Arrow Declarations Re‑energised: GSK’s Battle and Its Implications for Patent Strategy

After a decade-long pause, Arrow declarations—originating from the 2007 High Court decision in Arrow Generics Ltd & Anor v Merck & Co, Inc [2007] EWHC 1900 (Pat)—have returned to prominence following the Court of Appeal’s 2017 judgment in Fujifilm Kyowa Kirin Biologics Co, Ltd v Abbvie Biotechnology Ltd & Anor [2017] EWCA Civ 1. The Court confirmed that, in appropriate circumstances, a declaration that a medicinal product was obvious at the priority date could be granted, setting a new precedent for patent disputes.

Strategic Value of an Arrow Declaration

An Arrow declaration can be leveraged as a Gillette defence—referenced in Gillette Safety Razor Co v Anglo-American Trading Co Ltd (1913) 30 RPC 465. By establishing that a product was obvious at the priority date, a party can argue either that the product does not infringe the patent or that the patent itself is invalid, creating a powerful tool for patent litigation.

Glaxo Group v. Vectura: A Case Study

In the 2018 case of Glaxo Group Ltd & Ors v Vectura Ltd [2018] EWHC 375 (Pat), Judge Hacon was presented with Vectura’s request to strike out part of GSK’s claim seeking an Arrow declaration. GSK sought to prove that its manufacturing processes for respiratory inhalation drugs were obvious at the priority dates of five contested Vectura patents. To bolster its position, GSK cited other Vectura patents potentially covering its products and the existence of pending divisional applications.

Judge Hacon, referencing Lord Justice Floyd’s earlier comments in Fujifilm, ruled that pending applications alone were insufficient grounds for an Arrow declaration. Consequently, the strike‑out application for Arrow relief was granted.

Appeal and Court of Appeal Ruling

GSK appealed, contending that the Arrow claim should have proceeded to trial. On 28 June 2018, Floyd LJ delivered the Court of Appeal’s decision in Glaxo Group Ltd & Ors v Vectura Ltd [2018] EWCA Civ 1496. The court clarified that the trial judge—not the interim judge—holds discretion over Arrow relief. It was deemed premature to assess whether the facts were “unusual” at an early stage. Floyd LJ therefore allowed GSK’s Arrow claim to go to trial, deeming it a realistic prospect of relief.

Implications for Future Litigation

This ruling suggests that interim strike‑out applications for Arrow relief will be more difficult to succeed in the future. Whether GSK ultimately obtains the relief it seeks will depend on the forthcoming autumn trial.