Victor Paolone

The applicant sought judicial review of the Minister of Health's decision that SPRAVATO (esketamine hydrochloride) was not an "innovative drug" under the Food and Drug Regulations and thus not entitled to data protection.

The applicant argued the definition should be reinterpreted in light of CUSMA.

The Federal Court dismissed the application, finding the Minister reasonably interpreted the Regulations, which expressly exclude enantiomers of previously approved drugs.

The Court also upheld the Minister's finding that data protection eligibility is appropriately determined at the time a Notice of Compliance is issued.

The Respondent brought a motion to strike three affidavits filed by the Applicant in an underlying application for judicial review of a redetermination decision of the Patented Medicine Prices Review Board.

The Court granted the motion in part, striking the affidavit of the Applicant's patent expert in full and portions of a regulatory expert affidavit on the basis that they provided improper opinion evidence that sought to argue against the merits of the tribunal's decision.

The Court allowed a fact witness affidavit to stand as it provided non-controversial background information.