In a proceeding pursuant to the Patented Medicines (Notice of Compliance) Regulations, the Court was asked to consider three patents. Apotex alleged the patents were invalid on a number of grounds, including anticipation, obviousness, double-patenting, lack of utility, sufficiency and overbreadth.
The Court noted that Apotex tendered sufficient evidence to put the issues into play and therefore Takeda bears the burden. The Court found that the allegations of obviousness with respect to the three patents were justified, finding that the inventive concept and the relevant art, taken as a whole, were co-extensive. As a result, there was no gap to bridge. The Court then also noted that even if there had been gaps between the prior art and the inventive concepts of each of the three patents, no inventive steps would have been necessary to bridge the gap. Takeda’s application was dismissed with costs.