[2011] 2 F.C.R. D-15
Food and Drugs
Judicial review of June 2010 decision by Minister of Health rejecting applicant’s request to delete ELOXATIN from Register of Innovative Drugs—Minister granting authorization to Sanofi-Aventis Canada Inc. (Sanofi) on June 15, 2007 to sell ELOXATIN as innovative drug pursuant to Food and Drug Regulations, C.R.C., c. 870, s. C.08.004.1—Minister thus determining that medicinal ingredient, oxaliplatin, not previously approved in a drug—Applicant arguing that, by authorizing Sanofi’s wide-scale, high volume sales of ELOXATIN between 1995–2005, Minister approving safety, efficacy of drug, Minister erring in law in granting Sanofi innovative drug status—Minister rejecting that argument, applicant launching present judicial review—Applicant challenging Minister’s June 21, 2010 decision as “fresh decision” on correctness of 2007 authorization—Issues: (1) what is content of authority provided to Minister as entity charged with maintaining Register pursuant to Regulations, s. C.08.004.1(9); (2) whether judicial review available to hold Minister accountable for decisions made in exercising authority; (3) what is correct interpretation of term “approved” in definition of “innovative drug” in Regulations, s. C.08.004.1(1)—Issue 1: Patented Medicines (Notice of Compliance) Regulations, SOR/93-133 not a comparator for interpreting Minister’s authority under Regulations—However, no basis in present record to support argument that Regulations should not be interpreted to provide Minister with authority to add, delete from Register—Not logically possible for Minister to maintain Register without open dialogue with innovator, generic manufacturers based on understanding that, in appropriate case, Minister would take action to amend Register—As a result, Minister having authority to issue “fresh decision” of June 21, 2010—Issue 2: In initial arguments, Minister, Sanofi objecting to applicant’s standing because applicant not directly affected by matter—Applicant’s attempt to file Amended Abbreviated New Drug Submission (ANDS) rejected by Minister—Sanofi continuing argument at hearing that applicant must file ANDS in order to justify interest—Accepting such argument meaning that applicant having to abandon present application, commence new application with same arguments—This course of action not improving delivery of justice—By attempting to file ANDS, applicant perfecting standing to bring present application—Issue 3: Granting of market approval under Regulations for drug involving (1) acceptance by Minister of evidence that innovator’s drug safe, effective; (2) approval by Minister for sale by issuance of formal legal determination—Thus, factual finding required as condition precedent to making of legal determination—Issue to which this analysis applied is whether applicant discharging evidentiary burden to prove that oxaliplatin previously approved in drug by Minister—Necessary for applicant to prove that Minister making factual finding that oxaliplatin safe, effective—No evidence herein that such factual finding made—Minister correct that both (a) factual condition precedent of finding that drug safe, effective; (b) market authorization approved accordingly, required for drug to be “approved” as that term is used in definition of innovative drug in s. C.08.004.1(1)—Application dismissed.
Teva Canada Limited v. Canada (Health) (T-1172-10, 2011 FC 507, Campbell J., judgment dated May 2, 2011, 45 pp.)