2022 Guide to Canada’s Pharmaceutical Intellectual Property Regime

Our 2022 Guide to Canada’s Pharmaceutical Intellectual Property Regime is a convenient all-in-one reference to the important legal and regulatory regimes governing pharmaceuticals in Canada.

The Guide provides a detailed review of the key regimes, including:

• Data protection market exclusivity;
• The Patented Medicines (Notice of Compliance) Regulations (PMNOC), linking generic market access to patent rights;
• Certificate of Supplementary Protection (CSP) exclusivity;
• Biologics; and
• Drug pricing and market access.

We are honoured that the Guide includes a Foreword by our partner, The Right Honourable Brian Mulroney. During his tenure as the 18th Prime Minister of Canada, Mr. Mulroney championed a series of significant legislative reforms to improve protections for pharmaceuticals that continue to operate today. The COVID-19 pandemic has highlighted the importance of fostering investment in research, development and manufacturing by the innovative pharmaceutical industry in Canada. Norton Rose Fulbright’s pharmaceuticals and life sciences team understands the innovative pharmaceutical industry and will continue to work with innovators to defend their rights and maintain the benefits they bring to all Canadians.

We hope this Guide will assist in navigating the complex challenges of this rapidly evolving field.