Tuesday, April 15, 2014

Innovator with Drug on Register Has Standing in Review of Minister’s Decision as to Whether Data Protection Is Triggered by an NDS

Hospira Healthcare Corp v Canada (Health) 2014 FC 179 Tabib Pr
            oxaliplatin / ELOXATIN

Hospira filed an NDS for “Chemical Entity A,” which, for the purposes of this decision, was assumed to be oxaliplatin [4]. This NDS was rejected for reasons having nothing to do with data protection. Sanofi then listed its drug Eloxatin, with oxaliplatin as the API, on the Register of Innovative Drugs. The Minister then resumed consideration of Hospira’s NDS. In one of its answers to the Mininster’s inquiries, Hospira made reference to the product monograph for Eloxatin. The Minister considered that Hospira had thereby made “direct or indirect comparison” between its drug and Eloxatin, and therefore placed Hospira's application on what might be called “data protection hold” pursuant to section C.08.004.1 of the Food and Drug Regulations (the data protection provision) [5]. Hospira sought judicial review of this decision, and Sanofi sought to be named as a party on the basis that it was a person “directly affected by the order sought” under Rule 303(1)(a).

Prothonotary Tabib noted that the data protection regime is intended to protect the interests of innovative drug makers by preventing others from relying on their data during the exclusivity period, and “[i]t is beyond question that the order sought will directly prejudice Sanofi, as it will remove the protection and its right to the exclusion of Hospira’s product from the market, both of which were intended for Sanofi’s direct benefit” [19]. She therefore held that Sanofi did have a right to be added on the third branch of the test for interpreting Rule 303 set out in Forest Ethics Advocacy Assn 2013 FCA 236 [20].

In coming to this conclusion, Tabib Pr usefully pointed out that there are two lines clear lines of authority:

[13] On the one hand, it has been held 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 Drugs Regulations in respect of the issuance or proposed issuance of an NOC to another drug manufacturer

[14] On the other end of the spectrum, there is equally constant jurisprudence that an innovator whose patents are listed against a drug on the 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

She noted that neither of these lines of authority controlled the present case; the distinction cannot be based on whether it is the NOCRegulations or the Food and Drugs Regulations that are involved, as there is no principled reason for saying that a person’s interest is necessarily “directly affected” by one regulation but not the other [15].

UPDATE: aff'd 2014 FC 235 aff'd 2014 FCA 194

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