GSK awarded Arrow declaration in patent dispute with Vectura

13 December 2018

GlaxoSmithKline ("GSK") has succeeded in the High Court of England and Wales in its patent dispute with Vectura, a UK based pharmaceutical company specialising in formulation of inhalable medicaments. GSK was successful in both its Gillette defence and in obtaining the award of an Arrow declaration.

The judgment of Mr Justice Arnold in Glaxo Group Limited & Ors v Vectura [2018] EWHC 3414 (Pat) (13 December 2018) is notable for two key reasons:

  1. GSK's success in a case primarily based on a "Gillette defence": that GSK's own manufacturing processes and the resulting products would have been obvious to the skilled person at the priority date of the patent in suit. This was despite the judge declining to find that Vectura's patents in suit were obvious (although he did find them invalid for insufficiency by way of ambiguity);
  2. Arnold J's conclusion that on the "unusual" facts of this case, the award of an Arrow declaration would serve a useful purpose: it would formalise and emphasise that GSK's own manufacturing processes (and their direct products) were obvious. In the context of Vectura's further pending patent applications covering the use of key excipient ingredients, the Arrow declaration would avoid the judge's conclusions on the Gillette defence being interpreted as obiter.

GSK's successful Gillette defence

GSK's success on its Gillette defence (see Gillette v Anglo-American Trading [1913] 30 RPC 465) was specific to the facts of the case: in addition to the Judge finding that GSK's processes (for formulating its proprietary active ingredient) were obvious over the pleaded prior art, he also found that it was not possible to determine when the patented invention had been performed (i.e. whether 'magnesium stearate' had been structurally combined with, and "fused" to, particles of active ingredient). This meant that (i) each of Vectura's five patents in issue was insufficient for ambiguity and (ii) infringement of them had not been established.

GSK's success in securing the award of an Arrow declaration

The judge's reasoning underpinning his award of an Arrow declaration (see Arrow Generics v Merck [2007] EWHC 1900 (Pat) and Fujifilm v AbbVie [2017] EWHC 395 (Pat)) provides valuable further guidance on the conditions needed to be satisfied for an award of this relatively new form of relief, as well as on the types of factual situation in which those conditions may be satisfied.

Vectura's patents in suit were a subset of a wider group of patents defined by a previous agreement between GSK and Vectura as "Non-Assert Patents". In the course of Vectura's earlier unsuccessful attempt to strike out GSK's claim for Arrow relief, Vectura had given an undertaking not to sue GSK under any of the Non-Assert Patents. (Our commentary on the interim dispute regarding strike out is available here).

In the meantime, GSK had identified another pending application of Vectura's, "415", which was outside of the Non-Assert Patents, but which related to the same technical subject matter of the Non-Assert Patents, or at least had the potential for further divisional patents to be filed covering that technical subject matter. Vectura, however, declined to extend its undertaking beyond the Non-Assert Patents to cover 415 also.

Following the Court of Appeal's judgment in Fujifilm v AbbVie [2017] EWCA 1, it has been clear that for an Arrow declaration to be granted, there must be more than just a finding that the relevant subject matter is obvious (in this case the finding made as part of GSK's Gillette defence). As Arnold J put it in this GSK v Vectura judgment, "that is a necessary, but not sufficient, foundation for the relief": there must also be a "useful purpose" in granting the declaration.

In late 2017, in Generics v Yeda [2017] EWHC 2629 (Pat), Arnold J declined to grant an Arrow declaration for want of a useful purpose over the finding he had already made: that Generics' product in a particular dosing regimen was obvious at a particular date. In GSK v Vectura, however, Arnold J distinguished his judgment in Generics v Yeda in three ways:

"254. … First, Vectura have failed to establish infringement of the Patents because they have not been able to identify a suitable analytical technique to demonstrate that certain requirements of the claims of the Patents are satisfied. Vectura would not necessarily face the same difficulty with differently formulated claims."

"255. Secondly, I have not found that the Patents were obvious. It would be an open question as to whether patents with differently formulated claims were obvious or not."

"256. Thirdly, and most significantly, Vectura has given an undertaking which is designed to give GSK comfort that, if they are successful in defeating Vectura's claims for infringement of the Patents, then they will not be vexed by further claims for infringement of other patents by the same process and products; yet Vectura's undertaking does not extend to patents deriving from (for example) 415. Counsel for Vectura was unable to give me any explanation for Vectura's unwillingness to extend its undertaking to (at least) 415. It follows that GSK are potentially at risk of a claim for infringement of a patent deriving from (at least) 415."

It is the third reason, the most significant for Arnold J, which carries a warning for legal professionals. Offering undertakings during proceedings can be seen as a way to cut down the scope of dispute, and indeed in the case of a claim for an Arrow declaration may be a way to curtail such a claim before it gets off the ground, by stripping it of useful purpose.

However, in order to achieve this, an undertaking must go far enough to remove all useful purpose. If a party caveats or limits the scope of its undertaking, it must be ready to explain comprehensively why that is appropriate. Without such a comprehensive explanation, any partial undertaking is more likely simply to highlight to the court that there is, indeed, a useful purpose in the relief sought.

This case marks the second Arrow declaration to be granted, the first being Fujifilm v AbbVie [2017] EWHC 395 (Pat), in relation to which Gowling WLG also acted for the successful party.

A copy of the judgment can be found here Glaxo Group Ltd & Ors v Vectura Ltd [2018] EWHC 3414 (Pat).

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