[2012] 2 F.C.R. D-2
Food and Drugs
Judicial review of Minister of Health’s refusal to list applicant’s drug DEXILANT on Register of Innovative Drugs, provide data protection in accordance with Food and Drug Regulations, C.R.C., c. 870, s. C.08.004.1, as amended by Regulations Amending the Food and Drug Regulations (Data Protection), SOR/2006-2411—DEXILANT containing dexlansoprazole, used to treat gastroesophageal reflux disease—DEXILANT not meeting definition of “innovative drug” as required by Regulations since dexlansoprazole enantiomer of previously-approved medicinal ingredient—Whether Minister misinterpreting definition of “innovative drug” to exclude enantiomer, such as dexlansoprazole, as variation within meaning of Regulations, s. C.08.004.1(1)—Definition of “innovative drug” relatively clear—Drug not considered “innovative”, not entitled to data protection when containing previously approved medicinal ingredient or considered variation of previously approved medicinal ingredient—While term “variation” not explicitly defined, s. C.08.004.1(1) providing non-exhaustive list of examples representing types of chemical compounds presumed to fall under term “variation” of previously approved medicinal ingredient for purposes of “innovative drug” definition, data protection—Based on dictionary definition of “variation”, conceivable that enantiomer always constituting “variation” within meaning of s. C.08.004.1(1)—Data protection considered central to overall regulatory scheme in protecting public health, safety; providing innovators with incentive to develop “innovative drugs”—Minister correctly determining that, as enantiomer, dexlansoprazole in DEXILANT could not obtain data protection as variation within meaning of innovative drug definition in s. C.08.004.1(1), could not be listed on Register—Application dismissed.
Takeda Canada Inc. v. Canada (Health) (T-2044-10, 2011 FC 1444, Near J., judgment dated December 9, 2011, 17 pp.)