Judicial Review of SNDS Application

  • November 06, 2015

Hospira Healthcare Corporation v. The Minister of health and Sanofi-Aventis Canada Inc.2015 FC 1206 (Gagné J.)

November 6, 2015

Susan Beaubien for Hospira Healthcare Corporation (Macera & Jarzyna, LLP, OttawaA)
Sanderson Graham and Leah Garvin for the Attorney General of Canada
Judith Robinson and Brian Capogrosso for Sanofi-Aventis Canada Inc.

This case is a judicial review of the decision of the Minister of Health to require a Form V in association with the SNDS filed by Hospira for the generic version of ELOXATIN (i.e. OXALIPLATIN solution), in accordance with s. 5(2) of the PMNOC Regulations. This is a companion case to 2015 FC 1205 regarding the data protection afforded ELOXATIN. The Applicant was refused an approval for its SNDS, which was contested on the basis that the Applicant was not a “second person” under the PMNOC Regulations. The Court held that the Application was moot as the patent for ELOXATIN had expired, although the data protection afforded ELOXATIN still applied and prevented the issuance of an NOC to the Applicant.

By: Ken Clark, Aird & Berlis LLP