Arrow declarations

Dutch court confirms jurisdiction for arrow declarations

The District Court in the Hague has ruled in favour of Pfizer in a judgment concerning jurisdiction of arrow declarations. This is the first such jurisdictional challenge to occur in the Netherlands. The arrow declarations made by Pfizer against Hoffman-La Roche for the drug bevacizumab can now be heard in The Hague.

31 May 2019 by Amy Sandys

Arrow declarations, the Netherlands, divisions, secondary patent applications Pfizer has made arrow delcarations against Hoffman-La Roche concerning a biosimilar of the drug bevacizumab ©dvoinik/ADOBE STOCK

Swiss healthcare company Hoffman-La Roche currently owns the patent for bevacizumab. It treats eye disease and some cancers under brand name Avastin. The Roche patent expired in March 2018, and its corresponding SPC expires in June 2020. However, Roche also owns secondary patent applications. As a result, Pfizer has made arrow delcarations against Hoffman-La Roche.

Pfizer plans on entering the market following expiration of the SPC with a biosimilar for bevacizumab, and is currently awaiting market authorisation. Roche also owns secondary patent applications to cover the specific use of bevacizumab for metastatic breast cancer and ovarian cancer (EP 3 064 509 and EP 2 825 558). As the European Patent Office has not yet granted these patents, Pfizer cannot begin revocation proceedings.

Jurisdictional challenge

Judith Krens, Taylor Wessing, arrow declarations

Judith Krens

Represented by the Amsterdam office of Taylor Wessing, Pfizer instead filed three proceedings against Roche in the Netherlands (case IDs: C/09/557218/HA ZA 18-826, C/09/558313/HA ZA 18-892 and C/09/559368/HA ZA 18-951). All request arrow declarations on the secondary patent applications, stating the treatments are not inventive and are obvious over the prior art.

In January Freshfields Bruckhaus Deringer represented Roche in front of the District Court in The Hague on a jurisdictional challenge. The company argued that the arrow declarations cannot be heard in the Netherlands, given that Switzerland – not the Netherlands – is Roche’s home forum, and that the EPO has not yet granted the secondary patents. Roche claimed that the Dutch court has no jurisdiction to hear the arrow declarations.

Rutger Kleemans, partner, Freshfields Bruckhaus Deringer, arrow declarations

Rutger Kleemans

However, the District Court of The Hague ruled that it can legally hear Pfizer’s claims for arrow declarations and requests on future patent applications. This is in addition to any future divisionals in which the patent is granted.

The ruling is based on article 5(3) of the Lugano Convention and notes that the unlawful act – in this case, granting patent protection despite obviousness – could take place in the Netherlands.

This is despite the Pfizer biosimilar not yet being on the Dutch market, making the situation somewhat hypothetical.

Still, some lawyers suggest that the judgment paves the way for a broader applicability of arrow declaration decisions. In turn, this may lead to increased litigation.

Arrow declarations are new ground

This is the first ruling of its kind in the Netherlands. The jurisdictional plea has been accepted in prior judgments, but only in cases concerning a granted patent. Indeed, the effect may be severe – one Dutch lawyer speculates that the recent jurisdictional judgment could open the doors to forum shopping.

Roche must file a statement of response on the merits by mid-June. Although it is unknown if the Swiss company will appeal the jurisdictional decision, another Dutch source told JUVE Patent that the case is worth appealing, given its unprecedented outcome. In the UK, a trial has already taken place and the parties are awaiting a judgment.

Established histories

The Amsterdam office of Taylor Wessing is representing Pfizer. The team around Pfizer is led by attorney Judith Krens, one of three partners in the Amsterdam office and head of the life science and pharma team. The addition of Karen Shen, in-house counsel from the New York office of Pfizer, alongside two female Taylor Wessing associates cements the litigation team behind Pfizer as all-female. For the most part, this is relatively unusual in the Netherlands.

Pfizer is a long-standing client of Taylor Wessing. The relationships stems from the London office, particularly partner Nigel Stoate who worked with Hospira before the biosimilar was purchased by Pfizer in 2015. Stoate remains well-established with the pharmaceutical giant, mainly carrying out advisory and litigation work. Accordingly, the London office of Taylor Wessing acted for Pfizer in the parallel UK proceedings.

Mark Egeler, Freshfields Bruckhaus Deringer, arrow declarations

Mark Egeler

The Amsterdam office of Freshfields worked with Roche on the case, continuing its long-standing relationship with the firm. Freshfields often advise Roche on cases concerning intellectual property and competition law.

Rutger Kleemans, who led the case, is a partner in Amsterdam. Kleemans, along with litigators from Hogan Lovells, recently acted for Nikon on the Nikon vs. ASML case concerning optical exposure machines. Herbert Smith Freehills representend Roche in the London proceedings against Pfizer.

For Pfizer
Taylor Wessing (Amsterdam): Judith Krens (attorney, lead), Marthe Riewald, Charlotte Garnitsch
In-house (New York): Karen Shen

For Hoffman-La Roche
Freshfields Bruckhaus Deringer (Amsterdam): Rutger Kleemans (lead), Mark Egeler
In-house: Unknown

District Court of the Netherlands, The Hague