EPO Announces Symbicort® European COPD Use Patent Decision

AstraZeneca today announced that the European Patent Office (EPO) Technical Board of Appeal has made a final ruling that the European Combination patent covering the use of Symbicort® (formoterol and budesonide) for the treatment of chronic obstructive pulmonary disease (COPD) (EPB1014993) has been revoked, following an appeal from generic manufacturers Norton Healthcare and Generics UK.

The EPB1014993 is one of two patents covering the Symbicort® combination (formoterol and budesonide) in the use of treatment for COPD in the United Kingdom, Austria, Belgium, Denmark, France, Germany, Greece, Ireland, Italy, Spain, Sweden, Switzerland, the Netherlands, Finland, Portugal, Liechtenstein, Luxemburg, Monaco, Cyprus, Latvia, Romania and Slovenia. The original patent expiration for this patent was 2018. The second of the two patents (EPB1210943) is currently under separate opposition.

“Symbicort is a strong brand and constitutes an important part of our growth potential for the coming years in Europe, where we have data exclusivity protection until August 2010,” said David Brennan, Chief Executive Officer of AstraZeneca.

AstraZeneca will continue to defend and enforce its remaining intellectual property rights protecting Symbicort®. This portfolio includes patents and applications for processes, formulations, delivery devices (M3 Turbuhaler) and use ‘as needed’ (Symbicort SMART®), with expiration dates up to 2019. In addition to these patents, Symbicort® retains data exclusivity until August 2010 in some European markets. On October 18, 2007 the EPO Technical Board of Appeal made a final ruling that the European Combination patent for Symbicort (EPB 0613371) was revoked.

Worldwide sales of Symbicort® reached $1.58 billion in 2007, with Europe accounting for $1.34 billion. SYMBICORT® is a trade mark of the AstraZeneca group of companies.