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9 March 2005
EPO RULES SYMBICORT® COMBINATION PATENT STILL VALID

AstraZeneca today announced that the European Patent Office (EPO) has ruled that the European combination patent for Symbicort® is still valid, despite a challenge by several generic manufacturers.
This positive decision means that there will be no change in the validity of the patent for Symbicort, covering the combination of formoterol and budesonide in Austria, Belgium, Denmark, France, Germany, Greece, Ireland, Italy, Liechtenstein, Luxemburg, Monaco, the Netherlands, Portugal, Spain, Sweden, Switzerland and the United Kingdom.

AstraZeneca has a comprehensive intellectual property portfolio including both patents and data exclusivity for Symbicort. Most major European markets have data protection until 2010. No generic manufacturer can launch an equivalent product until AstraZeneca’s data exclusivity has expired or the generic company has submitted its own regulatory package, utilising its own clinical data. The European combination patent expires in 2012 with extension by SPC (supplementary protection certificate) to 2015 in some countries.

The US and other markets in Europe and rest of the world have different patent laws and enforcement systems and AstraZeneca will enforce its intellectual property as appropriate in those jurisdictions. Symbicort is a treatment for asthma and Chronic Obstructive Pulmonary Disease (COPD). The worldwide sales reached $797 million in 2004. Europe accounted for $701 million.



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