As previously reported, the Ontario Superior Court of Justice dismissed Abbott and Takeda’s motion for summary judgment in an action brought by Apotex under section 8 of the PMNOC Regulations. The action relates to lansoprazole, the active ingredient in Apo-Lansoprazole and Abbott’s PREVACID. On April 5, 2018, the Ontario Court of Appeal dismissed Abbott and Takeda’s appeal: Apotex Inc. v Abbott Laboratories Limited, 2018 ONCA 332. The appellants argued that Apo-Lansoprazole could not and would not have received regulatory approval in April 2007 and Apotex was not entitled to damages. The Court of Appeal disagreed, concluding that the motions judge did not err in finding that Apo-Lansoprazole would have received approval in April 2007. This date was consistent with Apotex’s expert evidence and the timing of Health Canada’s letter indicating that Apo-Lansoprazole was approvable in the real world. While Health Canada subsequently reversed its position, that reversal could only be relevant to the quantum of Apotex’s damages and did not render the earlier letter void ab initio.
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