Fujifilm Kyowa Kirin Biologics Co., Ltd (1) Samsung Bioepis UK Limited, (2) Biogen Idec Limited v AbbVie Biotechnology Limited, High Court of England and Wales, (Henry Carr J), London, UK, 3 March 2017, Neutral Citation Number: [2017] EWHC 395 (Pat)

In this judgment, Henry Carr J granted Fujifilm Kyowa Biologics (FKB) and Samsung Bioepis/Biogen Idec (S/B)’s request for declarations that particular dosage regimens for the administration of biosimilar adalimumab would have been known or obvious at the priority dates of certain pending EP patent applications belonging to AbbVie Biotechnology Limited (AbbVie). Adalimumab is sold by companies in the AbbVie group under the brand name Humira®.

As explained further below, this is the latest in a series of related judgments between the parties (see here, here, here and here), and the first of two actions on the merits. The trial of the second action is scheduled for June 2017.

FKB and S/B’s aim was to “clear the way” for their biosimilar adalimumab medicines by the date of expiry of the compound patent protection for adalimumab in October 2018. They had initially sought to revoke granted patents. However, in the course of the proceedings AbbVie had abandoned those patents, making it impossible for the revocation actions to proceed, whilst at the same time filing and/or maintaining at the EPO divisional applications covering the same subject matter, and threatening patent infringement actions against biosimilar competition throughout the world.

Henry Carr J found that, on the evidence provided at trial, the dosage regimens in question were known or obvious at the relevant priority dates. He therefore proceeded to consider whether, on the particular facts of the case, the court’s discretion for granting the declarations sought should be exercised.

Applying Financial Services Authority v Rourke [2002] C.P. Rep. 14 – in which the Court held that when considering whether to grant a declaration, the 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 Judge held that, in the unusual circumstances of the case, it was in the interests of justice to grant the declarations sought.

On the question of whether the declarations would serve a “useful purpose”, the Judge held that the test should be whether the declarations would serve a useful purpose in the UK (he held that a declaration that is sought solely for the benefit of foreign courts would rarely be justified). AbbVie had argued that the declarations sought would serve no useful purpose in the UK because it had offered undertakings that it would not obtain any patent protection in the UK that would be infringed by the claimants’ biosimilar products as a result of their use in accordance with the relevant dosage regimens.

However, the Judge disagreed and held that:
First, the declarations would dispel the commercial uncertainty in the UK (and European) market, which AbbVie’s threats of patent infringement actions had created. He referred to the clarity that such declarations would provide to third parties in the UK seeking to do business with FKB and S/B in relation to FKB and S/B’s biosimilar adalimumab medicines. In particular, he noted that such third parties might not understand the complex and long undertakings offered by AbbVie.

Second, the declarations would protect FKB and S/B’s UK market by protecting its supply chain; in particular he noted the evidence from FKB and S/B about how it was not possible to isolate the UK from the supply chain, and held that by granting the declarations, it would make it less likely that injunctive relief would be granted in other jurisdictions, which in turn would be of direct benefit to the UK market. However, notably, the Judge stressed that in his decision he had not taken the spin-off value of a judgment into account, other than to the extent that it may have an impact on the UK market.

Thirdly, he held that the declarations would also promote settlement.

The “special reasons” identified by the Judge, on the “most unusual facts of this case” included (i) AbbVie’s conduct of threatening infringement proceedings whilst abandoning validity proceedings at the last moment (in order to shield its patent portfolio from scrutiny), (ii) the amount of money at stake for FKB and S/B in terms of the investment they had put into clinical trials and also the threat of having to pay damages if they launched at risk (Humira is the world’s top-selling drug), and (iii) the need for commercial certainty, having regard to AbbVie’s threats to sue for infringement throughout the world.

Readers may be aware that a similar type of declaration was sought in Arrow v Merck [2007] EWHC 1900 (Pat) (see here), and that such declarations have subsequently been referred to as “Arrow declarations”. However, Henry Carr J noted that the main purpose of an Arrow declaration is to provide a “Gillette defence” to allegations of infringement in the UK (such a defence is that the accused product was not new or was obvious at the priority date) and, given how the circumstances of the present case had evolved, referring to the declarations sought by the claimants as “Arrow declarations” was a “potentially misleading shorthand”, as their purpose was different from that in the Arrow case.

Presumably, although not mentioned in the judgment, one should now refer to a declaration having the wider purpose of dispelling uncertainty in the UK and beyond as “Fujifilm declarations”.

A copy of the judgment can be found here.

Headnote: Laura von Hertzen, Bristows