• Minister’s Decision to Grant NOA to Generic Company Set Aside, as the Generic did not Comply with the NOC Regulations
  • March 6, 2015 | Authors: Adrian J. Howard; Beverley Moore; Chantal Saunders
  • Law Firm: Borden Ladner Gervais LLP - Ottawa Office
  • Pfizer Canada Inc. v. Teva Canada Limited, 2014 FC 1243

    In this proceeding, Pfizer sought to judicially review the Minister of Health’s decision to grant Teva a NOC for exemestane. A company called GMP filed an ANDS for exemestane. However, it sent a NOA to Pfizer for atorvastatin. Health Canada issued a NOC to GMP for exemestane. Teva then filed an administrative ANDS seeking approval to market exemestane, and was granted a NOC.

    In this proceeding, Pfizer sought to judicially review the Minister of Health’s decision to grant Teva a NOC for exemestane. A company called GMP filed an ANDS for exemestane. However, it sent a NOA to Pfizer for atorvastatin. Health Canada issued a NOC to GMP for exemestane. Teva then filed an administrative ANDS seeking approval to market exemestane, and was granted a NOC.

    The Court held that the Minister’s decision must be reviewed on the basis of correctness. The Court held that the NOC Regulations exist not only to allow generic companies to early work patented medicines, but also to balance these interests with those of the patentee in obtaining protection for inventions that are legitimately patented. The Court held that Teva made exactly the sort of comparison contemplated by the NOC Regulations. Once the purpose of the NOC Regulations was understood, it supports the conclusion that Teva must comply with them. Thus, the application was granted and the Minister’s decision granting Teva a NOC was set aside.