An Arrow Through Declaratory Relief?

• Published date: 23 December 2022
• Subject Matter: Intellectual Property, Patent
• Law Firm: Brown Rudnick LLP
• Author: Mr David M.G. Knight

What can a business do if it wants to launch a product on the market but a competitor with patent application rights keeps evergreening those patent applications by abandoning and filing divisionals? In this way, it can be that some patent applications are never fully tested, but nevertheless can create uncertainty for competitors considering launching a new product. Such uncertainty can exist in any sector, but it tends to happen most frequently in the pharmaceutical field.

The British courts have long provided assistance to a would-be market entrant in such circumstances in the form of a so-called Arrow Declaration which takes its name from the case Arrow Generics Ltd v Merck & Co Inc [2007] EWHC 1900 (Pat), [2008] Bus LR 487. In the words of Arnold LJ in the recent case of Teva UK Ltd and another v Novartis AG [2022] EWCA Civ 1617:

"An Arrow declaration is a declaration that a product, process or use was lacking in novelty or obvious as at the priority date of a patent application. The point of such declaration is that it is in effect a declaration that the claimant will have a Gillette defence to any subsequent claim for patent infringement in relation to that product, process or use: see Gillette Safety Razor Co v Anglo-American Trading Co Ltd (1913) 30 RPC 465. Thus it enables the court pre-emptively to determine a patent infringement case before the patent has even been granted without having to decide whether the patent would be invalid, or not infringed because the claimant's product, process or use would not fall within the claims, if and when granted."

In the recent Teva v Novartis case the Court of Appeal, upholding the decision of Bacon J in the High Court, decided that it was not proper in this case to make such a declaration. To understand the reasons why the application was brought but was ultimately unsuccessful, it is necessary to delve a little into the history to Novartis' patent applications and the litigation between the parties:

• Novartis marketed a drug under the trade mark Gilenya for the treatment of relapsing-remitting multiple sclerosis. The market for Gilenya is valuable - $2.8 billion worldwide, with annual sales in the U.K. alone of '46 million.
• Patent and regulatory protection for Gilenya finally expired on 22 March 2022.
• As is not uncommon in order to extend their exclusivity in Gilenya, Novartis had made patent applications for formulations of and dosage regimes, including:
• A European patent application EP 2 037 906 -...