The Data Protection Regulations (DPR) were designed to
clarify and implement Canada's obligations under the data
protection provisions of the North American Free Trade
Agreement (NAFTA) and the Agreement on Trade-related
Aspects of Intellectual Property Rights (TRIPS). The DPR
introduced a guaranteed period of market exclusivity of at least
eight years for manufacturers of "innovative
drug[s]". More particularly, the DPR prohibits a generic
manufacturer seeking a notice of compliance (NOC) for a new drug
"on the basis of a direct or indirect comparison between
the new drug and an innovative drug" from filing a New
Drug Submission (NDS) "before the end of a period of six
years after the day on which the first notice of compliance was
issued to the innovator in respect of the innovative
drug". In addition, the DPR prohibits the Minister of
Health from issuing a NOC to a generic drug manufacturer
"before the end of a period of eight years after the day
on which the first notice of compliance was issued to the innovator
in respect of the innovative drug". Thus, generic drug
manufacturers cannot obtain approval for their generic drug until
the period of market exclusivity of the innovative drug has
expired, even where there is no patent protection for that
The Federal Court of Appeal found that the Governor in
Council's use of innovator market exclusivity was
rationally connected to subsection 30(3) of the Food and Drugs
Act in order to give effect to the relevant provisions of
NAFTA and TRIPS and to ensure that data is protected against unfair
The Federal Court of Appeal also upheld the Federal
Court's finding that the DPR is constitutionally valid but
ultimately relied on a different head of federal power to justify
its findings. In particular, while the Federal Court found that the
DRP was intra vires the federal trade and commerce power
under subsection 91(2) of the Constitution Act,
1867, the three judges of the Federal Court
of Appeal unanimously agreed that the DPR in fact constitutes a
valid exercise of the federal criminal law power under subsection
91(27) of the Constitution Act, 1867.
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