Wednesday, May 18, 2011

Minister has On-Going Duty to Maintain Innovative Drug Register / Participation in SAP Does Not Disqualify from "Innovative Drug" Status

Teva Canada Ltd v Canada (Health) 2011 FC 507 Campbell J

ELOXATIN had been sold by Sanofi from 1999 to 2005 under the “Special Access Program” (SAP) provided for in C.08.010(1) of the Food and Drug Regulations. In 2007 Sanofi received a NOC for ELOXATIN on the basis of an NDS, and ELOXATIN was then listed on the Innovative Drug Register. Consequently, it was eligible for data protection for an eight and a half year term running from the 2007 issuance of the NOC. Teva challenged this listing in 2010. The case raised a procedural point and substantive point.

The procedural point arose because Teva did not challenge the listing in 2007, but in 2010 it requested that ELOXATIN be deleted from the Innovative Drug Register on the basis that it contained a medicinal ingredient that had been “previously approved” and so did not qualify as an “innovative drug” under the definition in C08.004.1(1). The Minister refused to delete it, and notified Teva by letter.

Sanofi argued that Teva could only challenge the listing decision at the time of the original decision, at least in the absence of any new information. The FC agreed with Teva and the Minister, that the Minister has an ongoing duty to maintain the register, and so a decision regarding listing can be made at any time. The Minister accepted that her decision was subject to judicial review, but there was a dispute as to whether Teva had standing. The FC held [18] that Teva did have standing, on the basis that the listing on the Register prevented it from filing an ANDS. The decision in CGPA v Minister of Health and GlaxoSmithKline Inc 2011 FC 465 holding that the Canadian Generic Pharmaceutical Association did not have standing to challenge a listing decision, was distinguished at [34] on the basis that the CGPA is an association which is incapable of filing an ANDS. (While Campbell J referred to this decision as having been released, it is not yet available on the Federal Court website.)

On the substantive point, Teva argued that the Minister’s course of action in allowing extensive use of ELOXATIN under the SAP showed that she must have been satisfied of the safety and efficacy [24]. The FCA rejected this, agreeing with the Minister that approval means market authorization, including safety and efficacy approval, on the basis of an NDS or ANDS under C.08.004. The functional rationale is that an SAP does not require the same data that the normal approval does, and it is the data submitted for the NDS that is the subject of data protection. Teva argued that the data which was the basis for the NDS arose from Sanofi’s participation in the SAP, and so was disclosed prior to the NOC being issued. However, even if this is true on the facts of this case, it is not necessarily true in general. The meaning of “previously approved” in the definition of an innovative drug cannot turn on the extent to which the particular information relied on in the NDS had been previously disclosed.

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