Appeal Dismissed for Dosage Regimen Patent

May 2016

The Court of Appeal has dismissed the appeal (Richter Gedeon Vegyeszeti Gyar RT v Generics (UK) Ltd (t/a Mylan) [2016] EWCA Civ 410 (26 April 2016))by Richter that their European Patent (UK) no. 1 448 207 was not invalid for obviousness.  

Stating that even though the facts of the case were unusual, in that the prior art which rendered the patent obvious contained an obvious error, the judgment confirmed the finding at first instance.   

In his judgment at the Court of Appeal, Sir Robyn Jacob held that there was no “logical distinction between a case where it obvious to look something up and one where it is obvious to ask and clear that the answer would be given and would be clear. The notional asking is exactly equivalent to the notional looking up. In both cases the prior art spurs the action of finding out in a non-inventive way”.

Lord Justice Floyd agreed, holding that obviousness is “concerned with what the skilled person would do in the light of disclosure comprised in the state of the art”. “…where it is established that the skilled person would have been prompted by the state of the art to ask for a specific piece of information from a source which would be obvious, and that the information requested would have been freely given, a finding of lack of inventive step is, as it was here, properly open. The case is no different from one where the skilled person would have to perform routine tests with a drug in order to arrive at a claimed pharmaceutical formulation or dosage range. There is no requirement that the results of those tests should have been prior published, far less that they be common general knowledge.” 

Although the point wasn’t pursued in argument before them, the Court of Appeal also noted that an oral description, " the evidence of which is inherently potentially ephemeral” was enough as a basis for an attack of lack of novelty or obviousness.