Servier sought a prohibition order against Apotex in relation to its DIAMICRON MR gliclazide product. The application was dismissed. The patent at issue claimed a new formulation for a breakable modified release tablet. The Court considered allegations of non-infringement, obviousness and lack of utility.
The Court held that Apotex’ allegations of non-infringement were justified, as its product did not contain a binder, which was an essential element of the patent. Furthermore, the in vitrodissolution profile of Apotex’ product was not identical to that in the patent. The Court conducted the obviousness analysis and concluded that the skilled worker would have been able to combine the mosaic of prior art into the claimed invention, as the step was not high and the gap was not broad.
The Court then considered the inutility allegations, holding that as of the filing date, the patent must either disclose demonstrated utility or a basis for a sound prediction of utility. Servier relied on two studies as evidence of demonstrated utility. However, these studies were not referenced in the specification of the patent. Furthermore, the study included in the patent tested a single tablet. The Court held that this was not sufficient for utility to be demonstrated. The Court then held that the patent was not soundly predicted.