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WEEKLY NEWS - MAY 06, 2008

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EPO revokes AstraZeneca’s pulmonary disease patent

Eklavya Gupte, London

One of AstraZeneca’s European patents covering Symbicort, a drug that treats pulmonary disease, has been revoked by the EPO following an appeal by generic manufacturers Norton Healthcare and Generics UK

The patent (EPB1014993) is one of two patents covering the Symbicort combination (formoterol and budesonide) used to treat chronic obstructive pulmonary disease.

The expiry date for the patent is 2018. The other patent covering the drug (EPB1210943) faces a separate opposition at the EPO.

In a statement issued today, David Brennan, chief executive of AstraZeneca, said: “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.”

AstraZeneca will defend and enforce its remaining IP rights protecting Symbicort, he added.

The generic drugs companies had urged the EPO’s Technical Board of Appeal to revoke the patent on the grounds that it involved insufficient inventive step. The Board has not yet released its written decision in the case.

On October 18 last year the EPO Technical Board of Appeal had made a final ruling that the European Combination patent for Symbicort (EPB 0613371) be revoked.

Symbicort recorded sales of $1.58 billion in 2007, $1.34 billion of which was made in Europe.

Last week AstraZeneca submitted a supplemental New Drug Application (sNDA) to the US Food and Drug Administration (FDA), seeking approval for a new indication for Symbicort.



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