• Court of Appeal Upholds Decision Relating to Sildenafil Use Patent
  • February 4, 2014
  • Law Firm: Borden Ladner Gervais LLP - Toronto Office
  • Pfizer Ireland Pharmaceuticals v. Apotex Inc., 2014 FCA 13
    Drug: VIAGRA® sildenafil

    In Apotex’ action for impeachment of the Pfizer patent relating to the use of sildenafil to treat erectile dysfunction, Apotex brought a motion for summary judgment, which was granted by the Court. This is an appeal of that decision.

    The Court of Appeal noted the litigation history of this patent, ending with a decision in a proceeding brought pursuant to the Patented Medicines (Notice of Compliance) Regulations (Regulations) by the Supreme Court of Canada (SCC) finding the patent invalid. This judgment was later amended by the SCC, resulting in the SCC dismissing the application for prohibition, instead of declaring the patent invalid.

    In respect of Apotex’ motion, brought and decided before the amendment by the SCC, the Court found that it was bound by the decision of the SCC finding the patent invalid because the disclosure is insufficient, even if the SCC ultimately amended the judgment. The Court of Appeal held that there was no error made by the Court in making this finding that warranted the intervention of the Court of Appeal.

    Pfizer argued that the construction by the Court in the previous proceeding was not determinative for all purposes because the proceeding was brought pursuant to the Regulations. The Court of Appeal agreed but held that Pfizer should have provided evidence with respect to the construction.

    The Court of Appeal considered the evidence that Pfizer adduced relating to testing that was done before the Canadian filing date and found “there is no disclosure that UK-114,542 was tested, and Pfizer has adduced no evidence that is capable of establishing that the skilled reader should have discerned from the specification that it was tested. Therefore, evidence that UK-114,542 was tested is not capable of established a genuine issue for trial on the question of the sufficiency of the disclosure.”