UK: Declaratory jurisdiction of the English Courts as to certain aspects of the validity of divisional patent applications that are still pending at the EPO

20 August 2007

Trevor Cook

Given the speed with which patent matters can be brought to full trial on the merits in the English courts it is now their well established practice to require those seeking to introduce a generic version of a well established pharmaceutical to “clear the path” of any patents that might block the way and be asserted against them, whether by seeking to revoke such patents, or seeking a declaration of non-infringement, or both. It is also not uncommon in early stage drug development for research based companies to use such English court procedures to try to increase their confidence that no valid claim of a certain third party patent that might on its face be thought to cover what they want to do is infringed. However to date such jurisdiction has only been available for granted patents. The decision of Mr Justice Kitchin in the Patents Court of 31 July 2007 in Arrow Generics Limited and anr v Merck & Co, Inc [2007] EWHC 1900 shows that the English courts are prepared in principle to make declarations as to some aspects of the validity of patent applications.

The Arrow decision is the latest in the long running alendronate saga. The patent applications in question are pending divisionals in the EPO of the Merck ‘292 patent for a dosing schedule of alendronate. The UK designation of the ‘292 patent was revoked by the Patents Court in January 2003, for inter alia lack of novelty and inventive step, and the Court of Appeal confirmed this in November 2003. The ‘292 patent, which granted in November 2001, had also been centrally opposed at the EPO. In July 2004 the EPO Opposition Division revoked the ‘292 patent also on lack of novelty and inventive step and the EPO Technical Board of Appeal upheld the revocation in March 2006, but on different grounds and without getting to the issues addressed by the Opposition Division. Meanwhile, Arrow and other generic manufacturers had entered the UK market with their alendronate products. One of the divisionals of ‘292 had granted but as the UK designation of this had been withdrawn before grant, the Patents Court found it had no jurisdiction over this. There is also case law by which the Patents Court had previously declined to entertain a declaration that an applicant “had not infringed any valid claim” of a patent. However in the particular circumstances of this case the Patents Court was prepared to allow Arrow to seek a declaration that its own product lacked inventive step at the priority date of the other still pending divisionals, thereby enabling Arrow again to clear the path, but without having to await the grant of such other divisionals.

Although this particular decision arose under a somewhat special set of circumstances, the increasing use of divisionals practice in Europe, which can only now have been further encouraged by the recent favourable decision of the EPO Enlarged Board of Appeal in Decision G 0001/05 of 28 June 2007, may well mean that this new declaratory jurisdiction will find increasing favour in the future.