Fujifilm Kyowa Kirin Biologics Co, Ltd v Abbvie Biotechnology Ltd & Anor  EWCA Civ 1
This recent decision of the Court of Appeal confirms that the High Court can, in certain circumstances, properly grant declarations that a product was old or obvious at a particular historical date. Such declarations are referred to as “Arrow declarations”, since they were first considered in the case Arrow Generics Limited v Merck & Co. Inc.  EWHC 1900 (Pat).
The judgement concerns a long-running dispute between Fujifilm Kyowa Kirin Biologics (FKB) and AbbVie, regarding the world’s largest selling prescription drug, adalimumab (a monoclonal antibody specific for human tumour necrosis factor a).
FKB intends to market a generic version of adalimumab in the UK when AbbVie’s basic patent protection for the drug expires next year. However, since AbbVie have filed additional European applications for patents protecting dosage regimens, formulations and uses of adalimumab, FKB is seeking to protect itself from any subsequent infringement action by applying for a declaration that their advised dosing regimen is old or obvious (and as such, cannot fall within the scope of any additional protection granted to AbbVie by the European Patent Office).
AbbVie argued that such a declaration would be contrary to UK patent law since sections 74-78 of the Patents Act 1977 make it clear that you cannot challenge the validity of pending patent applications, and that you cannot institute proceedings seeking only a declaration of invalidity of a granted patent.
The Court of Appeal, disagreeing with AbbVie, held that there is no issue of principle which prevents the granting of Arrow declarations in appropriate cases. The legal position was summarised with the following points:
“i) A declaration that a product, process or use was old or obvious at a particular date does not necessarily offend against section 74 of the Act.
ii) Such a declaration may offend against the Act where it is a disguised attack on the validity of a granted patent.
iii) Such declarations do not offend against the scheme of the EPC or the Act simply because the declaration is sought against the background of pending divisional applications by the counter-party.
iv) On the other hand, the existence of pending applications cannot itself be a sufficient justification for granting a declaration.
v) 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”.
With regard to the court’s discretion, the Court of Appeal noted that “an important factor to be borne in mind…is the existence of the statutory proceedings for revocation, which should be regarded as the normal vehicle for obtaining any desired findings of invalidity”.
Whether or not the Arrow declaration should be granted to FKB is now being considered at trial. However, the decision of the Court of Appeal to permit Arrow declarations as a point of principle provides a new opportunity for companies to clear the way before launching their products.