Humira/adalimumab litigation confirms Arrow declarations' availability

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…