This article was first published on EPLAW blog, September 2016

Fujifilm Kyowa Kirin Biologics Company Limited v AbbVie Biotechnology Limited and AbbVie Limited (Arnold J), London, UK, 8 September 2016, Neutral Citation Number: [2016] EWHC 2204 (Pat)

This judgment of Arnold J relates to an application made by the Defendants (collectively “AbbVie”) in the context of a wider claim in which the Claimant (“FKB”) had applied for: (1) a so-called “Arrow declaration” that at the priority date of EP (UK) 1,737,491 (a pending application) it would have been obvious and/or anticipated for certain dosage regimens for FKB’s biosimilar adalimumab product (adalimumab is sold by AbbVie as Humira®) to be used for the treatment of psoriasis, Crohn’s disease, and ulcerative colitis; and (2) an anti-suit injunction preventing AbbVie from threatening or commencing patent infringement proceedings against FKB and its customers in respect of acts which pertain to the Arrow declaration. The Defendants had applied to have these claims struck out, or alternatively dismissed by summary judgment.

(Arnold J only considered summary judgment as it was unnecessary to consider both of the Defendants’ applications when the summary judgment test was more favourable to AbbVie).

Arrow Declaration

Arrow declarations relate to pending patent applications and are named after the declaration sought in Arrow Generics v Merck & Co [2007] EWHC 1900 (Pat). Arnold J summarised the basis for such declarations as follows:

– it is within the Court’s power to grant such a negative declaration when useful to do so;

– such declarations serve a useful purpose in that they in effect establish a so called Gillette defence to a subsequent claim for patent infringement. A Gillette defence (named after the case Gillette Safety Razor v Anglo-American Trading (1913) 30 RPC 465) is that the accused product is either the same as, or only a non-patentable modification of, the prior art. As such, it can be determined, without even looking at the patent specification, that any subsequent patent with claims encompassing the accused product is invalid; and

– validity of the relevant patent is not “in issue”, and so section 74(1) of the Patents Act 1977 (which sets out the types of proceeding in which the validity of a patent can (and cannot) be put in issue) is not contravened. In this respect, Arnold J. noted that an appeal against this point in different proceedings between the same parties was due to be heard by the UK Court of Appeal in November 2016.

Arnold J. held that FKB had a real prospect of successfully obtaining the Arrow declaration and therefore dismissed AbbVie’s application for summary judgment. This was because the judge was satisfied that the conduct of the patentee (AbbVie Bermuda) in the prosecution of the relevant patent application was designed to delay the grant of the patent or at least prolong the prosecution process, and so avoid timely scrutiny of the patent by the UK Court.

That AbbVie Bermuda had been found to have undertaken similar conduct in respect of other patents for adalimumab was cited by the judge as further modest support for this conclusion. Arnold J came to the same conclusion in relation to AbbVie’s local UK affiliate, despite the local affiliate not at the time being an exclusive licensee (and therefore not having standing to sue for patent infringement).

Anti-suit Injunction

Following a review of the applicable law, Arnold J. concluded that the UK Court has the power to grant a domestic anti-suit injunction against a defendant in respect of whom it has jurisdiction on the ground that the defendant’s threated proceedings are vexatious, oppressive or an abuse of process. However, the judge noted that this power must be exercised with considerable caution and would normally only be granted with the qualification that proceedings may still be brought with the permission of the court.

Arnold J. held that, on the facts before him, there was a realistic prospect that FKB would successfully obtain the anti-suit injunction at trial, albeit that the scope of the injunction would need to be carefully worded so to avoid it restraining AbbVie from bringing proceedings for patent infringement which did not conflict with the Arrow declaration. The judge therefore also dismissed AbbVie’s summary judgment application in respect of the anti-suit injunction, but noted that if FKB failed to obtain the Arrow declaration at trial, it would not have a realistic prospect of obtaining the anti-suit injunction, and that the scope of any injunction would be tied to the scope of the declaration.

Jurisdiction

Arnold J also concluded that the UK Courts had exclusive jurisdiction over FKB’s claim by virtue of Article 24(4) Recast Brussels I Regulation (and therefore no permission was required to serve on AbbVie Bermuda outside the jurisdiction). He added that, if he was wrong, he would in any event give FKB permission to serve out.

A copy of the judgment can be found here.