ACT 18551/2024
—·EP3805248: PROCESS FOR CONCENTRATION OF ANTIBODIES AND THERAPEUTIC PRODUCTS THEREOF
- Case details
- Status—ActionProvisional measuresCategoryProvisional Measures
- Parties
- ClaimantsReps: Frank-Erich Hufnagel (Freshfields Bruckhaus Deringer); Kilian Seidel (Freshfields Bruckhaus Deringer); Cameron Marshall (Carpmaels & Ransford); Joanna Rowley (Carpmaels & Ransford)Respondents
- Division
- Dusseldorf LD
- Judges
- Berenice Thom · Legally Qualified Judge
- Alima Zana · Legally Qualified Judge
- Technology
- Organic Chemistry
- Language
- —
- First decided
- Sep 6, 2024
- 2024-09-06PI deniedPreliminary injunctionApplication for provisional measures
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.
Legal issues:Provisional measures (Art. 25, 62 UPCA)Imminent infringementClaim interpretationLis pendensNon-applicability of R. 295 RoP (stay) to PI proceedingsCosts in PI proceedings (R. 118.5 RoP analogy)Biosimilar / biologic patentDamages: 138,562.8
- 9673D137E47932C96EED7ACCDA4DB3EA_en.pdf2024-09-06EN
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.
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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.