Drug Marketing Approval and Patents

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

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.

Purepac Pharmaceutical Company v. FDA, U.S District Court 1998

In this case, a United States district court ruled that successfully defending a patent infringement dispute is not a necessary requirement for a generic manufacturer to benefit from a 180-day exclusivity period. US law provides, under certain circumstances, a 180-day period of exclusivity to reward the first launch of a generic copy of an originator drug.

Case Summary