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UK – Arrow declarations 1 – AbbVie misses with its first shot

06 Feb 2017

Fujifilm Kyowa Kirin Biologics Co., Ltd v AbbVie Biotechnology Ltd & AbbVie Ltd [2017] EWCA Civ 1

Regular readers will have noted that one of the themes of the English Patents Court in 2016 has been the resurrection of so-called Arrow declarations, in which a party seeks certainty in relation to pending patent applications by requesting a declaration that its product would have been anticipated or obvious at the earliest claimed priority date of the patent application(s) in question. The basis for seeking one is that it would provide the applicant with a ‘Gillette’ defence. These are a short-cut for an alleged infringer, as if it can show that the product (or process) in question was either disclosed in the prior art or is an obvious modification, that product (or process) cannot infringe any validly-granted claim, no matter its form.

The Court of Appeal has now clarified for the first time at appellate level that as a matter of principle the English Courts have the power to grant Arrow declarations in appropriate cases. This was an important decision as previous judicial pronouncements on the power to grant these declarations had been limited to three first instance interim decisions, in which the Patents Court had merely allowed the case to go to trial on the basis that there was a real prospect that the declarations sought might be granted at trial.

The Court of Appeal decision not only provides appellate authority but firmly establishes the existence of jurisdiction rather than simply ruling that such jurisdiction may be found to exist at trial (i.e. they establish that declarations can be made, rather than confirming that it is arguable that declarations can be made).

The idea of an Arrow declaration arose in 2016 in the course of two actions between Fujifilm Kyowa Kirin Biologics (“FKB”) and AbbVie relating to biosimilar adalimumab, which is the active ingredient in AbbVie’s blockbuster Humira® product. Henry Carr J (in ‘FKB1’) and Arnold J in (‘FKB2’) had both recognised the jurisdiction to grant Arrow declarations existed and that FKB had a real prospect of success on the facts that such declarations would be granted at trial.

The two judgments, as well as that of the Court of Appeal set out the relevant background to each case, but in summary FKB sought declarations that two different dosage regimes for biosimilar adalimumab for use in certain indications would have been known or obvious at the priority dates of certain pending applications of AbbVie at the EPO. In the case of the FKB1 action this included pending divisionals to two granted patents which FKB also sought to revoke. The judgments in FKB1 and FKB2 were then subject to this conjoined appeal, heard at the end of November 2016.

The Court of Appeal reviewed the statutory framework, noting that section 74 of the Patents Act 1977 limits the proceedings in which it is permissible to put validity in issue and that neither the Patents Act 1977 nor the European Patent Convention permits pre-grant opposition (unlike the previous incarnation of the UK Patents Act, which was amended in 1977 following the UK’s accession to the EPC). Nevertheless, the Court concluded that there was no issue of principle which prevented the granting of Arrow declarations in appropriate cases.

The Court did so on the basis that:
• A declaration that a product (or process or use) was old or obvious at a particular date did not necessarily offend against section 74 of the Patents Act.
• Such a declaration may offend against the Act where it is a disguised attack on the validity of a granted patent.
• 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.
• On the other hand the existence of pending applications cannot itself be a sufficient justification for granting a declaration.
• 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.

Having identified that the discretionary power exists, the Court of Appeal left it to the Patents Court to develop the principles for its exercise in more detail. Nevertheless, the Court did mention that the statutory proceedings for revocation (i.e. post-grant) should be regarded as the normal vehicle for obtaining any desired findings of invalidity. However, the facts of this case were at least open to an interpretation that AbbVie was deliberately trying to shield the claims of their patents from scrutiny in the EPO and in the national court. The main trial in FKB1 has already commenced (before Henry Carr J) and is expected to conclude on Friday 3 February.

A copy of the judgment can be found here.

Headnote: Gregory Bacon, Bristows LLP