In the Fujifilm Kyowa Kirin Biologics Co. Ltd & Anor (FKB) v Abbvie Biotechnology Ltd litigation, FKB has filed two claims (FKB1 and FKB2) to obtain so-called ‘Arrow declarations’. These are declarations that FKB’s own product, a biosimilar of adalimumab, is anticipated or obvious at the priority dates of several patent applications for particular dosages and indications of adalimumab that are still in prosecution (in the FKB1 claim: EP UK 2,940,044 and EP UK 1,944,322; and, in the FKB2 claim: EP UK 1,737, 491). A successful Arrow declaration would imply that any patent that is infringed by the adalimumab product must also be invalid by anticipation or obviousness – the ‘Gillette defence’.
Abbvie’s attempts to have these claims struck out on the basis that this form of relief has no real prospect of success at trial failed at first instance. This decision was appealed and the Court of Appeal has now, for the first time, addressed with this form of relief is possible in principle.
The key objection raised to Arrow declarations on appeal was that they are effectively a decision on validity. This is important, because section 74 Patents Act 1977 limits those actions in which validity can be raised, and does not include declarations of this type. Despite the practical effect of an Arrow declaration in a Gillette defence, the Court of Appeal has held that such a declaration is available in principle. The court states that it “does not necessarily offend against” section 74, but may do so “where it is a disguised attack on the validity of a granted patent”. However, and importantly in the context of this case, where the declaration is sought for the purpose of clearing the way of patent applications, the court adds that “such declarations do not offend against the scheme of the EPC or the [Patents] Act simply because the declaration is sought against the background of pending divisional applications by the counter-party”. Nonetheless, the Court of Appeal also states that “the existence of pending applications cannot itself be a sufficient justification for granting a declaration…”. Instead, whether such a declaration is justified depends on whether a sufficient case can be made for the exercise of the court’s discretion in accordance with established principles.
Attention now turns to whether the Patents Court will exercise its discretion to award the declarations sought after having heard trials on the merits of the claims (January 2017 for FKB1 and June 2017 for FKB2).