Fujifilm Kyowa Kirin Biologics v AbbVie Biotechnology (EWCA, [2017] EWCA Civ 1, 2017)

Dhenne Avocats · 11 October 2026

Our analysis

Summary

The Court of Appeal upheld the refusal to strike out claims by Fujifilm Kyowa Kirin Biologics (FKB) for declarations that the dosage regimens of its adalimumab biosimilar were old or obvious at given priority dates. It held that nothing in principle bars such an Arrow declaration: section 74 of the Patents Act 1977 concerns granted patents only, and the declaration does not trespass on the EPO’s competence. Whether to grant it is a matter of discretion, revocation remaining the normal route, but it may be justified where the patentee shields subject matter from the court through divisional applications.

Facts and procedure

AbbVie Biotechnology Limited (AbbVie Bermuda) owns the basic adalimumab (Humira) patent, extended by an SPC until 15 October 2018, and over 50 European applications (paras 27 to 29). FKB intends to launch a biosimilar, FKB 327 (para 32). In a first action, begun on 29 October 2015, FKB sought revocation of two dosage regimen patents and an Arrow declaration; AbbVie disapproved the text of those patents, leading to their revocation by the EPO, and withdrew the UK designation of a divisional shortly before grant (paras 33 to 42). In a second action, begun on 9 May 2016 against AbbVie Bermuda and AbbVie Limited, FKB seeks a declaration concerning higher initial dosing regimens and an injunction; AbbVie consented to revocation of the patent granted on 2 November 2016 (paras 46 to 49). Henry Carr J and Arnold J refused to strike out these claims (para 1).

The applicable law

CPR 40.20 allows binding declarations whether or not any other remedy is claimed (para 58), subject to their usefulness (paras 59 and 60). Section 74 of the Patents Act 1977 limits the proceedings in which validity may be put in issue and bars proceedings seeking only a declaration as to validity or invalidity (paras 18 to 22).

Question

May the English court declare that a product or use was old or obvious at a given date, where divisional applications are pending before the EPO and no UK patent has been granted?

Decision

Section 74 concerns granted patents only: domestic law has no concept of the validity of an application, and the section does not apply to a revoked patent, revocation operating ab initio (paras 76 and 77). A declaration mapping onto the features of a claim of a granted patent would be a disguised attack on validity requiring revocation proceedings (paras 81 and 82); that is not the case here (para 83). The declaration implies an inter partes finding of invalidity of a putative patent (para 84), but nothing in the EPC or the Act prevents it where there is real justification (para 86): it does not affect what the EPO can do (paras 87 to 89). The exclusive statutory remedy concerns granted patents only (para 92), but its existence bears on discretion: wanting to know whether an application will succeed is not enough, but the court may intervene where the statutory remedy is frustrated by shielding subject matter from national scrutiny (para 93). It rejected the floodgates argument and any conflict with Regulation 1215/2012, the declaration operating only as a matter of UK law (paras 95 to 97). As the pleaded facts were open to the interpretation that AbbVie was shielding its claims from scrutiny, the claim was not bound to fail (para 100). The injunction claim and the claim against AbbVie Limited survived (paras 107, 108 and 113 to 116), and the appeals were dismissed (para 117).

Key points for practice

• An Arrow declaration does not in itself offend section 74 of the Patents Act 1977, unless it is a disguised attack on a granted patent (para 98).
• Pending applications alone do not justify it; revocation proceedings remain the normal vehicle (paras 98 and 99).
• Practical point: the patentee’s conduct (disapproval of text, withdrawal of designation, successive divisionals) is central to the assessment (para 100); the declaration must target the features of the claimant’s own product.

Provisions applied

European Patent Convention

Art. 76; Rule 36

Regulation (EU) No 1215/2012

Art. 24(4)

National law

Patents Act 1977, sections 69, 71, 72, 74, 77 and 78; CPR 40.20

European Convention on Human Rights

Art. 6

Case law cited

Arrow Generics v Merck [2007] EWHC 1900 (Pat); Gillette Safety Razor v Anglo-American Trading (1913) 30 RPC 465; Traction Corporation v Bennett (1908) 27 RPC 819; Nokia v InterDigital [2006] EWCA Civ 1618; Fort Dodge v Akzo Nobel [1998] FSR 222; Messier-Dowty v Sabena [2001] 1 All ER 275; GAT v LuK (C-4/03)

Prepared by Dhenne Avocats from the text of the decision (National Archives, Find Case Law), consulted on 11 October 2026. Only the official text is authoritative.