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Patents Court rejects claim for Arrow Declaration

Posted on 09 July 2019

Patents Court rejects claim for Arrow Declaration

Recent years have seen the Courts considering whether to grant Arrow declarations to deal with particular instances of uncertainty caused by patentee prosecution strategies.  An Arrow declaration provides that a particular product intended to be launched by e.g., a generic or biosimilar manufacturer would have been obvious and/or lacked novelty in the light of the state of the art at a particular date, the priority date of a particular patent application.  As a result, if that application does subsequently proceed to a granted patent, the party with the benefit of the Arrow declaration can rely on it as a defence to any claim for patent infringement.

The Court of Appeal confirmed the jurisdiction to grant Arrow declarations in Fujifilm v AbbVie.  Because of the unusual circumstances in that case including AbbVie's conduct, and the need for commercial certainty, the Patents Court later decided it was appropriate to grant the declaration.

However, as an exercise of discretion, the decision to grant an Arrow declaration will very much depend upon the facts of the case, and the Court's assessment of whether it will serve a useful purpose.  In the latest case, Pfizer v Roche, the Patents Court has rejected Pfizer's application for an Arrow declaration in relation to its proposed launch in Europe of a biosimilar monoclonal antibody drug (bevacizumab) for the treatment of various cancers in combination with other drugs.  Roche markets a highly profitable bevacizumab product under the brand Avastin, and has a Supplementary Protection Certificate providing protection until June 2020. 

Pfizer's plans to launch immediately after expiry of the SPC in June 2020 are, it argues, hindered by a "thicket of second-line patents and patent applications" (all relating to combinations of bevacizumab with other known cancer drugs for use treating various types of cancers), which are causing general uncertainty.  Any of those current pending applications could lead to a granted patent on or after June 2020, and lead to potential interim injunction proceedings by Roche against Pfizer.  Given the uncertainty, Pfizer has applied for a European marketing authorisation based on a skinny label instead of a full label i.e., only for certain indications. Any declaration granted would be binding in the UK, but would also have strong persuasive effect in other European Patent Convention states, in particular in this case, Belgium (Pfizer intends to supply the UK market from Belgium).

However, the Court rejected the application for one key reason.  Roche has no relevant UK patent application and, a few weeks after Pfizer's court action began, it de-designated the UK from all relevant pending European Patent applications.  By this step, it abandoned any prospect of obtaining a UK patent in the future.  Pfizer argued that this was a "deliberate and transparent act of shielding" by Roche.  Given the UK was a valuable market for bevacizumab (both now and in the future), Pfizer argued this was clearly intended to prolong the commercial uncertainty. 

The Court concluded that the declarations sought would serve no useful purpose.  This was despite the fact that it inferred that Roche's motive for de-designating the UK was to shield its portfolio from the risk of an adverse decision in the UK court, and it recognised an Arrow declaration would be of real commercial value for Pfizer.  It also recognised that the true impact of such a declaration would be the spin-off value in foreign jurisdictions: "... the use of a UK patent judgment in other contracting states of the EPC can be very valuable and … it is legitimate for parties to rely on a judgment in that way". However "this cannot be taken too far and one needs to take into account the risk of forum shopping – where a declaration is sought from a UK court in a case with no connection to this jurisdiction". 

Of course, here, when the action began there were pending UK applications but where the only or predominant purpose of the declaration sought is to use the court's judgment in foreign jurisdictions, the Court will look very carefully at the case.  Here the Court was not persuaded that it was enough. Unlike the position in the Humira case, there was no outstanding uncertainty at all relating to bevacizumab and UK rights: "Pfizer does not need the Patents Court to tell it or anyone else that it can freely sell bevacizumab in this country without risk from the Roche patent families". 

It is possible that Pfizer will seek to appeal, albeit this is an exercise of the Court's discretion.  Interestingly, in May 2019, the District Court of the Hague confirmed in a landmark ruling in that jurisdiction parallel proceedings concerning bevacizumab that it has jurisdiction to grant Arrow declarations (which will now proceed to be determined). 

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