Thirty years of the Patented Medicines (Notice of Compliance) Regulations
Pharma in Brief
DECEMBER 3, 2023
The listed patents must be addressed by the manufacturer of a generic or biosimilar drug before its drug can receive a Notice of Compliance ( NOC ) and be sold in Canada. The early-working exception allows generic or biosimilar manufacturers to work a patented invention “for uses reasonably related” to obtaining regulatory approval.
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