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18 January 2018Big Pharma

UK Supreme Court grants BIA intervention request in plausibility case

The UK Supreme Court has granted the UK BioIndustry Association (BIA) permission to intervene in the case of Warner-Lambert Company v Generics and Actavis, which concerns the issue of ‘plausibility’.

The BIA announced its intervention had been granted in the case on Tuesday, January 16, and the Supreme Court’s review is set to commence on February 12.

In February, the Supreme Court will examine the issue of ‘plausibility’ in patent law, in a review which could change the quantity of evidence and data required for an invention to be patented. The role of plausibility in determining the validity of patents is not currently a defined concept in UK patent law.

As the trade association for UK bioscience companies, the BIA entered a submission on December 20, 2017 to intervene in the matter. The association hopes to “highlight the importance of the issue”, according to a release from the BIA.

The BIA recommends that a balance is struck so as not to unfairly punish bioscience companies by demanding “an unwarranted level of information” to show an invention’s plausibility, but without allowing rights owners to limit other people’s access to certain areas of research through filing applications with “vague indications of possible research objectives”.

The case itself centres on the drug pregabalin, which has historically been used to treat anxiety disorder and epilepsy.

US pharmaceutical company Warner-Lambert, which is part of Pfizer, owns EU patent number 0,934,061, which covers a second medical use of pregabalin for the treatment of neuropathic pain. Warner-Lambert sells the treatment under the brand name Lyrica.

Two competitors—Actavis, as well as Generics, trading under the name Mylan—applied to revoke the ‘061 patent on the grounds of insufficient disclosure.

In September 2015 Mr Justice Arnold, of the English High Court, held that the claim for treating neuropathic pain—both peripheral and central—was only partially plausible, as the patent does not plausibly treat central neuropathic pain.

Warner-Lambert applied to amend this claim, limiting it to peripheral neuropathic pain, which the court found to be an abuse of process.

The Court of Appeal’s Civil Division, led by Lord Justice Floyd, concurred with the lower court and upheld the finding. Warner-Lambert subsequently appealed.

Steve Bates, CEO of BIA, is “delighted” that BIA has been given permission to intervene.

He said: “The ability of bioscience companies to attract investment to develop life-changing innovations for patients is intrinsically linked to their ability to obtain reliable patent protection at an appropriate stage.

“We hope that the court will find a balance which will allow companies to protect and commercialise their discoveries whilst not unfairly closing down areas of research for other companies.”

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More on this story

Big Pharma
21 February 2018   Infringement and plausibility were the biggest issues on the battleground in the UK Supreme Court’s hearing in a case dealing with second medical use patents, as Claire Phipps-Jones, Katie Cambrook and Rachel Mumby of Bristows report.
Big Pharma
14 November 2018   The UK Supreme Court today dismissed Warner-Lambert’s appeal in its pregabalin patent dispute with Actavis, while clarifying the role of plausibility in the sufficiency of patent applications.
Big Pharma
12 November 2019   The UK BioIndustry Association has published a manifesto detailing its recommendations on how political parties can support innovation in the UK life sciences sector, ahead of the UK general election.