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Administrative law - Judicial review - Courts - Federal Court - Jurisdiction - Whether the Federal Court of Appeal was correct in declaring that in the absence of a valid notice of compliance, no one could sell or advertise Nu-Enalapril, and that in making his decision known to the Appellant and others, the Director General was exercising powers conferred by an Act of Parliament - Whether the Federal Court of Appeal was correct in determining that the issue of the validity or lawfulness of the decisions could not be determined in an action, but must be determined through a judicial review application in the Federal Court - Whether the Federal Court of Appeal was correct in determining that the action in the amended statement of claim was a collateral attack on the decisions.

The Appellant Nu-Pharm is a generic drug manufacturer that in 1997 filed an abbreviated new drug submission (ANDS) for Nu-Enalapril, comparing its product to Apo-Enalapril, itself a generic version of Merck’s Vasotec. Health Canada refused to review Nu-Pharm’s ANDS because it had not made its comparison to a valid Canadian Reference Product. On judicial review, this decision was quashed and Nu-Pharm obtained a notice of compliance (“NOC”) to market its product. Shortly after, Merck obtained an order quashing the Minister’s decision and this decision was upheld on appeal. Following the Court of Appeal judgment, the Director General at Health Canada sent letters to the Provincial Drug Benefit Managers, advising them that Nu-Pharm’s NOC was no longer valid and that Nu-Enalapril could not be sold or advertised. In April 2000, Nu-Pharm sent a letter to the Director-General, alleging that it did not require a NOC in order to market Nu-Enalapril because it was no longer a new drug. The Director General did not agree with this submission and maintained that a NOC was required. In February 2001, Nu-Pharm sought judicial review of that decision and a declaration that the Minister had no authority to state that the sale of Nu-Enalapril would contravene the Food and Drug Regulations, that the Minister was acting unlawfully in treating it as a new drug, and requiring the Minister to retract all statements that the sale of the drug would be unlawful. In February 2002, Nu-Pharm filed a statement of claim, claiming damages against the Crown as compensation for the profits it would have otherwise earned by marketing Nu-Enalapril. When Merck was granted leave to intervene, Nu-Pharm filed a notice of discontinuance in the judicial review application. The Minister then brought a motion for summary judgment on the ground that Nu-Pharm’s entire claim was contingent on a finding that the Director General’s decisions were unlawful, a determination that could only be made on judicial review.