Nexium patent setback for AstraZeneca

Following an appeal by by German generics drugmaker Ratiopharm, the European Patent Office has ruled that one of Anglo-Swedish drug major AstraZeneca's substance patents for its gastrointestinal product Nexium (esomeprazole; EP 0652872) will be rejected, overturning an earlier decision.

Expressing disappointment at the news, AstraZeneca noted that the original expiry for this patent was 2014 and has confidence in the intellectual property portfolio of its product, which is the world's second best-selling drug, generating global revenues of $4.6 billion in 2005, $1.1 billion coming from Europe, saying it will defend and enforce its IP.

This portfolio includes process, method of use and additional substance patents with expiration dates ranging from 2009 through to 2019. In addition to these patents, Nexium has data exclusivity valid to 2010 in major European markets. Process patent (EP 0773940) is under dispute with the EPO and an Opposition Division oral hearing is scheduled for March 7.