[2012] 3 F.C.R. D-4
Food and Drugs
Judicial review of decision by respondent through Office of Patented Medicines and Liaison (OPML) refusing to register applicant’s drug THALOMID on Register of Innovative Drugs on basis that medicinal ingredient in THALOMID, thalidomide, not innovative contrary to Food and Drug Regulations, C.R.C., c. 870, s. C.08.004.1(1)—Thalidomide previously approved under brand names KEVADON, TALIMOL before its withdrawal in response to its teratogenicity—Applicant commercializing thalidomide in treatment of cancer, other diseases—Claiming that THALOMID containing sensitive proprietary, confidential information, thus request to list THALOMID on Register—Under data protection regulation (DPR) contained in Regulations, OPML must consider whether medicinal ingredient previously approved in drug by respondent pursuant to definition of “innovative drug” in s. C.08.004.1(1)—Main issues proper interpretation of words “innovative drug”; whether withdrawal of approval giving thalidomide status of new medicinal ingredient—Respondent failing to apply purposive interpretation of DPR—Purpose of DPR to ensure that companies not granted data protection for something in previous use, for which no innovation required—Variations or minor changes to drug previously approved excluded from scope of data protection—Applicant showing herein that thalidomide useful, lifesaving drug by producing new data—Inconsistent with North American Free Trade Agreement, Agreement on Trade-Related Aspects of Intellectual Property Rights to refuse data protection when chemical entity put to new use on basis of new data ensuring its effectiveness, safety—Perverse to find that drug withdrawn for safety reasons previously approved—Apparent that approval should never have been granted in view of absence of data relating to deleterious effects—Even if KEVADON, TALIMOL not voided but only withdrawn from sale, Canadians not benefiting from discovery, development of thalidomide unless new medicines approved on basis of new information, data demonstrating their safety, efficacy—Prior approvals of KEVADON, TALIMOL not standing in way of data protection for later approved product—Application allowed.
Celgene Inc. v. Canada (Health) (T-148-11, 2012 FC 154, de Montigny J., judgment dated February 6, 2012, 35 pp.)