What are the patentees filing requirements?
Patentees have filing requirements under the Patent Medicines Regulations. For more information, patentees can also consult the Patentees’ Guide to Reporting. The filing requirements are: Intention to sell: Pursuant to section 82(1) of the Patent Act, patentees are required to inform the PMPRB of an intention to sell a patented medicine in a new market in Canada and date on which the patentee intends to offer the medicine for sale. For more information, please consult the Patentees’ Guide to Reporting – Schedule 6 – Notification of Intent to Sell Medicine Information Sheet (Form 1): Under the Patented Medicines Regulations, a patentee is to file information on patented drug products for which a Notice of Compliance (NOC) has been issued by Health Canada, or which are being offered for sale in Canada. Form 1 is to be submitted for each patented drug product within thirty days of it being issued a NOC or being offered for sale in Canada, whichever comes first. Information on the Identity
