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 proceedings.
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 following links:
The decision of the Federal Court: http://www.gowlings.com/resources/enewsletters/pharmacapsules/HtmFiles/bulletinPharma20090720.en.html
The decision of the Federal Court of Appeal: http://www.gowlings.com/KnowledgeCentre/enewsletters/pharmacapsules/HtmFiles/bulletinPharma20101210.en.html