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 However, that approval was withdrawn in the 1960s due to the tragic results of thalidomide use, and thalidomide reverted to "new drug" status.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.
The decision may be found at:
http://www.gowlings.com/knowledgecentre/enewsletters/pharmacapsules/pdfs/Celgene.pdf
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