Hot on the heels of its ground breaking decision last summer in Actavis UK Ltd v Eli Lilly & Co [2017] UKSC 48 (see our blog here), which introduced a doctrine of equivalents into English law, the Supreme Court is poised to hear another very significant patent case, Warner-Lambert v Generics (UK) Ltd and Actavis, this month, as we report in this blog.
The case will determine a number of issues including how much information needs to be included in a patent application to make an invention 'plausible'. This in turn will impact on how patent applications are drafted and, importantly, when they will be filed. The potential significance of the decision, with implications well beyond the life sciences sector, and perhaps the surprise expressed by many to the Supreme Court's decision in Actavis v Eli Lilly, has no doubt driven the numerous applications to intervene in the case which have been made. Ten applications to intervene and make written submissions have now been accepted, with interveners including the Secretary of State for Health (also with permission to make oral submissions) and several industry bodies (such as the UK BioIndustry Association and the Chartered Institute of Patent Attorneys).
Background
The underlying dispute concerns Warner-Lambert's patent for the new use (treating pain) of a known compound, (pregabalin) (the "Patent"). Pregabalin is sold through Pfizer for pain-relief under the trade mark LYRICA. In 2014, Actavis Group PTC EHF and Generics (UK) Ltd (trading as Mylan), each sought to revoke the Patent on various grounds, including insufficiency. The main insufficiency argument was that there was not enough information in the patent specification to make it plausible that pregabalin would work in treating all types of pain, as was claimed. Instead there was only enough information to make it plausible that pregabalin would be effective in treating some types of pain. The invention was not, therefore, disclosed in a sufficiently clear and complete manner for it to be carried out by a person skilled in the art and the patent should, therefore, be found invalid.
In 2015, Mr Justice Arnold ruled in favour of Actavis and Generics (see here), finding that several of the claims were invalid because they were insufficient. He agreed that the information in the Patent only made it plausible that pregabalin would be effective in treating some types of pain. His decision was subsequently upheld by the Court of Appeal in October 2016 (see here). Warner-Lambert appealed to the Supreme Court, which agreed to hear the case.
Appeal before the Supreme Court
There are several issues before the Supreme Court. The issue which appears to be attracting most interest is whether plausibility should play a role, and if so what role, in the statutory test for sufficiency of disclosure in patent applications. The word "plausible" does not appear in the European Patent Convention, nor the UK Patents Act 1977, but has its origins in the jurisprudence of the EPO Boards of Appeal. Earlier case law suggests it should have a role, but should only be a low-threshold test, designed to discourage patent applications based on speculative assertions.
The case is scheduled to start at the Supreme Court on Monday 12 February 2018 and is due to last for four days. We will report further on how the arguments of the parties unravel and on the positions expressed by the many interveners.