Summary
The Patents Court has refused to grant an Arrow declaration following de-designation of UK from pending patent applications because there was no uncertainty about UK patent rights and the true purpose of the declaration would be its use in foreign courts.
Background
In Arrow Generics Ltd v Merck & Co Inc, the High Court held that it had a discretionary power to grant a declaration (Arrow declaration) that a generic pharmaceutical was known or obvious at the priority date of divisional patent applications ([2007] EWHC 1900 (Pat)).
Where an alleged infringement differs in only a non-novel or non-obvious way from the prior art at the priority date of the patent, the defendant has a good defence to infringement (Gillette defence) and it is not necessary also to challenge the validity of the patent (Gillette Safety Razor Co v Anglo-American Trading Co Ltd [1913]).
Where a patentee had abandoned UK patent protection and offered undertakings that it would not obtain UK patent protection of the relevant scope, the Court of Appeal held that an Arrow declaration would still serve a useful purpose where there was still significant commercial uncertainty and, having found that a Gillette defence was made out, granted the declaration (Fujifilm Kyowa Kirin Biologics Co Ltd v AbbVie Biotechnology Ltd & Another, www.practicallaw.com/1-639-2973).
The Court of Appeal has held that the courts should only grant an Arrow declaration if the declaration would serve a useful purpose (Glaxo Group Ltd and others v Vectura Ltd [2018] EWCA Civ 1496).
Facts
P applied for an Arrow declaration in relation to its proposed launch in Europe, including the UK, of a product for the treatment of various cancers.
R already marketed the product, the active ingredient of which was protected by its patent. As a result of a supplementary protection certificate, the protection conferred by R's basic patent had been extended to June 2020. P intended to launch its biosimilar product after that, but R had a number of second-line patents and patent applications relating to combinations of the drug with other cancer drugs for use in treating various types of cancers. P was concerned that one of those applications might lead to a patent being granted either before or after June 2020, and that R might try to obtain an interlocutory injunction against P.
R denied that it had any intention of obtaining a UK patent in the future since it had "de-designated" the UK from all relevant pending patent applications.
P argued that it would have a Gillette defence to any patent claim should R sue after the launch of its product because, given the state of the art at the earliest claimed priority date for a given patent or application, the invention lacked novelty or was obvious. P sought an Arrow declaration to the effect that certain acts would have been obvious in light of the state of the art at the relevant priority date. P argued that, in Fujifilm, an Arrow declaration had been granted even where UK patent protection had been abandoned and no UK legal rights existed. P was also concerned that, because it intended to supply the UK market from Belgium, a preliminary injunction application in Belgium would not only have effect in that country but would disrupt the UK market as well.
P argued that the removal of the UK designation from the pending European applications was a deliberate strategy by R to shield their patent applications from the scrutiny of the UK courts. P also argued that R also had not engaged with the question of novelty and inventive step of the European patent applications at any point in the UK court proceedings.
Decision
The court refused P's application.
In Fujifilm, the patentee had claimed it had or would have certain legal rights in the UK, had generated significant commercial uncertainty about the nature and scope of those legal rights, and had offered complicated and unclear undertakings which did not clarify the situation. In those circumstances it was not hard to see why a court was prepared to grant an Arrow declaration.
Here, an Arrow declaration would be of real commercial value to P by reducing uncertainty in relation to its launch of the product all over Europe. If there had been pending UK patent applications, there would have been a clear case for an Arrow declaration and the court would have gone on to examine the merits of the Gillette defence in detail. However, following the de-designation of the UK from pending applications, there was no uncertainty about UK patent rights: P could freely sell the drug in the UK after June 2020. The uncertainty arose from the fact that the product was to be supplied from a separate jurisdiction (Belgium) and what P really wanted was a UK judgment to use in Belgium.
As the true purpose of the Arrow declaration was for P to use it in foreign courts to help defend itself against claims brought by R, this was not enough to justify the grant of declaratory relief.
Comment
R's strategy of abandoning the opportunity to obtain any future UK patent right for the drug based on its pending European patent applications proved effective here to avoid an Arrow declaration. The same tactic failed in Fujifilm due to the particular circumstances, emphasising the discretionary and fact-dependent nature of this form of relief.
The District Court of The Hague has decided that it is competent to hear P's claims for an Arrow declaration there.
Case: Pfizer Ltd v F Hoffmann-La Roche AG & Anor [2019] EWHC 1520 (Pat).
First published in the January/February issue of PLC Magazine and reproduced with the kind permission of the publishers. Subscription enquiries 020 7202 1200.
