Pfizer v Roche: jurisdiction for Arrow-declarations in the Netherlands

In a landmark ruling, the District Court of The Hague decided that it is competent to hear Pfizer’s claims for requested Arrow declarations.

Summary of proceedings

Bevacizumab

F. Hoffmann-La Roche AG (“Roche”) holds a European patent for the compound bevacizumab, which is marketed under the trade name Avastin® and used in treatment of various forms of cancer. The protection of this patent and rights connected to it expires in June 2020. After this date, Pfizer wishes to enter the market with its biosimilar of bevacizumab to be used in (among others) the treatment of ovarian cancer in combination with standard chemotherapies.

However in addition to the compound patent for bevacizumab, Roche has filed various patent applications aiming to cover the use of bevacizumab in combination with standard chemotherapies for such treatments and Pfizer expects Roche to file even more patent applications. As these (future) applications have not yet proceeded to grant, Pfizer cannot initiate revocation proceedings to clear the way for its bevacizumab biosimilar.

Arrow-declarations

Pfizer therefore requests negative judicial declarations that the proposed uses of Pfizer’s bevacizumab biosimilar are not new and are obvious over the prior art at the application date of the relevant patent applications and/or further divisionals thereof. Such declarations are often referred to as “Arrow”-declarations.

Jurisdiction challenge and judgement

Roche challenged the jurisdiction of the Dutch courts to hear Pfizer’s requests for these declarations. Roche argued that the Dutch court cannot assume jurisdiction as Switzerland – not the Netherlands – is Roche’s home forum.

In its judgement of 8 May 2019 the District Court of The Hague ruled that it is competent to hear Pfizer’s claims for the requested “Arrow”-declarations based on the applicable (EEX-equivalent) EVEX. The Court argues that whilst there are no granted patents yet and Pfizer is not yet on the market, this fact does not preclude assuming jurisdiction. The patentee, also before grant of a patent, is allowed to request reasonable compensation of possible infringers. The legal certainty arguments of Pfizer thus apply to the relevant patent applications and possible divisionals as well, rendering the Dutch court competent and rejecting the jurisdiction challenge as raised by Roche.

The relevance of the judgement

This judgement can be considered as a landmark decision as prior to this judgement it was unclear whether the Dutch courts would assume jurisdiction to hear claims regarding this type of declarations in the absence of any granted patent being challenged.