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.

Pfizer started a proceeding seeking to quash the NOC issued to Teva. GMP sent a letter to Health Canada indicating that it had sent the wrong NOA to Pfizer. Health Canada informed GMP and Teva that the NOCs would be rescinded and Pfizer discontinued its judicial  review.

GMP sent a NOA to Pfizer with respect to exemestane. Pfizer did not start a proceeding, as GMP does not sell products in Canada. GMP was issued a new NOC. Teva was also issued a new NOC. Health Canada’s records indicate that Teva filed an administrative ANDS, based on a licensing agreement with GMP and Health Canada determined that Pfizer’s AROMASIN exemestane product was the reference product for Teva’s exemestane product. Pfizer started the within judicial review.

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.