Innovative Drugs

April 20, 2022
Photograph of a doctor holding out small white pills
April 20, 2022

Data Protections Once Again Prevent Médunik From Launching Pediatric Drug

The Federal Court disagreed with Health Canada's interpretation of data protection regulations, once again reversing approval of pediatric drug RUZURGI.
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July 27, 2021
Photograph of centrifuge tubes in a test tube rack on a laboratory bench.
July 27, 2021

Variations on Previously Approved Drugs Are Ineligible for Data Protection

2021 FCA 137: 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.
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August 2, 2016
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).
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February 21, 2013
February 21, 2013

Divided FCA Denies Data Protection for THALOMID

Canada (Health) v. Celgene Inc., 2013 FCA 43 This was an appeal from a Federal Court decision granting Celgene’s application for judicial review and quashing the […]
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January 29, 2013
January 29, 2013

Data Protection: an Enantiomer of a Previously-Approved Racemic Mixture Is Automatically a “Variation”

Takeda Canada Inc. v. Canada (Health) – 2013 FCA 13 Takeda Canada appealed from the Federal Court’s decision dismissing Takeda's application for judicial review of a […]
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