Court upholds Seroquel XR formulation patent

The U.S. District Court for the District of New Jersey ruled that a formulation patent covering atypical antipsychotic Seroquel XR quetiapine extended release from AstraZeneca plc (LSE:AZN; NYSE:AZN) is valid and infringed by ANDA submissions from four generics companies. AstraZeneca filed the infringement claims in 2010. The court said in its decision that the sustained release formulation claimed in U.S. Patent No. 5,948,437 is not obvious because it provides several benefits over immediate release quetiapine, including a superior sedation profile and significant improvement in the speed with which it can be titrated. The patent expires in 2017.

Defendants were Anchen Pharmaceuticals Inc., now part of Par Pharmaceutical Cos. Inc. (NYSE:PRX); Mylan Inc. (NASDAQ:MYL); Osmotica Pharmaceuticals Corp. (Wilmington, N.C.); and Torrent Pharmaceuticals Ltd. (NSE:TORNTPHARM; BSE:500420). ...