GSK breathes easy after Arrow declaration success

December 2018

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 (“EP’415”) which was not covered by Vectura’s undertaking.  EP’415 claimed the use of MgSt as a formulation density modifier with umeclidinium and vilanterol as pharmaceutically active material. GSK therefore sought an Arrow declaration for the purposes of commercial certainty and to avoid Vectura reformulating and asserting the inventive concept using applications still on file, relying on EP’415.

Distinguishing Generics v Yeda

In Generics (UK) Ltd v Yeda Research and Development Co Ltd [2017] EWHC 2629 (Pat)Arnold J declined to grant an Arrow declaration as it would not have served a useful purpose beyond his finding that the use of the claimant’s product in a particular dosage regimen was obvious at a particular date. Whilst this argument was relied upon by Vectura, Arnold J found this case to differ as Vectura’s patents would not necessarily be formulated in a manner leading to the same findings of insufficiency and non-obviousness as in the present case.

The most notable difference however, was Vectura’s undertaking to GSK which intended to give GSK comfort that, if they succeeded in defeating Vectura’s claims for infringement of the Patents, then GSK would not face further claims for infringement of other patents by the same process and products. Arnold J noted however that Vectura’s undertaking did not extend to patents deriving from EP’415 and Vectura did not explain its unwillingness to extend its undertaking to EP’415. It followed that GSK would potentially be at risk of a claim for infringement of a patent deriving from EP’415 and other similarly filed patents.

Arnold J therefore concluded that the grant of an Arrow declaration would serve a useful purpose as it would formalise and confirm the Court’s findings with respect to the obviousness of GSK’s process and products.

Next steps

Whilst this case was specific to its facts, it highlights the importance of providing a detailed explanation of any caveat or limits to the scope of any undertakings. As such, when drafting an undertaking, it must be drafted in a manner to remove all useful purpose i.e. the scope of a dispute should not be cut down without a full explanation. An absence of such an explanation when drafting the undertakings would be likely to persuade the Court to find there is a useful purpose in granting an Arrow declaration.

This update was prepared by HGF IP Solicitor Maherunesa Khandaker.  If you would like further advice on this or any other matter, please contact Maherunesa Khandaker. Alternatively, you can contact your usual HGF representative or visit our Contact page to get in touch with your nearest HGF office.