Post-Filing Amendments to Drug Submissions Can Trigger Data Protection

In a recent ruling, the Federal Court held that generic drug manufacturers cannot entirely avoid the application of “data protection” by initially filing a new drug submission that does not make a comparison to an "innovative drug," and adding comparison information in a post-filing amendment.¹

What You Need To Know

• Under the Food and Drug Regulations, there are two data protection prohibitions:
• a generic may not file a new drug submission that makes a direct or indirect comparison to an "innovative drug" that enjoys data protection for a period of six years from the date the innovative drug was approved for sale in Canada; and
• a generic drug may not be approved for sale in Canada on the basis of a direct or indirect comparison to an "innovative drug" for a period of eight years from the date the innovative drug was approved for sale in Canada.
• In this case, Hospira filed a new drug submission that initially did not refer to an "innovative drug," but in the course of regulatory review, post-filing amendments to the submission included a direct comparison to an "innovative drug"
• The Federal Court held that although the initial submission was not caught by the first "no-file" prohibition, the post-filing amendments are subject to the second "no-approval" prohibition.

This case concerns the drug Eloxatin/oxalaplatin, which is marketed in Canada by Sanofi-Aventis Canada Inc. While oxaliplatin has been used in the treatment of colorectal cancer for over 30 years, it had never received marketing authorization in Canada, and was available in Canada only through the Special Access Program of Health Canada, which allows pre-approval access on a case-by-case basis to needed drugs.

In 2006, Hospira filed a new drug submission to oxalaplatin, which did not include any pre-clinical or clinical trial data, only literature references and post-marketing experience reports. This was necessary, as Hospira did not have access to the clinical trial data for Eloxatin, and it would be unethical to perform clinical trials to measure the efficacy of a "standard of care" treatment. Shortly afterwards, Sanofi-Aventis also filed a new drug submission for Eloxatin, which included clinical trial data.

The Sanofi-Aventis submission was approved first, and Eloxatin was held to be an "innovative drug," entitled to data protection. In response to Health Canada requests and rulings, Hospira eventually submitted information that was found in the approved Eloxatin product monograph. As a result of this information being included in Hospira’s submission, Health Canada held that Hospira’s submission could not be approved until the expiry of the data protection for Eloxatin. Hospira applied to the Federal Court for judicial review of Health Canada’s application of the data protection regulations.

Before the Federal Court, Hospira argued that the Hospira submission was not subject to the "no-file" prohibition as it was filed before Eloxatin was listed as an "innovative drug," and therefore the "no-approval" prohibition also did not apply. The Federal Court held that the two prohibitions were independent, and therefore a submission that did not initially make a comparison to an "innovative drug" (avoiding the "no-file" prohibition) could later be subject to the "no-approval" prohibition if a post-filing amendment included a comparison to an "innovative drug."

This ruling makes clear that generic manufacturers cannot circumvent the data protection regulations by filing an initial submission free of comparisons or references to an "innovative drug," and adding such information in a post-filing amendment at the behest of Health Canada.

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¹ Hospira Healthcare Corporation v Canada (Health), 2015 FC 1215.

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