During 2016 and 2017 the complex litigation about part of AbbVie's patent portfolio protecting its Humira/adalimumab product drew attention in part because of the granting of a so-called Arrow declaration. Arrow declarations provide a route to commercial certainty for a party seeking to launch or already marketing a product that may be covered by a pending patent application. The declaration is to the effect that the product in question would have been old or obvious at the priority date of a patent application of concern: thus, if the patent application proceeds to grant and were to be asserted against the holder of the declaration, the patent would be found invalid if the product would infringe it. The declaration holder has secured a Gillette defence in advance of any claim for infringement. However, Arrow declarations are not available as of right merely because there is a pending patent application: they are granted only in the Court's discretion after consideration of whether they would serve a useful purpose.

The Humira/adalimumab litigation was the first time that a contested Arrow declaration has found its mark. In the wake of the Courts' various decisions in that litigation, some have questioned whether it is likely that more would be granted in the future. Certainly, the circumstances of the Humira/adalumimab litigation were unusual and would seem unlikely to be repeated. In Mylan v Yeda [2017] EWHC 2629 (Pat) Arnold J refused to grant an Arrow declaration but did make a finding of obviousness which the judge appeared to consider would have the same practical utility between the parties as an Arrow declaration.

GSK clearly were not dissuaded from seeking an Arrow declaration as part of their strategy for their product Ellipta, in respect of which they were already seeking revocation of patents owned by Vectura. However, their claim for an Arrow declaration was struck out in the High Court.  HHJ Hacon took the view that there was insufficient basis for granting an Arrow declaration in this case: it was not unusual. GSK appealed.

The Court of Appeal has now confirmed that GSK's claim for an Arrow declaration may proceed to trial in its 28 June 2018 judgment in GSK v Vectura [2018] EWCA Civ 1496The Court has confirmed that, although the Arrow relief is discretionary, the exercise of this discretion is to involve a critical examination of the purpose that the relief is to serve. It would appear to follow from the Court's judgment that this examination should include consideration of what might be described as whether the case is sufficiently 'unusual' for an Arrow declaration but there is not an additional threshold of establishing the case is 'unusual' in order to engage the discretion.

The Court of Appeal has also made clear that the exercise of the discretion is one for the trial judge.  It is not exercised at the interim stage where the facts which affect the exercise of the discretion have not been established.

GSK's claim for an Arrow declaration will now proceed to trial in November alongside its claims for revocation of Vectura's patents. It seems unlikely that the Humira/adalimumab litigation has opened the flood gates to Arrow declarations being sought as a matter of course where a patentee has additional applications pending but the case again highlights the options available for establishing certainty for product launch in the UK even where the patent landscape is still in flux.

Authors

de Mauny-Christopher

Chris de Mauny

Associate (Barrister)
UK

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