Roche shields itself from a UK Arrow: Pfizer v Roche

The UK courts have discretion to grant a declaration that any future patent granted covering a product, would necessarily, be invalid (an "Arrow declaration", Arrow v Merck). In a High Court decision published last week, Mr Justice Birss considered whether an Arrow declaration may be granted even where there was no possibility of a UK patent right ever coming into existence: Pfizer v Roche [2019] EWHC 1520 (Pat). 

The case concerned two giants of the bio-pharmaceuticals world, Roche and Pfizer, and Roche's blockbuster biologic, Avastin. Roche markets the monoclonal antibody drug bevacizumab for the treatment of cancer, under the brand name Avastin. Roche's European sales for Avastin in 2018 were over £1 billion.

Arrow

The Supplementary Protection Certificate (SPC) for Avastin expires in June 2020. Pfizer has produced its own bevacizumab biosimilar that it plans to launch after expiry of the Avastin SPC. Pfizer's complaint to the UK court was that Roche has a "thicket" of second-line patents for bevacizumab with which Roche is deliberately hindering Pfizer and causing legal uncertainty. These patent applications relate to bevacizumab combination therapies and the use of bevacizumab to treat various types of cancer. Pfizer argued that an Arrow declaration should be given on the grounds that any patents granted to these second-medical uses of bevacizumab would necessarily lack novelty and inventive step. Therefore, if Roche tried to enforce such a patent, Pfizer would have a complete Gillette defence.

Would an Arrow declaration be useful?

As established in Glaxo v Vectura [2018] EWCA Civ 1496, the UK court should only grant an Arrow declaration if the declaration would serve a useful purpose. Roche and Pfizer disagreed as to the meaning of "useful" purpose. 

At the time of the trial, Roche had no relevant UK patents. Roche had also removed the UK designation from all the relevant pending EP applications (e.g. EP3064509 and EP2825558) shortly after the request for an Arrow declaration was filed. Given that therefore, a EP (UK) patent was not possible for the relevant indications, Roche argued that an Arrow declaration could serve no useful or legal purpose. As Mr Justice Birss summarised, "Pfizer does not need the Patent Court to tell it or anyone else that it can freely sell bevacizumab in this country without risk from the Roche patent family" (para. 118). 

In response, Pfizer argued that "useful purpose" could be interpreted as broadly as to mean anything that was useful to the claimant. Pfizer argued that, even though no UK rights could be enforced, a declaration would be useful because of it potential influence in Belgium, a EPC state that was still designated in the EP applications. Pfizer planned to supply the UK market from Belgium, so a preliminary injunction action in Belgium would disrupt both the Belgium and UK market for the biosimilar.

Mr Justice Birss agreed that just because UK rights were not at issue, a declaration could serve no useful purpose (para. 86): 

the true principle...is that in considering all the circumstances and the issue of useful purpose, the court will wish to identify what the real purpose of the declaration is.

Mr Justice Birss found that an Arrow declaration would have a real commercial value for Pfizer, as it would reduce the uncertainty for its bevacizumab launch all over Europe (para. 115). 

Was Roche shielding? 

Pfizer argued that the removal of the UK designation from the pending European applications was a deliberate strategy by Roche to shield their patent applications from the scrutiny of the UK courts. Roche also did not engage with the question of novelty and inventive step of the EP applications at any point in the UK court proceedings. Further evidence of shielding, said Pfizer. 

Roche characterised their position as "a principled stance on technical issues". Mr Justice Birss was not impressed with this: 

"The characterisation is self-serving and hypocritical. Roche is entitled to choose not to challenge the technical evidence if it wishes and I make no criticism at all. However this approach is not based on some high principle. Roche is simply seeking to do everything it can to minimise the utility to Pfizer of any relief Pfizer can obtain in this jurisdiction."

Mr Justice Birss further observed that "[a] patentee with faith in its case on the merits would be unlikely to engage in shielding" (para., 109). The Judge further concluded that the size of the bevacizumab European market outside the UK was considerable. As such, there was "no other rational explanation" than that Roche's motive for de-designating the UK was to shield its portfolio from the risk of an adverse UK court decision (para. 110). 

One point of contention was the normality of the Roche's European patent application prosecution strategy. Settling the point required the assistance of expert witnesses in the form of patent attorneys (one of whom, in the Judge's opinion, provided long but enthusiastic answers...para. 18 [correction, 1 July 2019]). Mr Justice Birss felt that "the focus on the minutiae of patent prosecution risks getting out of hand" [Merpel: surely not?]. However, in view of this evidence, Mr Justice Birss did find that the behaviour of Roche in withdrawing an appeal in order to avoid an adverse decision by a Board of Appeal (and the extra weight this would have over an Examining Division decision), was obvious shielding. However, Mr Justice Birss observed that Roche was perfectly entitled to do this:

"Nothing Roche has done is unlawful. Objectively this conduct gives rise to significant uncertainty for Roche's competitors. Roche knows that perfectly well. On the other hand Roche would no doubt like to get a valid patent for one of these indications if it can. It is entitled to try. "

Should an Arrow declaration be granted?

Mr Justice Birss summarised that what Pfizer really wanted was a UK judgement that it could use in Belgium. However, the Judge was unwilling to provide such a judgement, because:

"the issue which will come before the Belgian court (if it ever does) will be about a Belgian patent and Belgian law. The fact that a Belgian court would take a judge of this court into account does not alter the fact that the UK courts are in no better position to rule on those points of law...What will happen in Belgium...is nothing to do with any UK legal right"

Mr Justice Birss concluded that the true purpose of an Arrow declaration in the case in question would be for it to be used in foreign courts, and he was not persuaded that that was enough. Pfizer's request for an Arrow declaration was therefore refused.

Roche's strategy of abandoning the opportunity to obtain any future UK IP right for Avastin based on its pending EP applications proved effective in this case. Strategies such as this may interact interestingly with the new SPC manufacturing waiver that is to come into force on 1 July 2019. Under the waiver, biosimilar manufacturers will be able to export and stockpile biosimilar and generic drugs from the EU 6 months before the expiry of an SPC. If there is no patent or SPC in the UK, and the UK has left the EU, this will include export to the UK from the EU.

Notably, Pfizer is pursuing its request for an Arrow declaration elsewhere in Europe. Recently, the District Court of The Hague decided that it is competent to hear Pfizer’s claims for requested an Arrow declaration. The patent applications (as of today) still designate the Netherlands. For how much longer?