Fujifilm Kyowa Kirin Biologics v Abbvie Biotechnology Ltd

This practice can, of course, significantly increase the time and expense required for third parties to clear the way for launch of a competing product.  Such third parties can face the prospect of multiple sequential litigation as various divisional applications are granted by the EPO.

Clearing the Way Through the Thicket

The case of Fujifilm Kyowa Kirin Biologics (“FKB”) v AbbVie Biotechnology Ltd involves the Humira® antibody, the highest selling prescription drug in the world by global sales.  Patent protection for the antibody per se is due to expire in October 2018.  FKB is seeking to clear the way for the launch of a biosimilar product, and to that end had opposed a patent held by AbbVie for specific dosages of Humira^®.

AbbVie initially contested the EPO opposition proceedings on its dosage patent, but in November 2015 AbbVie disapproved the text of the granted patent.  This led to the automatic revocation of the European patent without a reasoned decision from the Opposition Division.  However, AbbVie had filed four divisional applications, the last of which was said to claim essentially the same subject matter as the parent patent which had been revoked.

FKB therefore asked the High Court to grant a Declaration to the effect that it was obvious, at the priority date of the patent applications at issue, to use its biosimilar product to treat various diseases at the relevant dosages.  If such a Declaration were to be granted, it would of course prevent AbbVie from asserting any patents derived from any of its divisional applications against the FKB biosimilar product when it is launched in the UK.

Declaration that the FKB Product was Obvious

AbbVie applied to strike out FKB’s action on the basis that the High Court does not have the necessary jurisdiction to grant the Declaration, and Judge Henry Carr heard the application².

Previous Cases Considered

When considering whether or not the case could proceed, the High Court reviewed Arrow v Merck³ from 2007.  In that case Arrow applied for a Declaration that as of July 1997 it was obvious to use sodium alendronate trihydrate in the form of a tablet containing about 70 mg active ingredient for oral administration for the treatment of osteoporosis.  Arrow wanted this Declaration in order to forestall any future infringement actions brought by Merck based on yet-to-be granted divisional patents which covered such a product.  If Arrow’s product was an obvious one to make in 1997, the priority date of the yet–to-be granted divisionals, then any patent infringed by that product would necessarily lack inventive step.

The Arrow case was obviously a powerful precedent – so much so that Judge Carr coined the phrase “Arrow Declaration” to describe the sort of order which FKB was seeking.  In the previous Arrow case, the High Court had decided that the English court could in principle grant declaratory relief along the lines sought by Arrow (although the case then did not progress further because Merck withdrew the designation of UK in the European division applications at issue).  Further, there was a corresponding Dutch litigation between Arrow and Merck where the Dutch court did proceed to issue a Declaration that the alendronate tablets at issue were obvious at the relevant date.

Jurisdiction of the High Court

Faced with the Arrow v Merck precedent, AbbVie argued that the court was wrong in that earlier case to conclude that it is permissible to make Declarations about whether or not a product is obvious.

AbbVie’s arguments were that:

1. the “black letter” statute (section 74 of the Patents Act 1988) provides an exhaustive list of proceedings in which the validity of a UK patent can be challenged, and that list does not include an application for Declaratory relief of this nature;
2. the proceedings begun by FKB would, in reality, constitute a pre-grant opposition procedure, and the legislators have not provided for pre-grant opposition at the EPO; and
3. the Declaration sought would usurp the EPO’s role in examining the validity of European patent applications in an unacceptable way.

The High Court acknowledged that there were force in these submissions, but ultimately dismissed these arguments and held that the English High Court did have jurisdiction to grant an “Arrow Declaration” to the effect that specific products were obvious at a particular date.  However, the Court did accept that such Declarations should not be granted as a matter of course, simply because there are pending applications at the EPO.  A full analysis of facts will be needed in each case.  The Court also helpfully outlined the factors to be considered in determining whether or not a Court should entertain proceedings for an Arrow Declaration, as follows.

1. Would the Declaration serve a useful commercial purpose?
2. Is the underlying issue sufficiently clearly defined?
3. Are there special circumstances why the Court should not grant the Declaration?

On the facts of this case these criteria were satisfied by FKB, and the Court therefore permitted the proceedings for Declaratory relief to proceed.

Implications Going Forwards

Given the real difficulties which can be faced by generic companies seeking to clear the way for a product launch in the face of multiple pending divisional applications, it is likely that such “Arrow Declarations” in the High Court will become an increasingly important weapon in the armoury available to generic companies.  By way of example, Samsung Bioepis UK Limited has issued a claim in the same terms as FKB’s claim for the same product.  In many cases, these “Arrow Declarations” will represent an efficient and cost effective option for achieving legal certainty in a short timescale.

Innovator companies will therefore need to consider carefully their strategy when filing divisional applications, to minimise the risk that an Arrow Declaration might become an option for generic challengers.  J A Kemp is well placed to advise on the issues to consider either when seeking to optimise patent protection for an existing product, or when seeking to clear the way for launch of a competing product.