Canada: Federal Court Dismisses Challenge To A Data Protection Listing On The Register Of Innovative Drugs [Eloxatin® (Oxaliplatin)]

Summary:

On May 2, 2011, Campbell J. of the Federal Court dismissed the application of Teva Canada Limited ("Teva") seeking to review the response of the Minister of Health ("Minister") which refused Teva's request to remove sanofi-aventis Canada Inc.'s drug ELOXATIN^® (oxaliplatin) from the Register of Innovative Drugs ("Register"). Ogilvy Renault represented sanofi-aventis Canada Inc. ("sanofi").

Teva had written to the Minister to challenge the listing of oxaliplatin on the grounds that it was not an "innovative drug" as defined in C.08.004.1 of the Food and Drug Regulations ("Regulations"). This provision states (in part) that an "innovative drug" is one which contains a medicinal ingredient not previously approved in a drug by the Minister. Teva asserted that oxaliplatin had been previously approved by the Minister by reason that the Minister had authorized a high volume of sales of oxaliplatin under the Special Access Program (SAP) pursuant to C.08.010(1) of the Regulations. These sales under SAP occurred prior to the issuance to sanofi of a Notice of Compliance (NOC) in 2007. The Minister disagreed that oxaliplatin had been "approved" under the SAP.

The Court held that the Minister was correct that both the factual condition precedent of a finding that a drug is safe and effective and a market authorization approved accordingly, are required for a drug to be "approved" as that term is used in the definition of an innovative drug in C.08.004.1 of the Regulations. The statement of the Federal Court of Appeal in Hospira 2010 FCA 354 that "the safety and efficacy of a drug cannot be established solely on the basis that its use had been permitted under the Special Access Programme" was found by Campbell J. to be irrelevant.

Despite sanofi's opposition, Justice Campbell agreed to hear the matter on the basis that Teva had standing by reason of Teva's attempt to file, after initiation of the proceedings, an ANDS for oxaliplatin and that to dismiss the matter for lack of standing would "do nothing to improve delivery of justice". The Court also determined that the response of the Minister to Teva's request to delist was a "fresh" decision capable of judicial review, and that the Minister had the authority to delete an entry from the Register.

Link To Decision:
http://decisions.fct-cf.gc.ca/en/2011/2011fc507/2011fc507.html

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