Federal Court of Canada Rules on Applications for Generic Esomeprazole Magnesium

Thursday, 17 June 2010

AstraZeneca today announced that the Federal Court of Canada has dismissed AstraZeneca's request to prohibit the Canadian Minister of Health from issuing a Notice of Compliance (NOC) for the regulatory applications for generic esomeprazole magnesium submitted by Apotex Inc. As a result, the 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.

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.

AstraZeneca is reviewing the ruling, which relates to only one of NEXIUM’s Canadian patents, and evaluating its options. AstraZeneca’s options include initiating a comprehensive patent infringement action. The company will 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 to launch a generic esomeprazole magnesium product in Canada. Any launch prior to patent expiration would be ‘at-risk’ and subject to a patent infringement action by AstraZeneca. AstraZeneca has many patents protecting NEXIUM in Canada, including Canadian patent number 2139653. AstraZeneca’s patents protecting NEXIUM in Canada expire between 2013 and 2019.

NEXIUM sales in Canada in 2009 were $217 million (USD). In the event of a near term ‘at risk’ launch of generic esomeprazole magnesium in Canada the company does not expect to alter its 2010 Core EPS guidance range of $6.05-$6.35.


About AstraZeneca

AstraZeneca is a global, innovation-driven biopharmaceutical business with a primary focus on the discovery, development and commercialisation of prescription medicines. As a leader in gastrointestinal, cardiovascular, neuroscience, respiratory and inflammation, oncology and infectious disease medicines, AstraZeneca generated global revenues of US $32.8 billion in 2009. For more information please visit: www.astrazeneca.com


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