Direct or indirect comparison: reliance on innovative drug data key to engaging data protection


15 August 2020 - The Federal Court recently issued its decision in Natco v Canada (Minister of Health), 2020 FC 788, providing useful guidance on the circumstances under which data protection under the Food and Drugs Regulations may be engaged. 

In particular, the Court commented on when the data protection provisions may be engaged in relation to subsequent products entering the market that contain the same medicinal ingredient as an innovative drug currently benefitting from active data protection.

A drug considered to be an "innovative drug" may be eligible for data protection under section C.08.004.1 of the Food and Drugs Regulations. An innovative drug is one that contains a medicinal ingredient not previously approved in Canada.

Data protection provides innovator manufacturers a prescribed period of market exclusivity from the date of the product's approval.

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Michael Wonder

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Michael Wonder