Novartis v Celltrion Healthcare Hungary (CFI, 6 September 2024)

Dhenne Avocats · 10 October 2026

Our analysis

Summary

By order of 6 September 2024 (UPC_CFI_165/2024, ACT_18492/2024), the Düsseldorf Local Division (R. Thomas, presiding, B. Thom, judge-rapporteur, A. Zana, J. Petersen) dismissed Novartis AG and Genentech, Inc.’s application for provisional measures against seven Celltrion group distribution companies, the first named being Celltrion Healthcare Hungary Kft., based on EP 3 805 248 for an anti-IgE antibody formulation and directed at the omalizumab biosimilar marketed as OMLYCLO. Although the product falls within claim 1, a threat of infringement was not established.

The decision sets a demanding threshold for imminent infringement in the biosimilar context: a marketing authorisation, press releases and commercial contacts are not enough until launch preparations are complete. It also orders the unsuccessful applicants to pay interim costs of EUR 138,562.80.

Facts and procedure

The EMA granted the marketing authorisation for OMLYCLO to the first defendant on 16 May 2024. Parallel proceedings were pending in the United Kingdom and the Netherlands, together with an EPO opposition filed on 16 October 2023. The application covered neither the Netherlands nor Malta. The applicants relied on press releases of 25 March and 24 May 2024, booths at the Belgian Dermatology Days in Bruges and the EAACI Congress in Valencia, an email of 10 April 2024 from the second defendant to a potential customer, and alleged price negotiations in France and samples offered to dermatologists. A parallel case, UPC_CFI_166/2024, was directed at the parent company, Celltrion Inc. The oral hearing took place on 31 July 2024.

The applicable law

Provisional measures are governed by Art. 62(1) UPCA and Rule 209.1 RoP. The division states that Art. 25 UPCA is uniform substantive law and Art. 62(1) UPCA uniform procedural law, both interpreted independently of national law. Jurisdiction over all defendants rests on Art. 33(1)(b) UPCA, the second defendant being domiciled in Germany and the group companies having a commercial relationship concerning the same alleged infringement.

Question

Is infringement imminent where a biosimilar manufacturer has obtained its marketing authorisation and announced its launch, but no marketing acts are established?

Decision

The division refuses a stay in favour of the Dutch proceedings: Art. 29 of Regulation 1215/2012 requires the same parties and the same cause of action and does not cover provisional measures, the identity of Celltrion Healthcare B.V. with the seventh defendant having moreover been established only at the end of the hearing. Art. 31 does not apply and a discretionary stay under Art. 30 is incompatible with urgency (section II). Rule 295 RoP refers to actions and does not apply to applications for provisional measures (section III). On the merits, histidine in the claim includes its protonated form with a counterion, and the product claim is not limited to the manufacturing process (section IV). OMLYCLO falls within claim 1, and the group companies would be cumulatively liable (section V).

Imminent infringement nevertheless requires concrete indications, in the overall circumstances, that the potential infringer has set the stage, with all pre-launch preparations completed so that an offer can be made at any time. Price negotiations in France are not established, the statements on samples are contradictory, and the other incidents are not sufficient (section V). The defendants’ request for security for costs is dismissed for want of any sign of insolvency (section VI). Interim costs are awarded by analogy with Rule 211.1(d) RoP, since an unsuccessful applicant is unlikely to bring an action on the merits (section VII). The value in dispute is set at EUR 7,500,000.

Key points for practice

• A marketing authorisation and an announced launch do not in themselves amount to imminent infringement.
• Rule 295 RoP on stays does not apply to proceedings for provisional measures.
• A defendant that defeats an application for provisional measures may be awarded interim costs by analogy with Rule 211.1(d) RoP.
• Practical point: a patentee targeting a biosimilar launch should gather consistent evidence of marketing acts, such as offers or samples, before seeking interim relief.

Provisions applied

Agreement on a Unified Patent Court

Arts. 25, 33(1)(b), 62(1) and 69(4)

Rules of Procedure

Rules 118.5, 158, 209.1, 211.1(d), 213.1 and 295

Regulation (EU) No 1215/2012

Arts. 29, 30 and 31

European Patent Convention

Art. 64

Case law cited

myStromer AG v Revolt Zycling AG, Düsseldorf Local Division, 18 October 2023 (UPC_CFI_177/2023), NanoString v 10x Genomics, Court of Appeal, UPC_CoA_335/2023

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.