Mark Chacksfield appeared on behalf of the Appellants Abbvie Biotechnology Limited (“Abbvie Bermuda”) and Abbvie Limited (“Abbvie UK” – together, “Abbvie”) in two linked appeals concerning FKB’s claims for declaratory relief in relation to its biosimilar products for the drug adalimumab (marketed by Abbvie as “Humira”).
In related actions (“FKB1” and “FKB2”) FKB had sought revocation of Abbvie’s patents for adalimumab. Abbvie had since de-designated these patents in respect of the UK and/or submitted to their revocation. FKB nonetheless sought declarations in the form of those granted in Arrow Generics Ltd v Merck & Co Inc  EWHC 1900 (Pat) (“Arrow”), to the effect that treatment with adalimumab biosimilars was obvious and/or anticipated at the priority date of the relevant patents. In FKB2, FKB additionally sought an injunction that would prohibit Abbvie from bringing infringement proceedings in respect of the products covered by the declaration.
Abbvie had applied to strike out the claims on the basis that (i) declarations in the Arrow form ought not to be granted because, inter alia, they were prohibited by section 74 of the Patents Act 1977 (“the Act”); (ii) there was no arguable case that the injunction sought in FKB2 should be granted; (iii) the claim against Abbvie UK had no prospect of success. At first instance, Henry Carr J (FKB1) and Arnold J (FKB2) had refused Abbvie’s strike out applications.
The Court of Appeal upheld the judgements in FKB1 and FKB2 and dismissed the appeals. The Court held that although a declaration which was a disguised attack on the validity of a granted patent would be contrary to section 74 of the Act, that section did not apply where, as in this case, the proceedings did not concern a granted patent at all. There was nothing in the scheme provided by the European Patent Convention or the Act to prevent declarations that, in effect, putative future patents covering the Claimant’s products would be invalid, where such declarations would serve a useful purpose. It was therefore open to the Court to exercise its discretion to grant declarations of the form sought. On the facts, there was a good arguable case that the declarations would be granted at trial.
The Court further held that the judge had been entitled to find that there was a real prospect the injunctions sought in FKB2 would be granted, and that there was a good arguable case that a declaration would also be granted against Abbvie UK at trial.