ACT_18551/2024
PROCESS FOR CONCENTRATION OF ANTIBODIES AND THERAPEUTIC PRODUCTS THEREOF
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.