Home > Insights > UK Supreme Court confirms plausibility requirement for sufficiency of second medical use claims
14 November, 2018

In a long awaited judgement the UK Supreme Court today confirmed that a second medical use claim is only considered sufficiently disclosed insofar as a patent is considered to make the claimed use plausible. This case concerned Warner-Lambert’s EP0934061 patent which included second medical use claims directed to pregabalin for the treatment of pain (claim 1), inflammatory pain (claim 2) and neuropathic pain (claim 3). Although the broadest claim was construed to cover the treatment of any type of pain, the patent contained data relating only to a mouse model of inflammatory pain. In the majority judgement the Supreme Court confirmed that such limited data could be considered to make plausible only the treatment of inflammatory pain and not the treatment of either pain generally or neuropathic pain, and rejected the patent for insufficiency.

As well as confirming the role of plausibility in assessing sufficiency, this landmark judgement also unanimously held that had claims 1 and 3 been valid they would not have been infringed by Actavis’ sale of the generic pregabalin product Lecaent. However, the Judges’ reasoning for this decision differed since the extent to which intention should be taken into account could not be agreed upon.

We will provide additional analysis of this decision shortly.