July 31, 2019

Facts

The claimant, Pfizer Ltd, issued proceedings against the defendants, F Hoffmann-La Roche AG and Roche Products Ltd (Roche), for Arrow declarations in relation to its proposed launch in Europe, including the UK, of a biosimilar monoclonal antibody drug called bevacizumab for the treatment of various cancers in combination with other drugs.

Roche already marketed a bevacizumab product in Europe under the brand name Avastin. Avastin was a successful product with a large market. A member of the Roche group held a patent for bevacizumab, which was due to expire in June 2020 and Pfizer wanted to launch of its own bevacizumats product immediately after that. However, Pfizer said that Roche had “a thicket” of second-line patents and patent applications that Roche could rely on after June 2020 to obtain an injunction against Pfizer. This was causing uncertainty generally. Pfizer contended that causing this uncertainty was a deliberate policy of Roche, as evidenced by its conduct of patent prosecution.

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

Mr Justice Birss noted that, assuming that to be true, then Pfizer would have a complete Gillette defence to any patent claim from Roche. However, Pfizer argued, an Arrow declaration (i.e. a declaration that certain acts would have been obvious in light of the state of the art at the earliest priority date) would allow the parties to resolve the dispute now and remove the uncertainty. It would be effective in the UK and would have a strong persuasive effect in other European Patent Convention states, including Belgium, from where Pfizer planned to supply the UK market.

A few weeks after Pfizer commenced proceedings Roche “de-designated” the UK from all of its relevant pending European patent applications. In principle, therefore, the risk of infringement proceedings against Pfizer after June 2020 fell away.

Pfizer argued that, despite this, the court should still grant an Arrow declaration, as there were other factors to consider. It said that the de-designation of the UK was a deliberate and transparent act of Roche shielding its patent applications from the scrutiny of the courts due to its case on novelty or obviousness being very weak. It said that the UK was, and would be in future, a valuable market for bevacizumab and that the only rational reason for Roche doing this was to prolong the commercial uncertainty.

The law

Declarations

It was not disputed that the court had the power to grant declarations, whether or not any other remedy was claimed. The factors that the court should take into account were set out in FSA v Rourke [2001] EWHC 704 (Ch):

“… when considering whether to grant a declaration or not, the court should take into account justice to the claimant, justice to the defendant, whether the declaration would serve a useful purpose and whether there are any other special reasons why or why not the court should grant the declaration”.

It was also not disputed that the court had the power to grant Arrow declarations. Jurisdiction for Arrow declarations was established in Arrow Generics v Merck & Co Inc [2007] EWHC 1900 (Pat), which stated that granting such a declaration was discretionary, but that while the existence of pending applications was necessary, it could not itself be a sufficient justification for granting a declaration; the declaration still had to serve a useful purpose.

Findings on Arrow declaration law

Birss J rejected Roche’s argument that the court had no jurisdiction to grant declarations where there was no dispute about UK legal rights or disputes of facts relevant to UK legal rights. Birss J said this was wrong because it purported to place a limit on the court’s power to grant a declaration even, when it would serve a useful purpose. The only relevant limitation was “useful purpose”.

For the same reason, Birss J also rejected Roche’s argument that there was a “hard-edged” point of principle that precluded the court from granting declarations in such circumstances. He also disagreed with Roche’s alternative argument that the useful purpose test should be related to a purpose that was useful in the context of a UK legal dispute. Birss J said that where forum shopping ((i.e. where a declaration is sought from a UK court in a case with no connection to this jurisdiction) was not a concern, the fact that the purpose was useful in relation to a dispute in a foreign court could justify granting a declaration (Deutsche Bank v Bright Food [2017] EWHC 3543 (Comm)).

Roche also argued that in the further alternative, and in any event, the circumstances did not justify granting an Arrow declaration because there was nothing in Roche’s conduct that justified it and because the only “useful purpose” relied on by Pfizer was the “spin-off value” of having a UK judgment to use in foreign jurisdictions, as Mr Justice Carr had called it in FujiFilm v AbbVie [2017] EWHC 395 (Pat). This was not enough.

In response, Birss J said that the true principle was that, in considering all the circumstances and the issue of useful purpose, the court should identify what the real purpose of the declaration was. There might be more than one purpose, he said, and the court should look carefully at a case in which the predominant purpose was to use the court’s judgment in foreign jurisdictions.

