Case Description
This case dealt with the interpretation of the Canadian Food and Drug Regulations, subsection C.08.004.1(1) concerning data exclusivity protection. The Federal Court of Canada ruled that the five-year data protection to originator manufacturers is not triggered if the subsequent manufacturer, generally a generic manufacturer, can establish the safety and effectiveness of its product on the basis of bioequivalence or bioavailability studies without the Minister having to consult the confidential data filed by the innovator.
Decision Year
1998
Case Summary
Keywords
Jurisdiction