Takeda Canada Inc. v. Canada (Attorney
General), 2011 FC 1444, dexlansoprazole 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" The content of this article is intended to provide a general
guide to the subject matter. Specialist advice should be sought
about your specific circumstances.
Federal Court Denies Request for Data Protection
ARTICLE
22 December 2011
Pharmacapsules @ Gowlings - December 14, 2011 - Volume 10, Number 8
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.