Plaintiff initiated steps to obtain permission to market generic version of esomeprazole magnesium product marketed by defendant as Nexium by filing abbreviated new drug submission. Defendant commenced applications under Patented Medicines (Notice of Compliance) Regulations, seeking to prohibit Minister of Health from granting plaintiff notice of compliance. Applications were all eventually discontinued or dismissed. Plaintiff obtained its notice of compliance. Plaintiff brought action seeking damages under s. 8 of Regulations for its losses suffered during time it was kept off market for its version of esomeprazole magnesium by operation of Regulations. Defendant and others brought action seeking damages and other remedies from plaintiff and another company for infringement of 653 patent and 994 patent once plaintiff obtained its notice of compliance. Plaintiff’s action dismissed. With regard to infringement action, certain declaration made. Supreme Court of Canada had effectively determined that 653 patent was valid. Assessment of compensation to be awarded in s. 8 action required determination of what would have happened in but-for world. It was more likely than not that, in but-for world, plaintiff would have launched its Apo-Esomeprazole product, and that such product would have infringed 653 patent. Plaintiff’s liability in but-for world for patent infringement fully offset its loss from being kept off market.
Apotex Inc. v. AstraZeneca Canada Inc. (2018), 2018 CarswellNat 1279, 2018 CarswellNat 810, 2018 FC 181, 2018 CF 181, George R. Locke J. (F.C.).