Generic manufacturers’ applications for a Notice of Compliance did not trigger notice requirements found in Patented Medicine (Notice of Compliance) Regulations

The Federal Court of Appeal allowed the appeals brought by generic drug manufacturers (Teva Canada Limited and Hospira Healthcare Corporation), the Minister of Health, and the Attorney General in respect of a decision from the Federal Court. The Federal Court had allowed applications for judicial review brought by Pfizer Canada Inc. and Janssen Inc. in respect of the Minister of Health’s decision to issue Notices of Compliance to Teva and Hospira.

Administrative law – Compliance with legislation – Correctness – Decisions of administrative tribunals – Intellectual property – Judicial Review – Ministerial orders – Patents – Reasonableness simpliciter – Standard of Review

Pfizer Canada Inc. v. Canada (Minister of Health), [2016] F.C.J. No. 1126, 2016 FCA 248, Federal Court of Appeal, October 12, 2016, E.R. Dawson, W.W. Webb and D.J. Rennie JJ.A.

The Minister of Health (the “Minister”) issued a Notice of Compliance (“NOC”) to Teva Canada Limited (“Teva”) for its generic version of exemestane tablets. Pfizer Canada Inc. (“Pfizer”) who markets exemestane tablets under the brand name AROMASIN, challenged the Minister’s decision to issue the NOC. A Federal Court judge applied a standard of correctness to the Minister’s decision, held the Minister’s decision was wrong, and set aside the NOC. Teva, the Minister, and the Attorney General appealed the Federal Court’s decision.

The Minister also issued a NOC to Hospira for its generic version of 100 mg/vial infliximab powder. Janssen Inc. markets infliximab under the brand name REMICADE. Janssen challenged the Minister’s decision to issue the NOC. By consent, the Federal Court set aside this NOC, without prejudice to the parties’ rights to appeal. Hospira, the Minister, and the Attorney General appealed the Federal Court’s decision.

The Court of Appeal reviewed the background to the creation of the “early working exception” set out in 55.2(1) of the Patent Act. This exception allows a person to use a patented invention (while the relevant patent is in force) for the sole purpose of obtaining regulatory approval to sell a product equivalent to the patented product on the expiry of the relevant patent. This exception eliminated the lengthy time delay between the expiry of a patent and the date when a generic manufacturer could obtain a NOC.

The Court of Appeal reviewed the content of the Patented Medicine (Notice of Compliance) Regulations (the “Regulations”) which were enacted at the same time as the “early working exception”. The Regulations provide for a mechanism by which a patent holder can delay the entry of a generic version of its patented drug onto the market. The patent has to meet certain criteria for the Minister to require the generic manufacturer to notify the original patent holder and meet certain criteria to obtain a NOC.

In this case, the Minister had decided the generic manufacturers’ applications for a NOC did not trigger the notice requirements in section 5 of the Regulations.

The Court of Appeal considered next the applicable standard of review for the Minister’s decisions. The Court of Appeal held that previous decisions did not satisfactorily determine the standard of review for the Minister’s decisions. The Court of Appeal held the question of whether a drug submission triggers section 5 of the Regulations is a question of mixed fact and law. The applicable standard of review is reasonableness, not correctness.

The Court of Appeal then considered whether the Minister’s decisions were unreasonable. The Court of Appeal held the Minister’s decisions were reasonable. The Court commented that it was still open to Pfizer and Janssen to pursue actions for patent infringement against the generic manufacturers.

The Court of Appeal allowed the appeals and set aside the judgments of the Federal Court, with costs, to be paid by Pfizer and Janssen.

This case was digested by Scott J. Marcinkow of Harper Grey LLP. If you would like to discuss this case further, please feel free to contact him directly at smarcinkow@harpergrey.com or review his biography at http://www.harpergrey.com.

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