GSK Breathes Easy After Arrow Declaration Success

GlaxoSmithKline (GSK) successfully pleaded a Gillette defence and obtained an Arrow declaration in a patent infringement action brought by Vectura in respect of inhalable medicaments - Glaxo Group Ltd & Ors v Vectura Ltd [2018] EWHC 3414 (Pat) (13 December 2018).

Background

Vectura alleged that GSK infringed its patents EP 1 337 240, EP 2 283 817, EP 2 283 818, EP 1 337 241 and EP 1 920 763 (the Patents) for inhalable medicaments by the manufacture and sale of its "Ellipta" dry powder inhalers containing the active ingredients vilanterol and/or umeclidinium to treat asthma and chronic obstructive pulmonary disease.

The Patents claimed methods of making (i) "composite active particles" or (ii) "microparticles" exhibiting delayed dissolution and (iii) such particles obtainable by those methods. The Patents all claimed use of magnesium stearate (MgSt) to form the composite active particles.

GSK denied infringement and claimed revocation, pleading insufficiency and a Gillette defence as its own process was objectively obvious in the light of the prior art. Although GSK's process used MgSt, they submitted this was disclosed by each of the three items of prior art. Additionally, GSK sought an Arrow declaration.

Gillette Defence

Arnold J found GSK's own process was obvious over its pleaded prior art. Although it was not obvious to use vilanterol or umeclidinium as the active at that date, as they were not known actives then, Arnold J found that this did not matter as it was obvious to apply the process to any active suitable for use in a dry powder inhaler.

Additionally, Arnold J found the Patents were insufficient as they did not enable the skilled person to determine that MgSt would be on the surface of the active particles, let alone structurally combined with and fused to them. It followed that Vectura had not established that GSK infringed the Patents.

GSK's claim for an Arrow declaration

At an earlier stage of this case Vectura unsuccessfully attempted to strike out GSK's claim for an Arrow declaration (a declaration that a party has a Gillette defence against claims of infringement of later patents - as discussed in the Fujifilm v AbbVie litigation.. In doing so, Vectura gave an undertaking not to sue GSK under any "Non-Assert Patent" families (a class of patent applications in respect of which GSK had the option to take a licence) as defined in an earlier agreement between the parties.

GSK later identified application EP 2 978 415...