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'. This is a rare form of relief and it is designed to effectively 'clear the way' of patents that are in prosecution for an indefinite or prolonged period of time, and has not before now been tested at the appeal level in the English court.

The Arrow declarations sought are 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 ('044) and EP UK 1,944,322 ('322); and, in the FKB2 claim: EP UK 1,737, 491 ('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, using the so-called 'Gillette defence'.

Arrow declarations on appeal

The key objection raised to Arrow declarations before the Court of Appeal in November 2016 was that they are effectively a decision on validity. This is important, because section 74 of the Patents Act 1977 limits those actions in which validity can be raised, and does not include declarations of this type. Despite the practical implications of an Arrow declaration for patent validity when the Gillette defence is applied, the Court of Appeal held, on 12 January 2017, 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.

Would the offer of concessions stop the trial?

The Court of Appeal decision followed shortly after a first instance decision, delivered on 29 December 2016, on an application by AbbVie in which they again sought summary judgment on the FKB1 and FKB2 claims or to have them struck out. Success in this application would have prevented the trial of FKB1 and FKB2 taking place. AbbVie's position on this application was that, as a result of certain concessions made, there was no longer a real prospect of a court finding that the declarations sought serve a useful purpose, and that the continuation of the proceedings would be an abuse of process and a disproportionate waste of court resources.

The concessions made by AbbVie were: de-designating the UK from the ‘044 patent; informing the EPO that the text of the ‘322 patent was no longer approved; and, indicating a willingness to submit to revocation in the UK of the ‘491 patent. AbbVie also offered undertakings, which it claims have the effect that it would not obtain any patent protection in the UK that would be infringed by the claimants' biosimilar products. AbbVie argued that these measures gave FKB what they want and what the Arrow declarations are designed to achieve – freedom to operate in the UK after October 2018 (the date of expiry of patent protection on the molecule).

It was held by Carr J that there was still a real prospect, when faced with the most unusual facts of this case, that the judge at trial would consider that there are special reasons supporting the grant of the Arrow declarations. In particular, the judge drew attention to AbbVie's previous conduct of threatening infringement whilst abandoning proceedings at the last moment (in order to shield its patent portfolio from scrutiny). The amount of money at stake for FKB in terms of investment in clinical trials and potential damages if they launch at risk was also important; as was the need for commercial certainty, having regard to AbbVie's threats to sue for infringement throughout the world. The judge also concluded that the continuance of the claims is a proportionate use of court resources, and is not unfair to AbbVie, given what is at stake and the huge size of the UK market.

Now the Court of Appeal has established that Arrow declarations are available in principle, attention 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. The decision of the first on these trials (FKB1) is imminent and the second trial (FKB2) is expected to follow in June 2017.

First published in Intellectual Property Magazine