UPC CFI 166/2024
Apr 9, 2024·EP3805248 · PROCESS FOR CONCENTRATION OF ANTIBODIES AND THERAPEUTIC PRODUCTS THEREOF
Action number: ACT 18551/2024
- Case details
- StatusCase ClosedActionProvisional measuresCategoryProvisional measures
- Parties
- Claimants
- Novartis AGOperating co.
- Genentech, Inc.Operating co.
Representatives- Kilian Seidel-Freshfields
- Frank-Erich Hufnagel-Freshfields
- Cameron Marshallsupporting-Carpmaels & Ransford
- Joanna Rowleysupporting-Carpmaels & Ransford
Respondents- Celltrion Inc.Operating co.
Representatives- Emilia Zalewska-Bird & Bird LLP
- Laurens Buijtelaar-Bird & Bird LLP
- Division
- Dusseldorf LD
- Technology
- ChemistryBiotechnology · Pharmaceuticals
- Language
- English
- First decided
- Sep 6, 2024
- EPO Opposition
- Celltrion Inc.Withdrawn2023-10-16
- Kilburn & Strode LLPAdmissible2023-10-18
| Preliminary injunction granted | Median days to first decision | |
|---|---|---|
| All UPC | 54% (38/70) | 124 |
| Dusseldorf LD | Locked | Locked |
| Judge Berenice Thom | Locked | Locked |
| Judge Alima Zana | Locked | Locked |
| Judge John Petersen | Locked | Locked |
At the UPC: Novartis AG (4 cases)·Celltrion Inc. (1 case)
1 other defendants litigating the same or a related patent
Start a free trial to see how each one ended.
More cases: Dusseldorf LD·2024
- 2024-09-06Application for provisional measuresPublic
Summary: Order by Düsseldorf Local Division (UPC_CFI_166/2024, 6 September 2024) rejecting Novartis AG and Genentech Inc.'s application for provisional measures against Celltrion Inc. for alleged infringement of EP 3 805 248 B1 (biologic/antibody). The application was dismissed on the merits (infringement insufficiently established). Applicants were ordered to pay interim costs of EUR 138,562.80. The court addressed claim interpretation, imminent infringement, non-applicability of stay of proceedings (R. 295 RoP) to PI proceedings, and the costs gap in the absence of main proceedings.
Show the legal issues (7)
- Provisional measures (Art. 25, 62 UPCA)
- Imminent infringement
- Claim interpretation
- Lis pendens
- Non-applicability of R. 295 RoP (stay) to PI proceedings
- Costs in PI proceedings (R. 118.5 RoP analogy)
- Biosimilar / biologic patent
| Document title | Date | Public |
|---|---|---|
| Case Closure Formal Check | 2025-03-27 | Not public |
| Headnote-and-Keywords | 2024-09-06 | Not public |
| Measures_DecisionOutcome_Notification.pdf | 2024-09-06 | Not public |
| Final Order on PI Application | 2024-09-06 | Public |
| Final Order on PI Application | 2024-09-06 | Not public |
| 18551-2024_OH_DUS-LOC_UPC202407310930AM_S01 | 2024-09-06 | Not public |
| 18551-2024_OH_DUS-LOC_UPC202407310930AM_S02 | 2024-09-06 | Not public |
| 18551-2024_OH_DUS-LOC_UPC202407310930AM_S03 | 2024-09-06 | Not public |
| 18551-2024_OH_DUS-LOC_UPC202407310930AM_S03 | 2024-09-06 | Not public |
| 18551-2024_OH_DUS-LOC_UPC202407310930AM_S01 | 2024-09-06 | Not public |
| 18551-2024_OH_DUS-LOC_UPC202407310930AM_S04 | 2024-09-06 | Not public |
| 18551-2024_OH_DUS-LOC_UPC202407310930AM_S02 | 2024-09-06 | Not public |
| 18551-2024_OH_DUS-LOC_UPC202407310930AM_S04 | 2024-09-06 | Not public |
| Receipt | 2024-09-03 | Not public |
| Exhibit FBD 46 | 2024-09-03 | Not public |
| Submission of EPO preliminary opinion | 2024-09-03 | Not public |
| Time limits for parties' oral submissions | 2024-07-24 | Public |
| Acknowledgement-of-lodging | 2024-06-27 | Not public |
| BB42 Witness Statement Annelies van Leeuwen | 2024-06-27 | Not public |
| BB41 Witness Statement Bart Buiks | 2024-06-27 | Not public |
| 20240627 Rejoinder UPC Celltrion v Novartis (signed) | 2024-06-27 | Not public |
| BB45b Annexes to expert declaration of Prof. dr. T. Dingermann | 2024-06-27 | Not public |
| BB44 Expert declaration Prof. dr. H.W. Frijlink of 26 June 2024 (Expert declaration of Prof. dr. H.W. Frijlink II) | 2024-06-27 | Not public |
