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 notice of compliance pursuant to the Data Protection Regulations (C.08.004.1) 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 that innovators should monitor 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) based on a comparison with an “innovative drug”. Once the generic’s submission has been filed, the minister is prohibited from issuing a notice of compliance 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 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 seeking a notice of compliance 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, which, by its nature, compares the generic drug with the innovative drug. The abbreviated new drug submission 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 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 new drug submission, 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 notice of compliance 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 recognise 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”. The prothonotary applied the test under Section 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.

The prothonotary found that, assuming that 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 a notice of compliance 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.

Christopher C Van Barr

This article first appeared in IAM magazine. For further information please visit www.iam-magazine.com.