The Court of Appeal has ruled that the discretion as to whether or not to award Arrow relief lies with the trial judge, for exercise in light of the facts and circumstances at the date of the trial.

In an application to strike out such a claim (i.e. before the trial has been reached), the task for the court is merely to determine whether the pleaded facts and arguments give rise to a realistic claim which should go to trial. At such a preliminary stage it is not appropriate for the court to determine whether the facts relied upon are sufficiently "unusual" to justify Arrow relief.

The Court of Appeal's judgment in Glaxo Group Limited & Ors v Vectura Limited [2018] EWCA Civ (28 June 2018), overturning HHJ Hacon's first instance judgment, is now available to read.

What is Arrow relief?

An Arrow declaration is, in effect, a declaration that a party has a Gillette defence, as of a particular date, against allegations of infringement of patents of later date. The Arrow name derives from the case of Arrow v Merck [2007] EWHC 1900 (Pat), in which the relief was first considered by the court.

The Gillette defence is a long-standing feature of English patent law, the name of which can be traced to the speech of Lord Moulton in Gillette Safety Razor Co v Anglo-American Trading Co Ltd (1913) 30 RPC 465. In a Gillette defence a defendant contends that his (allegedly infringing) product or process was obvious at a particular date and accordingly cannot fall within a valid claim of a later patent.

What are the conditions for obtaining Arrow relief?

The first award of Arrow relief was by the Patents Court (Henry Carr J) in Fujifilm Kyowa Kirin Biologics v AbbVie Biotechnology [2017] EWHC 395 (Pat), after the Court of Appeal paved the way for the award of such relief in appropriate cases in its interim judgment in the same case ([2017] EWCA Civ 1).

In the Fujifilm case, the Court of Appeal concluded that ([98]):

"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 Patents Act.

ii) Such a declaration may offend against the 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 European Patent Convention or the Patents 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."

In the Glaxo case, the Court of Appeal (Floyd LJ) noted that the statutory remedies of revocation and declaration of non-infringement may be obtained by any party in respect of a defendant's granted patent if the statutory tests are satisfied. (A declaration of non-infringement may of course be sought on the basis of a Gillette defence). In contrast, the award of Arrow relief, which is geared at providing the claimant with a shield against not-yet-granted patents, entails the exercise of the court's discretion. So what did paragraphs 98(iv) and 98(v) of the Court of Appeal's judgment in Fujifilm require?

HHJ Hacon had held at first instance that further to paragraph 98(iv) of Fujifilm: "it was necessary for "something more" than the existence of pending patent applications to be identified before the court could go on to exercise its discretion to grant relief". Glaxo had not shown "something more", so the claim was struck out.

In overturning HHJ Hacon, Floyd LJ said that 98(iv) and (v) must be read together. He reiterated that the identification of a relevant patent application is not "sufficient" for the award of such relief, but that it is necessary to go further and to examine whether Arrow relief would serve a "useful purpose" (per the "established principles" referred to in paragraph 98(v)). However, it is the facts and circumstances at the date of the trial which will ultimately be determinative of whether the discretion should be exercised. It was not "sensible to ask, at this stage [i.e. at a strike-out], whether the facts relied on are sufficiently "unusual" to justify Arrow relief. This would be a particularly difficult test to apply at this interim stage before any facts are found".

What is required in order to commence a claim and defeat any strike out application?

Floyd LJ ruled that provided "the pleaded facts and arguments give rise to a realistic claim for Arrow relief", it passes the "strike-out" threshold and the claim should be permitted to proceed to trial. "The discretion to grant Arrow relief is that of the trial judge, not that of the judge hearing the strike out application".

In accordance with the usual procedural principles, when considering Vectura's application to strike out Glaxo's claim for Arrow relief, the assumed facts could be taken from Glaxo's pleading and arguments before the court.

On the basis of Glaxo's pleaded case, it did have a realistic claim.

What were the pleaded facts and arguments that meant GlaxoSmithKline's claim was realistic?

Glaxo contended that Vectura had pursued a strategy of filing multiple patent applications to create a thicket of patents in relation to the use of magnesium stearate for formulations for dry powder inhalers. This was a strategy that had been pursued over many years and was continuing. The claim language had been formulated and re-formulated to describe in various ways what was essentially a single inventive concept. This was creating commercial uncertainty for Glaxo. Vectura had also taken the trouble to specify the active ingredients in Glaxo's Elipta products, which could be seen as an attempt to target Glaxo specifically. In the circumstances, Glaxo's contention was that the Arrow declaration sought would provide it with valuable commercial certainty - and therefore its grant would serve a "useful purpose".

"Clarity" of the declaration sought?

Vectura's Respondent's Notice raised the argument that the wording of the declaration being sought by Glaxo was not clear. Glaxo's declaration focussed on three features of its industrial process (in summary (i) pre-blending; (ii) de-lumping, and (iii) further blending) but with reference to a more detailed Product and Process Description ("PPD").

Floyd LJ confirmed that "there is no dispute that the declaration must be formulated with clarity", not just because the Court needs to know what the technical issues it has to decide are, but also because the facts ultimately declared by the Court must be clear.

In relation to Glaxo's drafted declaration in its prayer for relief, Floyd LJ said: "I do not accept that it is clear at this stage that either the general declaration [focussing on the three features] or the PPD declaration [including the full detail of the PPD] is so unclear that it could not be granted. In each case Glaxo would have to establish that the relevant features were old or obvious at the level of generality at which they are pitched."

It appears therefore that the precise terms of any "Arrow declaration" sought would be the subject of some degree of "negotiation" during the course of the trial procedure. This is similar to what happened in both the Arrow and Fujifilm cases (in which the precise wording of the declaration sought developed during the respective case).

Thus it appears that as long as a "realistic claim" for a declaration in the terms sought at the early stage of an action can be raised, it should be something that will survive a strike-out, and proceed to be determined on the facts at the trial.

What next for the Glaxo v Vectura dispute?

Glaxo's claim for Arrow relief will now proceed to trial along with its claims for (i) declarations of non-infringement and (ii) invalidity and revocation in respect of five granted patents. In the context of the declarations of non-infringement, the first instance judge's broad strike out, which had encompassed Glaxo's Gillette arguments in respect of the granted patents, had been wrong also.

Gowling WLG acted for GlaxoSmithKline.