Canada has a number of regulations that intersect with the
Patent Act and the drug approval process. These regulations inform
the business decisions that innovative companies must make when
bringing a new drug to market in Canada.
In this insight, we highlight the importance of communication
between a company's patent and regulatory groups at each step
of the drug development process, and how the engagement of a
Canadian patent agent well versed in these systems, or with access
to a lawyer who practices in this area, can help companies make the
most informed decisions.
Data protection
Pursuant to Canada's Food and Drug
Regulations, a generic or biosimilar
manufacturer cannot file a drug
submission with Health Canada or receive regulatory approval, for a
set period of time if that submission contains a direct or indirect
comparison to an innovative drug. Unlike in the U.S., the biologic
and small molecule drugs both have the same length of data
protection.
