Fujifilm Kyowa Kirin Biologics Co., Ltd (1) Samsung Bioepis UK Ltd), (2) Biogen Idec Ltd v AbbVie Biotechnology Ltd [2016] EWHC 3383 (Ch)

Warming to its theme (see earlier post), the English Patents Court gave yet another judgment concerning Arrow declarations in the ongoing litigation between FKB and AbbVie regarding biosimilar adalimumab. This was heard after the Court of Appeal hearing in FKB1 and FKB2, but decided earlier (in both cases, judgment was reserved). It provides a further gloss on the court’s exercise of its jurisdiction to grant declaratory relief in the form of an Arrow declaration.

This was a development in the FKB1 case subsequent to the judgment of Henry Carr J in March 2016. As set out in the earlier post, Henry Carr J held that FKB’s claims for an Arrow declaration were entitled to be heard at trial. This was notwithstanding that AbbVie had at that time caused the revocation of the one of the two granted patents in suit by writing to the EPO in ongoing opposition proceedings to indicate that it no longer approved of the text of the patent, thus leading to its revocation.

Two months before the scheduled trial in FKB1 in January 2017 AbbVie informed the EPO that it no longer approved the text of the second granted patent on which FKB had brought its claim, also leading to its revocation. Moreover, AbbVie had also de-designated the UK from one of the divisionals in the family that in the meantime had proceeded to grant at the EPO. AbbVie also offered undertakings that it would not obtain any patent protection in the UK by FKB’s biosimilar products as a result of their use of the dosage regimes for the indications specified in the declaration sought.

Following these steps, AbbVie argued that the trial should no longer go ahead as there was no longer a real prospect of the court finding that the declarations sought would serve a useful purpose, and also on the basis that the continuation of the proceedings would be an abuse of process and a disproportionate waste of court resources. AbbVie argued that FKB (as well as Samsung Bioepis and Biogen, who had been joined as claimants to the FKB1 proceedings, having their own biosimilar adalimumab product in development) had cleared the way of patent protection in the UK as a result of AbbVie’s actions and thus achieved the utility and commercial purpose of the declarations sought.

The claimants resisted AbbVie’s efforts to have the action discontinued. Henry Carr J agreed with the claimants, ruling that there was a real prospect, based on the “unusual circumstances of this case” that the judge at trial (also Henry Carr J) will exercise his or her discretion to grant the declarations sought and he thus allowed the case to proceed to trial.

The Judge relied on the following arguments put forward by the claimants as having force, and thus bases on which the trial judge might choose to exercise the jurisdiction to grant the declarations:

• There must still be a useful purpose in the claimants obtaining the declarations otherwise AbbVie would not continue to resist submitting to judgment or providing an acknowledgment in terms of the declarations. For example, the grant of the declarations might make it more difficult for AbbVie to continue is strategy of publicly stating its intention to enforce its patent portfolio against biosimilar adalimumab whilst at the same time shielding patents within the portfolio from scrutiny by the court, and thereby to create commercial uncertainty which will impede the launch of the claimants’ competing biosimilars.

• The spin-off value of the judgment in other European courts, particularly in cases of preliminary injunctions where validity cannot be challenged whilst patents are under opposition at the EPO. However, the Judge did note that if this had been the only useful purpose relied on by the claimants he doubted that continuation of the litigation would have been proportionate.

• Protection of the supply chain to the UK as well as other parts of Europe as certain components necessary for the Samsung Bioepis/Biogen product were to be sourced in parts of Europe. A declaration could therefore achieve commercial certainty by preventing suppliers from declining to provide necessary components to the claimants and also assisting the claimants in dealing with third parties, such as distributors, around Europe.

• The clarity that the declarations would provide in the UK compared to the complicated undertakings offered by AbbVie, particularly as the claimants were entitled to be sceptical that AbbVie had chosen to abandon all future patent protection for the UK market after SPC expiry, which was worth in excess of £400 million per annum.

• The possibility that granted declarations could promote settlement with AbbVie on a European or even worldwide basis. Henry Carr J also considered whether it would be a proportionate use of the UK court’s resources to allow the trial to proceed. He held it was proportionate and not unfair to AbbVie.

This was a case where a great deal was at stake given the size of the UK market. As indicated in our previous post, the main trial in FKB1 has already commenced and is expected to conclude on Friday 3 February.

A copy of the judgment can be found here