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ACCUPRIL impeachment action allowed to continue notwithstanding patent expiry

In 2003, Pfizer commenced a prohibition application under the Patented Medicines (Notice of Compliance) Regulations in respect of Canadian Patent Nos. 1,341, 330 and the 1,331,615 and Pfizer’s quinapril product, ACCURPIL.In 2005, Justice Heneghan dismissed the prohibition application finding that Pfizer had failed to establish that Apotex’s allegations of non-infringement of the 615 Patent and invalidity of the 330 Patent were not justified. In 2007, the Federal Court of Appeal allowed Pfizer’s appeal holding that Apotex’s allegation against both patents were unjustified. Apotex’s subsequent application for leave to appeal to the Supreme Court of Canada was dismissed

In August 2009, Apotex commenced an impeachment action seeking a declaration that the 330 and 616 Patents were invalid and would not be infringed. After the 615 Patent expired in August 2011, Warner-Lambert brought a motion seeking to dismiss the action in respect of the 615 Patent for mootness.  That motion was granted by Justice Lemieux in February 2012.  Apotex then appealled

Court of Appeal’s Judgment

The Court of Appeal, following Gilbert Surgical Supply Co. Ltd. and Gilbert v. Frank W. Horner Ltd. (1960), 34 C.P.R. 17, allowed Apotex appeal. While Apotex’ impeachment claim against the 615 Patent was moot, a determination of the validity of the 615 Patent would be relevant to Apotex’s rights that it intends to assert under the Statute of Monopolies:

[8]               Had the judge considered the effect on the appellant’s rights, in the light of the Statute of Monopolies and the decision of the Ontario Court of Appeal in Gilbert, he would, in our respectful opinion, have had to conclude that the appellant’s rights would be affected by a dismissal of its action and that it was appropriate, in the circumstances, to allow it to continue with the impeachment action of both the 330 and the 615 patents.

[9]               We are satisfied that the use of scarce judicial resources does not outweigh the effect of the dismissal of the applicant’s action on its rights arising under the Statute of Monopolies.

Having so held, the Court of Appeal held that it did not have to determine Apotex analogous argument under section 8 of the Patented Medicines (Notice of Compliance) Regulations.

A copy of the Court of Appeal’s Reasons for Judgment may be found here.


According to the recorded entries of the Federal Court Docket, the impeachment action settled and Apotex discontinued the underlying  action of February 15, 2013.