Celgene obtained data protection (innovative drug status) for
THALOMID® brand drug (thalidomide). In a decision released
February 6, 2012, the Federal Court granted Celgene's
application for judicial review against the Minister's decision
to refuse data protection to Celgene in respect of THALOMID®
brand drug (thalidomide).
The Minister's Decision
With the issuance of the NOC to Celgene for its THALOMID®
brand drug, the Minister considered and rejected data protection
for Celgene's drug. In doing so, the Minister concluded that
thalidomide did not come within the definition of an
"innovative" drug within the Data Protection
Regulations ("Regulations"), because the definition
of innovative drugs is restricted to those containing a medicinal
ingredient not "previously approved". The Minister
concluded that THALOMID® brand drug did not qualify because
the medicinal ingredient, thalidomide, was approved in the
1960s. However, that approval was withdrawn in the 1960s due
to the tragic results of thalidomide use, and thalidomide reverted
to "new drug" status.
Celgene brought a judicial review application of the decision,
inter alia, on the basis that in order to obtain an NOC in
2010, Celgene had filed voluminous, original research data to
satisfy the Minister that THALOMID® brand drug was safe and
efficacious. In its application, Celgene pointed to this fact as
well as many other facts and arguments, which the Court accepted in
its granting of the application.
The Court's Decision
Key to the Court's decision yesterday was its finding that
the purpose and intent of the Regulations is to encourage
innovation and the development of drugs that can be used by
Canadians. The Court held that the Minister had failed to
apply a purposive interpretation of the Regulations. The
Court found that the effort required by Celgene in order to obtain
an NOC in this case was substantial and fell within the purpose and
intent of the Regulations.
The Court rejected the Minister's arguments that the
Regulations were restricted to "new chemical
entities", because although that language is in international
treaties, it is not a part of the definition of "innovative
drug" in Canadian legislation. Thus, the Court concluded
Celgene's innovation was to take something that had been banned
as dangerous and that had not been found to be safe and efficacious
and show it to be a useful, life saving drug. In doing so,
Celgene did not and could not rely on old data and had to produce
an entirely new data package. The Court held it would be
inconsistent with the international treaties to refuse data
protection when a chemical entity is put to entirely new use on the
basis of extensive and genuinely new data ensuring its
effectiveness and safety.
The Court also noted that the 1960s-era approvals should not
have been granted. The old drugs had reverted to new drug
status and could not be considered as Canadian reference products
for the purposes of an ANDS. Another factor considered was
the fact the drug approval regime in Canada changed dramatically in
1963 as a result of the tragedies surrounding prior thalidomide
products. The significant regulatory revision reinforced the
conclusion that the prior approvals of old thalidomide drugs should
not stand in the way of data protection for the later approved
product. The fact that post-1963 submissions necessarily
include new and more extensive data, combined with the facts that
prior approval for thalidomide was short-lived, it never should
have been given at the time, the drug was banned until Celgene came
up with its NDS and lastly, that approval was granted for
Celgene's product on the basis of completely new studies and
data, militated in favour of declaring thalidomide is an
"innovative drug" eligible for data protection.
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