Apotex Inc. v. Canada (Health), 2012
FCA 322

Apotex commenced an application for
judicial review of the Minister of Health’s treatment of its submission for a
Notice of Compliance (NOC) for omeprazole magnesium tablets (tablets). A judge
of the Federal Court dismissed the application, and Apotex appealed.

Appeal is dismissed.

Apotex did not have a vested right
to a NOC for its tablets. When the Minister exercises her discretion under
section C.08.004 of the Food & Drug Regulations to issue a NOC, she
must be satisfied that the drug is safe and effective. There may well be a time
delay between the point where the Minister informs an applicant that the safety
and efficacy requirements are met, and the point when the NOC may issue. If,
during that period, information comes to the Minister that casts doubt on her
initial conclusions, she may reconsider issuing the NOC.

The broader purpose of the Regulations,
and the discretion given to the Minister to give it effect, contemplate that
the Minister has the discretion to revisit an application which is on patent
hold when she deems it necessary to reconsider the safety and efficacy of the
drug. If the Minister revisits the initial conclusion and then decides not to
issue a NOC to the second party, there will be no section 8 claim under the PM(NOC)
Regulations.

The doctrine of legitimate
expectations does not confer substantive rights of the nature sought by Apotex,
i.e. a vested right to a NOC.