US Judge Backs AstraZeneca’s Seroquel XR patent

AstraZeneca announced earlier today that a US district court has ruled that the formulation patent for its extended-release version of the antipsychotic blockbuster, Seroquel XR, is valid and has been infringed by generics companies.

The court in New Jersey found the formulation patent protecting Seroquel XR (quetiapine fumarate) extended-release tablets to be valid and ruled that four firms – Anchen Pharmaceuticals, Osmotica Pharmaceutical Corp, Torrent and Mylan have infringed it.  The formulation patent expires in November 2017.

AstraZeneca reached an agreement in September with Handa Pharmaceuticals, which prevents Handa from selling a generic form of Seroquel XR until November 2016.

The decision comes a week after the UK High Court announced that the patent on Seroquel is invalid, following a challenge by Accord Healthcare, Intas Pharmaceuticals, Novartis’ Hexal and Sandoz generics units and Teva.  The UK court was the first to rule the patent invalid, in contrast to the decision made by the District Court in The Hague, Netherlands on March 7th in support of its validity.

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.

The ruling in the USA is very welcome for AstraZeneca, which has seen several firms launch their generic versions of the drug on both sides of the Atlantic this week.

AstraZeneca has been trying to get injunctions stopping generic forms of Seroquel XR, and sued the US Food and Drug Administration (FDA) but the lawsuit has been thrown out and requests for injunctions have been dismissed.


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