Federal Court Confirms: NOCs Based on Cross-referenced Generic Submissions Cannot be Issued without Compliance with Section 5 of the PM(NOC) Regulations

On January 9, 2015, the Federal Court released the decision of Justice Gleason in Pfizer Canada Inc. v. The Minister of Health et al, dated December 19, 2014. ¹ The proceeding was an application for judicial review of the Minister of Health’s (Minister) decision to issue a Notice of Compliance (NOC) to Teva for a generic version of Pfizer’s product, AROMASIN^® (exemestane). The decision was made in accordance with a Health Canada guidance document that permits a generic drug manufacturer who is seeking a NOC by way of a cross-reference to the regulatory submission of another generic NOC-holder to avoid first addressing the relevant patents listed by an innovator.² The Court’s decision confirms that a generic drug manufacturer seeking a NOC on this basis is still considered a “second person” for the purposes of section 5 of the Patented Medicines (Notice of Compliance) Regulations³ (Regulations) and, contrary to Health Canada’s guidance, is required to address any patents listed for the innovative product before it can receive a NOC.

The NOC at Issue

The NOC at issue in Pfizer was granted to Teva pursuant to a so-called "administrative" Abbreviated New Drug Submission (ANDS) that was based on an arrangement with another generic manufacturer who had submitted an ANDS making a comparison with the Pfizer product and who received a NOC after complying with the Regulations.⁴ In these types of cases, the first generic manufacturer will have filed a submission (such as an ANDS) subject to review by the Minister, and the second generic manufacturer’s submission for its NOC will merely consist of a statement that it will be selling the first generic’s product under a different name.⁵

The NOC was issued further to a recent amendment to a Health Canada guidance document relating to the Regulations. In the guidance document, Health Canada took the position that an administrative submission for a NOC by a generic manufacturer did not trigger the requirements of section 5 of the Regulations—i.e., that a person seeking a NOC on the basis of a direct or indirect comparison with, or reference to, an innovative product (a second person) must address the patents listed for that product.⁶ As such, under the guidance document, the mandatory language of section 7, which prevents the Minister from issuing a NOC to a second person unless and until the requirements of section 5 have been met, did not apply to these administrative ANDSs.

The Court’s Decision

Justice Gleason first addressed the appropriate standard of review. In her view, the Minister’s decision to issue the NOC to Teva inherently involved an interpretation of the Regulations.⁷ While previous decisions of the Federal Court had applied a standard of correctness to the Minister’s interpretation of the Regulations in this context, Justice Gleason held that the standard had not been determined since the Supreme Court’s decision in Dunsmuir.⁸ Accordingly, Justice Gleason reviewed the standard anew. She held that the appropriate standard was correctness, and that the interpretation of the Regulations was not something in which the Minister (or its delegates) ought to be afforded deference, as the Regulations did not provide the Minister any discretionary or policy-making powers and instead employed mandatory language about when a NOC could and could not be issued. The issue raised in the proceeding was held to be a matter of pure legal interpretation in which no deference was owed.⁹

Justice Gleason held that the correct interpretation of the Regulations prevented the Minister from issuing the NOC to Teva in these circumstances. Although Teva had filed an administrative submission relying on the work of another generic, GMP, Justice Gleason found that Teva was indeed making a direct or indirect comparison with the Pfizer product as the Canadian Reference Product. It therefore fell squarely within the language of subsection 5(1). It was irrelevant to subsection 5(1), in Justice Gleason’s view, whether Teva itself was actually “early working” Pfizer’s patents, or whether the comparison was made directly or indirectly via GMP’s submission.¹⁰

Ultimately, Justice Gleason held that the Minister, through its guidance, was incorrect in its interpretation of the Regulations and was not permitted to issue the NOC to Teva until the conditions set out in section 7 were met. As such, Justice Gleason ordered that the Minister’s decision be set aside.¹¹

Conclusion

The Court’s decision confirms that the Minister’s policy of treating these types of administrative ANDSs as exempt from compliance with the PM(NOC) Regulations is invalid and that NOCs issued pursuant to that policy can be set aside. Following the Court’s decision, generic manufacturers will be required to address listed patents regardless of whether they file their own independent ANDS or seek to rely on the submission of another generic manufacturer.

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¹ 2014 FC 1243 [Pfizer].

² Similar issues were raised in Actelion Pharmaceuticals Canada Inc. v. Canada (Attorney General) et al., Federal Court File No. T-1332-12 [Actelion]. The application was heard the day prior to the Pfizer proceeding. The release of Justice Gleason’s reasons in Actelion is pending.

³ SOR/93-133.

⁴ Typically, a second-entry pharmaceutical manufacturer who wishes to obtain marketing approval for a generic version of an innovative drug will file an ANDS, comparing the proposed generic product with another manufacturer’s (typically the innovator’s) approved drug product and establishing its bioequivalence. In the Pfizer case the first generic was Generic Medical Partners Inc. (GMP), who had filed an ANDS relating to the Pfizer product. See Pfizer at para. 46.

⁵ Pfizer at paras. 26-29.

⁶ See Pfizer at paras. 26-29, 33. This was a change from previous versions of the guidance document where such submissions were stated to trigger section 5.

⁷ Pfizer at paras. 54, 120.

⁸ Dunsmuir v. New Brunswick, 2008 SCC 9. The Supreme Court’s decision in Dunsmuir re-articulated the proper approach to determining the standard of review in judicial review of administrative decisions.

⁹ Pfizer at paras. 114, 116, 118-120.

¹⁰ Pfizer at paras. 56, 135, 137, 141, 144-145.

¹¹ Pfizer at para. 145.