Cross-referenced drug submissions must still address listed patents – Federal Court

On December 19, 2014 Justice Gleason released her Judgment and Reasons in a judicial review application brought by Pfizer seeking to quash a marketing authorization granted to Teva for its generic exemestane tablets.

The judicial review flows from a 2012 Health Canada Guidance Document, dealing with administrative drug submissions where a second generic manufacturer licenses submission of a first generic manufacturer.  In such cases, where the first generic had already complied with its obligations under the PM(NOC)Regulations, the Guidance Document indicates that second generic is not required to re-engage the PM(NOC) Regulations:

When a manufacturer of a currently marketed drug licenses another manufacturer to sell the identical drug in Canada under a different name, the licensee is required to file an administrative drug submission and such a submission must be cross-referenced to the licensor’s drug submission. Under the previous requirements, drug manufacturers who submitted administrative drug submissions pursuant to a licensing agreement triggered the application of section 5 of the PM(NOC) Regulations.

While compliance with section 5 is appropriate for most new drug submissions approved on the basis of a direct or indirect comparison or reference to an innovative drug, such compliance becomes redundant, for example, in the case where an administrative drug submission is approved on the basis of a cross-reference to a previously submitted new drug submission (NDS) or ANDS, which in turn was approved on the basis of a direct or indirect comparison or reference to an innovative drug. Requiring a licensee, who seeks approval to sell the identical drug in Canada as that of the licensor under a different name, to re-address patents already addressed by the licensor in its submission is not specifically required under section 5 of the PM(NOC) Regulations.

Teva’s exemestane product

In August 2013, Generic Medical Partners (“GMP”) served a Notice of Allegation against Canadian Patent No. 2,409,059, the only patent listed against AROMASIN, Pfizer’s exemestane product. Pfizer did not commence a prohibition application against GMP and the Minister approved GMP’s exemestane on October 13, 2013. On the same day, the Minister of Health also issued a Notice of Compliance to Teva on the basis of Teva’s administrative ANDS cross-referencing GMP’s exemestane submission. Teva’s NOC identified Pfizer’s AROMASIN as the Canadian Reference Product.

Pfizer then brought a judicial review application challenging the Minister’s decision to issue the Teva NOC.

Standard of Review

A significant issue before Justice Gleason was the proper standard of review to be accorded to the Minister’s decision. In the late 1990s and early 2000s, in two cases involving the generic manufacture Nu-Pharm, the Federal Court of Appeal had held the proper standard of review for the Minister’s decision to issue a Notice of Compliance in analogous circumstances was correctness.

However, starting with its decision of in Dunsmuir, the Supreme Court of Canada has substantially reformulated the approach to determining the appropriate standard of review.  After an extensive review, including considering the divided jurisprudence of the Federal Court of Appeal and the post-Dunsmuir decisions of the Supreme Court of Canada, Justice Gleason held:

1. The presumptive application of the reasonableness standard applies to Ministerial interpretation of its constituent statute or regulations.
2. The 2014 decision of the Supreme Court of Canada in CN does not establish a fixed rule that Ministerial interpretation of its constituent statute are always to be subject to a reasonableness standard unless the decision falls within one of four exceptions enumerated in Dunsmuir.
3. pre-Dunsmuir considerations such as the presence or an absence of a privative clause, the purpose and expertise of the tribunal and the nature of  the question in issue, are relevant to the contextual analysis that may rebut the presumption that the reasonableness standard applies.
4. She was not bound to apply correctness standard in the Nu-Pharm cases as the standard of review jurisprudence had been overtaken by Dunsmuir and the subsequent cases of the Supreme Court of Canada.

Applying this jurisprudence, Justice Gleason held that the Minister’s decision to issue the Teva NOC was entitled to the presumptive reasonableness standard but also held that contextual pre-Dunsmuir considerations were sufficient to rebut this presumption. Accordingly, Justice Gleason applied the correctness standard for reviewing the Minister’s decision:

[120] I therefore conclude that the presumption of the applicability of the reasonableness standard of review is rebutted here and that the correctness standard is applicable to the review of Health Canada’s decision to issue an NOC to Teva and to the implicit interpretation of the PMNOC Regulations enshrined in that decision (that is fully enunciated in the amendments to the Guidance Document).

Minister’s decision was not correct

The main issue before Justice Gleason was whether Teva’s administrative ANDS was a “submission” that was caught by the PM(NOC) Regulations.  Justice Gleason agreed that the regulations must be purposively construed in light of the charging statutory authority contained in section 55.2 of the Patent Act, as set out by the Supreme Court of Canada in AstraZeneca and Biolyse.

Justice Gleason’s holding that Teva’s comparison to AROMASIN was the precise type of comparison held to fall within the PM(NOC) Regulations in Biolyse, led to her finding that Teva had been required to address the 059 Patent. Other jurisprudence holding that supplemental submissions filed by innovators to subvert the timing requirements of patent listing are not “submissions” under the PM(NOC) Regulations were found to be distinguishable.

In fact, Justice Gleason held that she was bound by decisions of the Court of Appeal in the Nu-Pharm matters that the PM(NOC) Regulations exist to require all generic companies who obtain their rights through a licence to address listed patents and did so despite the fact that in the Nu-Pharm matters, no company had had to address the PM(NOC) Regulations:

 [141] In both Nu-Pharm cases the generic company, just like Teva, had acquired the right to produce the drug in question under a licence from another generic company. In light of this and given the fact that the Court of Appeal did not limit its reasoning in these cases to the particular facts before it, I believe these cases are binding on me and apply to this case. Just like the generic companies in the Nu-Pharm cases, Teva has filed a submission that makes a direct or indirect comparison to AROMASIN and has filed a submission for an NOC. It therefore follows that the Minister was incorrect in issuing the NOC to Teva.

Accordingly, Justice Gleason set aside the NOC for Teva’s exemestane product.

Teva was represented by Aitken Klee LLP

A copy of Justice Gleason’s Judgment and Reasons may be found here.