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ARTICLE · 23 NOVEMBER 2006

Canada Amends Regulations Governing Generic Drug Approval Process

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The Canadian government has announced substantial amendments to the Patented Medicines (Notice of Compliance) Regulations (the NOC Regulations) and the Food and Drug Regulations (the FD Regulations) that will significantly alter the nature of litigation between innovator and generic drug companies.

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Article by Anthony Prenol, © 2006, Blake, Cassels & Graydon LLP

Originally published in Blakes Bulletin on Intellectual Property, November 2006

The Canadian government has announced substantial amendments to the Patented Medicines (Notice of Compliance) Regulations (the NOC Regulations) and the Food and Drug Regulations (the FD Regulations) that will significantly alter the nature of litigation between innovator and generic drug companies.

Background

The NOC Regulations were initially implemented by the Canadian government in 1993, at the same time that the government abolished the specific compulsory licensing scheme that had been in place for patented pharmaceuticals for many years and also enacted an early-working exception.

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