The High Court has refused to strike out a claim for a declaration that a generic manufacturer would have a Gillette defence to a claim for infringement of a divisional patent application once granted.
The High Court has held that it had discretionary power to grant a declaration that a generic pharmaceutical was obvious at the priority date of divisional patent applications (an Arrow declaration) (Arrow Generics Ltd v Merck & Co Inc ).
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 ).
AB and AU (together, A) owned patents protecting a drug used to treat inflammatory diseases, and a related supplementary protection certificate (SPC), which were due to expire. A filed numerous applications for secondary patents protecting dosing regimes, formulations and uses of the drug (the secondary applications).
F intended to launch a generic equivalent in the UK when the SPC expired, so wanted to clear the way of any patents granted on A's secondary applications. F brought an action against AB seeking revocation of two European patents and an Arrow declaration (the first action). F's application to strike out the claim for an Arrow declaration was dismissed. F's appeal against this decision is pending.
F brought an action against A (the second action) seeking:
- An Arrow declaration to provide F with protection against subsequent claims for infringement of any patents within a family of the secondary applications.
- An injunction to restrain A from threatening or commencing proceedings for patent infringement in respect of acts covered by the declaration.
In the second action, F was granted permission to serve on AB outside the jurisdiction.
A applied to set aside the order in respect of AB, and to strike out, alternatively for summary judgment dismissing, the claim against AU.
The court dismissed A's applications. The court had power to grant an Arrow declaration, including a negative declaration. An Arrow declaration served a useful purpose because it was in effect a declaration that F would have a Gillette defence to a subsequent claim for patent infringement in relation to its product. Arrow declarations do not involve the validity of a patent being put in issue. Rather, they enable the court to pre-emptively 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, when granted.
F sought an injunction restraining A from threatening or bringing patent infringement proceedings. The court had power to grant a domestic anti-suit injunction against A on the ground that the proceedings which A threatened to bring were vexatious or oppressive or an abuse of process. However, this power had to be exercised with caution and any injunction was likely to be qualified so as to permit A to commence proceedings with the permission of the court. The scope of the injunction would have to be carefully considered at trial. F had a real prospect of obtaining an injunction, but not independent of the Arrow declaration.
F's claim for an Arrow declaration was concerned with the validity of prospective European patents because it would require the court to determine the single question of whether F had infringed a valid claim of those patents. The fact that it would enable the court to do so pre-emptively before the patents had been granted was irrelevant. It did not matter that the court would not have to decide whether the patents would be invalid, or whether F's product would not infringe any of the patents because it would fall outside the claims. If the Arrow declaration was granted, it would mean that the claims would either be invalid or not infringed, and it did not matter which.
F had a good arguable case that the court had jurisdiction over its claim for an Arrow declaration against AB on the basis of a tort claim where jurisdiction is conferred on the courts for the place where the harmful event occurred or may occur, which may be either the place where the damage occurred or the place where the event giving rise to the damage occurred. This also applied to claims for negative declarations. Alternatively, jurisdiction could be on the basis that A was a necessary or proper party, or on the basis of an injunction to do or refrain from doing acts in the jurisdiction.
There was no alternative forum. England was the appropriate forum for F's claims because they were concerned to establish F's freedom to market its product in the UK under UK patent law. The strength or weakness of F's claim for an injunction was irrelevant to the exercise of the discretion to give permission to serve out of the jurisdiction, given that England was clearly the appropriate forum and more than one of the jurisdictional gateways had been established.
The combination of the Gillette defence and the power to grant Arrow declarations makes the UK a favourable jurisdiction for generic pharmaceutical manufacturers faced with a patent owner attempting to extend its monopoly over a very profitable drug by extensive filings of secondary formulation, dosage and use patents. As a result of this decision, steps taken during the prosecution of these patents which appear to have no good reason apart from continuation of uncertainty as to the scope and validity of those patents will make it easier for a generic company to get an Arrow declaration. However, A's appeal challenging the correctness of the Arrow decision in the first action has yet to be heard.
Case: Fujifilm Kyowa Kirin Biologics Company Ltd v Abbvie Biotechnology Ltd and AbbVie Ltd  EWHC 2204 (Pat).
First published in the November issue of PLC Magazine and reproduced with the kind permission of the publishers. Subscription enquiries 020 7202 1200.