UPC: the Düsseldorf LD on the concept of “imminent infringement”

By order dated 6 September 2024, the Düsseldorf Local Division of the UPC elaborated on when a situation of “imminent infringement” exists which entitles the patent holder to an interim injunction under Article 62(1) UPCA (UPC_CFI_165/2024, Novartis AG – Genentech Inc vs Celltrion group).

Specifically, Novartis and Genentech (Applicants) requested an interim injunction against several companies of the Celltrion group (Defendants) claiming infringement of their pharmaceutical patent EP 3 805 248 (EP248). In fact, the Applicants alleged that the Defendants were about to launch a biosimilar to Novartis’s XOLAIR product, containing the patented formulation, produced by Celltrion Inc and distributed in several EU countries by the other Defendants under the name OMLYCLO. Evidence of such immediate lunch was given by the fact that the Defendants:

-       in August 2022 had publicly announced their intention to launch the product in Europe in 2024;

-       in 2023 had commenced invalidity and non-infringement proceedings in the UK and the Netherlands and filed an opposition against EP284 before the EPO;

-       in March 2024 had issued a press release emphasising their intention to launch the product in EU as soon as possible after obtaining the European market authorisation;

-       on 16 May 2024 had obtained the marketing authorisation for OMLYCLO from the EMA;

-       on 24 May 2024 had issued another press release announcing the approval of the European marketing authorization and their plan to rapidly expand their market share.

In the decision at issue, the Court noted that the Defendants had not substantially disputed that the OMLYCLO fall within the scope of claim 1 of EP248. Nevertheless, the injunction could not be granted as the Defendants’ conduct did not yet constitute an imminent patent infringement pursuant to Art. 62(1) and Art. 25(a) UPCA.

Specifically, the Court noted the following:

• “Since claim 1 of the patent in suit is a product claim, the requirements for direct infringement are – in addition to the product being the subject matter of the patent in suit – acts of use namely making, offering, placing on the market, or using a product which is the subject matter of the patent, or importing or storing the product for those purposes. Only offering is seriously alleged in the present case and the Court cannot find any conduct of the Defendants which already constitutes offering”;

• “A situation of imminent infringement must be characterised by certain circumstances which indicate that the infringement has not yet occurred but that the potential infringer has already set the stage for it to occur. The infringement is only a matter of starting the action. The preparations for it have been fully completed. (…) “The question to be answered is whether the conduct of the Defendants leads to the conclusion that they more likely than not intend to enter the market during the patent term without any further ado”.

• “In order for an infringement to be imminent, in the present case means that all pre-launch preparations must have been completed in such a way that an offer can be made at any time”. However, “The Court cannot find that that the Defendants have already completed all the pre-launch preparations as such. (…) There is no specific information that any price negotiations or reimbursement applications by the Defendants have already started or are ongoing. Nor is there any specific situation in which samples were actually presented to potential customers”. Consequently, “at the time of the Court's order, there is not yet sufficient evidence that the infringement is imminent”.

The order also provides a few other takeaways, summarised hereunder.

i)    In case of multiple Defendants, where one of them has its residence within the territory of the Local Division seized, the latter is competent to hear the case under Art. 33(1)(b) UPCA, regardless of whether the other Defendants are located inside or outside the Contracting Member States or the EU. Indeed, the only requirements to be met are that: 1) the multiple Defendants have a commercial relationship; 2) the action relates to the same alleged infringement. The fact of belonging to the same group and having related commercial activities aimed at the same purpose (such as R&D, manufacturing, sale and distribution of the same products) is sufficient to be considered as “a commercial relationship”.

ii)   The Defendants are cumulatively liable because they acted in a close and interdependent commercial relationship.

i)    The court decided not to stay the proceedings in favour of the Dutch proceedings as:

-         the parties and the causes of action were not the same, hence art. 29 and art. 31(1) Brussels Ibis (Regulation EU no. 1215/2012) did not apply;

-         a stay of the proceedings was incompatible with the urgent nature of provisional measures, hence also art. 30(1) Brussels Ibis on related actions did not apply;

-         rule R. 295 RoP refers unambiguously to actions and is therefore not applicable to applications for provisional measures.

ii)   If a party necessarily considers that a technical argument must be substantiated by a party’s expert opinion, it shall present the technical argument to the Court in a concentrated and comprehensible form. This is not the case where mere reference is made to a party’s expert report.

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