Digests

Food and Drugs

Judicial review of decision by Minister of Health refusing to qualify CEPLENE as “innovative drug” pursuant to Food and Drug Regulations, C.R.C., c. 870, s. C.08.004.1(1)—Amendments to Food and Drug Regulations concerning extension of market exclusivity, data protection, implementing North American Free Trade Agreement (NAFTA), Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) provisions—Applicants relying on market exclusivity provided by data protection to protect CEPLENE following issuance of notice of compliance—CEPLENE’s medicinal ingredient previously approved in several drugs using drug identification number (DIN) process or current method under Natural Health Products Regulations, SOR/2003-196—Health Canada deeming CEPLENE as “new drug” but refusing to add product to Register of Innovative Drugs because definition of “innovative drug” contemplating that medicinal ingredients not previously approved in any drug are to be considered in assessment of eligibility for data protection—Whether Minister erring in determining CEPLENE not “innovative drug”—Applicant contending Minister’s interpretation preventing “new drugs” from obtaining data protection associated with “innovative drug” where unrelated homeopathic products containing same, similar medicinal ingredient previously approved—Considering Food and Drug Regulations, enabling legislation, relevant NAFTA, TRIPS provisions, definition of “innovative drug” prohibiting innovators from obtaining additional terms of data protection for variations of previously approved medicinal ingredients—At heart of issue meaning ascribed to second reference to “drug” in r. C.08.004.1(1)—Whether second reference limited to approved “new drug” or including all approved drugs—Applicant contending second reference should be interpreted as “new drug”, excluding consideration of drugs approved under DIN, Natural Health Products Regulations—Applicant’s argument must fail, first reference to be interpreted as “new drug”, second reference to be interpreted as any drug—Applicant’s position based on argument data protection regulations protecting extensive clinical data—However, according to relevant NAFTA, TRIPS provisions, Food and Drug Regulations protecting “new chemical entities”—Not all “new drugs” constituting “new chemical entities”—Applicant asserting two interpretations in one provision incoherent—While interpreting both drug references differently not desirable, result more coherent, consistent with other statutes, regulations dealing with same subject-matter—Application dismissed.  

Epicept Corporation v. Canada (Health) (T-2009-09, 2010 FC 956, Near J., judgment dated September 24, 2010, 36 pp.)