Court of Appeal finds CIALIS dosage regimen patent obvious

Unpredictable. Through the ages, humans and Kats have had to deal with the unpredictable, random and the volatile nature of life and, in particular, human behavior.  After the events of 2016/7, many of us may instituted more robust psychological tools to deal with unpredictable times - with varying degrees of success.  But an area where you cannot employ such tools is in patent litigation, where the fate of your patent or your defence depends on an inherently unpredictable fictional character/s - the skilled person/team - viewed through the prism of expert evidence and weighted with the perception of whatever judge you are before.  The Court of Appeal's decision last week in Actavis v ICOS [2017] EWCA Civ 1671 is a reminder that the uncertainty that can plague this and the resulting outcome of a court hearing, may not extend to the skilled team embarking on a routine clinical trial program.

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The Court of Appeal consisting of Lord Justice Kitchin, Lord Justice Floyd and Lord Justice Lewison overturned Mr Justice Birss' first instance decision (handed down last August - see here) that the '181 Patent was valid and infringed.  The '181 Patent covers the dosage regimen for tadalafil - a PDE5 inhibitor - sold under the brand name CIALIS (for male erectile dysfunction) and ADCIRCA (for pulmonary arterial hypertension).  The 2014 market for CIALIS in the UK amounted to $99 million and ADRICA amounted to $1 million.  Actavis and Teva appealed the decision on the '181 Patent on five grounds - construction/infringement, lack of entitlement to priority, added matter, novelty and obviousness. The Court of Appeal held that the '181 Patent was invalid for obviousness.  Birss J had held that the other patent at issue in the first instance proceedings - the '092 Patent - which covered the formulation was invalid.  ICOS (patent owner)/Lilly (exclusive licencee) did not appeal that decision.