Food and Drug Regulations

July 27, 2021
Photograph of centrifuge tubes in a test tube rack on a laboratory bench.

Variations on Previously Approved Drugs Are Ineligible for Data Protection

On July 12, 2021, the Federal Court of Appeal issued a decision dismissing an application for judicial review of a decision of the Minister of Health denying data protection for a drug. Janssen Inc. had sought protection for its drug SPRAVATO but was rejected on the basis that it was not an “innovative drug” eligible for such protection.
August 2, 2016

FC Denies Data Protection for Ester of a Previously Approved Medicinal Ingredient

2015 FC 959 - The Health Minister denied data protection for Cysview after finding it was not an “innovative drug”, and the FC indicated the scope of “innovative drug” does not extend to combinations of the enumerated variations of previously approved medicinal ingredients in the Regulations (salt, ester, enantiomer, solvate or polymorph).