Canadian court dismisses AstraZeneca's request for NOC relating to generic Nexium

The Federal Court of Canada has dismissed Anglo-Swedish drug major AstraZeneca's request to prohibit the nation's Minister of Health from issuing a Notice of Compliance (NOC) for the regulatory applications for a generic version of the firm's blockbuster gastro-intestinal drug Nexium (esomeprazole magnesium) submitted by local generics company Apotex.

As a result, says the London, UK-headquartered drugmaker, the Canadian Minister of Health is now free to issue an NOC to Apotex, if its regulatory submissions are in an approvable form, prior to the expiration of Nexium's Canadian patents.

In a Canadian proceeding seeking prohibition of an NOC, a presiding court does not rule on the validity of patents, and this decision has no bearing on cases in other jurisdictions. The proceedings, under the Patented Medicines Notice of Compliance Regulations, are summary in nature and involve no discovery process or witness testimony in court.