On November 6, 2015, the Federal Court dismissed an application for judicial review of the Minister of Health’s decision to not issue a notice of compliance (NOC) for Hospira’s OXALIPLATIN FOR INJECTION pending expiry of the data protection term for ELOXATIN: Hospira Healthcare Corp v Canada (Health), 2015 FC 1205. Hospira’s new drug submission (NDS) was filed before Sanofi-Aventis’s NDS for ELOXATIN was filed. The Court found that the Minister was correct that post-filing amendments to an NDS can trigger data protection under the Food and Drug Regulations, s. C.08.004.1.
Direct comparison to Sanofi’s ELOXATIN in a post-filing NDS amendment. In 2006, Hospira and Sanofi each filed an NDS with the Minister, in October and November respectively, seeking approval to market oxaliplatin products. Sanofi’s NOC for ELOXATIN issued in 2007 and it was granted data protection until December 15, 2015. As previously reported, the Federal Court of Appeal confirmed that ELOXATIN was an “innovative drug”: Teva Canada Ltd v Canada (Health), 2012 FCA 106.
Hospira’s NDS was rejected by the Minister at the screening stage because it, unlike Sanofi’s NDS, contained no clinical data. As oxaliplatin was the standard of care for certain cancers, no further clinical trials could ethically be done. Although the Federal Court of Appeal ordered the NDS back to the Minister for a redetermination (2010 FCA 345), as previously reported, the Minister issued a notice of noncompliance (NON) in 2012. The NON identified chemistry, manufacturing and clinical issues, including noting that the literature references cited did not suffice to establish clinical safety and efficacy. In responding to the NON, Hospira indicated that the basis for its request for approval included the Summary Basis of Decision for ELOXATIN and the product monograph for ELOXATIN. On October 31, 2013, the Minister determined that an NOC could issue, but not until after the expiry of the market exclusivity period for ELOXATIN. Hospira applied for judicial review.
Hospira was accorded procedural fairness. The Court rejected the assertion that the Minister had a duty to inform Hospira that it was considering adopting an interpretation of the data protection provisions that would delay Hospira’s NOC. The Court found that it was clear from the combined wording of subsections C.08.004(1) and C.08.004.1(3) of the Regulations that comparison with an innovative drug could make the issuance of an NOC subject to the data protection provisions. Moreover, Hospira could not be prejudiced by the order in which the Minister dealt with (i) safety and efficacy and (ii) data protection, as the former was a prerequisite for marketing a new drug irrespective of the latter. The Court also found that Hospira had chosen not to take advantage of the full opportunity to be heard, as Hospira had refused the Minister’s offer to consider further written submissions on the October 31, 2013 decision.
Post-filing amendment to Hospira’s NDS correctly triggered data protection. The Court determined that the Minister’s interpretation of the data protection provisions of the Regulations was reviewable on a correctness standard for the reasons provided by Stratas J.A. in Takeda Canada Inc v Canada (Health), 2013 FCA 13, at paragraphs 26-30 (dissenting, but not on this point). However, the standard of review was not determinative, as the Court found the Minister’s interpretation to be both reasonable and correct.
The Court held that while subsection C.08.004.1(3) of the Regulations “is not sufficiently precise” and is “silent on post-filing amendments”, when cross-referenced to other provisions in section C.08.004, “it is clear that post-filing amendments are subject to the data protection prohibition imposed on the Minister”. In particular, subsection C.08.004(3) clearly stipulates that the issuance of an NOC after completing an examination of any additional information filed in respect of an NDS is subject to the data protection provisions. In the Court’s view, this conclusion was confirmed by the purpose of the data protection provisions, namely meeting Canada’s treaty obligations and its commitments to protecting innovators from unfair commercial use of undisclosed data.
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