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14 May 2019

Pfizer PFE B.V. v. F. Hoffmann-La Roche AG, Roche Nederland B.V., District Court The Hague, 8 May 2019, Case no. ECLI:NL:RBDHA:2019:4515

Pfizer initiated three separate proceedings on the merits against Roche in The Netherlands requesting negative judicial declarations (so called “Arrow”-declarations). Roche responded by filing a motion to the District Court in The Hague to decline jurisdiction in the case against the Swiss Roche entity and render the case against the Dutch Roche entity inadmissible.

In the current judgment the Court dismisses the motion on jurisdiction. The Court declares itself competent to hear Pfizer’s claims for negative judicial declarations that certain intended treatments with a pharmaceutical are not new and are obvious over the prior art at the application date of the relevant patent applications and/or further (future) divisionals thereof.

Summary of the relevant proceedings

Roche AG was the holder of an EP patent for the active compound bevacizumab, the connected Supplementary Patent Certificate will expire in June 2020. Roche markets bevacizumab under the tradename Avastin®.

In addition to this patent, Roche has filed various patent applications, including EP 509 and EP 558 aiming to protect certain treatments of ovarian cancer with bevacizumab in combination with other pharmaceuticals. Roche could file further divisionals under EP 509 and/or EP 558.

Pfizer has developed a biosimilar for bevacizumab which it intends to bring to the market. The biosimilar is currently in the registration phase for a marketing authorization in the European Union.

The motion and grounds for dismissal thereof

The motion that is the subject of these proceedings was dismissed by the Court on the following grounds.

The Court accepted jurisdiction based on Article 5(3) of the Lugano Convention (EVEX, similar to EEX) as the harmful event occurred or may occur in the Netherlands. A negative judicial declaration denying liability arising from an unlawful act is within the scope of that article.

The Court recalls that there are no granted EP patents yet but only (future) patent applications and that the Pfizer biosimilar is not yet on the Dutch market. While for now the unlawful situation to be assessed is hypothetical, the Court confirms that this fact in itself does not preclude the acceptance of jurisdiction (with reference to CJEU 25 October 2012, C-133/11 (Folien Fischer) and Court of Appeal The Hague, 19 December 2017 (Tata v. AcelorMittal)).

As a side note, the Court points out that the situation is not entirely hypothetical. It refers to Article 72 of the Dutch Patent Act (‘DPA’), that grants a patent holder the right to claim reasonable compensation for actions preceding the grant of a patent (after a notice of infringement and after the patent has been granted). Roche is therefore, with retroactive effect, able to claim compensation for acts carried out by Pfizer relating to its biosimilar prior to the grant of Roche’s patent rights. Market participants such as Pfizer therefore have, also in this respect, an interest in the legal certainty a negative judicial declaration offers. Prior to the grant of a patent they must be able to turn to the Court, invoking article 5(3) of the Lugano Convention.

Continuing the line of arguments for applicability of Article 5 of the Lugano Convention, the Court then finds there is sufficient connection to the Netherlands. Roche has designated the Netherlands as a country for which it wishes to receive patent protection. The Pfizer group has announced its intended market introduction of the biosimilar of bevacizumab and it seems obvious that Pfizer wishes to introduce its bevacizumab biosimilar in the Netherlands. Finally Roche did not confirm to Pfizer that it would not enforce its future patent rights in case of a market introduction in the Netherlands.

The next question was whether the jurisdiction of the Court extends to judicial declarations in connection with potential future divisionals of patent applications EP 509 and/or EP 558.

Again the Court considers that the fact that it is a hypothetical situation does not preclude application of Article 5(3) of the Lugano Convention. The above mentioned Article 72 DPA, that grants reasonable compensation to the patent holder, also applies to divisionals. As a result the legal certainty arguments as raised by Pfizer in relation to the patent application also apply to potential divisionals, resulting in jurisdiction for the Dutch Court.

Finally, the Court considers that Roche’s strategy seems to be focused on keeping open the possibility to file further divisionals. Therefore, Pfizer’s statements in this respect are in fact not merely hypothetical.

The Court then argues that within the Netherlands it is the District Court in The Hague that has exclusive territorial jurisdiction according to Article 80(2)(b) DPA. The District Court in The Hague finds that this is the place where the harmful event in the sense of Article 5(3) Lugano Convention may occur. It would also have been foreseeable for Roche to be sued before a Dutch judge.

Also, Roche’s statements that Pfizer tries to circumvent the jurisdiction of the EPO are rejected as the Dutch action does not limit the jurisdiction of the EPO.

The Court further notes that Article 22(4) of the Lugano Convention does not lead to a different result in this case, as applicability of this article to further EP patents valid in the territory of the Netherlands, would also result in jurisdiction of the Dutch Courts.

Finally, the Court resolves any uncertainty around the fact whether Pfizer’s claims would be cross-border and accepts that the claims only relate to the parties subject to these proceedings related to infringement in the Netherlands on the Dutch part of EP patents.

The motion of Roche related to jurisdiction is dismissed. The questions regarding compensation of legal costs and admissibility of the claims pertaining to Roche NL will be decided in the main action.

A copy of the judgment (in Dutch) can be found here.

Headnote and summary: Eelco Bergsma, Taylor Wessing