Pharmacapsules @ Gowlings: April 13, 2012

Edited by Jennifer Wilkie and Isabel Raasch

Teva Canada Limited v. Minister of Health and Sanofi-Aventis Canada Inc.  2012 FCA 106, data protection case
By: Jane Clark

On April 10, 2012, the Court of Appeal affirmed Justice Campbell's decision dismissing Teva's application to remove Eloxatin^® from the Innovative Drug Register. This case involved an interpretation of the first part of the two prong definition of "innovative drug" that excludes from eligibility for listing on the Register drugs that were previously approved.

The Minister and Court below found that authorizations under the Special Access Program ("SAP") that provide a drug by way of emergency treatment did not count as "previously approved". The Court of Appeal agreed noting that "previously approved" was not itself defined. 

The Court cited three reasons in rejecting Teva's argument that the wide distribution of Eloxatin^® under the Special Access Program and the need to avoid an "inordinate and unjustifiable monopoly" should have excluded Eloxatin^® from data protection on the basis that it was previously approved:

1. The definition of "innovative drug" is not aimed at achieving a compromise between providing monopolies to innovators and allowing generics to obtain timely access but at the safety and efficacy of drugs, a matter that is evidenced only by approvals based on data and studies strictly defined under the Regulations. 
2. Teva's argument that the wide distribution via SAP was a unique circumstance sufficient to constitute "previous approval" would create uncertainty and lack of clarity which the Regulations were trying to eliminate.
3. The definition of "innovative drug" was aimed at a limited specific purpose of implementing Canada's treaty obligations. Teva's proposed interpretation would unduly narrow the definition and undercut Canada's treaty obligations.  Authorization under SAP is different than approvals. The use is authorized despite the absence of safety and efficacy data in an emergency situation as a compassionate permission rather than a drug approval. The treaty provisions aimed to protect an innovator who submits undisclosed data in support of an application for approval to market a drug containing a new chemical entity.  This encourages the development of new drugs. The relevant aspect of the treaty provisions that shed light on "previously approved" is the repeated mention of the concept of marketing approval. In Canada, this means the issuance of a Notice of Compliance and drug identification number.

While two issues (lack of standing and no reviewable decision) were improperly raised by way of cross-appeal, in effect, attempting to appeal reasons, the Court took the opportunity to provide guidance on the issues. 

First, Teva had standing to challenge the listing of Eloxatin^® on the Register. Those who file an ANDS and have it rejected because a drug is listed on Register are directly affected by that listing. The timing of the attempt to file an ANDS need not be before an application for judicial review was commenced. To find otherwise would lead to pointless cost, delay and waste.

Second, the Minister's 2010 rejection of Teva's request to de-list Eloxatin^® constituted a fresh and reviewable decision. The Minister is obligated to maintain the Register of Innovative Drugs which gives power to add or delete information as necessary. Refusing Teva's request was a fresh exercise of discretion and a decision susceptible to judicial review.

The full text of this decision can be accessed at:
http://decisions.fca-caf.gc.ca/en/2012/2012fca106/2012fca106.html

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.