Teva Canada Limited v. The Minister of Health and
sanofi-aventis Canada Inc
NATURE OF CASE:
Judicial Review - Data Protection Regulations
The Minister of Health and sanofi-aventis Canada
DATE OF DECISION:
May 2, 2011
On May 2, 2011, Campbell J. of the Federal Court dismissed the
application of Teva Canada Limited ("Teva") seeking to
review the response of the Minister of Health
("Minister") which refused Teva's request to remove
sanofi-aventis Canada Inc.'s drug ELOXATIN®
(oxaliplatin) from the Register of Innovative Drugs
("Register"). Ogilvy Renault represented sanofi-aventis
Canada Inc. ("sanofi").
Teva had written to the Minister to challenge the listing of
oxaliplatin on the grounds that it was not an "innovative
drug" as defined in C.08.004.1 of the Food and Drug
Regulations ("Regulations"). This provision states
(in part) that an "innovative drug" is one which contains
a medicinal ingredient not previously approved in a drug by the
Minister. Teva asserted that oxaliplatin had been previously
approved by the Minister by reason that the Minister had authorized
a high volume of sales of oxaliplatin under the Special Access
Program (SAP) pursuant to C.08.010(1) of the Regulations.
These sales under SAP occurred prior to the issuance to sanofi of a
Notice of Compliance (NOC) in 2007. The Minister disagreed that
oxaliplatin had been "approved" under the SAP.
The Court held that the Minister was correct that both the
factual condition precedent of a finding that a drug is safe and
effective and a market authorization approved accordingly, are
required for a drug to be "approved" as that term is used
in the definition of an innovative drug in C.08.004.1 of the
Regulations. The statement of the Federal Court of Appeal
in Hospira 2010 FCA 354 that "the safety and efficacy
of a drug cannot be established solely on the basis that its use
had been permitted under the Special Access Programme" was
found by Campbell J. to be irrelevant.
Despite sanofi's opposition, Justice Campbell agreed to hear
the matter on the basis that Teva had standing by reason of
Teva's attempt to file, after initiation of the proceedings, an
ANDS for oxaliplatin and that to dismiss the matter for lack of
standing would "do nothing to improve delivery of
justice". The Court also determined that the response of the
Minister to Teva's request to delist was a "fresh"
decision capable of judicial review, and that the Minister had the
authority to delete an entry from the Register.
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