EPO Hearing for Symbicort
AstraZeneca PLC
18 October 2007
EPO Announces Symbicort(R) European Combination
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 for
Symbicort(R) (formoterol and budesonide) (EPB0613371) has been revoked,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(R) 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(R)
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 U.S. and
Japan,' said David Brennan, CEO of AstraZeneca. 'We do not believe that the EPO
decision will have an immediate impact in the EU or any impact on the U.S. or
Japanese patents. In fact, with the recent launch of Symbicort SMART(R) 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.'
AstraZeneca will continue to defend and enforce its remaining intellectual
property rights protecting Symbicort(R). 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(R) 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(R)
for COPD and are currently under appeal and opposition respectively.
Worldwide sales of Symbicort(R) reached $1.18 billion in 2006, with Europe
accounting for $1.02 billion.
18 October 2007
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