2016 is the year that the Arrow declaration has made its comeback. These declarations concern pending patent applications and are so named after a case from 2007, Arrow v Merck [2007] EWHC 1900 (Pat). In essence, a party seeking to clear the way of a granted patent (which it is encouraged to do in the UK if it relates to a generic pharmaceutical product) can apply to revoke the patent prior to launch of a product. On the other hand, a party cannot do so in relation to pending patent applications as the law does not allow for pre-grant opposition. Nevertheless, the English Patents Court in the Arrow case held (in summary proceedings) that it was at least arguable that the Court had jurisdiction to grant a declaration that a particular product would have been anticipated and/or obvious at a given date in order to protect a manufacturer of that product from a subsequent claim for infringement of a later-granted patent having that date as priority date. This would support a defence that such product could not infringe a valid patent with that priority date, regardless of the form of the claims of that patent (a version of the so-called Gillette defence). Although the earlier Arrow case settled before trial, the Claimant in the recent case of Fujifilm Kyowa Biologics v AbbVie [2016] EWHC 2204 (Pat) has sought to rely on this jurisdiction for the second time in a year.
The background to the case – FKB 1
Fujifilm Kyowa Biologics (FKB) has been developing a biosimilar adalimumab product to AbbVie’s blockbuster Humira® product. It had issued a claim in late 2015 to revoke two granted patents in AbbVie’s name relating to dosage regimes for use of adalimumab in various clinical indications. In light of a number of pending divisional applications to those granted patents, FKB also sought a declaration (following the Arrow case) that a specific dosage regime for adalimumab would have been obvious at each of the claimed priority dates of the two patents in suit. Shortly after issue of the claim form, AbbVie indicated in opposition proceedings at the EPO that it no longer approved the text of one of the granted patents, leading the EPO to revoke that patent. Nevertheless, FKB wished to pursue its claim for an Arrow declaration in relation to the priority date of this patent due to the pending divisional applications, on which AbbVie sought summary judgment and/or to strike out. In his judgment from March of this year (FKB v AbbVie [2016] EWHC 425 (Pat)), Carr J held that the Court had jurisdiction to grant a declaration of the type sought and that FKB had a real prospect of succeeding at trial in persuading the Court to grant such a declaration on the sufficiently unusual facts of the case, even though he accepted that the jurisdiction needed to be exercised with caution.
The latest case – FKB 2
This second and recent case concerned another family of patent applications in AbbVie’s Humira patent portfolio. These also relate to dosing regimens for adalimumab. In a new action, FKB again sought an Arrow declaration that a specific dosage regime for adalimumab would have been anticipated and/or obvious at the claimed priority date of this additional patent family. FKB also sought an injunction against AbbVie to restrain it from threatening or commencing proceedings for patent infringement in relation to acts covered by the declaration sought. AbbVie applied to set the claim aside in summary judgment and/or strike out proceedings.
In this second case, AbbVie accepted (subject to appeal) that the FKB 1 case had been decided correctly and that the jurisdiction to grant Arrow declarations existed. Nevertheless, AbbVie argued that, it being a jurisdiction that should be exercised cautiously, it should not be exercised on the facts of this second case which were different to those in FKB 1. On its part, FKB sought to rely on two principal facts to argue that AbbVie was seeking to shield its patent portfolio from the scrutiny of the English Courts and the EPO Opposition Division. First, it cited the fact that shortly before grant of a patent within the new family (i.e. after the EPO had announced its intention to grant the patent), AbbVie had indicated on the last possible date that it no longer approved the text proposed for grant and sought to make narrowing amendments to the claims whilst expressly reserving the right to pursue the deleted subject matter by way of further divisional application(s). Second, FKB sought to rely on AbbVie’s conduct in the FKB 1 case by way of similar fact evidence. In this case, Arnold J was persuaded that FKB had a real prospect of success against the patentee and allowed the claim to continue to trial.
FKB also sought the Arrow declaration against the AbbVie’s UK affiliate (and MA holder for Humira in the UK), who is not the patentee. AbbVie resisted on the basis that the UK affiliate had not committed the acts in the EPO which were complained of and also that the UK company had no interest in the patent rights complained of. Arnold J was of the view that it could not be said that FKB had no legitimate interest in obtaining a declaration that was binding on the UK affiliate given that the latter party was the one with the most direct financial interest in FKB’s proposed acts relating to its biosimilar adalimumab product, and therefore allowed the claim to proceed to trial.
Arnold J also reviewed the case law on anti-suit injunctions and concluded that the Court had the power to grant a domestic anti-suit injunction against a defendant over which it has jurisdiction where the defendant’s threatened proceedings were vexatious, oppressive or an abuse of process. Nevertheless, this was a power that should be exercised with considerable caution. On the facts, the judge held that FKB had a real prospect of obtaining such an injunction (although not if it failed to obtain the declaration sought) and allowed the matter to proceed to trial.
As a final point, Arnold J also held that FKB’s claim for an Arrow declaration fell within the exclusive jurisdiction of the UK courts pursuant to Article 24(4) of the Recast Brussels I Regulation, even though the declaration is formulated to cover a particular product rather than an as yet to be granted patent. This had the consequence that no permission was required to serve on the patentee (a Bermuda company) outside the jurisdiction, although Arnold J added that had he been wrong he would in any event have granted permission to FKB to serve out.
What happens next?
The Patents Court will now decide in both the FKB 1 and FKB 2 cases whether to grant Arrow declarations in each case. To date, the UK Courts have never granted an Arrow declaration, although the Hague District Court in the Netherlands did grant such a declaration in the Dutch Arrow case (relating to alendronate). The trial of the action in FKB 1 has been fixed to be heard in January 2017, whilst the trial of the FKB 2 action has been provisionally listed for a window of May to July 2017. In the meantime, the Court of Appeal will be hearing AbbVie’s appeal in FKB 1 regarding the decision to allow FKB’s application for an Arrow declaration to proceed to trial. The appeal hearing is fixed for the end of November 2016, and could potentially determine both that part of the first action that relates to the Arrow declaration and the second action.