Patented Medicines (Notice Of Compliance) Listing Update

Listing a patent on the Patent Register maintained by the Minister of Health is the gateway through which an innovator gains access to the provisions of the Patented Medicines (Notice of Compliance) Regulations (PMNOC Regulations). Any person seeking to market a generic copy of a pharmaceutical product in Canada, in respect of which a patent is listed, must address the infringement and/or validity of that patent or await its expiry. There is an opportunity for the innovator to seek an order from the Federal Court prohibiting the Minister from issuing a Notice of Compliance (NOC) to the generic on the basis that allegations of non-infringement and/or invalidity are not justified. As this exercise is conducted prior to generic entry, it can prevent disruption of the marketplace. Conversely, in a patent infringement action, given the absence in Canada of effective injunctive relief, the generic entrant will often have access to the market over the course of the action. If the Minister refuses to list a patent on the Register at the time of...