Life Sciences
Significant decision

Novartis & Genentech v Celltrion (UPC_CFI_165/2024)

Decision date:

06 September 2024

Court
Düsseldorf LD
Patent
EP 3 805 248

Full decision available here:

Osborne Clarke summary

  • Novartis and Genentech's application for provisional measures (preliminary injunction) was rejected by the Düsseldorf LD.
  • Novartis and Genentech were the proprietors of an EP and they alleged (imminent) infringement by the defendants. The defendants are all part of the Celltrion group, the parent company of which is involved in parallel UPC litigation. The parent company has developed a biosimilar and the defendant group companies have a manufacturing and distribution network.
  • In the case of multiple defendants, where one of the defendants has its residence within the territory of the LD seized, Article 33(1)(b) UPCA must be applied, regardless of whether the other defendants are located outside of that territory or inside or outside the EU. The requirements that must be met for the court to have competence are therefore that the multiple defendants have a commercial relationship and the action relates to the same alleged infringement.
  • There was competence here as Novartis and Genentech sufficiently stated that i) one of the defendants was domiciled in Germany; ii) all the defendants had a commercial relationship and iii) the application concerned the same alleged infringing acts.
  • The court disagreed with the defendants that different national approaches should be applied to assess the "threat of imminent infringement" during the UPC's transitional period: it is the for the UPC to determine, on the basis of the UPCA, what requirements must be met in order for an infringement to exist.
  • The court concluded that there was not yet sufficient evidence that the alleged infringement was imminent. Imminent infringement involves "certain circumstances" which suggest that although the infringement has not yet occurred, "the potential infringer has already set the stage for it to occur". This is assessed on a case by case basis. The court did not find that the defendants had already completed all the pre-launch preparations. Although the first defendant had obtained a marketing authorisation and there was some promotion of this, the advertising materials did not include a specific timeline, there was no information on any price negotiations or reimbursement applications by the defendants, and samples were not presented to customers.

Issue

Preliminary injunction refused
Provisional measures

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