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8 October 2019Big PharmaSarah Morgan

Sandoz secures victory against GSK in passing off case

The English High Court has sided with pharmaceutical company Vectura and Novartis-owned Sandoz in a passing off lawsuit brought by rival GSK.

Late last week, Vectura said the court had dismissed all of GSK claims related to the packaging of AirFluSal Forspiro. Forspiro is a dry powder inhaler developed by Vectura and licensed to Sandoz for use with the AirFluSal inhaler.

AirFluSal Forspirol is a generic version GSK’s product Seretide Accuhaler, used to treat asthma and chronic obstructive pulmonary disease.

On Friday, October 4, Lord Justice Arnold of the English High Court dismissed GSK’s claim that Vectura and Sandoz had used shades of purple similar to GSK’s Seretide packaging to pass off AirFluSal Forspiro as being related to GSK’s product.

“This case is about the colour purple,” said Arnold. “Although GSK’s pleaded case also relies upon certain other aspects of the get-up and packaging, by the end of the trial the only feature Glaxo really relied upon was the use of purple.”

GSK brought the proceedings in December 2015, but the dispute only reached trialed in July 2019. According to Vectura, the claim is one of a number of actions brought throughout Europe by GSK against Sandoz.

Arnold said: “Regrettably, both sides have approached the matter as if it were a state trial: there was a great deal of interlocutory skirmishing which continued right up to trial, a large volume of both documentary and witness evidence was produced and I received extensive written and oral submissions.”

In addition to dismissing GSK’s claim for passing off by a misrepresentation to patients as to the trade origin of AirFluSal Forspiro, Arnold also concluded that it was “wholly improbable”, due to lack of evidence, that patients would be confused as to the characteristics of the AirFluSal.

GSK also charged Sandoz and Vectura with recklessness, a contention that Arnold dismissed.

“It can now be seen that there never was any proper basis for the charge of recklessness. It follows that, as the defendants submit, the entire investigation into the defendants' state of mind has been a complete waste of time and money,” he added.

GSK said it was disappointed with the court’s decision not to grant an injunction against Sandoz and will now carefully consider its next steps.

A spokesperson for the company said:  “GSK is not opposing in any way the entry into the market of a combination medicine comprising salmeterol and fluticasone propionate in dry powder form (a generic form of Advair/Seretide), our issue was simply with the colour of the device itself and its similarity to GSK’s Advair/Seretide.”

GSK added that the use of purple in a generic inhaler could "lead to confusion" among patients, pharmacists and healthcare providers.

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More on this story

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16 September 2019   A district court has upped Vectura’s award of $89.7 million in damages by $10m, after a jury trial earlier this year found that GlaxoSmithKline has willfully infringed one of its patents.