Bayer Inc. v. The Attorney General of Canada and the Minister of Health (1998), Federal Court of Canada, 84 C.P.R. (3d) 129

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