Apotex Inc. v. Eli Lilly and Company and Eli Lilly Canada Inc.

(Ontario) (Civil) (By Leave)




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Intellectual property – Patents – Medicines – Civil procedure – Pleadings – Motion to strike – Respondents seeking to strike portions of applicant’s statement of claim pertaining to claims for unjust enrichment and disgorgement of respondents’ profits as remedy for wrongful market exclusion – Whether there is a single cause of action for unjust enrichment that encompasses “restitution for wrongs” line of cases, or is that cause of action confined to “subtraction” cases involving “transfer of wealth” from plaintiff to defendant – Whether decision also raises issue of extent to which tripartite conceptualization of "unjust enrichment' should be applied to profit from wrongdoing cases, and if so how.

The Respondents (collectively, “Eli Lilly”) owned the ‘735 patent relating to the use of atomexetine hydrochloride in the treatment of Attention Deficit Hyperactivity Disorder. Eli Lilly received its Notice of Compliance (“NOC”) in 2004 and entered the market as sole supplier of the medicine. In 2008 Apotex Inc. (“Apotex”) developed its generic version of the drug and sought to obtain a NOC to also enter the market. It served Eli Lilly with a Notice of Allegation under the Patented Medicines (Notice of Compliance) Regulations, SOR/93-133 (“Regulations”), claiming that the ‘735 patent was invalid on the grounds of anticipation, obviousness and inutility. Eli Lilly commenced a proceeding under the Regulations, seeking an order to prohibit the issuance of a NOC to Apotex, triggering the statutory stay and effectively keeping Apotex from gaining market entry for a period of two years. Meanwhile, in another proceeding, the ‘735 patent was declared to be invalid for want of disclosure. As a result, Eli Lilly’s prohibition application in the within action was dismissed. Apotex claimed damages against Eli Lilly under s. 8 of the Regulations for losses suffered as a result of its exclusion from the market during the prohibition period from October 10, 2008 to September 21, 2010. Apotex sought relief, inter alia, pursuant to unjust enrichment principles, for disgorgement of Eli Lilly’s profits earned during the period of market exclusion.

Lower Court Rulings

February 22, 2012
Ontario Superior Court of Justice

2013 ONSC 1135
Respondents’ application for leave to appeal order regarding claim for unjust enrichment granted.
September 19, 2013
Ontario Superior Court of Justice

379/12, 2013 ONSC 5937
Respondents’ appeal allowed; Apotex’s claim for unjust enrichment struck from statement of claim.
May 5, 2015
Court of Appeal for Ontario

C58293, 2015 ONCA 305
Apotex’s appeal dismissed.