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Intellectual property — Patents — Medicines — Administrative law — Standard of review — Patented Medicines (Notice of Compliance) Regulations, SOR/93-133, s. 5(1) — Generic company filing new drug submission before patent issued on comparison drug — New drug submission nominated Hospira Healthcare Corporation as distributor of generic drug — Minister issuing notice of compliance to Hospira without requiring generic company to address patent — What criteria should inform the choice between reasonableness and correctness standards of review — What factors, if any, should widen or narrow the spectrum of defensible outcomes on a reasonableness standard of review — Is it in accordance with the law and in the public interest that generic drug companies be allowed to avoid addressing patents listed under the Patented Medicines (Notice of Compliance) Regulations?

In April 2012, Health Canada changed the Guidance Document: Patented Medicines (Notice of Compliance Regulations) so that submissions that do not require scientific review would be treated as administrative, would not have to comply with s. 5. On November 14, 2012, Celltrion Healthcare Co. Ltd. filed a new drug submission (“NDS”) seeking approval to market its subsequent entry biologic inflectra, which contained the medicinal ingredient infliximab 100 mg/vial in powder for solution dosage. In its NDS, Celltrion sought to demonstrate similarity between inflectra and remicade, for which Janssen Inc. had not yet received a patent. Celltrion’s NDS nominated Hospira to be the distributor for inflectra. On January 15, 2014, the Minister of Health issued a notice of compliance (“NOC”) to Hospira. Janssen sought judicial review of that decision.

Meanwhile, in Pfizer Canada Inc. v. Canada (Health), 2014 FC 1243, the Federal Court had decided that the Minster’s decision to issue a NOC in relation to an administrative ANDS without requiring the generic company to address the patent for the innovator’s drug was to be reviewed on a correctness standard, and that the decision was incorrect, so it set the Minister’s decision aside. Pfizer sought judicial review of that decision. On consent, and in order to allow the appeals to be heard together, the Federal Court set aside the decision to issue the NOC to Hospira, without prejudice to the right to appeal so that the parties could have the appeals heard together. Teva appealed the former decision (A-27-15), as did the Attorney General of Canada and the Minister of Health (A-28-15). Hospira appealed the latter decision (A-172-15), as did the Attorney General of Canada and the Minister of Health (A-143-15). Those two appeals were also consolidated. The Court of Appeal ordered that both consolidated appeals be heard together. It allowed the appeals, setting aside the judgment of the Federal Court and dismissing the applications for judicial review. Janssen and the Kennedy Trust apply for leave to appeal.