Janssen Inc. v. Canada (Attorney General), 2021 FCA 137

Justice Mactavish; Justice Stratas; Justice Rennie - 2021-07-12

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The Minister of Health refused to grant data protection for Janssen Inc.’s SPRAVATO drug on the basis that it was not an “innovative drug” eligible for such protection. This was because SPRAVATO’s medicinal ingredient was a variant of a medicinal ingredient in a drug that had been previously approved by the Minister. ... Janssen asks us to revisit Takeda [2013 FCA 13], and to come to a different conclusion with respect to proper the interpretation of the regulation in issue. However, Janssen has not shown that the circumstances of this case would justify reconsideration of this Court’s decision in Takeda. Nor has Janssen shown that new evidence should be admitted on this appeal, or that the Federal Court erred in its application of the reasonableness standard of review to the remainder of the issues raised by Janssen. Consequently, I would dismiss the appeal.

Decision relates to:


Canadian Intellectual Property