Federal Appeal

Industrial and Intellectual Property

Phrase “previously approved” should be strictly construed

This was appeal of judge’s decision granting application for judicial review. Appellant Minister of Health refused to register respondent’s drug THALOMID on register of innovative drugs. Medicinal ingredient in THALOMID was thalidomide. In 1960 and 1961, two companies received approval for sale of drug, including thalidomide under brand names KEVADON and TALIMOL. In 1961 and 1962, thalidomide was dramatically withdrawn from world market because of its potential to produce fetal malformation. In 1962, sale of thalidomide was absolutely prohibited. However, thalidomide was found to be effective treatment of leprosy and related conditions and form of cancer. THALOMID was first available in 1995 through program that was designed to provide exceptional access to drugs not approved for sale in Canada. Respondent applied for notice of compliance, which was issued in August 2010. Minister advised respondent that THALOMID would not be eligible for data protection pursuant to Food and Drug Regulations (Can.), because its medicinal ingredient thalidomide had been previously approved by Minister in at least two drugs, KEVADON and TALIMOL. Minister confirmed decision not to list respondent’s product on innovative drugs register. Respondent applied for judicial review. Judge determined that prior approval of KEVADON and TALIMOL should not stand in way of data protection for THALOMID. Judge found that approval of thalidomide was short lived, that thalidomide was banned until respondent came up with new drug submissions for THALOMID and that notice of compliance was granted based on new studies and data. Appeal allowed. THALOMID was new drug and Minister’s approval must be obtained before it could be sold in Canada. Thalidomide was medicinal ingredient previously approved in drug by Minister. “Previously” should not be construed as meaning “currently”. Reading words “and currently” into data protection provisions could open door to unintended scenarios. Phrase “previously approved” should be strictly construed. Courts should not inquire into why notice of compliance was suspended or withdrawn. Although thalidomide had exceptional history, there was no cogent legal basis to create exception.

Celgene Inc. v. Canada (Minister of Health) (Feb. 15, 2013, F.C.A., Johanne Gauthier J.A., K. Sharlow J.A., and M. Nadon J.A., File No. A-75-12) Decision at 212 A.C.W.S. (3d) 814 was reversed.  226 A.C.W.S. (3d) 1144.

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