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
Whether Canada's compliance with international duties is in
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
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
A recent Saskatchewan Court of Queen's Bench decision allowed a court-appointed receiver to sell and transfer intellectual property rights free and clear of encumbrances, finding that a license to use improvements of an invention was a contractual interest and not a property interest.
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