Glaxo Group Ltd & Ors v Vectura Ltd

An Arrow declaration that a product, process or use was old or obvious at a specified date is discretionary relief. A relevant pending patent application is necessary but insufficient. The court must examine whether the declaration would serve a useful purpose, including by providing commercial certainty against later patents.

On an application to strike out such a claim, the question is whether the pleaded facts disclose a realistic claim for relief. The trial judge must exercise the ultimate discretion by reference to the circumstances at trial.

The proposed declaration must clearly identify the combination of product or process features whose obviousness is to be determined. It need not identify every feature, but excluding a feature limits the protection afforded by the declaration.

GSK brought revocation proceedings concerning five of Vectura's patents for the delivery of drugs by inhalation. Vectura counterclaimed that GSK's Ellipta products and their manufacturing processes infringed those patents. GSK additionally sought an Arrow declaration that specified products and processes were obvious on or after the patents' claimed priority date, seeking commercial certainty against ungranted patents.

HHJ Hacon struck out the Arrow claim and the pleading that the products and processes were themselves obvious: [2018] EWHC 375 (Pat). GSK appealed. Vectura contended by respondent's notice that the declaration lacked sufficient clarity and improperly excluded the products' active ingredients.

The central issue was whether the pleaded facts disclosed a realistic claim for discretionary Arrow relief which should proceed to trial.

1. Appeal allowed. The pleaded claim for an appropriately worded Arrow declaration was sufficiently realistic to proceed to trial. Birss J agreed with Floyd LJ.

2. An Arrow declaration is, in effect, a declaration that a party has a Gillette defence as at a specified date. It may protect against later patents because a product or process which was obvious at the relevant date cannot fall within a valid claim of such a patent. The declaration nevertheless remains discretionary.

3. The statutory remedies concerning granted patents explain the need for caution but create no jurisdictional threshold requiring an applicant to establish that its case is sufficiently unusual. Under sections 71 and 72 of the Patents Act 1977, the existence of an identified granted patent permits the statutory remedies without further justification. By contrast, a pending application is necessary but insufficient for Arrow relief. The court must critically examine whether the proposed declaration would serve a useful purpose.

4. GSK relied on more than the mere existence of pending applications. It pleaded that Vectura had repeatedly reformulated substantially one inventive concept in different patent claims, could continue doing so despite revocation of the existing patents, and had declined to give an undertaking covering later patent families. Those allegations could establish that the declaration would provide useful commercial certainty.

5. The judge hearing the strike-out application was not exercising the trial court's discretion to grant Arrow relief. The interim question was whether the pleaded case had a realistic prospect of success. The ultimate discretion must be exercised by reference to the facts and circumstances existing at trial. It was therefore inappropriate at the interim stage to ask whether the facts were sufficiently unusual.

6. The allegation that GSK's products and processes were obvious should also remain pleaded as a Gillette defence to the granted patents. Although conventional patent cases are not decided solely by that approach, it can operate as a cross-check.

7. The respondent's notice was rejected. A declaration must clearly identify the combination of features upon which obviousness is to be assessed, both to prevent further disputes and to define the technical issues for decision. Neither proposed formulation was shown to be incapable of satisfying that requirement. A declaration need not identify every feature of a product or process. Excluding the active ingredient would merely limit the resulting protection. Further case management could define the disputed features before trial.

1. Court of Appeal (Civil Division): The appeal was allowed. The Arrow claim, and the allegation supporting the Gillette defence, were permitted to proceed to trial: [2018] EWCA Civ 1496 .
2. High Court, Patents Court: HHJ Hacon struck out the claim for an Arrow declaration, the related prayer for relief and the pleading that the products and processes were obvious: [2018] EWHC 375 (Pat).