| BB38 Higher Regional Court Dusseldorf judgment of 2009 2012 (I 2 U 44 12) | 2024-06-27 | Not public |
| BB45a CV of Prof. dr. T. Dingermann | 2024-06-27 | Not public |
| BB47 Presta et al J Immunol 1993 Vol 151 No 5 p 2623 2632 | 2024-06-27 | Not public |
| BB43 Witness Statement of DongKyu Kim | 2024-06-27 | Not public |
| BB38a English machine translation of Exhibit BB38 | 2024-06-27 | Not public |
| BB46 Cacia et al Biochemistry 1996 Vol 35 No 6 p 1897 1903.pdf | 2024-06-27 | Not public |
| BB39 Witness Statement Taeksang Kwon | 2024-06-27 | Not public |
| BB49 Expert declaration Dr. L. de Leede of 26 June 2024 | 2024-06-27 | Not public |
| BB40 Witness Statement Joel van Ruyskensvelde | 2024-06-27 | Not public |
| BB49b Annexes to expert declaration dr. L. de Leede of 26 June 2024 | 2024-06-27 | Not public |
| BB48 Notice from the EPO regarding accelerated proceedings of 17 June 2024 | 2024-06-27 | Not public |
| BB43a Exhibit 1 to Witness Statement of Dongkyu Kim | 2024-06-27 | Not public |
| BB49a CV of Dr. L. de Leede | 2024-06-27 | Not public |
| BB45 Expert declaration Prof. dr. T. Dingermann of 26 June 2024 | 2024-06-27 | Not public |
| BB44a Annexes to Expert declaration of Prof. dr. H.W. Frijlink II | 2024-06-27 | Not public |
| Outcome of the Order | 2024-06-14 | Not public |
| 2024-06-14 Procedural Order (declaration) | 2024-06-14 | Public |
| Receipt | 2024-06-07 | Not public |
| Receipt | 2024-06-07 | Not public |
| Application pursuant to R. 262.2 RoP UPC | 2024-06-07 | Not public |
| Exhibit FBD 35 | 2024-06-07 | Not public |
| Exhibit FBD 45a | 2024-06-07 | Not public |
| Exhibit FBD 43 | 2024-06-07 | Not public |
| 24-06-06 - Xolair - EP 248 - vs. Celltrion Inc. - Reply | 2024-06-07 | Not public |
| Exhibit FBD 37 (CONF) | 2024-06-07 | Not public |
| Exhibit FBD 44 | 2024-06-07 | Not public |
| Exhibit FBD 45 | 2024-06-07 | Not public |
| Exhibit FBD 42 | 2024-06-07 | Not public |
| Exhibit FBD 34 | 2024-06-07 | Not public |
| 24-06-06 - Xolair - EP 248 - vs. Celltrion Inc. - Reply | 2024-06-07 | Not public |
| Exhibit FBD 36 (CONF) | 2024-06-07 | Not public |
| Exhibit FBD 39 (CONF) | 2024-06-07 | Not public |
| Exhibit FBD 40 (CONF) | 2024-06-07 | Not public |
| Application pursuant to R. 9 RoP UPC | 2024-06-07 | Not public |
| Exhibit FBD 41 | 2024-06-07 | Not public |
| Exhibit FBD 37 (CONF) | 2024-06-07 | Not public |
| Exhibit FBD 40 (CONF) | 2024-06-07 | Not public |
| Exhibit FBD 38 (CONF) | 2024-06-07 | Not public |
| Exhibit FBD 36a (CONF) | 2024-06-07 | Not public |
| Exhibit FBD 39 (CONF) | 2024-06-07 | Not public |
| Exhibit FBD 36a (CONF) | 2024-06-07 | Not public |
| Exhibit FBD 36 (CONF) | 2024-06-07 | Not public |
| Exhibit FBD 38 (CONF) | 2024-06-07 | Not public |
| summons | 2024-05-16 | Not public |
| Procedural Order Oral Hearing | 2024-05-16 | Public |
| Document technical reasons | 2024-05-16 | Public |
| Panel-Appointment | 2024-05-16 | Not public |
| BB35A - JP H04-198195 - translation of description | 2024-05-14 | Not public |
| BB30 - Crommelin Pharmaceutical Biotechnology Fundamentals and Applications (second edition) | 2024-05-14 | Not public |
| BB26K - Yadav et al. Pharmaceutical Research 2011 vol. 28 p. 1750-1764 submitted by letter of Novartis 26 July 2021 (Yad | 2024-05-14 | Not public |
| BB23 - EP 4 104 859 A1 | 2024-05-14 | Not public |
| BB27 - Statement of Defence by Novartis in the Dutch proceedings 3 April 2024 | 2024-05-14 | Not public |
| BB36 - Hernandez et al. 2022 | 2024-05-14 | Not public |
| BB26I - Tomar et al. journal of the Taylor Francis Group 2017 vol. 9 p. 476-489 submitted by letter of Novartis 26 July | 2024-05-14 | Not public |
| BB26M - Letter Novartis regarding third party observation 4 October 2021 | 2024-05-14 | Not public |
