Obviousness And Discoveries From Routine Testing: UK Supreme Court Decides Correct Approach

The UK Supreme Court has handed down its judgement in Actavis v ICOS [2019] UKSC 15 unanimously upholding the earlier decision of the Court of Appeal that the patent to a specific dosage regimen of tadalafil was obvious. However, in doing so the UK Supreme Court has allayed the concerns of innovators and big pharma by confirming there is no automatic bar to dosage claim discoveries, made through well-established or routine procedures provided they involve an inventive step.

Background to the dispute

This case concerned the dosage patent EP(UK) 1,173,181 (the '181 Patent') and in particular claims relating to a specific low 5mg dose of the drug tadalafil marketed under the brand name CIALIS and used to treat erectile dysfunction or 'ED'. The CIALIS drug is a competitor (second in class) of the well-known branded drug VIAGRA. However, VIAGRA had certain side effects. Both tadalafil and sildenafil, the active ingredients in VIAGRA, are inhibitors and work by blocking