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AstraZeneca's Seroquel XR patent deemed invalid by UK high court

Blow for pharma company's attempt to keep its big-selling antipsychotic franchise alive

AstraZeneca has suffered a major blow in its legal battle to protect its Seroquel XR brand after the UK's High Court deemed the patent on the antipsychotic drug to be invalid.

The legal standing of the drug, which is an extended release version of AstraZeneca's Seroquel, had been challenged by the generics companies Teva Pharmaceutical, Teva UK, Sandoz, Accord Healthcare, Intas Pharmaceuticals and Hexal AG.

The active ingredient of Seroquel, quetiapine, is due to face patent expiry at the end of the month and AstraZeneca had hoped to prolong the franchise's life with the introduction of its extended release version Seroquel XR.

Patent protection on this version of the drug was due to last until May 2017, but the latest court ruling means this won't be the case in the UK. The High Court decision does, however, contradict a District Court ruling on March 7, 2012, in the Netherlands that sided with AstraZeneca.

The pharma firm, which has headquarters in both the UK and Sweden, told PMLiVE it would carefully review the decision and was "evaluating all legal options" open to it.

There are several other Seroquel court cases ongoing across the world, with decisions on concluded trials pending in both the US and Spain.

AstraZeneca has further legal action in the US regarding the Seroquel franchise, announcing a lawsuit last week against the Food and Drug Adminsitration (FDA) to protect the exclusivity for the use of clinical trial data that appears on the drug's label.

This data provides a warning regarding suicide and hyperglycaemia warnings which would have to appear on any generic product, with the company claiming any such drug shouldn't be allowed onto market until December, 2012, when the data exclusivity expires.

23rd March 2012

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