| BB21B - Annexes to the expert declaration of Prof. dr. H.W. Frijlink | 2024-05-14 | Not public |
| BB26E - European Search Opinion 10 June 2021 | 2024-05-14 | Not public |
| BB26A - International search report 12 April 2006 | 2024-05-14 | Not public |
| BB26B - Letter EPO to remedy deficiencies (submission of claims) 28 October 2020 | 2024-05-14 | Not public |
| BB26D - Letter Novartis on submission of claims 1-21 3 November 2020 | 2024-05-14 | Not public |
| BB21A - CV of Prof. dr. H.W. Frijlink | 2024-05-14 | Not public |
| BB20 - EP 2 116 265 B1 | 2024-05-14 | Not public |
| BB32 - EP 0 025 275 A2 | 2024-05-14 | Not public |
| BB26N - Notice Examiner 31 January 2022 | 2024-05-14 | Not public |
| BB37 - EP 1 786 830 B1 | 2024-05-14 | Not public |
| BB26H - Adjusted claims 1-3 by letter of Novartis 26 July 2021 | 2024-05-14 | Not public |
| BB27A - English machine translation of Statement of Defence by Novartis 3 April 2024 | 2024-05-14 | Not public |
| BB28 - Letter Novartis regarding submission of patentees 18 July 2022 | 2024-05-14 | Not public |
| BB29 - EP 1 610 820 B2 | 2024-05-14 | Not public |
| BB26O - Third party observation 24 May 2022 | 2024-05-14 | Not public |
| BB26J - Liu et al. Journal of Pharmaceutical Sciences 2005 vol. 94 p. 1928-1940 submitted by letter of Novartis 26 July | 2024-05-14 | Not public |
| BB25 - Decision of the Board of Appeal EPO on EP 636 5 May 2022 | 2024-05-14 | Not public |
| BB26C - Claims 1-21 submitted by letter of Novartis 3 November 2020 | 2024-05-14 | Not public |
| BB24 - EP 4 108 259 A1 | 2024-05-14 | Not public |
| BB26G - Letter Novartis regarding the adjustment of the claims 26 July 2021 | 2024-05-14 | Not public |
| BB21 - Expert declaration of Prof. dr. H.W. Frijlink on arginine(-HCl) (Expert declaration of Prof. Frijlink I) | 2024-05-14 | Not public |
| BB26F - European Search Report 31 May 2021 | 2024-05-14 | Not public |
| BB31 - Chen et al. Pharmaceutical Research 2003 Vol. 20 No. 12 p. 1952-60 (Chen) | 2024-05-14 | Not public |
| BB22 - Technical primer for the Patent | 2024-05-14 | Not public |
| 20240515 Objection UPC Celltrion v Novartis (signed) | 2024-05-14 | Not public |
| BB34 - WO 9006764 A1 | 2024-05-14 | Not public |
| BB33 - WO 03072060 A2 | 2024-05-14 | Not public |
| BB35 - JP H04-198195 | 2024-05-14 | Not public |
| BB26L - Third party observation 22 September 2021 | 2024-05-14 | Not public |
| 2024-05-13 Order TQJ | 2024-05-13 | Public |
| Consent to allocation of technically qualified judge | 2024-05-13 | Not public |
| Consent to allocation of technically qualified judge | 2024-05-13 | Not public |
| Consent to the appointment of a TQJ | 2024-05-10 | Not public |
| Pre Order TQJ | 2024-05-02 | Not public |
| Pre Order TQJ | 2024-05-02 | Not public |
| Repeated upload of order 10 April 2024 | 2024-05-02 | Not public |
| Date of a possible oral hearing | 2024-04-23 | Public |
| Acknowledgement of access to case | 2024-04-18 | Not public |
| Confirmation of notification of appointment | 2024-04-18 | Not public |
| Service to Celltrion Inc. | 2024-04-18 | Not public |
| Letter for Service | 2024-04-12 | Not public |
| Panel-Appointment | 2024-04-11 | Not public |
| R. 207.8 Order | 2024-04-10 | Public |
| Template-Order | 2024-04-10 | Not public |
| Panel-Appointment | 2024-04-10 | Not public |
| Application-For-Measures-Receipt | 2024-04-10 | Not public |
| Formal-checks_Notification-of-positive-outcome | 2024-04-10 | Not public |
| Receipt | 2024-04-09 | Not public |
| Application to request confidentiality from the public (RoP262.2) | 2024-04-09 | Not public |
| Application-For-Measures-Acknowledgement | 2024-04-09 | Not public |
| Exhibit FBD 11 | 2024-04-09 | Not public |
| Exhibit FBD 22 | 2024-04-09 | Not public |
| Exhibit FBD 25 | 2024-04-09 | Not public |
| Exhibit FBD 33 | 2024-04-09 | Not public |
| Exhibit FBD 19 | 2024-04-09 | Not public |
