Canada: Federal Court Affirms Standing For Innovative Drug Manufacturer

Last Updated: April 29 2014
Article by Christopher C. Van Barr and James Holtom

Most Read Contributor in Canada, October 2018

What rights do innovative drug manufacturers have in situations where generics challenge certain Health Canada decisions but do not name the innovators as parties?

On February 26, 2014, in Hospira Healthcare Corporation v. Canada (Health), 2014 FC 179, Prothonotary Tabib held that an "innovative drug" manufacturer has standing to appear on a generic's application for judicial review of the Minister of Health's decision to withhold the generic's NOC pursuant to C.08.004.1 (the Data Protection Regulations) of the Food and Drug Regulations, CRC 870. On March 11, 2014, Justice Mactavish dismissed Hospira's appeal and upheld the Prothonotary's decision, 2014 FC 235.

This case highlights an important point for innovators: innovators should monitor the judicial review proceedings at the Federal Court for proceedings implicating their rights. Without quick action, innovators may miss out on opportunities to make representations to the Court concerning their valuable interests.

Under the Data Protection Regulations, a generic is prohibited from filing a drug submission for a period of six years where the generic seeks marketing approval (a Notice of Compliance or NOC) based on a comparison with an "innovative drug". Once the generic's submission is filed, the Minister is prohibited from issuing a NOC for a further two years, or two years plus six months in cases where the innovator submitted test data in paediatric populations.

"Innovative drugs" are a special class of drugs, defined in the Data Protection Regulations and by the case law, which contain medicinal ingredients that have not been previously marketed in Canada.

Sanofi manufactured and sold the drug ELOXATIN, which contained the active ingredient oxaliplatin, a platinum-based antineoplastic agent, indicated for the treatment of colorectal cancer. On June 15, 2007, the Minister of Health granted ELOXATIN "innovative drug" status, protecting it against generic comparison under the Data Protection Regulations.

On October 27, 2006, before ELOXATIN was granted "innovative drug" status, Hospira filed a New Drug Submission (NDS) seeking a NOC for a drug containing "Chemical Entity A", which Hospira would neither confirm nor deny was, in fact, oxaliplatin.

The usual course for generics is to file an Abbreviated New Drug Submission (ANDS), which, by its nature, compares the generic drug with the innovative drug. The ANDS represents that the generic and innovative drugs are bioequivalent such that the Minister should rely on the safety and efficacy data submitted in the innovator's New Drug Submission (NDS) to approve the generic version. In such a case, the Data Protection Regulations are automatically implicated.

In this unusual case, it appears that Hospira's submission was a NDS, which itself contained safety and efficacy data required for the Minister to approve the drug. Frequently, when processing a submission, the Minister will have questions about the drug product and will direct those questions to the applicant. In answer to one such question, Hospira referred to the ELOXATIN Product Monograph, which had by then been granted "innovative drug" status.

The Minister considered this reference to be a comparison to ELOXATIN and refused to issue a NOC until the end of the data protection period. Hospira applied for judicial review of the Minister's decision and Sanofi, aware of the application, moved to amend the style of cause to recognize it as a proper respondent.

Section 18.1 of the Federal Courts Act states that an application for judicial review may be made "by anyone directly affected by the matter in respect of which relief is sought." Prothonotary Tabib applied the test under s 18.1 as most recently stated in Forest Ethics Advocacy Assn. v. Canada (National Energy Board), 2013 FCA 236 at para. 20: "A party has a 'direct interest' under subsection 18.1(1) of the Federal Courts Act when its legal rights are affected, legal obligations are imposed on it, or it is prejudicially affected in some direct way."

Prothonotary Tabib found that, assuming "Chemical Entity A" is oxaliplatin, it was "clear that an order reversing the Minister's determination that the data protection regime was engaged and ordering the issuance of an NOC to Hospira would prejudicially affect Sanofi in a direct way". Accordingly, she held that Sanofi was a proper respondent to the proceeding. Had Sanofi not become aware of Hospira's application for judicial review, its rights may have been prejudiced without any ability to make representations before the Court.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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