GSK awarded Arrow declaration in patent dispute with Vectura
The English High Court has ruled in favour of GSK in its patent dispute with Vectura, a UK-based pharmaceutical company which specialises in inhalable medicaments.
Vectura alleged that GSK had infringed its patents in the manufacture and sale of dry powder inhaler, Ellipta.
The allegations concerned three patents (UK numbers 1337240, 2283817, 2283818) under the name “Method of making particles for use in a pharmaceutical composition”, one patent (UK number 1337241) named “Method of preparing microparticles for use in pharmaceutical compositions for inhalation”, and another (UK number 1920763) titled “Pharmaceutical compositions for inhalation”.
All five patents include the use of magnesium stearate (MgSt).
GSK denied infringement and claimed that the patents should be revoked on the grounds of obviousness and insufficiency.
The English High Court ruled on Thursday, December 13, that while Vectura’s patents were not obvious, they were invalid for insufficiency.
Mr Justice Arnold said that it was not possible to determine when the patented invention (MgSt) had been created. This rendered each of Vectura’s five patents insufficient, and therefore an infringement of them could not be established.
He ruled that GSK’s products were obvious, so could not be subject to patent protection by Vectura. He added that GSK’s own manufacturing processes and resulting products would have been obvious to the skilled person.
GSK was also granted relief in the form of an Arrow declaration. This is a declaration that products, processes or particular uses (in this case, the methods in Vectura’s patents) are not new or were obvious at a particular date, and therefore cannot be the subject of valid patent protection.
The ruling stated that Vectura’s patents were a subset of a wider group of patents defined by a previous agreement between GSK and Vectura as “non-assert patents”.
Vectura had entered into an agreement with GSK which stated that it would not take legal action against GSK for any of the non-asserted patents.
GSK identified a pending application, filed in 2013 by Vectura, for a patent titled “Use of stearate in an inhalable formulation” (UK number 2978415). This patent was outside of the non-asserted patents group of patents but related to the same technical subject matter of them.
Vectura declined to extend its agreement beyond the non-asserted patents to also cover the ‘415 patent, a move that would put GSK at risk to a claim for patent infringement, Arnold said.
In his ruling, Arnold said that for an Arrow declaration to be granted, there must be more than just a finding that relevant subject matter is obvious. He described this as a “necessary, but not sufficient foundation for relief”. He also said that there must be a “useful purpose” in granting the declaration.
In this case, Arnold said Vectura had entered an agreement which was designed to give GSK comfort that, if GSK were successful in defeating Vectura’s claims of patent infringement, GSK will not be targeted by further claims of infringement.
Vectura was unable to provide an explanation for its unwillingness to extend its agreement to include the ‘415 patent.
Arnold concluded that on the “unusual facts of the case”, the award of an Arrow declaration would serve a useful purpose as it will “formalise and emphasise” that GSK’s manufacturing processes and products were obvious.
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