On February 2, the FCA allowed Apotex's appeal of a $61 million award disgorging Apotex's profits for its generic perindopril (COVERSYL). The lower Court had rejected Apotex's NIA defence based on export sales Apotex alleged it could and would have made from other countries, thereby avoiding infringement in Canada. The Court of Appeal remitted to the Federal Court (decision now under reserve) the factual issue of whether Apotex could and would have obtained non-infringing perindopril from three specific offshore suppliers, and, if so, whether Apotex could and would have sold this material to its Australian and UK affiliates. Following affirmation by the FCA of the validity of AstraZeneca's omeprazole formulation patent on January 12 (Apotex's SCC leave application was subsequently denied), on July 26, the reference trial Judge found that Apotex failed to prove that it could and would have sold a NIA of its omeprazole capsules. Apotex's defence to AstraZeneca's claim for Apotex's profits was based on a number of formulations it designed for the purpose of the quantification trial, and in the alternative, product from third party foreign suppliers. Apotex has appealed.
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