Federal Court of Appeal affirms data protection for Sanofi’s ELOXATIN (oxaliplatin)

On April 10, 2012, the Federal Court of Appeal (“FCA”) dismissed Teva’s appeal of a data protection decision of Justice Campbell (2011 FC 507).

In 2007, the Minister of Health granted “innovative drug” status (data protection) to Sanofi’s drug ELOXATIN.  In 2010, Teva requested that the Minister remove ELOXATIN from data protection on the basis that it was not an “innovative drug” pursuant to subsection C.08.004.1(1) of the Food and Drug Regulations (“Regulations”).  Specifically, Teva argued that ELOXATIN had been “previously approved” since 1999 on the basis that the Minister had authorized thousands of uses of ELOXATIN under the emergency treatment provision of the Special Access Programme (“SAP”).  Having been “previously approved”, Teva submitted that ELOXATIN was not eligible for data protection.

The Minister refused Teva’s request on the basis that SAP authorizations do not constitute a “previous approval” in the context of data protection.  Rather, a “previous approval” means when a drug receives “market authorization” i.e. whether a notice of compliance or drug identification number has been issued for the drug.

Teva filed an application for judicial review to the Federal Court.  Justice Campbell dismissed the application and the FCA has affirmed his decision finding that the Minister’s interpretation of the Regulations is correct.

The FCA dismissed Teva’s appeal for three main reasons:

1)      Wording, architecture and purpose of the Regulations – The Regulations are not to be viewed through the prism of monopolies to innovators and timely market access to generics but rather through the prism of safety and efficacy of drugs.  In order for a drug to be marketed in Canada, it must be demonstrated to be safe and effective.  On the other hand, SAP authorizations are not based on a demonstration of safety and efficacy.  Rather, these authorizations are provided in emergency situations as a “last resort” treatment and are “best seen as compassionate permissions, not as approvals for the drug.”

2)      Lack of clarity and uncertainty – Teva’s position would create uncertainty and lack of clarity which the Regulations strive to eliminate.  For example, how many SAP authorizations would be required to make a drug “approved”?

3)      Subsection C.08.004.01(1) of the Regulations is a limited, special purpose provision – this subsection was introduced to implement Canada’s treaty obligations with respect to data protection.  Teva’s interpretation would run counter to such obligations.

The FCA also dismissed Sanofi’s cross appeal challenging Teva’s standing to judicially review the Minister’s decision.  A copy of the FCA decision can be found here.