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GSK v Vectura, Patents Court, London, UK, 13 December 2018, Case no. [2018] EWHC 3414 (Pat)

This judgment is the first instance decision of Arnold J, dealing with GSK’s claim for revocation of five of Vectura’s patents and Vectura’s counterclaim for infringement by GSK’s dry powder inhaler products for the treatment of asthma and chronic obstructive pulmonary disease. The inhalers contain the active ingredients vilanterol trifenatate and/or umeclidinium bromide, in blends with magnesium stearate and lactose.

The patents in suit fell into two groups: those covering “composite active particles” and those covering “microparticles suitable for delayed dissolution”, and the methods for their manufacture. All five patents claimed the use of magnesium stearate in the formation of the composite active particles.

The parties agreed that the skilled person was “a formulation scientist with an interest in (and experience of) formulating pharmaceuticals for delivery by inhalation, both at laboratory scale and on a larger scale for manufacture”.

GSK denied infringement. The Judge considered whether GSK’s process involved the following steps: the magnesium stearate particles becoming structurally combined with the active particles to form composite active particles; the magnesium stearate being fused to/smeared over the surfaces of the active particles so as to form a coating; and the magnesium stearate being evenly distributed over the active material.

Vectura relied on experiments to demonstrate the nature of the association between the active particles and the magnesium stearate. However, the Judge agreed with GSK that it was not possible to conclusively determine the nature of the association from the experiments. As a result of the limitations of the experiments, it was held that Vectura had not established that GSK had infringed the patents in suit.

GSK did not succeed in demonstrating that any of the patents in suit were obvious over any of the three prior art documents. However, GSK successfully argued that the patents do not enable the skilled person to determine whether or not there are composite active particles with additive particles fused to/smeared over the active particles so as to form a coating, and/or do not enable the skilled person to make such a determination without undue burden.

The Judge agreed that the limitations of the analytical methods available meant that a skilled person would be unable to determine whether a process or product fell within the claims, for the same reasons as Vectura had been unable to conclusively demonstrate infringement. Therefore, the Judge held the patents in suit to be insufficient.

GSK also successfully argued that its own process (and the products obtained by its process) was obvious at the priority date. The Judge accepted GSK’s argument that although the active ingredients in its products were not known at the priority date, it was obvious to use the known process with any active ingredient which was suitable for use in a dry powder inhaler.

As a result of the above determinations, the Judge went on to consider whether GSK was entitled to a declaration that it had a Gillette defence against a claim of infringement at a certain date (a so-called Arrow declaration). The Court’s discretion to grant an Arrow declaration had been considered by the Court of Appeal in Fujifilm v. AbbVie ([2017] EWCA Civ 1).

The Court of Appeal had also heard GSK’s appeal of an earlier strike-out application in this case, in which Vectura had successfully had the claim for declaratory relief struck out. The Court of Appeal, allowing GSK’s appeal, re-iterated that such declarations can be granted when there is a “useful purpose” in doing so, and that the declaration must clearly identify the features of the product or process on which the assessment of obviousness is based. It also stated that there is no requirement that the declaration needs to identify all the features of the product or process.

The Judge considered Vectura’s patent filing strategy and its unwillingness to give undertakings that would give GSK sufficient comfort that it would not be subject to further infringement claims under other Vectura patents. Based on the “unusual” set of circumstances, the Judge concluded that a declaration would serve a useful purpose and allowed an Arrow declaration to be granted.

A copy of the decision can be read here.

Headnote: Scott Parker, Simmons & Simmons