Changes to NOC Regulations

October 18, 2006

Today, the Government of Canada published Industry Canada's Regulations Amending the Patented Medicines (Notice of Compliance) Regulations and Health Canada's Regulations Amending the Food and Drug Regulations.

Under these amendments, the most significant change relates to new and innovative drugs, which will receive a minimum of eight years of marketplace exclusivity, up from five years. These changes are especially important to Canada's biotechnology industry, since biologic drugs often have little patent protection left by the time they are approved for sale due to lengthy development and regulatory review times. The regulations also provide an additional six months of market exclusivity to innovative drugs that are the subject of pediatric studies, in order to encourage companies to provide more information about the effects their products have on children. Limits to extending the patent term of pharmaceuticals by exploiting subsequently-filed related patents, known as "evergreening," is also codified in the amendments.

The changes came into force on October 5, 2006 and apply to patents on the patent list submitted on or after June 17, 2006.

Valadares Law Group is experienced in building patent portfolios in the biopharma industry and in assessing the strength and validity of existing patents and published applications. For more information about how the new regulations will impact your business, please contact us.