This was a motion that raised the issue of an innovator’s standing and right to be made a party to a judicial review of the Minister of Health’s administration of the Food and Drugs Regulations implementing the data protection regime.
Sanofi-Aventis Canada Inc. (“Sanofi”) manufactures and sells the drug Eloxatin, which contains oxaliplatin as an active pharmaceutical ingredient. On June 15, 2007, Eloxatin was placed on the Register of Innovative Drugs (the “Register”) maintained pursuant to the Foodand Drugs Regulations. On October 27, 2006, before oxaliplatin was listed on the Register, Hospira filed a New Drug Submission (“NDS”) seeking an NOC for a drug containing “Chemical Entity A” as its active ingredient. While not necessary, it was assumed for the purpose of this hearing that “Chemical Entity A” is oxaliplatin. The Minister initially rejected Hospira’s NDS for reasons that have nothing to do with data protection. However, Hospira successfully reversed the Minister’s initial refusal and the Minister resumed his examination of Hospira’s NDS. By that time, Eloxatin and oxaliplatin had been listed on the Register. The Minister sought additional information from Hospira, and Hospira made reference to the product monograph of Eloxatin. The Minister then considered that Hospira had made “direct or indirect comparison” between its drug and Eloxatin and declined to issue Hospira’s NOC. Hospira thus brought an application judicially reviewing the Minister’s decision on the basis that the data protection provisions do not apply to its NDS because it was filed before Eloxatin was entered on the Register.
While Hospira’s notice of application for judicial review did not name Sanofi, Sanofi argued that to the extent that “Chemical Entity A” is in fact oxaliplatin, it is a person directly affected by the order sought by Hospira, and that Hospira ought to have, and should have been ordered to, name it as a party respondent.
The Court noted that there are two clear lines of jurisprudence on the issue of standing in respect of the regulations made under the Food and Drugs Act. The first giving rise to the notion that an innovator drug manufacturer does not have standing to bring or respond to an application to judicially review a decision of the Minister of Health under the Food and Drugs Act or the Food and Drug Regulations in respect of the issuance or proposed issuance of an NOC to another drug manufacturer. The second being that an innovator whose patents are listed against a drug on the drug register maintained under the PM(NOC) Regulations does have standing where the issue in a judicial review is whether or not the rights and protections afforded to it under the PM(NOC) Regulations are engaged by another manufacturer’s application for an NOC. From these two lines of cases, the Court concluded that it could not draw simple and absolute propositions that are determinative of the matter at issue in this case. The Court held that it comes down to “whether the order sought affects the legal rights of the innovator, imposes legal obligations on it, or prejudicially affects it in some direct way.” With that, the Court found it was clear that an order reversing the Minister’s determination that the data protection regime was engaged and ordering the issuance of an NOC to Hospira would prejudicially affect Sanofi in a direct way, and not merely because it would suffer economic or competitive prejudice. The order sought would, in the Court’s view, remove the protection and Sanofi’s rights to the exclusion of Hospira’s product from the market, both of which were intended for Sanofi’s direct benefit.
For these reasons, the Court was satisfied that the innovator whose product is listed on the Register as corresponding to “Chemical Entity A” was a person directly affected by the order sought and that it was to be added by Hospira as a respondent to the Application. Costs were ordered payable by Hospira to Sanofi in the amount of $2,000.