English High Court refuses to grant Pfizer Arrow declaration

Pfizer’s attempt to secure an Arrow declaration in relation to its proposed launch of a cancer drug in Europe was shot down yesterday, June 20, by the English High Court.

Pfizer was seeking an Arrow declaration (a declaration that certain acts would have been obvious in light of the state of the art at a particular date) for its proposed launch of a biosimilar monoclonal antibody drug called Zirabev (bevacizumab), which is used to treat various cancers in combination with other drugs.

Defendant Roche markets a bevacizumab product under the brand name Avastin. European sales of Avastin in 2018 were over £1 billion ($1.3 billion).

Genentech (a member of the Roche group) held a patent for bevacizumab and, as a result of a supplementary protection certificate (SPC), the protection conferred by the basic patent continues until June 2020.

Pfizer wants to launch Zirabev immediately after the expiry but claimed that Roche has a “thicket of second-line patents and patent applications” which hinder Pfizer and are causing uncertainty.

One of the uncertainties is that a currently pending application might lead to a patent being granted either before or after June 2020 and Roche might try to obtain an interlocutory injunction against Pfizer. Pfizer has claimed that causing this uncertainty is a deliberate policy of Roche.

Pfizer argued that a judgment on these issues would have a strong persuasive effect in other European states.

In the decision, Justice Birss said: “Pfizer plans to supply the UK market from Belgium and so a preliminary injunction application in Belgium would not only have effect in that country but would disrupt the UK market as well.”

According to the court, Pfizer can obtain a marketing authorisation to use its drug to treat colon, lung, renal and cervical cancer and can market its product after expiry of the SPC. However, Roche’s patents relate to breast and ovarian cancer.

Pfizer claimed that bevacizumab, in combination with the other cancer drugs for the treatment of breast cancer and ovarian cancer, lacked novelty and/or was obvious, given the state of the art at the earliest claimed priority date for the relevant patent/applications.

Roche disagreed with this, claiming that it hadn’t deliberately created uncertainty or that its conduct could be characterised as ‘shielding’ in the manner the term is used in the cases on Arrow declarations.

Importantly, Roche doesn’t have a relevant UK patent and has abandoned any prospect of obtaining such a UK patent in future. In November 2017, Roche completed the ‘de-designation’ of the UK from all relevant pending European patent applications.

Roche said that this means the UK court shouldn’t grant an Arrow declaration as it would serve no legal purpose.

Birss said that the value of Pfizer's bevacizumab could be kept out of all the indications at issue in the UK is very substantial.

“It is far more than the cost of this sort of litigation. Keeping the contested indications of Pfizer's bevacizumab out of the UK market by using patents would be a prize worth fighting this litigation for,” he added.

However, the future UK market is only a fraction of the market protected by Roche’s European patents, said the judge.

“I infer the Roche's motive for de-designating the UK is to shield its portfolio from the risk of an adverse decision in this court. There is no other rational explanation,” concluded Birss.

He added: “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.”

Birss also concluded that an Arrow declaration would be of real commercial value for Pfizer and would reduce the uncertainty which it faces.

However, the judge refused to grant an Arrow declaration.

He said: “If today there were pending UK applications in any of the families, this would be a plain case for an Arrow declaration … However given the complete absence of the possibility of UK rights in future, the reality is that the commercial value of an Arrow declaration to Pfizer is the utility it might have (along with a reasoned judgment) in helping Pfizer defend itself against suits brought by Roche in other European countries.”

In this case, the true purpose of the declaration would be for it to be used in foreign courts and Birss was “not persuaded that that is enough”.

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