Federal Court Of Appeal Grants Minister Of Health The Right To Be Wrong

In a decision1 dated October 12, 2016, the Federal Court of Appeal upheld two decisions of the minister of health (the "minister") to issue Notice of Compliances ("NOCs") to generic drug manufacturers without addressing the requirements of the Patented Medicines (Notice of Compliance) Regulations (the "NOC Regulations"). Importantly, the Court of Appeal held that the minister's decisions were to be reviewed on a standard of reasonableness, unlike prior Supreme Court jurisprudence, which had applied a correctness standard to the minister. The Court of Appeal found both of the minister's decisions to be reasonable, overturning the Federal Court's finding that they were incorrect, and effectively granting the minister the right to be wrong.

Background of the cases: the two drug submissions at issue

This appeal involved two different NOCs for different products. The first NOC was obtained by Teva Canada for a generic version of the AROMASIN product marketed by Pfizer Canada. Teva had filed an abbreviated new drug submission ("ANDS") without any data establishing bioequivalence between its generic product and AROMASIN. Instead, Teva included a certification that its drug product was identical in all respects to a previously-approved generic version of AROMASIN. Teva did not serve a Notice of Allegation on Pfizer to address the patents listed on the Patent Register against AROMASIN. Nevertheless, the minister issued an NOC to Teva.

A second NOC was issued to Hospira Healthcare Corporation ("Hospira") for its generic version of the REMICADE product marketed by Janssen Inc. ("Janssen"). Unlike AROMASIN, REMICADE is a biologic. Generic versions of biologics are approved by filing an NDS demonstrating similarity to the reference biologic drug, rather than by filing an ANDS. Hospira's NDS however did not contain any data. Hospira instead certified that it had entered into a license agreement to take over the marketing of a previously-approved generic REMICADE product. The previous generic manufacturer would no longer market the drug. Hospira did not issue a NOA to Janssen to address the patents listed against REMICADE, yet still received an NOC.

Pfizer and Janssen filed separate judicial review applications relating to the minister's decisions to issue NOCs without addressing the listed patents listed against their respective drugs.

The underlying Federal Court decisions

Pfizer's application was heard and decided first.2 The Federal Court found that...