Innovative drugs are eligible for eight years of data protection
(data exclusivity) in Canada. For six of these eight years, a
generic drug manufacturer may not even file an abbreviated new drug
submission to get its marketing approval by relying on this
protected clinical trial data. A recent case involving
Celgene's THALOMID (thalidomide) looked at the controversy over
whether a drug qualifies as "innovative" and is entitled
to data protection (appeal pending)1. An
"innovative drug" is defined in the Data Protection
Regulations2 in part as "a drug that contains
a medicinal ingredient not previously approved in a drug by the
Minister." This case will be of interest to companies
developing old drugs for new uses. It established an exception to
the clear rules stating the ineligibility of previously approved
drugs (and their mere variations) for data exclusivity. The Court
tried to limit the future of the applicability of the case but it
remains of significant interest as a potential foot in the door to
expand the definition of innovative drugs. Last Fall, Health Canada
issued guidance on another expansive exception, where prior
approval of a drug for veterinary use would not preclude it from
being an "innovative drug" when approved for human use,
and vice versa3.
Celgene argued that THALOMID was an "innovative" drug
despite the fact it contained the previously approved medicinal
ingredient thalidomide. The thalidomide drug was approved in Canada
as early as 1960 and prescribed to treat sleeplessness and morning
sickness in pregnant woman. Thalidomide was permanently taken off
the market in 1962 when it was discovered that it was associated
with severe birth defects, such as deformed limbs.
Celgene's research in the 1990's revealed that, despite
its controversial past, 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. At the same time however, the government
advised Celgene that THALOMID was not eligible for data protection
because the medicinal ingredient had been previously approved.
Celgene brought an application for judicial review of the
In overturning the decision, the Federal Court noted that
Celgene's innovation was to take something that was banned as
dangerous and which had not been found to be safe and efficacious
and to show it to be a useful, lifesaving drug. To do so, Celgene
could not rely on old data, but had to produce new data.
The purpose of the data protection provisions of the
Regulations is to encourage and reward innovation by
protecting the innovator's data. As the previous approvals had
been withdrawn, Canadians could not benefit from the re-development
of thalidomide unless new information and data demonstrated its
safety and efficacy.
The Court found that the prior thalidomide approval should not
stand in the way of data protection of THALOMID. Drug submissions
filed after the 1960's must include new and more extensive
data. Further, the Court held that (1) the prior approval for
thalidomide was short-lived and never should have been given at the
time, (2) the drug was essentially banned until Celgene submitted
its new drug submission for THALOMID, and (3) approval was granted
for Celgene's product on the basis of completely new studies
and data. Thus, THALOMID was an "innovative drug" and
eligible for data protection.
The circumstances of the present case involving a scorned drug
are unlikely to arise very often. If the decision survives on
appeal, innovators will use it to try to expand availability of
data exclusivity. We will then see if the Court is correct in its
prediction that the decision will have only a "limited impact
in the foreseeable future."
1 Celgene Inc. v. The Minister of Health (2012 FC
3 Publication of Clarifications to the Guidance Document:
Data Protection under C.08.004.1 of the Food and Drug
Regulations (Health Canada. October 1, 2011).
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