On April 10, 2012, the Federal Court of Appeal issued its
decision in Teva Canada Limited v. Canada
(Health), confirming that drugs made available in Canada
pursuant to the Special Access Programme (SAP) are not considered
to be "previously approved" under subsection
C.08.004.1(1) of the Food and Drug Regulations and
therefore remain eligible for data protection. This decision
provides further clarity on the circumstances under which drugs may
qualify for data exclusivity in Canada.
In 2007, the Minister of Health placed Sanofi-Aventis Canada
Inc.'s anti-cancer drug, Eloxatin, on the register of
"innovative drugs". The Minister's decision has
allowed Eloxatin to benefit from the data protection provisions
under the Regulations by preventing other manufacturers,
like Teva, from marketing generic versions of the drug. In 2010,
Teva requested that the Minister remove Eloxatin from the register
on the basis that it did not meet the definition of innovative drug
as Eloxatin had been available under the SAP since
1999.1 Teva's request was rejected by the Minister
on the basis that authorizations under the SAP do not constitute a
previous approval for the purposes of the definition of
"innovative drug" under the Regulations. On
judicial review, the Minister's decision was affirmed by the Federal Court.
Federal Court of Appeal Decision
In denying Teva's appeal of the lower court decision, the
Court considered the issue of whether authorizations under the SAP
could make a drug "previously approved" for the purposes
of the data protection provisions under the Regulations.
The Court provided three main reasons to support its decision on
First, having regard to the wording, architecture and purpose of
the Regulations, the Court found the safety and efficacy
of drugs to be of primary concern. Under the Regulations,
before marketing authorization is granted in the form of a Notice
of Compliance (NOC) and a Drug Identification Number (DIN),
manufacturers must demonstrate the safety and effectiveness of
their drugs using data and studies. The Court stated that the
routes to obtain an NOC and a DIN are well-defined in the
Regulations and that they do not include the
Second, the Court stated that the Regulations have been
carefully drafted to provide clarity and certainty in the drug
approval process, such that the issuance of an NOC and DIN may be
relied upon as an indication of regulatory approval. The adoption
of an interpretation that an SAP authorization could constitute
"previously approved" would lead to complicated factual
inquiries and difficult questions that run counter to the theme of
clarity and certainty in the area of approvals under the
Lastly, the Court held that subsection C.08.004.1(1) of the
Regulations is designed to implement certain specific
treaty obligations that aim to protect an innovator who submits
undisclosed data in support of an application for approval to
market a drug containing a new chemical entity. The Court noted
that the treaty provisions repeatedly refer to the concept of
marketing approval and that in Canada, marketing approval under the
Regulations requires the issuance of an NOC and a DIN.
Based on the foregoing reasons, the Court concluded that drugs
for which previous authorizations under the SAP have been granted
are not considered "previously approved" within the
meaning of subsection C.08.004.1 of the Regulations.
1. Subsection C.08.004.1(1) of the Regulations
states that for a drug to qualify for data protection in Canada, it
must (among other requirements) be "a drug that contains a
medicinal ingredient not previously approved in a
drug by the Minister [...]". [emphasis added]
2. Notably, the Court of Appeal stated that the SAP allows
for the use of certain drugs despite the absence of data and
studies showing the safety and efficacy of the drug and that
authorizations under the SAP are best seen as compassionate
permissions and not approvals.
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