Teva Canada Limited v. Minister of Health and
Sanofi-Aventis Canada Inc. 2012 FCA 106, data protection
On April 10, 2012, the Court of Appeal affirmed Justice
Campbell's decision dismissing Teva's application to remove
Eloxatin® from the Innovative Drug Register. This
case involved an interpretation of the first part of the two prong
definition of "innovative drug" that excludes from
eligibility for listing on the Register drugs that were previously
The Minister and Court below found that authorizations under the
Special Access Program ("SAP") that provide a drug by way
of emergency treatment did not count as "previously
approved". The Court of Appeal agreed noting that
"previously approved" was not itself defined.
The Court cited three reasons in rejecting Teva's argument
that the wide distribution of Eloxatin® under the
Special Access Program and the need to avoid an "inordinate
and unjustifiable monopoly" should have excluded
Eloxatin® from data protection on the basis that it
was previously approved:
The definition of "innovative drug" is not aimed at
achieving a compromise between providing monopolies to innovators
and allowing generics to obtain timely access but at the safety and
efficacy of drugs, a matter that is evidenced only by approvals
based on data and studies strictly defined under the
Teva's argument that the wide distribution via SAP was a
unique circumstance sufficient to constitute "previous
approval" would create uncertainty and lack of clarity which
the Regulations were trying to eliminate.
The definition of "innovative drug" was aimed at a
limited specific purpose of implementing Canada's treaty
obligations. Teva's proposed interpretation would unduly narrow
the definition and undercut Canada's treaty obligations.
Authorization under SAP is different than approvals. The use is
authorized despite the absence of safety and efficacy data in an
emergency situation as a compassionate permission rather than a
drug approval. The treaty provisions aimed to protect an innovator
who submits undisclosed data in support of an application for
approval to market a drug containing a new chemical entity.
This encourages the development of new drugs. The relevant aspect
of the treaty provisions that shed light on "previously
approved" is the repeated mention of the concept of marketing
approval. In Canada, this means the issuance of a Notice of
Compliance and drug identification number.
While two issues (lack of standing and no reviewable decision)
were improperly raised by way of cross-appeal, in effect,
attempting to appeal reasons, the Court took the opportunity to
provide guidance on the issues.
First, Teva had standing to challenge the listing of
Eloxatin® on the Register. Those who file an ANDS
and have it rejected because a drug is listed on Register are
directly affected by that listing. The timing of the attempt to
file an ANDS need not be before an application for judicial review
was commenced. To find otherwise would lead to pointless cost,
delay and waste.
Second, the Minister's 2010 rejection of Teva's request
to de-list Eloxatin® constituted a fresh and
reviewable decision. The Minister is obligated to maintain the
Register of Innovative Drugs which gives power to add or delete
information as necessary. Refusing Teva's request was a fresh
exercise of discretion and a decision susceptible to judicial
In an industry where one out of 10,000 drugs makes it to market, and where many drugs fail after millions of dollars of investment, one of the challenges is to create an environment that enhances the chance of success and mitigates the high cost of failures.
In the recent decision, the British Columbia Court of Appeal addressed the issue of liability on the part of a Canadian government regulator for damages arising out of negligent performance of its duties where the performance of those duties led to a recall of the plaintiff's product.