Briefing Note For Patent Practitioners: An Analysis Of Arrow Declarations Following Glaxo v Vectura

The purpose of this briefing note is to raise awareness of the increasing use of Arrow declarations, following on from the Fujifilm v AbbVie decision, which was handed down on 12th January 2017 in the Court of Appeal. The latest case of Glaxo v Vectura ([2018] EWHC 3414 (Pat)) looks at the approach being taken by the English Patents Court and seeks to learn lessons from this. To this extent, it is hoped that patent prosecutors and litigators alike will find something useful to help in their everyday practices.

Fujifilm v AbbVie - A reminder

In what is probably an extreme case, AbbVie sought to extend the protection of its' blockbuster HUMIRA drug which treated various inflammatory diseases, beyond the SPC expiry date of 15 October 2018. It did so by filing numerous applications in respect of various dosage regimes essentially for the same compound. However, as happened in the UK proceedings, shortly before the Patents Court was due to consider the issue of validity and infringement, AbbVie filed a subsequent divisional application, and subsequently they would either disapprove the text or de-designate the EP(UK), so that the Patents Court never had sight of a granted patent. In one case, they were on the 5th divisional application.

What AbbVie sought to achieve was the uncertainty that FKB's generic product under the original granted patent, might inevitably infringe something in the other patent families and their divisionals, particularly if the dosage regime was different, for example. It was for this reason that FKB sought a declaration that their product, at a specific date (in this case the priority date of the original parent application), was old and obvious even though there was no issue relating to the validity of a granted patent, as required under s.74 PA 1977.

Arnold J. stated he could make such a declaration and granted Fujifilm the relief sought. AbbVie subsequently appealed.

In essence, the Court of Appeal approved the approach in Arrow Generics v Merck & Co [2007] in accepting that it is possible for an English Patents Court to grant such declarations. They therefore dismissed AbbVie's appeal.

Glaxo v Vectura

The facts

This case revolved around two sets of patents (the "Patents") for a method of making particles for use in a pharmaceutical composition, and a method of preparing microparticles for use in pharmaceutical compositions for inhalation. In essence, the first group of patents claimed methods of making "composite active particles" and the second group related to methods of making "microparticles" which exhibited and delayed dissolution...