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The European Patent Office (EPO) has ruled that AstraZeneca’s European process patent for Nexium® (esomeprazole) is valid, despite opposition from German generic manufacturer Ratiopharm.
The patent was upheld as granted with regard to two claims but two others saw minor amendments.
The patent for Nexium covers a process for manufacturing esomeprazole and its salts in Austria, Belgium, Switzerland, Germany, Denmark, Spain, France, the UK, Greece, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Monaco, the Netherlands, Portugal, Slovenia and Sweden.
The EPO’s decision means that the patent in its amended form still covers the manufacturing process for Nexium, and it will not expire until 2015.
The portfolio includes additional patents with expiry dates ranging from 2009 to 2018. In addition to these patents, Nexium has data exclusivity valid until March 2010 in most major European markets.
The drug, a proton pump inhibitor, reduces the production of acid in the stomach. It is used to treat patients with gastro-oesophageal reflux disease and stomach ulcers.
In 2006, worldwide Nexium sales reached £2.5bn, with the European market worth £591m.
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