Data Protection Provisions Block Post-Filing NDS Amendments for Generic Drug

Data Protection Provisions Block Post-Filing NDS Amendments for Generic Drug

Hospira Healthcare Corporation v Canada (Health), 2015 FC 1205

Normally, when a drug company seeks approval to sell a generic drug in Canada, the applicant cannot rely on a comparison of the generic drug to an existing similar drug unless the existing drug has been approved for a certain length of time. Known as “data protection” provisions, these rules are meant to incentivize investment in the development of new drugs by slowing the entry of generics into the market. [73, 83] In this Federal Court case, a quirk in the rules was resolved that could make the entry of generics into the market even slower if the generic tries to make post-filing amendments to its application.


The traditionally generic company Hospira was developing an alternative to Oxaliplatin, the current standard of care treatment for colorectal cancer. [15] Dubbed OXALIPLATIN FOR INJECTION, Hospira sought regulatory approval to sell the drug in Canada through consultation with Health Canada from 2004 to 2006, and ultimately filed a New Drug Submission in October of 2006. [14] However, since Oxaliplatin was the current standard of care, Hospira could not ethically run clinical trials comparing OXALIPLATIN FOR INJECTION to Oxaliplatin. [15] Thus, Hospira decided to compare OXALIPLATIN FOR INJECTION to a newer drug, ELOXATIN, which at that time was currently being developed by the innovator company Sanofi, and had only been filed as recently as late November of 2006, one month after the Hospira application. [15] Hospira made a post-filing amendment to its application to make the comparison to Oxaliplatin.

Even though the Hospira application was filed first, it was blocked by Health Canada and the data protection provisions protecting Eloxatin. [40, 64]

Data Protection Provisions

According to C.08.0014.1(3) of the Food and Drug Regulations, an application comparing a proposed new drug to an existing drug cannot be filed until 6 years after the existing drug was approved, and the application cannot be approved until 8 years after the existing drug was approved. [12] The issue in this case was whether or not the data protection provisions apply to the applicant’s request for a NOC for OXALIPLATIN FOR INJECTION. [76]

Hospira argued that “[t]he applicant clearly did not ‘seek’ a NOC [approval] on the basis of a comparison with an innovative drug. Post-filing amendments do not fall within the scope of subsection C.08.004.1(3).” [65] And since Hospira filed its New Drug Submission before Eloxatin, it was clear of the 6-year filing bar, and argued that must also be free of the 8-year bar against having its application approved. [67]

The Minister of Health disagreed. The Minister argued that the 6-year filing bar and the 8-year approval bar are separate, and that Hospira was still caught by the 8-year approval bar. [69]

The Federal Court sided with the Minister, writing that “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),” [79] thus upholding the application of the 8-year approval bar.

The Federal Court thought this result to be consistent with the purpose behind the data protection provisions, which it agrees is to protect undisclosed data generated by an innovative manufacturer from unfair use, thus providing an incentive for the development of new drugs. [73, 83]