| Exhibit FBD 7 | 2024-04-09 | Not public |
| Exhibit FBD 8 | 2024-04-09 | Not public |
| Exhibit FBD 5 (Confidential) | 2024-04-09 | Not public |
| Exhibit FBD 21-1 | 2024-04-09 | Not public |
| Exhibit FBD 30 | 2024-04-09 | Not public |
| Exhibit FBD 24 | 2024-04-09 | Not public |
| Exhibit FBD 6 | 2024-04-09 | Not public |
| Exhibit FBD 4 | 2024-04-09 | Not public |
| Application for Provisional Measures | 2024-04-09 | Not public |
| Exhibit FBD 16 | 2024-04-09 | Not public |
| Exhibit FBD 12 | 2024-04-09 | Not public |
| Exhibit FBD 10 | 2024-04-09 | Not public |
| Exhibit FBD 5 (Confidential) | 2024-04-09 | Not public |
| Exhibit FBD 2 | 2024-04-09 | Not public |
| Exhibit FBD 28 | 2024-04-09 | Not public |
| Exhibit FBD 12 | 2024-04-09 | Not public |
| Application for Provisional Measures | 2024-04-09 | Not public |
| Exhibit FBD 13 | 2024-04-09 | Not public |
| Exhibit FBD 21 | 2024-04-09 | Not public |
| Exhibit FBD 20 | 2024-04-09 | Not public |
| Exhibit FBD 26 | 2024-04-09 | Not public |
| Exhibit FBD 15 | 2024-04-09 | Not public |
| Exhibit FBD 14 | 2024-04-09 | Not public |
| Exhibit FBD 32 | 2024-04-09 | Not public |
| Exhibit FBD 27 | 2024-04-09 | Not public |
| Exhibit FBD 18 | 2024-04-09 | Not public |
| Exhibit FBD 9 | 2024-04-09 | Not public |
| Exhibit FBD 23 | 2024-04-09 | Not public |
| Exhibit FBD 3 | 2024-04-09 | Not public |
| Exhibit FBD 17 | 2024-04-09 | Not public |
| Exhibit FBD 31 | 2024-04-09 | Not public |
| Exhibit FBD 1 | 2024-04-09 | Not public |
| Exhibit FBD 29 | 2024-04-09 | Not public |
Novartis AG and Genentech, Inc. applied for provisional measures against Celltrion Inc. before the Düsseldorf Local Division concerning EP 3 805 248 B1, a patent directed to antibody concentration processes (relevant to biosimilars). The court dismissed the application because infringement was insufficiently established on the merits, and ordered Novartis/Genentech to pay interim costs of EUR 138,562.80. The court also clarified that R. 295 RoP stay provisions do not apply to PI proceedings.
Infringement insufficiently established; imminent infringement not proven to the required standard
RespondentLegal basis: Art. 62(1) UPCA; Art. 25 UPCANote: The Düsseldorf Local Division rejected the PI application on the merits, finding that Novartis/Genentech had not established infringement sufficiently for provisional measures.
R. 295 RoP (stay of proceedings) does not apply to PI proceedings
ClaimantLegal basis: R. 295 RoPNote: The court held that R. 295 RoP refers to 'actions' and is therefore not applicable to applications for provisional measures, rejecting any basis for a stay in this PI context.
Companies outside contracting member states that play a key role in distribution network may be considered infringers
ClaimantLegal basis: Art. 25 UPCANote: The court articulated that group companies outside contracting states that supply products to group members in contracting states for onward distribution can be considered infringers under certain conditions — though this principle alone did not save the application.
Preliminary injunction should be granted to prevent imminent infringement of EP 3 805 248 by Celltrion's biosimilar
ClaimantLegal basis: Art. 62(1) UPCA; Art. 25 UPCAReason: The court found infringement insufficiently established on the merits; specific claim interpretation and infringement evidence were not adequate to meet the standard required for provisional measures.
Browse other cases on this principle.
The court stated that claim interpretation is not only mandatory for the court but also for the parties, who must submit their proposed interpretations in their briefs. Technical argumentation must be focused and precise, especially in PI proceedings given ambitious time limits. No specific disputed term construction is detailed in the available excerpt.