Pregabalin

The Supreme Court in the UK handed down its long-awaited judgment in Warner-Lambert v Generics, concerning the drug pregabalin, on 14 November 2018. The judgment included extensive considerations on the thorny issues of “plausibility” and the infringement of “Swiss-style” second medical use claims.

The doctrine of “plausibility” has been applied in many recent European Patent Office and national court decisions. It is relevant to the validity of patents with claims which refer to a therapeutic product which is said to have some sort of desirable biological activity. The EPO Boards of Appeal and the national courts in the UK have taken the view thus far that there must be enough technical information in the application as filed to render it plausible that the product has the relevant biological activity. The Supreme Court has now provided further guidance on how the doctrine is to be applied in the UK.

The considerations that should apply when assessing infringement of Swiss-style medical use claims were also debated at length during the Supreme Court hearing and form a substantial portion of the resulting written judgment.

In this webinar, we review the Supreme Court’s findings on both of these issues. We also seek to answer questions about the likely impact of the judgment on the patentability and enforcement of claims to second medical uses in the UK going forward.