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November 2016

There has been much interest over the last four years in the English Actavis v Eli Lilly¹ decisions, which accepted jurisdiction to award a declaration of non-infringement for Italy, Spain, Germany, France and the UK, in circumstances where the defendant was domiciled in the United States and the claimant undertook not to raise validity of the patent in dispute.

There is now a question about whether it might be possible to obtain a cross-border form of the 'Arrow declaration' at issue in the recent Fujifilm Kyowa Biologics ("FKB") v Abbvie Biotechnology Ltd². If this is possible it may have implications for the cross-border reach of the English court on matters of patent validity as well as non-infringement.

In the FKB proceedings, FKB sought a declaration that its own product was anticipated or obvious at the priority dates of two patents owned by Abbvie (a so-called Arrow declaration³). The purpose of seeking the declaration was to ensure that FKB could market its own product, an every other week, single dose, subcutaneous injection biosimilar of adalimumab, in circumstances where a number of divisionals sharing the same priority date as those patents and also concerning this product were in prosecution. As applications, the divisionals could not be challenged for invalidity in the English Patents Court, preventing FKB from clearing them out of the way. The purpose of the declaration was therefore to provide an alternative means to protect itself from a patent infringement action in respect of marketing its product: a Gillette defence. This defence provides that, if the FKB product lacks novelty and/or is obvious then any patent claim asserted to cover it must also be novel and/or obvious. Such a patent claim is invalid and must be removed from the patents register. So far, at an interim stage, and subject to detailed examination of the evidence at trial, there is a realistic prospect that such a form of declaratory relief can, in principle, succeed.

The appeal of this decision is taking place in November 2016 and, providing FKB succeed, there will be a trial of the merits in January 2017. If eventually successful, the FKB action raises the possibility of the English court going a step further and awarding such an Arrow Declaration cross-border. If the English court were to allow a cross-border Arrow declaration, its effect would be to bring into doubt the validity of foreign patents indirectly, by the 'back door'. This could have persuasive value in some foreign proceedings where the validity of a patent is in issue, including defending preliminary injunctions and requesting the stay of infringement proceedings pending a separate validity action.

This possibility is still subject to a number of uncertainties. A cross-border Arrow declaration would require the English Court to determine whether the product in question is invalid at the priority date of the patents or patent applications of concern under the substantive law of foreign courts. While this is not a validity attack on the patents in those countries directly, this is necessarily its effect when deployed in the Gillette defence. Indeed, that is its purpose. It therefore remains to be seen whether such a declaration could be challenged under EU jurisdictional rules preventing national courts deciding on the validity of foreign patents⁴, even though the validity of those patent would actually never need to be raised to obtain the declaration.

Developments in this most interesting area are awaited.

If you have any questions on this article or would like to propose a subject to be addressed by Synapse please contact us.

¹[2012] EWHC 3316 (Pat) and [2013] EWCA Civ 517.

²[2016] EWHC 425 (Pat).

³After Arrow Generics v Merck [2007] EWHC 1900 (Pat).

⁴See, for example, Coin Controls Ltd v Suzo International (UK) Ltd [1999] Ch 33.

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