Data Protection: Sanofi Gains Standing In Hospira’s Objection To Application Of Data Protection

On February 26, 2014, the Federal Court of Canada granted standing to Sanofi-Aventis Canada Inc. (Sanofi) in a case involving a Sanofi product on the Register of Innovative Drugs (the Data Protection Register). The product is currently on the Data Protection Register and subject to data protection under the Food and Drug Regulations (the F&D Regulations).¹

Data Protection Under the F&D Regulations

Under the F&D Regulations, a drug manufacturer filing a New Drug Submission (NDS) for a Notice of Compliance (NOC) may apply for data protection to prevent other manufacturers from using the information supporting the NDS in their own regulatory filings. The data protection regime is triggered when, on a manufacturer's request, the Minister of Health (the Minister) adds a drug (and by extension the active ingredient) to the Data Protection Register. When a drug is added to the Data Protection Register, a period of six years must pass before the Minister may accept a