In Celgene Inc. v. The Minister of Health, 2012 FC 154,
the Federal Court considered a judicial review application
challenging the Minister of Health's refusal to list
Celgene's drug THALOMID on Health Canada's Register of
Innovative Drugs (the "Register"). In the result, the
Federal Court granted the judicial review, and declared that
THALOMID is an "innovative drug" and eligible for listing
on the Register.
By way of background, with amendments to the Food and Drug
Regulations ("FDR") in 2006, a generic
manufacturer may not file an ANDS on the basis of a comparison to
an "innovative drug" within the first six years of the
eight-year period after the innovative drug has received a notice
of compliance ("NOC"). In addition, the Minister of
Health may not issue an NOC to the generic manufacturer before the
end of the eight-year period. It is these prohibitions that result
in what is known as "data protection." In short, Health
Canada cannot approve generic versions of drug products that are
listed on the Register until the expiry of the data protection
term. An "innovative drug" is defined in C.08.004.1(1) of
the FDR as "a drug that contains a medicinal
ingredient not previously approved in a drug by the Minister and
that is not a variation of a previously approved medicinal
ingredient such as a salt, ester, enantiomer, solvate or
polymorph." The interpretation of this definition, and in
particular the words "previously approved" was the focus
of this judicial review.
As described by the Court, the drug thalidomide was originally
approved in 1960 (KEVADON) and 1961 (TALIMOL) before being
withdrawn from the market in 1962 due to its teratogenicity.
Despite its tragic history, thalidomide was eventually found to be
effective in the treatment of leprosy and other conditions,
including cancer. As set out by the Court, Celgene was exclusively
devoted to the commercialization of thalidomide to treat
life-threatening diseases, including cancer and a painful condition
associated with leprosy. Celgene's THALOMID brand of
thalidomide was available in Canada through Health Canada's
Special Access Programme starting in 1995. In 2009, Celgene filed a
new drug submission ("NDS") with Health Canada, and a NOC
was issued in 2010.
The Minister of Health advised Celgene, however, that THALOMID
was not eligible for data protection because the medicinal
ingredient, thalidomide, had been previously approved by the
Minister in at least two drugs, and sought submissions from Celgene
on the issue. Celgene took the position that thalidomide should not
be considered as having been previously approved within the meaning
of C.08.004.1 of the FDR; in addition, Celgene argued that
THALOMID should be added to the Register because the NDS for
THALOMID contained new, significant independent data. Ultimately,
the Minister of Health determined that THALOMID was not eligible to
be added to the Register, and Celgene brought this judicial review
of the Minister's decision.
In the result, the Court held that the prior approvals of
KEVADON and TALIMOL should not stand in the way of data protection
for the later approved product. Submissions filed post-1963
necessarily include new and more extensive data, including data
relating to efficacy, as compared to data filed in a pre-1963
This, combined with the fact that (1) prior approval for
thalidomide was short-lived and should never have been given at the
time, (2) this new drug was effectively banned until Celgene came
up with its NDS for THALOMID, and (3) approval was granted for
Celgene's product on the basis of completely new studies and
data, militated in favour of the Court declaring that THALOMID is
an "innovative drug" and eligible for listing on the
Register. The Minister of Health has appealed the Federal
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A recent Saskatchewan Court of Queen's Bench decision allowed a court-appointed receiver to sell and transfer intellectual property rights free and clear of encumbrances, finding that a license to use improvements of an invention was a contractual interest and not a property interest.
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