Drug: amlodipine besylate
In 2006, the Federal Court of Appeal allowed an appeal from a decision of the Federal Court and issued an Order of prohibition (prohibition Order) preventing the Minister of Health from issuing a Notice of Compliance until expiry of the patent. The decision of the Federal Court can be found here. ratiopharm brought this motion pursuant to Rule 399 of the Federal Courts Rules, to set aside the Order of the Court of Appeal.
The motion was brought under Rule 399(2)(a) and (b), arguing a matter that was discovered subsequent to the making of the prohibition Order and because the prohibition Order was obtained by fraud. The basis for the motion was the decision by the Federal Court, and affirmed by the Court of Appeal, wherein Pfizer’s patent was found to be invalid in an impeachment action. ratiopharm highlighted in its motion materials that it will be entitled to seek compensation pursuant to Section 8 of the NOC Regulations if the prohibition Order is set aside.
The Court agreed with Pfizer that the appeal is moot with respect to a determination that a new matter has been discovered. However, the Court of Appeal agreed with ratiopharm that the motion is not moot with respect to the allegation of fraud. Specifically, the Court of Appeal noted that the principle of finality does not apply when the judgment is obtained by fraud.
The Court found that the subsequent finding of invalidity in the impeachment action is not a new matter and accordingly does not provide a basis upon which the prohibition Order should be set aside. With respect to the allegation that the prohibition Order was obtained on the basis of fraud, the Court noted that the fraud must be material and in order to be material, it must have been committed in the proceeding in which the prohibition Order sought be set aside was rendered. The Court held that no perjured evidence and no forged documents were filed in the NOC proceedings; nor was there anything that indicated an intention to mislead. Furthermore, the Court held that the NOC proceeding was not an adjudication of the validity of the patent, and merely gave effect to the presumption of the validity of the patent.
Thus, the Court dismissed the motion to set aside the prohibition Order, holding that there was nothing on the record that showed the prohibition Order to have been induced by or resulting from the misrepresentations later found in the impeachment proceedings to have been made to obtain the patent.