Drug: LIPIDIL EZ® (fenofibrate)
The Court heard this application and the next application consecutively and issued decisions on the same day, however, indicated that each was considered separately. The Court dismissed the application for a prohibition order.
As a preliminary consideration, the Court examined challenges made to the expert evidence. The majority of these were either dismissed or said to go to weight. However, in one case, the expert was found not to possess the necessary expertise of a person skilled in the art. Thus whenever his evidence was in conflict with another expert or not supported by other evidence, his evidence was disregarded.
The Court considered the evidence relating to the allegation of non-infringement and held that on the balance of probabilities, there was no evidence from which the Court could conclude that the particle size of the fenofibrate particles in the Sandoz tablet infringed the patent. Although this finding was dispositive of the application, the Court went on to consider the validity allegations raised. The allegation of anticipation was found not to be justified; as were the allegations obviousness, overbreadth, lack of utility, lack of sound prediction, insufficiency and ambiguity.