As we reported, Abbott Laboratories Limited, Takeda Pharmaceuticals Company Limited and Takeda Pharmaceuticals America Inc. sought dismissal of Apotex’s action for s. 8 damages in the Ontario Superior Court by summary judgment. The Ontario Court of Appeal (ONCA) affirmed the lower court’s finding that a real-world notice of non-compliance – withdrawal (NON-W) issued by Health Canada did not operate to void the patent hold letter ab initio. The ONCA held it was open to the motions judge to accept “essentially unrefuted” expert evidence that in the hypothetical but-for world Health Canada would have issued Apotex its Notice of Compliance as of its patent hold date and that Health Canada would not have suspended or revoked the Notice of Compliance in the absence of exceptional circumstances.

The Court of Appeal found no palpable and overriding error in the judge’s decision, as there was evidence that supported the judge’s conclusions.

NON-W Could Impact Quantum of Damages

The motions judge invited evidence at trial on whether the NON-W would interrupt Apotex’s sales in the but-for world, and the ONCA agreed it will be open to the trial judge to consider the relevance of Apotex’s real-world NON-W on the quantum of damages.


Apotex Inc v Abbott Laboratories Limited, 2018 ONCA 332