Innovative Drug Register
Supreme Court denies leave to appeal to Takeda for DEXILANT
Takeda Canada Inc. v. Minister of Health, et al., SCC #35276, (June 13, 2013)
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:
- What is the legal threshold for protection under Regulations?
- Whether Canada's compliance with international duties is in jeopardy
- Whether interpretation of "innovative drugs" in lower courts was incorrect and overly rigid approach that excluded five broad categories of medicine from the definition of "innovative drug"
- Whether presumption of deference set out in Alberta (Information and Privacy Commissioner) v. Alberta Teachers' Association, 2011 SCC 61 applies equally to decisions of departmental officials and Minister interpreting home statutes.