R. 262A.1 - R262.2) (Confidential - signed)2025-08-08Not public
Exhibit PM-004 - Document 2 - Confidential (R.262A.1 RoP)2025-08-08Not public
Exhibit PM-005 - Document 3 - Confidential (R. 262A.1 RoP)2025-08-08Not public
Exhibit PM-002 - NL bailiff report (NL and EN) Confidential (R.262A.1)2025-08-08Not public
Exhibit PM-001 - BE bailiff report (NL and EN) Confidential (R.262A.1)2025-08-08Not public
Exhibit PM-002 - NL bailiff report (NL and EN) Confidential (R.262A.1)2025-08-07Not public
2025.08.06 - Confidentiality request Organon (Art. 58 - R. 262A.1 - R262.2) (Confidential - signed)2025-08-07Not public
2025.08.06 - Confidentiality request Organon (Art. 58 - R. 262A.1 - R262.2) (Confidential - signed)2025-08-07Not public
Exhibit PM-003 - Document 1 - Confidential (R.262A.1 RoP)2025-08-07Not public
Exhibit PM-002 - NL bailiff report (NL and EN) Confidential (R.262A.1)2025-08-07Not public
Exhibit PM-005 - Document 3 - Confidential (R. 262A.1 RoP)2025-08-07Not public
Exhibit PM-004 - Document 2 - Confidential (R.262A.1 RoP)2025-08-07Not public
Exhibit PM-005 - Document 3 - Confidential (R. 262A.1 RoP)2025-08-07Not public
Exhibit PM-001 - BE bailiff report (NL and EN) Confidential (R.262A.1)2025-08-07Not public
Exhibit PM-001 - BE bailiff report (NL and EN) Confidential (R.262A.1)2025-08-07Not public
Exhibit PM-003 - Document 1 - Confidential (R.262A.1 RoP)2025-08-07Not public
Exhibit PM-004 - Document 2 - Confidential (R.262A.1 RoP)2025-08-07Not public
Written Comments2025-08-04Not public
Written Comments2025-08-04Not public
Exhibit FS36A2025-08-04Not public
Exhibit FS36.B2025-08-04Not public
Written Comments2025-08-04Not public
Exhibit FS36.A2025-08-04Not public
Exhibit FS36.B2025-08-04Not public
Comments pursuant to RoP2642025-08-04Not public
Receipt2025-08-04Not public
2025.08.01 - Comments on confidentiality order (Signed)2025-08-01Not public
Preliminary Order2025-08-01Public
Receipt2025-07-29Not public
2025.07.29 - Confidentiality request Organon - Confidential (Art. 58 - R. 262A.1 - R. 262.2)2025-07-29Not public
Exhibit PM-004 - Document 2 - Confidential (R.262A.1 RoP)2025-07-29Not public
Exhibit PM-001 - BE bailiff report (NL and EN) Confidential (R.262A.1)2025-07-29Not public
Exhibit PM-003 - Document 1 - Confidential (R.262A.1 RoP)2025-07-29Not public
Exhibit PM-005 - Document 3 - Confidential (R. 262A.1 RoP)2025-07-29Not public
Exhibit PM-002 - NL bailiff report (NL and EN) Confidential (R.262A.1)2025-07-29Not public
Staying Procedure2025-07-28Not public
Staying Procedure2025-07-28Not public
Comments Application for Review2025-07-28Not public
Panel-Appointment2025-07-28Not public
Application-For-Measures-Receipt2025-07-28Not public
Application-For-Measures-Acknowledgement2025-07-28Not public
Exhibit 1.1. - CV of Dr Uwe Gottschalk2025-07-28Not public
Request for Review to saisie orders 23121/2025 and 23125/20252025-07-28Not public
Exhibit 2 - EMA Procedural Advice Centralised Procedure2025-07-28Not public
Exhivit 1 - expert declaration of Dr Uwe Gottschalk2025-07-28Not public
Acknowledgement of access to case2025-07-28Not public
Acknowledgement of access to case2025-07-28Not public
Receipt2025-07-28Not public
Request regarding scheduling of oral hearing2025-07-25Not public
Receipt2025-07-24Not public
Application for Penalty Payments and Remedy Request2025-07-23Not public
