Post-filing Amendments are Subject to Data Protection

In Hospira Healthcare Corporation v. The Minister of Health, Attorney General of Canada and Sanofi-aventis Canada Inc., Hospira was unsuccessful in its application for judicial review of a decision of the Minister refusing to issue a Notice of Compliance for its OXALIPLATIN FOR INJECTION product due the application of the data protection provisions of the Food and Drugs Regulations.


Oxaliplatin is a “standard of care” drug used for colorectal cancer for over 30 years. Since 1999, oxaliplatin has been available in Canada through the Special Access Program. Sanofi had not sought a NOC for the sale in Canada of its oxaliplatin product, ELOXATIN, until November 2006 when it filed its NDS. It received a priority status review and a NOC was issued in June 2007. ELOXATIN was added to the Register of Innovative Drugs and granted data protection for a term expiring on December 15, 2015.

ELOXATIN had no NOC and no term of data protection when Hospira filed its NDS in October 2006 for its own NOC. Further, ELOXATIN was listed on the Innovative Drug Register after Hospira filed its NDS.

In December 2006, Health Canada rejected Hospira’s NDS at a screening stage because it did not include pre-clinical or clinical data. Hospira brought a judicial review of the rejection that was initially dismissed, but on appeal was remanded back to the Minister for further consideration. In June 2011, Health Canada determined that Hospira’s NDS was acceptable for examination.

Post-filing Comparison

During the initial review, Health Canada issued a number of clarification requests to Hospira to expand on, add precision to or re-analyse existing information or data in the submission. Hospira responded but in March 2012, the Minister found the literature references in Hospira’s NDS insufficiently robust to establish the clinical safety and efficacy and rejected the submission.

Hospira ultimately satisfied the safety and efficacy requirements by making a comparison to ELOXATIN and referencing new information, including the Canadian product monograph for ELOXATIN. Hospira’s product was recommended for NOC approval but the data protection assessment had not yet been considered. A data protection assessment is undertaken after the safety and efficacy of a new drug has been demonstrated.

In October 2013, the Minister completed an examination of Hospira’s NDS and determined that the NOC could not issue until after the expiry of the market exclusivity period for ELOXATIN given the data protection provisions of subsection C.08.004.1(3) of the Food and Drug Regulations. Hospira declined to file written submissions regarding the Minister’s decision to reject the NDS and sought this judicial review instead.

Standard of Review

In considering the judicial review, Gagné J affirmed that the standard of review of the Minister’s interpretation of the data protection provisions is correctness. She affirmed that a reviewing Court must give attention to the text, context and purpose surrounding the provisions at issue.

Procedural Fairness

Gagné J concluded that the Minister did not breach procedural fairness by not informing Hospira earlier in the approval process that the data protection provisions would prevent the issuance of its NOC. In her view, the Minister did not have to advise Hospira that if it sought a NOC for a new drug on the basis of a direct or indirect comparison with an innovative drug, the issuance of that NOC could be subject to the data protection provisions, because that is clear from the combined wording of subsections C.08.004(1) and C.08.004.1(3).

The safety and efficacy assessment is a prerequisite for the marketing of that new drug in Canada, whether before or after the expiration of the data protection period. Hospira cannot argue that it was prejudiced by the order in which the different issues were dealt with by different departments of Health Canada. Gagné J noted that Hospira declined to take advantage of the full opportunity to be heard, as it omitted the reconsideration process that was available and instead sought this judicial review.

Post-filing amendments

Hospira argued before Gagné J that because it had initially filed its NDS prior to ELOXATIN being added to the Register of Innovative Drugs, that it was not caught by the data protection provision because section C.08.004.1(3) provides Health Canada authority to consider post-filing amendments. Since Hospira was not subject to the 6 year “no-file” period prescribed by C.08.004.1(3)(a), because it had filed it drug submission prior to Sanofi, it could not be subject to the “no approval” provisions prescribed by C.08.004.1(3)(b).

Gagné J noted that while subsection C.08.004.1(3) is silent on post-filing amendments, other provisions of C.08.004(3) clearly stipulate that an examination of the additional information filed is also subject to the data protection provisions:

[79] In my view, while I agree with the applicant that subsection C.08.004.1(3) is not sufficiently precise, I find that when its text is read by cross-reference to the other provisions found in section C.08.004, it is clear that post-filing amendments are subject to the data protection prohibition imposed on the Minister by paragraph (b) of subsection C.08.004.1(3).

[83] In my view, this conclusion is confirmed by the purpose behind the data protection provisions … In my view, the interpretation the applicant urges would run contrary to Canada’s NAFTA and TRIPS obligations and undercut its commitments to protecting innovators from unfair commercial use of undisclosed data, which took considerable effort to negotiate and implement.

Gagné J concluded that the Minister correctly interpreted subsection C.08.004.1(3) and accordingly dismissed Hospira’s judicial review application.

A copy Justice Gagné’s Reasons may be found here.