Tuesday, December 23, 2008

Court denies data protection: first test of new Food and Drug regulations

An article by Alison Lester

The Federal Court determined that EBIXA was not entitled to data protection because it received marketing approval in 2004 and refused to prevent two generic companies from comparing products to EBIXA for the purpose of obtaining regulatory approval.

On December 16, 2008, Justice Lemieux dismissed proceedings brought by Lundbeck Canada Inc. against ratiopharm Inc. and Cobalt Pharmaceuticals Inc (2008 FC 1379).

Both ratiopharm and Cobalt are seeking regulatory approval (i.e., receipt of a Notice of Compliance, or NOC) of memantine hydrochloride products. In their regulatory submissions, both ratiopharm and Cobalt compared their memantine hydrochloride products to EBIXA, which is currently marketed in Canada by Lundbeck Canada Inc. pursuant to a NOC with conditions obtained in 2004.

Lundbeck argued that because its NOC is subject by Health Canada to certain conditions, EBIXA cannot be used as a reference product in any generic regulatory submission. Furthermore, Lundbeck argued that EBIXA should be entitled to data protection once the conditions are removed from its NOC.

The court rejected Lundbeck’s argument, holding that there is no difference between a NOC and a NOC with conditions because under the Food and Drugs Act Lundbeck cannot market its product at all without a NOC. The court concluded that the NOC with conditions is a term coined for administrative convenience and has no legal effect. Accordingly, EBIXA is an appropriate reference product for generic submissions.

The court went on to reject Lundbeck’s attempt to secure data protection for EBIXA, finding that the old data protection regime continues to apply to a product that obtained a NOC before June 17, 2006, regardless of any conditions placed on the NOC.

The court also based its decision on two technical grounds. Firstly, that a brand company has no standing to challenge the regulatory review of a generic company’s product or the Minister’s application of the data protection provisions during the course of that review.

Secondly, the court determined that the Minister’s decision to accept ratiopharm and Cobalt’s regulatory submissions for review was an interlocutory decision and therefore not subject to judicial review.

Alison Lester
Gilbert’s LLP

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