[2016] 2 F.C.R. D-7
Food and Drugs
Judicial review of Minister of Health (respondent) decision refusing to issue notice of compliance (NOC) for applicant’s OXALIPLATIN FOR INJECTION (OXALIPLATIN) product — Respondent finding that applicant’s new drug submission (NDS) seeking NOC on basis of direct or indirect comparison to Sanofi-Aventis Canada Inc.’s innovative drug ELOXATIN — Therefore, respondent applying data protection provisions found in Food and Drug Regulations, C.R.C., c. 870, s. C.08.004.1; concluding applicant’s NOC could not issue until expiry of data protection for ELOXATIN — Applicant arguing inter alia that Health Canada wrongly applying data protection regulation to NDS for OXALIPLATIN FOR INJECTION since nothing in regulatory scheme providing authority for Health Canada to apply data protection when only post-filing amendments making direct or indirect comparison to innovative drug; alternatively arguing that decision under review unreasonable, that Health Canada breaching duty of fairness owing thereto — OXALIPLATIN FOR INJECTION, finished pharmaceutical dosage product with oxaliplatin as active medicinal ingredient, used for treatment of colorectal cancer — Applicant’s NDS for OXALIPLATIN screened, going through numerous regulatory procedures before notice of noncompliance issued — Applicant refusing to make submissions regarding respondent’s decision when provided opportunity to do so — Health Canada notifying applicant that since applicant making comparisons in submission to ELOXATIN, an “innovative drug” listed on Register of Innovative Drugs, data protection provisions applying, NOC for OXALIPLATIN would not be issued until expiry of term of market exclusivity for ELOXATIN — Whether respondent breaching procedural fairness by failing to inform applicant earlier in approval process that data protection provisions preventing issuance of NOC; whether respondent erring in finding that Regulations, s. C.08.004.1(3) applying to post-filing amendments made pursuant to s. C.08.004(2) — Degree of fairness owed to applicant in present circumstances low given that regulatory process under Regulations more administrative in nature — Respondent not having to advise applicant that, if applicant choosing to seek NOC for new drug on basis of direct or indirect comparison with innovative drug, issuance of NOC could be subject to data protection provisions given clarity of combined wording of Regulations, ss. C.08.004(1), C.08.004.1(3) — Moreover, assessment of safety, efficacy of OXALIPLATIN by Health Canada’s Bureau of Metabolism, Oncology & Reproductive Sciences constituting prerequisite for marketing of new drug in Canada whether before or after expiration of data protection period — Applicant cannot argue prejudiced by order in which different issues dealt with by different Health Canada departments — Even if procedural irregularity in treatment of applicant’s NDS occurring in present case, cured at later stage of proceeding — Applicant choosing not to take advantage of opportunity to be heard since foreclosing reconsideration process clearly available thereto — Thus, respondent not breaching procedural fairness herein — As to data protection provisions, needing to determine whether provisions at issue applying to applicant’s request for NOC for OXALIPLATIN — While Regulations, s. C.08.004.1(3) not sufficiently precise, when text read by cross-reference to other provisions found in s. C.08.004, clear that post-filing amendments subject to data protection prohibition imposed on respondent by s. C.08.004.1(3)(b) — Regulations, s. C.08.004.1(3) silent on post-filing amendments but s. C.08.004(3) clearly stipulating that examination of additional information filed also subject to data protection provisions — Conclusion confirmed by purpose behind data protection provisions — Interpretation applicant urging running contrary to Canada’s obligations under North American Free Trade Agreement Between the Government of Canada, the Government of the United Mexican States and the Government of the United States of America, December 17, 1992, [1994] Can. T.S. No. 2 (NAFTA), Agreement on Trade-Related Aspects of Intellectual Property Rights, Annex 1C of the Marrakesh Agreement Establishing the World Trade Organization, signed in Marrakesh, Morocco, 15 April 1994, 1869 U.N.T.S. 299 (TRIPS); would undercut commitments to protecting innovators from unfair commercial use of undisclosed data — In conclusion, respondent correctly interpreting Regulations, ss. C.08.004.1(3), C.08.004(2), holding that no breach of procedural fairness occurring in present case — Application dismissed.
Hospira Healthcare Corporation v. Canada (Health) (T-1963-13, 2015 FC 1205, Gagné J., judgment dated November 6, 2015, 28 pp.)