Thursday, November 24, 2011

No Vested Right to an NOC

Apotex Inc v Canada (Health)/ Apo-Omeprazole 2011 FC 1308, Barnes J

In March 2003 the Therapeutic Products Directorate advised Apotex that the examination of Apo-Omeprazole had been completed but Apotex’s application for a NOC was on patent hold. In the fall of 2009 the TPD revoked the approval status on the basis that the bioequivalence study filed by Apotex with its ANDS had not been appropriately conducted. The TPD refused to reconsider this decision (for a review of the facts see 2010 FC 1310, [3], a motion to strike on this application). Apotex challenged the TPD’s decisions by way of this application, which was dismissed as untimely under the Federal Courts Act s 18.1(2). On the only substantive point that was discussed, Barnes J held that there can be no vested right to an NOC:

[33] There is no legal significance attaching to an application for a NOC that has been placed on patent hold. The Minister is fully entitled to revisit scientific issues at any point in the process up to the actual issuance of a NOC. It is only at that point that the Minister’s examination is completed in accordance with C.08.004 of the Food and Drug Regulations, RSC 1985, c F-27. Indeed, given the lengthy delays that can arise, the Minister would be remiss if such applications were approved at the expiry of the patent hold period without further scrutiny.

This conclusion strikes me as neither surprising nor controversial.

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