Humira/adalimumab litigation confirms Arrow declarations' availability

24 July 2017

Christopher de Mauny

Fujifilm v AbbVie; Samsung v AbbVie [2017]; EWHC 395 (Pat) and [2017] EWCA (Civ) 1

Litigation centred on the antibody adalimumab (marketed as Humira by AbbVie and indicated for psoriasis and some forms of arthritis) has confirmed the ability to obtain so-called Arrow declarations in the English courts.

What is an Arrow declaration?

In the UK a patent cannot be challenged until it grants. However, a patentee can, after grant, claim damages for acts committed prior to grant if they would have infringed the patent (subject to certain conditions). This regime can create a substantial damages liability for businesses which launch products at risk with respect to pending patent applications.

An Arrow declaration states that a claimant's intended product or process was known or would have been obvious at the priority date of a patent application of concern. Obtaining such a declaration does not have any effect on the patent application proceeding to grant. However, if a patent grants in the future and is asserted against the party which has obtained the Arrow declaration, the declaration can be deployed by way of a Gillette defence: i.e. if the product or process was known or obvious at the priority date then if it infringes the patent the patent must be revoked. The advantage of the Arrow declaration is that a claimant can test its position before launching their product and thereby before any damages might start to accrue.

Criteria for an Arrow declaration

Prior to this litigation there had been uncertainty about whether the English courts could grant Arrow declarations. The first attempt to obtain one took place in proceedings between Arrows Generics and Merck in 2007: the Patents Court refused to strike out the then-novel claim for an Arrow declaration but no further jurisprudence was generated on the matter.

In January 2017 the Court of Appeal approved judgments from 2016 in which the Patents Court had refused to strike out the claims concerning adalimumab. In doing so the Court referred to the jurisprudence about giving declarations in general which require among other things that the declaration sought should serve a useful purpose. Commercial certainty in patent matters has been recognised as one form useful purpose.

The Court of Appeal did not set out detailed criteria for obtaining Arrow declarations, holding rather that the detailed principles should be developed by the Patents Court. In March these principles were explored by the Patents Court in a judgment by Mr Justice Henry Carr, in particular whether a useful purpose would be served by the declarations sought. This arose in particular because AbbVie had taken a number of actions over the course of the litigation to surrender or de-designate various patents so far as they related to the UK and/or given undertakings not to acquire such patents (e.g. from pending applications or divisional applications) that would cover the product as contemplated by the claimants' declarations. Thus, AbbVie said, there was no useful purpose in the UK that the declarations could serve. However, AbbVie had a very large European patent portfolio protecting Humira, including many outstanding applications that could give rise to further divisional applications.

The claimants relied not only on the position in the UK on the "spin-off" value of an Arrow declaration, i.e. the use if might have in influencing other European courts. They argued that AbbVie appeared to be seeking to avoid Court scrutiny of its patents' validity by removing them from the UK courts' jurisdiction and thereby maintaining commercial uncertainty in the market.

Mr Justice Henry Carr accepted that an Arrow declaration must be limited to the UK but that did not mean that a useful purpose would not be served by granting the declaration even where no UK patents still remained. He agreed that AbbVie's conduct had been such as to shield its patents from scrutiny. In parallel AbbVie had consistently expressed both confidence in its patent portfolio protecting Humira and its intention to enforce its patents against competitors' biosimilar products. It had preserved uncertainty for third parties by systematically abandoning patents but filing further divisional applications concerning the same subject matter.

Overall he held that the declarations would serve a useful purpose in dispelling uncertainty in the UK and elsewhere in Europe. However, in the UK AbbVie had offered undertakings not to obtain further protection: was that enough to prevent the declarations serving a useful purpose in the UK? Mr Justice Henry Carr held not in the circumstances here: the claimants put forward evidence that the declarations would promote settlement and also assist in them resisting injunctive relief in other jurisdictions which formed part of the supply chain for the UK market. Thus the declarations continued to have a useful purpose for the UK. Separately, the judge accepted spin-off value was valuable but did not take it into account here: he did not rule on whether spin-off value alone could provide sufficient useful purpose for an Arrow declaration.

A large part of the trial was also concerned with a challenge to priority in respect of one of the patents which AbbVie had abandoned, which affected the date at which the Arrow declaration should be judged. Priority was maintained on the facts.

Arrow declarations in the future

The circumstances of the adaliumab litigation were unusual, particular in respect of AbbVie's strategy in avoiding scrutiny of its portfolio. While establishing that such declarations are available the principles explored in the case are tied to the facts. It remains unlikely that Arrow declarations will be granted frequently but they are now confirmed as a tool in the arsenal of those looking to launch a product protected by a patent, be it a generic or biosimilar product. At least one claimant has already sought such a declaration as recorded in the judgment of Mr Justice Arnold on an application for an expedited trial, Generics v Yeda [2017] EWHC 708 (Pat) at [11].

Authors

de Mauny-Christopher

Christopher de Mauny

Associate (Barrister)
UK

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