In Canada, drugs that are classified as "Innovative
drugs" are eligible for eight years of data protection (data
exclusivity). In April 2012, the Federal Court (Trial Division)
held that Celgene's new use of THALOMID for treating multiple
myeloma was an "innovative drug" despite the previous
approval of the medicinal ingredient thalidomide.1 (For
further information please see
Scorned Drug Makes Unexpected Comeback that is
"Innovative" Enough to Qualify for Canadian Data
Exclusivity.) The Minister of Health appealed the Federal
Court's decision, and in a decision released February 15, 2013,
the Federal Court of Appeal held that THALOMID is not an innovative
drug and overturned the lower Court.2
Thalidomide has a controversial past: while it was approved in
Canada as early as 1960 and prescribed to treat sleeplessness and
morning sickness in pregnant woman, it was permanently taken off
the market in 1962 when it was discovered that it was associated
with severe birth defects.
Research by Celgene in the 1990's established that
thalidomide was useful for treating conditions such as cancer and
leprosy. Marketing authorization was issued to Celgene on August 4,
2010, for the use of THALOMID for treating multiple myeloma.
However, the government advised Celgene that THALOMID was not
eligible for data protection because the medicinal ingredient had
been previously approved. Celgene applied for judicial review of
the government's decision and the Federal Court sided with
Celgene, holding that the prior thalidomide approval should not
stand in the way of data protection of THALOMID.
The Canadian Data Protection Regulations (the Regulations)
define an "innovative drug" as a "drug that contains
a medicinal ingredient not previously approved by the
Minister."3 Writing for the majority of the
Federal Court of Appeal, Justice Gauthier rejected Celgene's
argument that the word "approved" refers to the current
status of the drug. Celgene submitted that reading down the
definition of an innovative drug in this manner is consistent with
the purpose and object of the Regulations and Canada's
international treaty obligations.
The Court of Appeal held that a medicinal ingredient such as
thalidomide that once received regulatory approval is
"previously approved" for the purposes of the
Regulations. Data protection is limited to new medicinal
ingredients which means, in this context, submitted for the first
time to the appropriate authority. The fact that Celgene had to
submit a considerable amount of confidential data gathered at
significant cost does not, in and of itself, justify stretching the
definition of "innovative drug." The Court expressed
concern that reading in the additional limitation of
"currently approved" to the definition of
"innovative drug" could open the door to unexpected
scenarios whereby drugs may be treated differently depending on why
their approval was withdrawn.
The dissenting opinion of Justice Nadon emphasized that after
the thalidomide tragedy, the sale of thalidomide in Canada was
expressly prohibited by law. As thalidomide was removed from the
market by legislation, thalidomide was not "previously
approved" but rather the previous approval had been
essentially nullified. Justice Nadon rejected any "slippery
slope" concerns because the fact situation of thalidomide is
highly unusual and any precedent set by the decision is narrow.
No appeal has been filed with the Supreme Court of Canada to
date. Overall, the Court of Appeal's narrow take on what
constitutes an "innovative drug" is consistent with
recent case of Takeda Canada Inc. v. Canada (Health),
where the Court of Appeal held that all enantiomers of previously
approved medicinal ingredients were excluded from qualifying as
"innovative drugs", regardless of the amount of clinical
data collected on the enantiomer4 (For further
information please see
Enantiomers Not Eligible for Data Protection in Canada). Drug
manufacturers should take note that the courts are taking a strict
approach to the definition of "innovative drug." This
will prevent data protection if there is a previously approved drug
or variant, even when an innovator company has expended
considerable effort, ingenuity and expense to develop its own
1Celgene Inc. v. The Minister of
Health(2012 FC 154)
2Canada (Health) v. Celgene Inc.(2013 FCA 43)
3 Section C.08.004.1 of theFood and Drug
4 2013 FCA 13
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