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Pfizer Ltd v F. Hoffmann-La Roche AG & Anor [2019] EWHC 1520 (Pat)

In a High Court judgment handed down at the end of June, Birss J refused Pfizer’s request for so-called “Arrow” declaratory relief in relation to five of Roche’s drug combination patents covering bevacizumab (marketed by Roche as Avastin).

Pfizer intend to launch their biosimilar version of bevacizumab (known as Zirabev) on expiry of the bevacizumab basic patent SPC in June 2020. In addition to the basic patent for bevacizumab, Roche has several European patent families (including pending divisional applications) that cover combination therapies of bevacizumab with other cancer drugs.

By the time of trial, Roche had no relevant UK patents (the UK having been de-designated for some families well before proceedings began and others shortly thereafter) and furthermore had abandoned any prospect of obtaining such a UK patent in the future. Pfizer sought Arrow declaratory relief, namely that that the combination of their Zirabev product with the other cancer drugs in question lacked novelty and/or was obvious at the priority date of the earliest patent family.

At a high level there were two main issues in the case:
1. The technical issue about novelty and/or obviousness of the various bevacizumab combinations for the relevant cancer indications; and

2. The ‘declaration issue’ which covered both (a) whether Arrow declarations should be granted (assuming the technical issue was established), and (b) whether the court should enter into the technical issue in any depth at all if it would not grant a declaration.

Arrow declaratory relief
Birss J reviewed the general case law in relation to Arrow declarations, establishing that they are discretionary remedies which can be granted in circumstances where the court considers that they will serve a “useful purpose”. Roche’s submission that there was no jurisdiction to grant a declaration where there was no dispute over a UK legal right was rejected. On the issue of so called “spin off” value (i.e. value that a declaration and judgment would have in other European jurisdictions), Birss J expressed the view that the court must look carefully at a case in which the only or predominant purpose of the declaration sought is to use the court’s judgment in foreign jurisdictions.

Belgian law
Belgium, which forms part of Pfizer’s supply chain for the European (including UK) Zirabev product, was the key focus. Having considered both parties’ expert evidence on Belgian law, Birss J found that a reasoned judgment of the UK court granting an Arrow declaration could play a significant role in resisting a preliminary injunction in Belgium.

Useful Purpose
Birss J considered the following factors:

Prima facie merits of the technical case
Roche chose not to put forward any expert evidence on the technical case, whereas Pfizer served expert reports from specialists in ovarian and breast cancer. Birss J considered the merits of the case very briefly, concluding that the technical evidence made a compelling case in Pfizer’s favour, i.e. in support of lack of novelty and/or obviousness. It was relevant to examine the apparent merit of the technical case as it may shed light on the patentee’s motives. A patentee with faith in their patent is unlikely to engage in shielding.

Shielding by Roche
Pfizer argued that Roche had engaged in shielding behaviour, in an attempt to prevent the validity of its patents being properly examined by the courts and to deliberately create uncertainty in the market. Having considered both parties’ evidence from patent attorneys on patent prosecution practice, Birss J concluded that there was no rational explanation for Roche’s de-designation of the UK patents other than seeking to shield their patent portfolio from scrutiny by the UK courts.

Real commercial value of a declaration
In addition to assisting with resisting a preliminary injunction in Belgium, Pfizer had argued that a reasoned judgment would help them decide if Zirabev should be launched on a full label or on a skinny label carving out the patented indications. As there would be only one label for the whole as Europe, this would have a direct UK impact. Birss J agreed with Pfizer that there was real commercial value in the Arrow declaration for these reasons.

Birss J noted that settlement can be useful purpose, and that it probably applied in this case, but considered that on the facts it was not enough to make a difference.

Conclusion on Useful Purpose
Birss J noted that if there had been pending UK applications, then this would have been a clear case for Arrow relief. In this case however, there was no possibility of any UK rights arising in the future. The reality was that the commercial value of the Arrow declaration was the utility that it (and the associated reasoned judgment) might have in defending against preliminary injunctions in other European jurisdictions.

Whilst uncertainty remained for the UK market since the product is supplied from Belgium, and despite having found that the Belgian court would take a UK judgment into account, ultimately the UK courts are in no better position to rule on those points of patent law. Although what will happen in Belgium is likely to affect the UK market, that is due to the local effect in Belgium of a Belgian designation of the European patent and is nothing to do with a UK legal right.

Technical Judgment
Having concluded that he would not grant an Arrow declaration in this case, Birss J decided that he would not examine the merits of the case as “to do so would be tantamount to doing the very thing I have decided not to do”.

A copy of this judgment can be read here.

Elsa Glauert and Amy Crouch, Simmons & Simmons LLP