Earlier this week, Canada, the United States and Mexico reached
an agreement in principle on the successor to NAFTA, dubbed the
United States-Mexico-Canada Agreement (USMCA).1 For a
general overview of the USMCA, please see our commentary here.
In this post we highlight four important changes to intellectual
property rights.
- 10-Year Data Protection for
Biologics
Canada imposes an eight-year period of market exclusivity to
manufacturers of innovative drugs, during which a generic
manufacturer cannot obtain approval to market a generic version of
the innovative product. This period of market exclusivity is called
"data protection" because it protects undisclosed data
necessary to determine the safety and efficacy of the innovative
drug.