Exhibit FS33 - Bailiff report Oss2025-07-23Not public
Exhibit FS34 - Bailiff report Heist2025-07-23Not public
Exhibit FS35 - Seized document 'Plan'2025-07-23Not public
Headnote-and-Keywords2025-07-20Not public
Outcome of the Order2025-07-19Not public
Time period R. 198(1) RoP2025-07-19Public
Receipt2025-07-18Not public
Request for clarification deadline initiating merits2025-07-17Not public
Receipt2025-06-27Not public
Notification of Execution2025-06-27Not public
Notification Of Service2025-06-26Not public
Notice of appointment as an expert2025-06-26Not public
Outcome of the Order2025-06-25Not public
Adding Exhibits2025-06-25Public
Receipt2025-06-24Not public
FS322025-06-23Not public
Brief re sharing of documents with experts2025-06-23Not public
FS312025-06-23Not public
Notice of Provisional measures and instructions for access to proceedings2025-06-10Not public
Notice of Provisional measures and instructions for access to proceedings2025-06-10Not public
Notice of Provisional measures and instructions for access to proceedings2025-06-10Not public
Notice of Provisional measures and instructions for access to proceedings2025-06-10Not public
Measures_DecisionOutcome_Notification.pdf2025-06-10Not public
Order to Preserve Evidence2025-06-10Public
Attachment to ORD_27384/20252025-06-10Public
Attachment to ORD_27384/20252025-06-10Not public
substantive order2025-06-10Not public
Recording2025-06-10Not public
Recording2025-06-10Not public
Summon-Oral-Hearing2025-06-10Not public
Outcome of the Order2025-06-07Not public
Closing Workflow2025-06-07Public
Outcome of the Order2025-06-07Not public
Closing Workflow2025-06-07Public
Outcome of the Order2025-06-07Not public
Closing Workflow2025-06-07Public
R. 192 RoP2025-05-30Public
Oral Hearing RoP 194.1 c 23/05/20252025-05-26Not public
Oral Hearing RoP 194.1 c 23/05/20252025-05-26Not public
Receipt2025-05-23Not public
FS292025-05-23Not public
Brief 23 May 20252025-05-23Not public
FS302025-05-23Not public
Receipt2025-05-23Not public
Receipt2025-05-23Not public
Brief re ex parte hearing attendees and request2025-05-22Not public
Brief2025-05-18Not public
FS282025-05-18Not public
Hearing-Dates2025-05-15Not public
R. 194 (1)(c) RoP2025-05-15Not public
Panel-Appointment2025-05-08Not public
Application-For-Measures-Receipt2025-05-07Not public
Formal-checks_Notification-of-positive-outcome2025-05-07Not public
Application-For-Measures-Acknowledgement2025-05-06Not public
FS062025-05-06Not public
FS162025-05-06Not public
FS142025-05-06Not public
FS27B2025-05-06Not public
FS25A2025-05-06Not public
FS242025-05-06Not public
FS26B2025-05-06Not public
FS08A2025-05-06Not public
FS052025-05-06Not public
FS23B2025-05-06Not public
FS072025-05-06Not public
FS132025-05-06Not public
FS25D2025-05-06Not public
FS23A2025-05-06Not public
FS042025-05-06Not public
FS172025-05-06Not public
FS092025-05-06Not public
FS25C2025-05-06Not public
FS222025-05-06Not public
FS192025-05-06Not public
FS022025-05-06Not public
Application2025-05-06Not public
FS25B2025-05-06Not public
FS182025-05-06Not public
FS212025-05-06Not public
FS102025-05-06Not public
FS152025-05-06Not public
FS122025-05-06Not public
FS202025-05-06Not public
FS26A2025-05-06Not public
FS27A2025-05-06Not public
FS032025-05-06Not public
FS08B2025-05-06Not public
FS112025-05-06Not public
FS012025-05-06Not public