The UK Bioindustry Association (BIA) has been allowed to intervene in a Supreme Court case, reviewing Warner-Lambert Company LLC v Generics (UK) Ltd and Actavis.
Legal outcome
In this review, the issue of ‘plausibility’ in patent law will be examined, which could impact the amount of data and evidence that will be required before an invention can be patented in the future. BIA’s intervention in this case is to stress the importance of this issue to the UK’s bioscience sector.
“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,” explained BIA CEO Steve Bates. “We are delighted that the Supreme Court will take account of the arguments we are making on behalf of the UK bioscience sector. 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.”
The subject of the case in question is the drug pregabalin for which Warner-Lambert is the proprietary owner of a patent for a second medical use in the treatment of neuropathic pain. Generics and Actavis applied to revoke the patent in part as a result of insufficient disclosure of the specification. The judge deemed in this case that the treatment claim (claim 3) for the second medical use was only partially plausible as it did not cover central neuropathic pain as well as peripheral, leading Warner-Lambert to apply for an amendment to claim 3 to limit it to peripheral neuropathic pain. This amendment application was held to be an abuse of process and this judgement was upheld by the Court of Appeal. This decision is now being appealed by Warner-Lambert.
According to the BIA, there is a trend occurring in patent cases to attack the validity of a patent on the grounds that the invention was not plausible because of the data and evidence used at the time of the application. Therefore, companies in the bioscience sector are having to decide on whether to file a patent early and potentially risk facing an allegation that the invention is not plausible, or to delay filing until further tests are completed and incur extra costs and potentially run the risk of losing patent protection. These issues have the potential to affect investment opportunities.
It is expected that the Supreme Court will provide further guidance on the role of plausibility in assessing potential patent validity when it delivers its judgement. This case will be heard on 12 February.