KieferPix /
9 November 2015Europe

English High Court grants Warner-Lambert’s injunction against Sandoz

The English High Court has granted Warner-Lambert an injunction in its patent dispute with generics company Sandoz and LloydsPharmacy.

The dispute concerns Novartis-owned Sandoz’s marketing of a full-label generic version of Warner-Lambert’s Lyrica (pregabalin) drug, which is used to treat epilepsy, general anxiety disorder (GAD), and neuropathic pain.

At the centre of the dispute is European patent number 0,934, 061, titled “Isobuytlgaba and its derivatives for the treatment of pain”, which is owned by Warner-Lambert. Pfizer, which acquired Warner-Lambert in 2000, owns the rights to marketing the Lyrica drug in the UK.

The ‘061 patent covers the treatment of neuropathic pain and is set to expire in 2017. A patent covering the treatment of epilepsy and GAD expired in 2013.

In February, Sandoz sought to market a generic version of the pregabalin drug with skinny and full-label authorisation.

Marketing authorisation for Sandoz’s generic drug covering both full and skinny-label products was granted in June.

In September, Arnold said that the '061 patent was partially valid. He accepted the Actavis and Mylan's claims of “insufficiency” against some patent claims but rejected their claims that the patent claims were obvious. Following the September judgment, Sandoz sought to market its full-label generic product.

However, Arnold has since allowed Warner-Lambert to appeal against the judgment and in the meantime stayed the invalidity ruling.

Last month, in this separate case, Warner-Lambert filed an application for an interim injunction against both Sandoz and Lloyds, a pharmacy chain, to restrain the parties from selling the full-label product.

By this point, Sandoz had supplied more than 100,000 packets of its generic product to 1,500 Lloyds retailers. Mr Justice Colin Birss quickly issued an injunction against the sale of the product on the grounds that Sandoz failed to properly inform Warner-Lambert of the sale of its full-label generic product.

Following further review, Arnold ordered the injunction to remain in place in a decision issued on Thursday, November 4.

“In my judgment, granting the relief sought by Warner-Lambert would create a lesser risk of irremediable harm than refusing it. This is for two main reasons. First, I consider that there is a greater risk of Warner-Lambert suffering unquantifiable and irremediable loss if an injunction is refused than there is of Sandoz suffering unquantifiable and irremediable loss if an injunction is granted.

“Secondly, I consider that there is a strong case for preservation of the status quo pending trial. If no injunction is granted, the arrival of full-label generic pregabalin on the market will make it significantly more difficult for the court to ensure appropriate compensation of those parties which it is finally determined merit compensation,” he added.

Berkeley Phillips, medical director at Pfizer, which acquired Warner-Lambert in 2000, said: “We welcome the court’s decision preventing the further sale, supply and dispensing of Sandoz’s full label pregabalin product, because a world in which intellectual property is not respected or protected is one in which no innovative industry would survive.

“Patents are the lifeblood of medical innovations and advancements, which have a significant impact on public health and our economy,” he added.

Sandoz declined to comment.

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