Edited by Jennifer L. Wilkie and Isabel J. Raasch

Federal Court Denies Request for Data Protection

Takeda Canada Inc. v. Canada (Attorney General), 2011 FC 1444, dexlansoprazole

By: Kiernan A. Murphy

On December 9, 2011, the Federal Court (Justice Near) dismissed Takeda Canada's application for judicial review of the Minister of Health's refusal to list its drug (DEXILANT) on the Register of Innovative Drugs.  DEXILANT was thus ineligible for data protection under the Food and Drug Regulations ("FDR").  As an enantiomer of a medicinal ingredient in a previously approved drug, the Minister took the position that DEXILANT was automatically a "variation" falling outside of the definition of "innovative drug" and there was therefore no need to consider extensive clinical studies performed to obtain regulatory approval for DEXILANT.

C.08.004.1(1) of the FDR defines an "innovative drug" as a "drug that contains a medicinal ingredient not previously approved in a drug by the Minister and that is not a variation of a previously approved medicinal ingredient such as a salt, ester, enantiomer, solvate or polymorph."

Justice Near first applied a standard of correctness for review since the primary issue involved assessing conflicting approaches to statutory interpretation.  In particular, he held that the Minister's expertise was confined to scientific assessments as opposed to legal interpretation, such as the interpretation of the "innovative drug" definition.  Therefore the Minister's decision was entitled to little deference.

The judge held that, in its grammatical and ordinary sense, a drug will not be entitled to data protection if it is considered a variation of a previously approved medicinal ingredient.  Noting the non-exhaustive list exemplary of the undefined term "variation", he held that an enantiomer might always constitute a "variation".  Justice Near held that inquiry beyond identifying the nature of the drug, such as assessing new and significant clinical data involving considerable effort, was contemplated only for arguable variations, not for identified examples, such as enantiomers.  Such examples are presumed to constitute variations outside the scope of data protection, and the Minister would be entitled to dismiss these types of medicinal ingredients by their very nature, irrespective of any considerable effort undertaken to obtain approval.  Justice Near held that this interpretation was consistent with Canada's international treaty obligations from which the data protection provisions originated and which contemplated such protection only for "new chemical entities".

Given this interpretation, Justice Near held that the Minister was correct to exclude DEXILANT from data protection, as its medicinal ingredient is a recognized enantiomer of a medicinal ingredient contained in a previously approved drug. 

While Justice Near found it unnecessary to deal extensively with whether the Minister breached its duty of fairness, he found that the process was fair as it provided an opportunity to present written submissions and reasons were given.

The full text of the decision is attached.

"http://www.gowlings.com/knowledgeCentre/enewsletters/pharmacapsules/pdfs/T-2044-10-Dec-9-2011.pdf"

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