Apotex Inc. v. Merck Frosst Canada Ltd., 2010 FC 1264 (Lovastatin*)

Justice Snider - 2010-12-22

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The Defendant, Merck Frosst Canada Ltd. (Merck Canada), held rights to Canadian Patent No. 1,161, 380 (the '380 Patent), through the patent holder Merck & Co. Inc. (Merck & Co.). The '380 patent, which related to a process for manufacturing the drug lovastatin, was issued in 1984 and expired in 2001. In 1993, the Plaintiff, Apotex Inc. (Apotex), attempted to enter the market with a generic version of lovastatin and, to that end, applied to the Minister of Health (the Minister) for a Notice of Compliance (NOC) pursuant to the relevant provisions of the Patented Medicines (Notice of Compliance) Regulations, SOR/93-133, as amended by SOR/98-166 [the PMNOC Regulations or the Regulations]. An NOC is required before a drug can be marketed in Canada. Apotex alleged that it would not infringe the '380 Patent, as it would not use a process to produce lovastatin that would fall within the scope of the '380 Patent.

Decision relates to:


Canadian Intellectual Property