The Supreme Court of England and Wales on 27 March 2019 handed down judgment in the case of Actavis Group PTC EHF v ICOS Corp on appeal from the Court of Appeal. Finding in favour of the respondents, Acatvis, TEVA and Mylan, the court upheld the Court of Appeal’s decision that a dosage patent for tadalafil in the treatment of male erectile dysfunction was invalid for lack of inventive step. The methodology employed by the Supreme Court to the question of inventive step affirms the current practice of the UK courts and the jurisprudence of the EPO. In the court’s view, it was clear that a skilled team was engaged in the familiar and routine testing of a drug to establish the appropriate dosage regimen in order to implement the teaching of the prior art. It was obvious to embark on that exercise and carry out tests in a routine way until the appropriate dose was ascertained, and such tests included the completion of dose-ranging studies routinely carried out in Phase IIb of clinical trials.

 

Our comment in (2019) 41 EIPR, Issue 7 considers the judgment and its implications.