Missed! Arrow Declarations - Pfizer v Hoffmann La Roche

Author: User:Drgd.mscLicence:  Copyright waived by the owner
Source: Wikipedia Arrow 

Jane Lambert
Patents Court (Mr Justice Birss) Pfizer Ltd v F. Hoffmann-La Roche AG and another [2019] EWHC 1520 (Pat) (20 June 2019)

An "Arrow declaration" is a declaration that a product or process was known or obvious at a particular date and therefore could not fall within the claims of a patent.  It takes its name from the decision of Mr Justicce Kitchin as he then was in Arrow Generics Ltd and another v Merck & Co,  [2007] FSR 39, [2007] EWHC 1900 (Pat), [2008] Bus LR 487 where his lordship refused to strike out an application for such a declaration. The purpose of Arrow declarations is to determine in advance issues that might prevent or delay a  competitor from entering a market immediately after a monopoly is due to come to an end.  Thus, in Arrow, the launch of a competing product was threatened by the revival of several divisional applications that had been derived from a revoked patent.  Had the competitor not applied for the declaration when it did it might have been challenged by new patents as soon as the divisional applications proceeded to grant.

In Pfizer Ltd v F. Hoffmann-La Roche AG and another [2019] EWHC 1520 (Pat) (20 June 2019) the claimant sought Arrow declarations in relation to the proposed launch of a drug called bevacizumab, for the treatment of certain cancers in combination with other drugs. The defendants had held a patent for bevacizumab the monopoly of which was extended by a supplementary protection certificate until June 2020. The defendants' sales of the product exceeded £1 billion in 2018.  The claimant planned to launch bevacizumab as soon as the SPC expired but the defendants had what the claimant called a "thicket of second-line patents and patent applications" which hindered it in various ways and caused uncertainty generally. The claimant alleged that that uncertainty was a deliberate policy. The claimant feared that one of those applications might be granted before the SPC expires which might enable the defendants to obtain a preliminary injunction to restrain the marketing of its competing product.  The defendants responded by removing the UK from the list of countries for which patents from those applications could be granted.

The action came on before Mr Justice Birss.  He discerned two issues at paragraph [13] of his judgment. One was the technical issue about the novelty or obviousness of the use of the various bevacizumab combinations for the relevant cancer indications. The other was the declaration issue. The declaration issue was not simply whether the court should grant a declaration assuming the technical issue was established. It was also whether the court should enter into the technical issue in any depth at all if it would not grant a declaration irrespective of the outcome on the technical issue.  As none of the patents that might be granted to the defendants would apply to the United Kingdom there was nothing to prevent the marketing of the claimant's products after the expiry of the SPC. Any decision on the novelty or obviousness of the claimant's products would apply to the remaining jurisdictions, and in particular, Belgium from where claimant hoped to supply the UK.

His lordship directed himself that he had power under CPR40.20 to make binding declarations whether or not any other remedy is claimed.  That power was considered by Mr Justice Neyberger (as he then was) in Financial Services Authority v Rourke [2001] EWHC 704 (Ch), [2002] CP Rep 14 (19 Oct 2001):

"It seems to me that, 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. "

He reminded himself that the court had power to grant declarations that certain acts would have been obvious in light of the state of the art at a particular date. He referred to the judgment of the Court of Appeal in Fujifilm Kyowa Kirin Biologics Co, Ltd v Abbvie Biotechnology Ltd and another  [2017] EWCA Civ 1, [2018] Bus LR 228 in which Lord Justice Moore-Bick had said at paragraph [98]:

"We have said enough to explain why we do not consider that there is any issue of principle which prevents the granting of Arrow declarations in appropriate cases. Drawing the threads together: (i) A declaration that a product, process or use was old or obvious at a particular date does not necessarily offend against section 74 of the 1977 Act. (ii) Such a declaration may offend against the 1977 Act where it is a disguised attack on the validity of a granted patent. (iii) Such declarations do not offend against the scheme of the EPC or the Act simply because the declaration is sought against the background of pending divisional applications by the counter-party. (iv) On the other hand the existence of pending applications cannot itself be a sufficient justification for granting a declaration. (v) Whether such a declaration is justified depends on whether a sufficient case can be made for the exercise of the court's discretion in accordance with established principles."

He noted that the Court of Appeal had also held in Glaxo Group Ltd and others v Vectura Ltd.  [2018] EWCA Civ 1496, [2019] Bus LR 648, [2018] WLR(D) 400 that any declaration that the court might make had to serve a useful purpose.

After taking all those matters into account, Mr Justice Birss refused to grant the declaration that the claimant had sought. 

He explained at [118] that if there had been pending UK applications in any of the patent families, there would have been a plain case for an Arrow declaration. Given the complete absence of the possibility of UK rights in future, the reality was that the commercial value of an Arrow declaration to the claimant was the utility it might have (along with a reasoned judgment) in helping it defend itself against suits brought by the defendants in other European countries. The case was unlike FujiFilm in that in relation to bevacizumab there was no outstanding uncertainty at all relating to UK rights. The claimant did not need the Patents Court to tell it or anyone else that it could freely sell bevacizumab in the UK without risk from the defendant's patent families.

He understood that what the claimant wanted was a UK judgment that it could use in Belgium. Though a Belgium court might well take his decision into account any litigation in Belgium would concern a Belgian patent to be determined in accordance with Belgian law. This was not a case like Deutsche Bank (China) Co Ltd, Shanghai Branch v Bright Food Hong Kong Ltd [2017] EWHC 3543 (Comm) where there was an issue of English law upon which an English court could conveniently rule.  His lordship concluded at [122]:

"When the action began it was not forum shopping at all. There were pending UK applications which provided a basis for considering an Arrow declaration. However now they have gone. There might have been other factors which justified Arrow relief such as arose in Fujifilm but on examination in this case, there are not. There is no evidence of uncertainty about UK patent rights. The true purpose of an Arrow declaration in this case would be for it to be used in foreign courts. I am not persuaded that that is enough."

This is an example of an Arrow declaration that did not work.  The reason it failed is that the defendants were prepared to sacrifice the whole UK market.  That may well be the best tactic for dealing with such an action.  Anyone wishing to discuss this article or Arrow declarations, in general, should call me on +44 (0)20 7404 5252 during office hours or send me a message through my contact page.