Belgian law

On the expert evidence, Birss J found that a Belgian court faced with a decision from the UK court would indeed examine its relevance and take all the circumstances into account, as Pfizer contended. That would include the fact that Roche had de-designated the UK. If Roche, in Belgium, advanced arguments it had not advanced here, it would be entirely open to the Belgian court either to decide that a UK court judgment was relevant or not.

Decision

Applying the law to the facts, Birss J focussed on whether an Arrow declaration would serve a useful purpose.

The prima facie merits of the technical case

Without going into too much detail, Birss J examined the prima facie merits of the technical case, saying it was relevant as it could help to explain Roche’s motives. In Birss J’s view, a patentee with faith in its case on the merits would be unlikely to engage in shielding.

Birss J found that, by the relevant earliest priority date for the relevant patent family, Bevacizumab was known to be a treatment with a different mechanism of action from the other standard drugs. Clinical trials showed that it was effective in combination with other standard drugs to treat certain cancers, and further trials were under way or, in some cases, had already reported on the efficacy of using the drug with established standard chemotherapy combinations. There was also an apparently strong case that it would be obvious to combine it with the other standard chemotherapy combinations and an apparently strong case that a skilled person would have reasonable prospects of success in providing improved efficacy that way. The evidence as a whole made a compelling case in favour of a Gillette defence.

Roche’s conduct and shielding

Birss J found that the potential value to Roche of the future UK market for Avastin was “very substantial”. The value, if Pfizer’s bevacizumab could be kept out of all the indications in issue in this case in the UK, was itself “very substantial”. Keeping the contested indications of Pfizer’s bevacizumab out of the UK market by using patents was, therefore, “a prize worth fighting this litigation for”, he said. On the other hand, looking at the market protected by the European patents as a whole, the future UK market was only a fraction of it. The same was true for the value of the market relating to the contested indications.

Birss J therefore inferred that Roche’s motive for de-designating the UK was indeed to shield its portfolio from the risk of an adverse decision in this court. There was no other rational explanation.

Further, some of Roche’s patent prosecution practice indicated shielding, Birss J said. For example, in relation to one of its applications, Roche had appealed the initial refusal by the examining division, but had then aborted the appeal. Birss J inferred that it had done that to avoid the risk of an adverse decision on appeal, which would carry more weight than a refusal by the examining division. “It was shielding”, Birss J concluded.

Nothing Roche did was unlawful, Birss J said, but its conduct did cause significant uncertainty for Roche’s competitors. Whilst Roche might have had a bona fide belief that, despite the obvious weakness of its portfolio, it might get or hold on to some kind of valid patent claim, that should not prevent the court from making an Arrow declaration when Roche had taken steps to shield the patents from scrutiny.

Real commercial value of a declaration?

Birss J said that an Arrow declaration would be of “real commercial value” for Pfizer, as it would reduce the uncertainty it faced in relation to its launch of bevacizumab all over Europe. A judgment could indeed be taken into account in Belgium and help Pfizer resist a patent case brought by Roche in that country.

Useful purpose – overall findings

If there were pending UK applications in any of the patent families, this would be a plain case for an Arrow declaration, Birss J said. However, given the complete absence of the possibility of UK rights in future, the reality was that the commercial value of an Arrow declaration to Pfizer was basically the benefit of a UK judgment to assist it to defend itself against proceedings brought by Roche in other European countries. However, the issue that would come before the Belgian court would be about a Belgian patent and Belgian law. The fact that a Belgian court would take a UK judgment into account did not alter the fact that the UK courts were in no better position to rule on those points of patent law.

A declaration might also be useful to assist settlement and it was probably applicable in this case, but on the facts, it was not enough to make a difference.

As for forum shopping, when the action began there were pending UK applications, but they had now gone. Although there might have been other factors to justify Arrow relief, in this case there were not. There was no evidence of uncertainty about UK patent rights. The true purpose of an Arrow declaration in this case was for it to be used in foreign courts and Birss J was not persuaded that that was enough.

Accordingly, irrespective of the merits of the Gillette defence claimed by Pfizer, Birss J did not grant an Arrow declaration. He did not examine the merits of the Gillette defence in any detail as to do so would be tantamount to doing the very thing he had decided not to do. (Pfizer Ltd v F Hoffman-La Roche AG [2019] EWHC 1520 (Pat) — to read the judgment in full, click here).