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Supreme Court denies leave to appeal to Takeda for
DEXILANT
Takeda Canada Inc. v. Minister of Health, et al., SCC #35276, (June
13, 2013)
Additional Links: our
previous summary and the
Court of Appeal decision.
Although the Court of Appeal had split 2-1, the Supreme Court
refused Takeda's application for leave as well as the motion to
intervene by Canada's Research-Based Pharmaceutical Companies.
As is usual practice, no reasons were provided.
The Supreme Court had summarized the appeal as relating to The
Minister of Health's refusal to list Takeda Canada Inc.'s
("Takeda") drug, DEXILANT, on the Register of Innovative
Drugs that would have provided data protection under s. C.08.004.1
of the Food and Drug Regulations. Data protection is
available for innovative drugs and provides for a period of market
exclusivity for innovators. Takeda filed a New Drug Submission for
DEXILANT on August 11, 2009 based on extensive clinical trial data
to establish the safety and efficacy of the drug. A Notice of
Compliance to market the drug was issued by the Minister on July
22, 2010. DEXILANT contains the medicinal ingredient
dexlansoprazole, that is an enantiomer (mirror image) of
lansoprazole. Lansoprazole is marketed as the drug, PREVACID, a
racemic mixture of the two enantiomers. Takeda requested data
protection for its DEXILANT studies. The Minister determined that
DEXILANT was not eligible for data protection because it did not
meet the definition of "innovative drug" under the
Regulations because dexlanoprazole was the enantiomer of a
previously-approved medicinal ingredient, lansoprazole.
The questions asked of the Supreme Court included: