UK court finds SEROQUEL XR® formulation patent invalid

AstraZeneca today announced that the High Court in the UK has rendered its opinion on the formulation patent protecting SEROQUEL XR® (quetiapine fumarate) prolonged-release tablets currently pending in the UK court. The court found the formulation patent protecting SEROQUEL XR (marketed as SEROQUEL XL in the UK) to be invalid. The patent was challenged by Accord Healthcare Limited, Intas Pharmaceuticals Limited, Hexal AG and Sandoz Limited, Teva UK Limited, and Teva Pharmaceutical Industries Limited.

This is the first court decision providing a determination that the SEROQUEL XR formulation patent is invalid. In the Netherlands on 7 March, the District Court in The Hague found the formulation patent protecting SEROQUEL XR to be valid. The High Court decision is limited to the UK and is not binding in other countries. AstraZeneca is engaged in numerous other proceedings regarding SEROQUEL XR related patents and regulatory exclusivity for SEROQUEL XR. In addition to the UK and the Netherlands, trials have concluded in the US and in Spain, and decisions are pending in those jurisdictions. Further updates will be provided on a quarterly basis as part of the Company’s earnings report.

AstraZeneca is disappointed with the court’s decision. However, the company remains committed to defending its intellectual property protecting SEROQUEL XR.