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Ontario Court of Appeal dismisses appeal of judgment awarding Apotex damages from contract research organization for delayed FDA approval of two products

As previously reported, in December 2017, Apotex was awarded over $11M in damages and pre-judgment interest for losses flowing from delays in the US Food and Drug Administration’s (FDA) approval of Apotex’s amoxicillin-clavulanic acid and levodopa-carbidopa products caused by the contractual breaches and negligence of MDS Pharma Services (MDS), a contract research organization hired to carry out bioequivalence studies for those products. On January 16, 2019, the Court of Appeal for Ontario dismissed MDS’ appeal and Apotex’s cross-appeal of that judgment: Apotex Inc v Nordion (Canada) Inc, 2019 ONCA 23. The Court rejected MDS’ argument that the trial judge had erred in finding that Apotex’s claim was not time-barred. Rather, the Court found that the limitations period did not begin to run until 6 months after the date on which the trial judge concluded that it began. The Court found no palpable and overriding error in the trial judge’s interpretation of the contract or his finding that Apotex had adequately mitigated its damages. With respect to Apotex’s cross-appeal, the Court found no palpable and overriding error in the trial judge’s assessment of damages, and rejected Apotex’s argument that damages ought to have been fixed at $12.6M.