Minister refused to register applicant`s drug on Register of Innovative Drugs on basis medicinal ingredient was not innovative. Applicant argued its drug should be considered innovative despite thalidomide having been previously approved by Health Canada in 1960 and 1961. Applicant argued it became null and void when approval was withdrawn for safety reasons in 1962. Application for judicial review was allowed. Minister failed to apply purposive interpretation of regulation which was to encourage and reward innovation by protecting data innovator had to generate to obtain approval for drug. Applicant’s innovation was to take something that was banned as dangerous and that was found to not to be safe and to show it to be useful lifesaving drug. Applicant could not and did not rely on old data.
Celgene Inc. v. Canada (Minister of Health)
(Feb. 6, 2012, F.C., de Montigny J., File No. T-148-11) 212 A.C.W.S. (3d) 814 (36 pp.).