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Pfizer Canada Inc. (“Pfizer”), brought an application for judicial review against The Minister of Health, The Attorney General of Canada and Teva Canada Limited (“Teva”)[1]. It was brought to set aside the decision made by the Minister of Health, which awarded an early Notice of Compliance (“NOC”) to Teva to market a generic version of a drug that Pfizer holds patent rights for under the Patented Medicines (Notice of Compliance) Regulations (“PMNOC Regulations”)[2].

Facts[]

In order to have an understanding of the legal arguments made, an explanation of the facts of the application is necessary and will assist in critically analyzing the judgment. The applicant, Pfizer, produces and sells the drug exemestane under the brand name AROMASIN, in Canada. The patent held against AROMASIN is listed on the Patent Register as 059 Patent, expiring in the year 2021. Generic Medical Partners Inc. (“GMP”), a generic drug manufacturer in the United States, filed an abbreviated new drug submission (“ANDS”) for an NOC with the Minister of Health to market its exemestane under the generic name. Health Canada received the ANDS and subsequently, issued an NOC for exemestane to GMP. Simultaneously, Teva filed an administrative drug submission with Health Canada to approve their proposal to market exemestane under the generic name and was issued an NOC. Pfizer heard that an NOC had been issued to GMP and Teva for exemestane. Pfizer brought an application for judicial review seeking to quash the NOC issued to Teva. Consequently, Health Canada informed GMP and Teva that they should not have been issued the NOCs, which were rescinded. Pfizer discontinued the judicial review application. Pfizer received a Notice of Allegation (“NOA”) from GMP against the 059 Patent but chose not to commence a prohibition against them, as GMP does not sell products in Canada. Following this, Health Canada issued a new NOC to GMP for exemestane. Further, after obtaining a licencing agreement with GMP, Teva, based on an administrative ANDS, applied for and received, an NOC from Health Canada.

Issues[]

The issues raised by the Federal Court on application for judicial review, extended and clarified administrative law in identifying the standard of review. The first issue for consideration is, the impact of the previous case law applying a correctness standard to the review of decisions of the Minister of Health under the PMNOC Regulations. More specifically, whether the correctness or reasonableness standard is to be applied to the review of the Minister of Health’s decision to award an NOC to Teva. The second issue in dispute is the impact of the identity of the decision maker, where the decision maker is the Minister of Health as opposed to an administrative tribunal. The final issue raised was on the impact of the decision of the Supreme Court of Canada in Canadian National Railway Co. v. Canada (Attorney General) (“CN”)[3], which is a recent authority on standard of review issues.

The Significance of Canadian Administrative Law[]

The Honourable Madam Justice Gleason, as well as any court in deciding on an application for judicial review, is to apply the two-step analytical framework as found in Dunsmuir v. New Brunswick (“Dunsmuir”)[4] to determine how much deference should be given to the Minister of Health. By asking the first question of the framework, it was concluded that previous case law did not satisfactorily settle the applicable standard of review and thus the presumption of reasonableness applies. There were no past cases that had decided the standard of review to be applied to this type of administrative decision. Therefore, the second question to ask is whether the presumption of reasonableness can be rebutted, which required the standard of review analysis set out in Dunsmuir. The Court applied four factors: (1) the presence or absence of a privative clause; (2) the purpose of the tribunal as determined by interpretation of enabling legislation; (3) the nature of the question at issue; and (4) the expertise of the tribunal.[5] After considering these factors, the conclusion is that the presumption of reasonableness is rebutted and the correctness standard of review is applied.

Decisions[]

The decision in question, was whether the ANDS Teva had filed based on a licensing agreement with GMP, was a proper submission for an NOC which compared its product to Pfizer’s drug AROMASIN, listed on the Patent List as 059 Patent under the PMNOC Regulations. The Court applied low deference to the review of the Minister of Health’s decision to issue Teva an NOC and to the interpretation of the PMNOC Regulations. According to Nu-Pharm cases[6], Teva had filed a submission for an NOC. Where the Minister of Health used discretion to issue an early NOC to Teva, section 7 of the PMNOC was not complied with. The Federal Court found that because Teva did not make a submission for an NOA to address the 059 Patent, under section 7 of the PMNOC, the Minister should not have issued Teva an NOC. The nature of the question at issue was an error in law. The Minister of Health had no particular expertise in legal interpretation in the PMNOC Regulations and there was nothing in it that suggested deference should be given to the Minister. Applying the correctness standard, the Court found the Minister’s decision was incorrect and the NOC issued to Teva was in breach of section 7 of the PMNOC Regulations. The application was granted and the decision was set aside.

Ratio[]

This application for judicial review raised issues of substantive review and was a concise representation of a thorough analysis applied when determining the standard of review. The reason for applying the standard of review is to assess the legality and consider the substance of the decision. Initially, it was difficult to understand the parties conflicting arguments and relate their reasoning to jurisprudence. Each side also had arguments that applied precedent which made it difficult to understand whose argument was stronger as both applied relevant case law that held merit.  However, once the judge applied the framework to the facts of the case, it was easier to understand the legal process used by the courts and adopted by case law, when faced with administrative decision-making issues.

Sources[]

[1] Pfizer Canada Inc. v. Canada (Attorney General), 2014 FC 1243

[2] Patented Medicines (Notice of Compliance) Regulations, SOR/93-133

[3] Canadian National Railway Co. v. Canada (Attorney General), 2014 SCC 40, [2014] 2 S.C.R. 135

[4] Dunsmuir v. New Brunswick, 2008 SCC 9, [2008] SCR 190

[5] Pfizer, supra at note 1

[6] Nu-Pharm Inc. v Canada (Attorney General), 1997 5135 FC, [1998] 7436 FCA, [1998] FCJ No 274 FCA

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