The United States Court of Appeals affirmed the district court’s decision, holding that AstraZeneca’s labeling change of its antipsychotic medication Seroquel was not entitled to an additional period of market exclusivity.

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.

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.