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Striking Out Claims for an Arrow Declaration

In a recently reported case, Glaxo Group Ltd and Others v Vectura Ltd 2018 EWCA Civ 1496, the Court of Appeal reviewed the case law relating to the grant of a discretionary relief known as an “Arrow Declaration” and determined that interim proceedings had only to decide whether the pleaded facts and arguments gave rise to a “realistic claim” for such relief.

The Arrow declaration is an order of the UK Courts that a product, process or use was known or obvious at a particular date – and cannot later be the subject of valid UK patent protection.

The declaration may be sought during court proceedings for revocation or infringement of a patent when there are related patent applications (such as divisional applications) which would also threaten the launch of the product, process or use and the grant would serve a “useful purpose”.

Here, the Court of Appeal had to consider whether a decision from the High Court to strike out a claim for an Arrow declaration on the basis that “there we no prospect of the Court granting the declaration on the facts as they presently appeared or as they might emerge at the trial” was correct.

The original proceedings arose from an application for revocation of five patents (with priority date 30 November 2000) belonging to Vectura for which Glaxo Group (GSK) had not exercised its option to take a licence but had instead sought an acknowledgement that it would not infringe those patents and an assurance that Vectura would not assert any patent claims arising from as yet ungranted patents.

Vectura refused to give such an acknowledgement and counterclaimed for infringement of the patents.  However, following the start of the proceedings Vectura gave an undertaking that in the event that none of the claims of the patents were held to be valid and infringed in a final decision from the proceedings (i.e. one which could not be appealed), it would not assert in the UK any patent applications relating to the patents which subsequently proceeded to grant.

The undertaking did not, therefore, relate to certain other patent applications that might give rise to later patents which could be asserted against its Ellipta® products.

Accordingly, GSK had sought an Arrow declaration in the form:

  • [GSK’s] Processes, namely a process in which (i) lactose monohydrate and magnesium stearate are first blended together to produce a lactose/magnesium stearate pre-blend (ii) micronized active ingredient combined with a portion of the pre-blend is then sieved to de-lump the active ingredient, and (iii) the remaining pre-blend is added and the whole batch further blended to produce an homogenous blend, was obvious as of 30 November 2000 or any date thereafter; and
  • [GSK’s] Products insofar as they are the direct products of [GSK’s] Processes (and save for the active ingredient therein) were obvious as of 30 November 2000 or any date thereafter.

In considering the question before it, the Court of Appeal pointed out its earlier decision in Fujifilm Kyowa Kirin Biologics Co. Ltd v AbbVie Biotechnology Limited and Another [2017] EWCA Civ 1 395.

Lord Justice Floyd referred to paragraph 98 of that decision as stating that “the existence of pending applications cannot of itself be a sufficient justification for granting a[n Arrow] declaration” and that “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”.

Lord Justice Floyd considered the High Court to have accepted that GSK had relied on other matters including Vectura’s long history of splitting divisional applications out of existing patent applications but that it had concluded these were not sufficient reasons for a claim for an Arrow declaration to proceed to trial.

In allowing the appeal, Lord Justice Floyd said that GSK’s case for the grant of Arrow relief “does not depend on the mere existence of further applications. [The] resolution of the issues which arise in relation to the granted patents may not give them, in the circumstances of this case, the commercial certainty which they require.  Vectura has the potential to continue to reformulate the inventive concept using applications which are still on file, even if GSK are successful in revoking each of the five patents”.

He added that he “did not accept that the [High Court] was exercising [its] discretion when striking out the claim for Arrow relief.  The task which [the High Court] was required to undertake was to determine whether the pleaded facts and arguments gave rise to a realistic claim for Arrow relief which should go to trial.  The discretion to grant Arrow relief is that of the trial judge, not that of the judge hearing the strike out application”.

Lord Justice Floyd went on to say that “[i]n approaching this task at the interim stage, one should have in mind that it is the facts and circumstances at the date of the trial which will ultimately be determinative of whether the discretion will be exercised” – adding that for similar reasons, he did not accept that it is sensible to ask, at this stage, whether the facts relied upon are sufficiently unusual to justify Arrow relief and that “this would be a particularly difficult test to apply at this interim stage before any facts are found”.

We note Lord Justice Floyd to say that proceedings before trial should not decide on whether the grant of an Arrow declaration would serve a “useful purpose” but only on whether there was a “realistic claim” for such relief.

This notwithstanding an apparent lack of clarity in the Arrow declaration and the exception of the active ingredient from the obviousness of the Processes and/or Products:

Vectura argued that the products and processes of which the declaration was sought were not sufficiently well defined to be justiciable – saying that it was not clear whether the declaration was sought only in relation to GSK Processes and Products at the level of detail in the body of the declaration or whether it was intended that the declaration should extend to every aspect of the process described in the Product and Process Description (PPD) annexed to the Particulars of the Claim.

However, Lord Justice Floyd said that he did not accept that it is clear at this state that either “the general declaration” or the “PPD declaration” is so unclear that it could not be granted.  He added that he rejected the ground that the PPD declaration would impose an unmanageable task on the Court and gave recommendations concerning the case management.

Vectura also argued that the Arrow declaration could not be granted because the patent application relied upon included active ingredients in its claim (as currently drafted) and GSK had specifically excluded the obviousness or otherwise of their active ingredients from the terms of the declaration.

Having regard to this, Lord Justice Floyd said that “it is clear……that there is no requirement that an Arrow declaration should identify all the features of the product or process.  The consequence of the exclusion of the active ingredient from the characteristics of the processes declared obvious is that it will limit the protection available to GSK by the granted declaration”.

He accepted, therefore, that the Arrow declaration sought by GSK would not provide protection if the patent application relied upon is granted with the claims in the form in which they presently exist – but considered that those claims were not set in stone and that the main relevance of the patent application was to show that Vectura continued to seek ways of protecting the use of magnesium stearate in these processes and products.

We observe that it remains to be seen if the Arrow declaration is sufficiently clear or can be amended to be made clear and whether the circumstances are such that its grant is considered to serve a “useful purpose”.

What is clear from this decision is that interim applications to strike out claims for Arrow relief are likely to be difficult to obtain.

Please get in touch with Simon Fortt on mail@tlip.co.uk for further information.