Federal Court Decides That Cross-Referenced Administrative Drug Submissions Must Address Listed Patents Under The PMNOC Regulations

On December 19, 2014, the Federal Court released the decision of Justice Gleason in Pfizer Canada Inc v Canada (AG), 2014 FC 1243 (Exemestane), an application for judicial review brought by brand drug manufacturer Pfizer Canada Inc (Pfizer) of a decision of the Minister of Health (Minister) to issue a Notice of Compliance (NOC) to generic drug manufacturer Teva Canada Ltd (Teva) for a generic version of Pfizer’s breast cancer drug AROMASIN® (exemestane).

Pfizer argued that the Minister’s decision to issue Teva the NOC should be overturned because Teva had not addressed Pfizer’s patent listing against AROMASIN® as required by the Patented Medicines (Notice of Compliance) Regulations (PMNOC Regulations). The Minister argued that the PMNOC Regulations were not triggered by Teva’s drug submission because it was an administrative drug submission cross-referenced to the abbreviated new drug submission of a third company, Generic Medical Partners Inc (GMP). GMP had (i) received a NOC for exemestane by serving Pfizer with a Notice of Allegation pursuant to section 5(1) of the PMNOC Regulations (Pfizer had declined to institute prohibition proceedings against GMP, resulting in the issuance of GMP’s NOC ) and (ii) licensed Teva to make the identical drug for which GMP had market authorization. The Minister relied on the April 2012 revision to the Health Canada Guidance Document on the PMNOC Regulations, which states that a cross-referenced drug submission does not trigger section 5(1) of the PMNOC Regulations.

The issue of standard of review was dealt with at length by Justice Gleason in her reasons. Justice Gleason held that a presumption of a reasonableness standard applies to decisions of the Minister to issue NOCs under thePMNOC Regulations, but the presumption can be rebutted based on “a contextual analysis if it demonstrates that the issue in question is not one that the legislature intended to leave to the decision-maker to determine because it falls more appropriately within the expertise of a reviewing court.” Justice Gleason found that the presumption was rebutted in this case and that a correctness standard applied. In the Court’s view, the most significant contextual factor in support of a correctness standard was that decisions of the Minister under the PMNOC Regulations are cast in mandatory terms and do not suggest any role for the Minister to exercise discretion or interpret the law based on policy.

Faced with the question of whether the Minister’s decision to issue Teva’s NOC in light of the PMNOC Regulations was correct at law, Justice Gleason determined that it was not. On a purposive construction of both the PMNOC Regulations and of section 55.2 of the Patent Act, which provides the regulation-making authority for the PMNOC Regulations, Justice Gleason held that Teva’s cross-referenced administrative submission must trigger thePMNOC Regulations in order to strike the required balance between the rights of innovators, generics, and the public that is the objective of the PMNOC Regulations. Consequently, the decision of the Minister to issue Teva’s NOC was set aside.

On December 19, 2014 the Federal Court also released the concurrent decision of Justice Gleason in Actelion Pharmaceuticals Canada Inc v Canada (AG), 2014 FC 1249 (Bosentan), a case dealing with similar facts toExemestane. Cobalt Pharmaceuticals Company (Cobalt) and Sandoz Canada Inc (Sandoz) had been issued NOCs by the Minister for generic versions of Actelion Pharmaceuticals Canada Inc’s (Actelion’s) TRACLEER® (bosentan) without engaging the PMNOC Regulations. As inExemestane, Cobalt and Sandoz received their NOCs from the Minister based on a licence from a third company, Pharmascience Inc, already in possession of a NOC for bosentan. For the same reasons as inExemestane, Justice Gleason declared that the decision of the Minister to issue NOCs to Cobalt and Sandoz was not consistent with the objective of the PMNOC Regulations and was incorrect at law. Of note, since the listed patent against TRACLEER® has now expired, the NOCs issued to Cobalt and Sandoz were not quashed.