Warner-Lambert v Actavis: day one from the UK Supreme Court
LSIPR attended a packed UK Supreme Court yesterday for day one of a four-day hearing, with Warner-Lambert debating the role that plausibility plays in patent law. Below we provide an overview of the case and its core issues.
The case revolves around the drug pregabalin, which has historically been used to treat anxiety disorder and epilepsy.
Part of Pfizer, Warner-Lambert owns EU patent number 0,934,061, which covers a second medical use of pregabalin for the treatment of neuropathic pain.
Actavis and Generics (trading as Mylan) applied to revoke the patent on the grounds of insufficient disclosure.
Mr Justice Arnold of the English High Court held that the claim for treating neuropathic pain in the peripheral and central senses of the word was only partially plausible. He ruled that the patent does not plausibly treat central neuropathic pain.
Warner-Lambert applied to amend the claim and limit it to peripheral neuropathic pain. However, the court found this to be an abuse of power.
The Court of Appeal’s Civil Division agreed with the lower court and upheld the finding, against which Warner-Lambert appealed.
Last month, LSIPR reported that the UK BioIndustry Association (BIA) was granted permission to intervene in the case.
This week, the BIA will join the discussions on the role plausibility should play in the statutory test for sufficiency. The discussions will focus on whether a patent should be held insufficient for the lack of plausibility even though it is enabled across the scope of the claim.
The schedule for the proceedings is as follows:
Monday
Thomas Mitcheson QC, on behalf of Warner-Lambert, took to the court to argue the validity of its patent.
LSIPR heard Mitcheson argue that the claim should be amended to only cover peripheral neuropathic pain, as there is no mention of central neuropathic pain in the claim.
According to Mitcheson, the skilled eye would read the claim and recognise that it only applies to peripheral neuropathic pain, not central neuropathic pain.
He said all of the company's arguments are supported by the general policy consideration in its overall submission. “If the courts below and the respondents are right, then the UK is out of step with the European Patent Office and the other signatory states to the European Patent Convention.”
He said that the consequence would be that the innovation does not receive the recognition it achieved in Europe and other parts of the world.
Also representing Warner-Lambert throughout the week are Lord Pannick QC, Miles Copeland and Tim Austen.
Those representing Generics and Actavis are Adrian Speck QC, Pushpinder Saini QC and Kathryn Pickard.
Tuesday
Warner-Lambert is again being heard today, alongside the respondents Generics and Actavis.
Wednesday
The respondents have the full day to argue why the patent should not be allowed.
Thursday
The respondents will begin the day’s proceedings, before the intervener, Secretary of State for Health Jeremy Hunt, will take to the court.
This will be followed by Warner-Lambert and Generics and Actavis giving their reply.
The case is being overseen by the following judges: Lord Hodge, Lord Sumption, Lord Mance, Lord Reed and Lord Briggs.
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