AstraZeneca announced that the European Patent Office (EPO) Technical Board of Appeal has made a final ruling that the European Combination patent for Symbicort (formoterol and budesonide) (EPB0613371) has been revoked, following an appeal from a group of generic manufacturers: Liconsa, Miat, Generics UK and Norton Healthcare; but parties to the proceedings are also the additional opponents (Chiesi Farmaceutici SpA, Zambon Group SpA, Yamanouchi Europe B.V.).
The EPB0613371 patent covers the Symbicort combination (formoterol and budesonide) and use thereof in asthma treatment in Austria, Belgium, Denmark, France, Germany, Greece, Ireland, Italy, Liechtenstein, Luxemburg, Monaco, the Netherlands, Portugal, Spain, Sweden, Switzerland and the United Kingdom. The original patent expiry for this patent was 2012 with extension by Supplementary Protection Certificate (SPC) to August 2015 in most European countries.
"Although we are clearly disappointed with today's EPO decision, Symbicort will remain an important part of our growth potential over the next few years in Europe and over the long term in other major markets, including the US and Japan We do not believe that the EPO decision will have an immediate impact in the EU or any impact on the US or Japanese patents. In fact, with the recent launch of Symbicort SMART in Europe, we have a tremendous opportunity to transform the way asthma is managed, providing patients and physicians with important new options in controlling asthma," said David Brennan, CEO, 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 (Turbuhaler), use in COPD and use 'as needed' (Symbicort SMART), with expiration dates up to 2019. In addition to these patents, Symbicort has data exclusivity valid until at least August 2010 in most major European markets.
Two granted patents (EPB1014993 and EPB 1210943) cover the use of Symbicort for COPD and are currently under appeal and opposition respectively. Worldwide sales of Symbicort reached $1.18 billion in 2006, with Europe accounting for $1.02 billion.