On 8th September 2016, Mr Justice Arnold handed down his decision in Fujifilm Kyowa Kirin Biologics Co Ltd. v AbbVie Biotechnology Limited and AbbVie Limited, refusing to strike out or summarily judge Fujifim’s claims for an Arrow declaration and anti-suit injunction against AbbVie Bermuda and its UK subsidiary AbbVie UK (collectively “AbbVie”). The case has significance for manufacturers wishing to clear the way for generic pharmaceuticals as it extends the possibilities for protecting both itself and its customers from infringement proceedings by a patentee.
This application is part of a series of interlocking disputes concerning FKB327, a compound Fujifilm plans to market which is a biosimilar compound to AbbVie’s adalimumab (“Humira”), a monoclonal antibody treatment for conditions including arthritis, psoriasis and Crohn’s disease. As far as patent estates are concerned, the stakes could hardly be higher; Humira is the most prescribed drug in the world and AbbVie sold £438.6m of it in the UK alone in 2014. AbbVie’s basic patent for adalimumab expires in 2018 but it has filed numerous secondary patents protecting the dosing regimens, uses for and formulations of adalimumab which would provide protection to 2022 and beyond.
In attempting to clear the way for its compound, Fujifilm commenced a number of actions seeking Arrow declarations, namely that a generic product would have been obvious at the priority date of a secondary patent application and therefore the generic compound does not infringe the basic patent (Arrow Generics v Merck). In one such action, Fujifilm Kyowa Biologics v AbbVie Biotechnology  EWHC 374, AbbVie argued that Arrow had been wrongly decided; the court rejected this argument but the decision is being appealed by AbbVie on the grounds that the declaration is incompatible with section 74 of the Patents Act 1977 and the case will be heard in the Court of Appeal on 29th-30th November 2016.
In the action described here, Fujifilm’s sought an Arrow declaration in respect of one of AbbVie’s secondary patents, European Patent Application No 1 737 491 (“EP 491”), but with the added measure of an anti-suit injunction preventing AbbVie from threatening or commencing proceedings for patent infringement in respect of acts covered by the associated Arrow declaration. Fujifilm applied to amend its particulars of claim in order to do this, and AbbVie applied for strike out or alternatively summary judgment to dismiss the claims for both the Arrow declaration and the injunction.
For the Arrow declaration, Fujifilm pointed to the fact that that AbbVie had filed divisional applications to protect adalimumab, only to revoke them on the last day allowed by the European Patent Office. Fujifilm argued that this “prolonged the period of uncertainty” around whether EP 491 can found a valid patent, because proceedings putting into question the validity of a patent may only be brought by proceedings described in section 74 of the Patents Act 1977, which does not include patent applications. Arnold J held that this conduct was to “shield” AbbVie’s patents from “timely scrutiny by the court” and said conduct was “sufficiently unusual” to give Fujifilm a real prospect of success in its claim for an Arrow declaration.
AbbVie argued that it was AbbVie Bermuda, not the UK subsidiary that was the prospective patentee for EP 491, and that there were presently no license provisions benefitting AbbVie UK; therefore an Arrow declaration could not possibly succeed because AbbVie UK had no legally enforceable interest in the patent in suit. Arnold J rejected this line of argument for two reasons; one, that the “financial realities of the situation” pointed to the fact that once granted, a license for the patent in favour of AbbVie UK would almost certainly be forthcoming; second, that even if this were not the case, AbbVie UK would still benefit from the exploitation by AbbVie Bermuda of the patent, and therefore had a “legitimate interest” in the patent; this was sufficient that the declaration should bind AbbVie UK.
Turning to the injunction, Arnold J reviewed the case law concerning domestic anti-suit injunctions and concluded that the court has power to issue such injunctions where the defendant has threatened actions which are “vexatious, oppressive or an abuse of process“. Significantly, this included threatened proceedings to an applicant’s customers or other associated parties, and accepted Fujifilm’s evidence that there was a high chance that AbbVie would make such threats. AbbVie argued that if the Arrow declaration were granted the injunction was unjustified, as AbbVie could be expected to abide by the terms of the declaration. Again, Arnold J sided with Fujifilm; the injunction was sought both as a means of enforcement of the Arrow declaration but also as a free-standing remedy; and that the mere respectability of a defendant was not a reason not to grant injunctions against them. For these reasons, Fujifilm were permitted to amend their particulars of claim to incorporate the pleading for injunction.
The remainder of the judgment concerned whether Fujifilm was entitled to serve AbbVie Bermuda with a claim form, once again finding in favour of Fujifilm.
Assuming the Court of Appeal upholds the decision in Arrow, this case is significant for several reasons. The decision in Arrow has made the process of “shielding“, where incumbent patentees game the system “to avoid a timely determination of [patent] validity” much more difficult. This case extends the toolkit available to generics manufacturers in clearing the way for their compounds, since it is now known an Arrow declaration can bind third parties if the claimant can show that party has some legitimate interest in the patent application in question; and that an Arrow declaration can be complemented by, or stand separately from, anti-suit injunction covering the same acts as the declaration, which is useful in giving comfort to prospective customers of the generics manufacturer.