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14 January 2015Big Pharma

AstraZeneca’s Seroquel XR patent claim thrown out in Germany

The Federal Court of Justice of Germany, the country’s highest court, has rejected an appeal from AstraZeneca (AZ) in which the pharmaceutical company claimed that a patent used in its drug Seroquel XR (quetiapine) is valid.

Seroquel XR is the extended release version of Seroquel, an anti-psychotic drug used to treat people suffering from schizophrenia and bipolar disorder. In 2013, the standard and extended release versions were estimated to have made $1.34 billion globally for AZ.

In 2012, a group of pharma companies including Teva, Hexal and Accord Healthcare challenged the validity of a formulation patent covering the drug at the Federal Patent Court of Germany.

The court ruled that the patent was invalid, which led to AZ filing for an appeal at the Federal Court of Justice of Germany.

On Tuesday (January 13), the court dismissed AZ’s appeal. The decision means current generic versions of the drug manufactured by Teva and Hexal can remain on the market in Germany.

A spokesperson for AZ told LSIPR that it was "disappointed with the court's decision", but "remains confident in its intellectual property and is committed to vigorously defending its patent rights".

Similar challenges to the validity of the Seroquel XR patent have been made in the US and the UK, but with mixed results.

In 2013, the UK Court of Appeal ruled against AZ and declared the patent invalid.

But the US Court of Appeals for the Federal Circuit held a different view and declared that the patent was valid, ruling that generic versions of the drug manufactured by pharma companies Mylan and Torrent Pharmaceuticals were infringing it.

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