The US District Court for the District of New Jersey has found the formulation patent protecting Seroquel XR (quetiapine fumarate) extended release tablets to be valid. The court also ruled that Anchen Pharmaceuticals, Inc., Osmotica Pharmaceutical Corporation, Torrent Pharmaceuticals Ltd, Torrent Pharma Inc., Mylan Pharmaceuticals Inc. and Mylan Inc. have infringed the Seroquel XR formulation patent. The Seroquel XR formulation patent expires in 2017. This judgment is limited to the US market only and is not valid in other countries.
This follows a decision made in the UK on March 22, 2012, which found the formulation patent protecting Seroquel XR to be invalid. In the Netherlands, however, on March 7, 2012, the District Court in The Hague found the formulation patent protecting Seroquel XR to be valid.
AstraZeneca is pleased with the US District Court’s decision, which the company believes underlines the strength of its patents.
In October 2011, the US District Court for the District of New Jersey conducted a trial of the pending patent infringement actions against four generic filers: Anchen Pharmaceuticals, Inc., Osmotica Pharmaceutical Corporation, Torrent Pharmaceuticals Limited, Torrent Pharma Inc., Mylan Pharmaceuticals Inc. and Mylan Inc.
Prior to the October trial, AstraZeneca settled its patent infringement case against Handa. On September 29, 2011, AstraZeneca granted Handa a license to the 5,948,437 patent effective November 1, 2016, or earlier under certain circumstances.
Additionally, on October 5, 2011, AstraZeneca settled its patent infringement action against Accord. AstraZeneca granted Accord a license to the 5,948,437 patent effective November 1, 2016, or earlier under certain circumstances. In both instances, the Court dismissed the action against the filers.