The Court of Appeal has decided that, in principle, a claimant may obtain an 'Arrow declaration' where the circumstances of the case are such that it would be appropriate to do so. An Arrow declaration (named after the first case in which such a declaration was considered, Arrow v Merck) is to the effect that a product would have been obvious and/or anticipated at the priority date of a particular patent application. As a result, if that application proceeds to grant, the party with the benefit of the Arrow declaration can rely on it as a defence (i.e., as a squeeze through a 'Gillette' defence) to a claim for infringement.
The Court of Appeal's decision in Fujifilm v AbbVie upholds two trial decisions in the Patents Court, by Henry Carr J and Arnold J, which had considered the legitimacy of Arrow declarations. It is the latest instalment in a battle concerning AbbVie's 'Humira' product, which contains the antibody adalimumab. Humira is the highest-selling prescription drug in the world and is approved for the treatment of rheumatoid arthritis, psoriatic arthritis and psoriasis. Whilst the Court of Appeal has confirmed the grant of Arrow declarations in appropriate cases, it is now for the Patents Court to determine whether such a declaration should be granted in this case.
AbbVie has obtained or applied for a number of patents and divisional patents relating to adalimumab, including for the use of various dosage regimens.
In October 2015, Fujifilm began proceedings to revoke two of AbbVie's dosage regimen granted patents (EP (UK) 1 406 656 and EP (UK) 1 944 322) and also sought a declaration that "products containing a biosimilar monoclonal antibody to the antibody adalimumab for the treatment of rheumatoid arthritis, psoriatic arthritis and/or psoriasis by the administration of 40mg every other week by subcutaneous injection…" would have been obvious at the priority dates of the 656 and 322 Patents. Fujifilm's intention is to clear the way for a biosimilar product, which it wishes to launch after AbbVie's supplementary protection certificate on Humira expires in October 2018. The aim of the Arrow declaration is to prevent Abbvie bringing infringement proceedings in the UK against Fujifilm in the event that certain pending applications proceed to grant.
Divisional patent applications
An important factor in this case was that AbbVie had applied for five divisional patents on Humira. As the Court explained, a divisional application is a patent application in its own right, which an applicant may file at any time when an earlier application is pending. It is possible for divisional applications to be based on applications which are themselves divisionals, leading to a 'cascade' of pending divisional patent applications. Further, an applicant can wait until an earlier application has been in prosecution for many years before filing their first divisional application. Therefore, the final form of any protection based on the subject matter of the parent patent application, in this case a dosage regime for adalimumab, may take a very long time to emerge.
Whilst the protection conferred by the parent application may have ended, many divisionals and sub-divisionals based on the same subject matter may still be in the pipeline and some of those will not have yet been published by the Patent Office (and there may even be more to come which have not yet been filed). This is known as the 'submarine divisional' problem. As noted by the Court, it can give rise to real, practical problems for third parties - in particular generic pharmaceutical companies - in determining the extent of patent protection surrounding the patentee's product when they wish to launch a competing product
Declaration sought by Fujifilm
Given the uncertainty of AbbVie's 'submarine divisionals', Fujifilm sought an Arrow declaration in respect of its proposed product. Fujifilm also sought an injunction against AbbVie to restrain it from threatening or commencing patent infringement proceedings in respect of the acts covered by the proposed declaration. Fujifilm's aim was to obtain protection from any subsequent infringement action by AbbVie on the basis of one of its divisional applications, once they had proceeded to grant.
AbbVie applied to strike out Fujifilm's claim for a declaration on the basis that (1) it was contrary to section 74 of the Patents Act 1977 (which governs proceedings in which the validity of a patent may be put in issue) and (2) the Arrow v Merck decision had been wrongly decided.
The Court of Appeal decided that the Court did have jurisdiction to make Arrow declarations in appropriate cases.
The general approach to the grant of a negative declaration is that there should be "no reluctance to grant a negative declaration where it is useful to do so". In deciding whether to grant a negative declaration, a Court should take into account justice to the claimant, justice to the defendant, whether the declaration would serve a useful purpose and whether there are any other special reasons why, or why not, the Court should grant the declaration.
The key issue before the Court was whether s.74 of the Patents Act 1977 precluded the grant of an Arrow declaration. Section 74 makes clear that validity can only be put in issue in relation to a granted patent. By asserting that the dosing regimen was old or obvious, the declarations would be making it clear that future patent claims to that regimen would be invalid, i.e., any patent granted would be pre-emptively judged as invalid.
Having considered the competing arguments, the Court of Appeal concluded:
- A declaration that a product, process or use was old or obvious at a particular date would not necessarily offend against s.74;
- It may offend against the Act where it is a disguised attack on the validity of a granted patent;
- An Arrow declaration will not offend against the scheme of the European Patent Convention or the Act, simply because it is sought against the background of pending divisional applications;
- However, the existence of pending applications cannot itself be a sufficient justification for granting a declaration; and
- Whether a declaration is justified will depend upon whether a sufficient case can be made for the exercise of the court's discretion.
Turning to the exercise of discretion, the Court of Appeal noted that the pleaded facts were at least open to the interpretation that AbbVie was deliberately trying to shield the claims of its patents and divisionals from scrutiny in the EPO and the national court.
The Court was, however, careful to note that a party "cannot seek an Arrow declaration simply because it would like to know whether a patent application in the course of prosecution will result in a valid patent… Where, for example, it appears that the statutory remedy [to seek to invalidate the patent] is being frustrated by shielding subject matter from scrutiny in the national court, it should be open to the court to intervene" i.e. by granting a declaration.
The Court was more hesitant about whether Fujifilm would, in principle, be entitled to an injunction as it had "considerable doubt" whether there would be sufficient justification for an injunction, at least in the wide terms sought. However it did not strike the claim for an injunction out and said that "an appropriately framed injunction may be an alternative to the declaration".
The Court of Appeal's decision confirms the availability of Arrow declarations. Whilst both this case and the Arrow decision related to pharmaceutical products, there is no reason why such a declaration could not be sought in relation to other areas of technology. It remains to be seen whether, in fact, the Patents Court will grant Fujifilm an Arrow declaration in this case and we can expect further guidance from the Court on this issue shortly as the trial of this action began on 16 January 2017.