Today, the Supreme Court of Canada denied leave to Apotex Inc.
and the Canadian Generic Pharmaceutical Association, refusing to
hear an appeal that would question the validity of the data
protection regulations (section C.08.004.1 of Canada's Food
and Drug Regulations). The Regulations protect clinical
and test data, which must be submitted by innovative
pharmaceutical manufacturers to Health Canada to
demonstrate safety and efficacy of innovative products, from being
used by others seeking to market generic versions of the same
product for a period of at least 8 years.
The applicants had lost at both the Federal Court and the
Federal Court of Appeal, where the courts decided in favor of the
Attorney General that the Regulations were within the federal
competence, and as well, that there was regulatory authority to
implement the regulations. Canada's Research-Based
Pharmaceutical Companies ("Rx&D") and Eli Lillly
Canada Inc. intervened in each of the two lower court
Notably, there was a difference of view as between the two
courts below; the Federal Court held that the constitutional
authority for the Regulations was not the criminal law power but
rather, that the federal authority for implementing the Regulations
fell under the federal trade and commerce authority. In
contrast, the Federal Court of Appeal held that the enactment of
the Regulations was a valid exercise of the federal criminal law
power contained in subsection 91(27) of the Constitution
Act. Having found the Regulations valid under the
criminal law power, the Court of Appeal found that it need not
consider whether the Regulations may also be upheld under
another head of federal power such as trade and commerce.
With the Supreme Court's decision to deny
leave, the constitutional validity of the data protection
regulations, which protect
"innovative drugs", is confirmed.
The Supreme Court does not provide reasons for its
decisions on leave applications; however, please see
Gowlings' prior reports on the lower court decisions at the
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