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news.Federal Court of Canada has rejected AstraZeneca's request to forbid the issuance of a notice of compliance (NOC) by the the Canadian Minister of Health for generic Esomeprazole magnesium submitted by Apotex.
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Canadian Minister of Health is now free to issue an NOC to Apotex, if their regulatory submissions are in an approvable form, prior to the expiration of Nexium’s Canadian patents.
AstraZeneca is reviewing the ruling, which relates to only one of Nexium’s Canadian patents, and estimating its options. AstraZeneca’s options include initiating a comprehensive patent infringement action. The company is expected to continue to vigorously defend its intellectual property for Nexium.
After receiving the court’s decision, Apotex must obtain an NOC or regulatory approval from the Minister of Health before being able tointroduce a generic Esomeprazole magnesium product in Canada.
AstraZeneca stated that any introduction prior to patent expiration would be ‘at-risk’ and subject to a patent infringement action by it. AstraZeneca has many patents protecting Nexium in Canada, including Canadian patent number 2139653 which is expected to expire between 2013 and 2019.