Fujifilm Kyowa Kirin Biologics Co, Ltd & Ors v Abbvie Biotechnology Ltd & Anor

The grant of an Arrow declaration is discretionary and depends on a pragmatic, multifactorial assessment. Relevant considerations include justice to the claimant and defendant, whether the declaration serves a useful purpose, proportionality, and any special circumstances. A defendant’s withdrawal of UK patent protection does not automatically remove the utility of declaratory relief, particularly where the defendant resists equivalent judgment or acknowledgement and its conduct creates continuing commercial uncertainty. The potential influence of a UK judgment in other European jurisdictions may be a legitimate factor, but will not ordinarily justify disproportionate litigation by itself. Claims are not an abuse of process merely because substantial court resources are required, where significant commercial issues remain and the declarations may serve useful purposes.

The claimants sought declarations that patents concerning adalimumab dosage regimes were invalid, enabling them to market biosimilar products after expiry of the basic patent and SPCs. AbbVie subsequently abandoned or undertook to abandon UK patent protection and offered undertakings, but refused to submit to judgment or provide acknowledgements in the terms sought.

AbbVie applied for summary judgment or strike-out on abuse of process grounds. The claimants sought amendments relying on further evidence concerning AbbVie’s conduct, commercial uncertainty, supply chains, settlement, and the possible value of UK declarations in other European proceedings. The central questions were whether there was a real prospect that the trial judge would grant the declarations and whether continuation of the claims would be disproportionate or abusive.

1. Applications and amendments. AbbVie’s applications for summary judgment and strike-out as an abuse of process were dismissed. The claimants’ amendments to their Particulars of Claim were allowed.
2. Declaratory relief. The court applied the discretionary principles governing declarations, including the need to consider justice to each party, useful purpose, and special reasons. There was a real prospect that the trial judge would find useful purposes in granting the declarations, notwithstanding AbbVie’s abandonment of UK patent protection and proposed undertakings.
3. Those purposes could include preventing continuing commercial uncertainty, providing clarity to the claimants and third parties, protecting supply chains, promoting settlement, and testing AbbVie’s stated intention to enforce its Humira patent portfolio. The unusual history of abandoning patent rights shortly before trial while pursuing further divisionals was relevant to that assessment.
4. The potential influence or spin-off value of an English judgment in other European proceedings was legitimate but, standing alone, might not justify the continued use of UK court resources. It was one factor among several and did not determine proportionality.
5. Abuse of process. The proportionality principle requires attention both to the parties’ costs and to the use of court resources. This was not a case in which the litigation was disproportionate to what was at stake. The UK market was substantial, the claimants sought relief which AbbVie refused to provide, and there was a real prospect that the declarations would serve a useful purpose. Continuation of the proceedings was therefore proportionate and not abusive.

The judgment records earlier first-instance decisions in the same litigation, including the FKB1 judgment dated 1 March 2016 and the FKB2 judgment dated 8 September 2016. Appeals from those decisions had been heard by the Court of Appeal, with judgment reserved. The present judgment concerned subsequent applications and amendments.