Canada amended its Data Protection Regulations in 2006
to provide protection for innovative drugs in a second attempt to
implement Canada's 1994 NAFTA (North American Free Trade
Agreement) and TRIPS (Trade-Related Aspects of Intellectual
Property rights treaty obligations. These treaties require the
protection of data that is originated from considerable effort and
required to be submitted for government approval. The current term
of protection is eight years counting from the innovative
drug's date of approval (issuance of the notice of
compliance (NOC)). For the first six years, no one else may file a
submission that makes a direct or indirect comparison based on the
innovator's data. In the final two years, such a submission
may be filed but an NOC cannot issue until expiry of the eight year
term. In addition, subject to certain conditions, a pediatric six
month extension is available. If CETA (Comprehensive Economic and
Trade Agreement), is concluded, among other things, the term could
be extended to ten years.
The Register of innovative drugs is maintained by the Minister
of Health and lists all drugs that have been found to be eligible
for protection. Protection is typically requested by the innovator
during the regulatory submission process. Once listed, a drug may
lose protection if it is not marketed in Canada or if a person with
standing is successful in a delisting application.
The Regulations survived a challenge to their validity
(2010 FCA 334; leave to appeal to SCC denied July, 2011). Since the
Current Issues update in 2012 , appellate cases have
continued to explore the criteria to qualify as innovative drugs.
Three Federal Court of Appeal cases have considered the innovative
drug definition. The definition is exclusionary specifying two
components that exclude a drug from eligibility: if it was
previously approved; or, if it is a variation of a previously
medicinal ingredient such as a salt, ester, enantiomer solvate, or
a polymorph. As such, if a drug is previously approved or a
variation, it does not qualify for data protection.
Two appellate cases considered the first exclusion: what
constitutes a "previous approval". In Celgene
(2013 FCA 43, Noel JA dissenting; reversing 2012 FC 154), the
Federal Court of Appeal denied data protection for thalidomide.
Although it was withdrawn from the market as unsafe and then
approved decades later based on substantial research, the original
approval made the drug previously approved. On the other hand, in
Sanofi-Aventis Canada (2012 FCA 106; aff'g 2011 FC
507), data protection was confirmed for a drug that was previously
available under the Special Access Program. SAP access was not
sufficient to make a drug previously approved. There is a third
case (not appellate) on the previously approved definition that was
discussed in last year's CurrentIssues
(Epicept, 2010 FC 956). A medicinal ingredient approved by
DIN (Division 1), as homeopathic/over the counter drugs was a
previous approval that denied data protection for a subsequent
Division 8 drug. While it was a new drug, it was not an innovative
drug, having been previously approved under the less rigorous
The final appellate decision considered the second exclusion
(Takeda Canada Inc. v. Canada (Health) 2013 FCA 13,
Stratas JA dissenting, affirming 2011 FC 1444). The Court
interpreted the group of five examples within the phrase "not
a variation of a previously medicinal ingredient such as a salt,
ester, enantiomer, solvate or polymorph" as absolute bars. The
Court denied protection to the enantiomer DEXILANT as a matter of
law. Falling within one of the enumerated examples of variations
meant no entitlement to data protection regardless of the nature
and extent of the data necessary to be submitted to obtain
approval. The dissent held that on a purposive construction of the
"innovative drug" definition in accordance with the
treaties, the five listed chemicals should not be treated as
absolute. An application for leave to appeal to the Supreme Court
of Canada has been filed.
The main decisions in the last year give guidance on the scope
of the Regulations, eligibility criteria and what
constitutes an innovative drug. One of the three Federal Court of
Appeal decisions found the drug was entitled to data protection.
Each of the other two decisions, denying data protection to the
drugs at issue, had dissents. We expect in the next year, the
precise scope will continue to be defined in the jurisprudence and,
if CETA is concluded, that there will be further amendments to the
Regulations to implement Canada's treaty
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