Quetiapine (Seroquel) generic delayed: Court granted summary judgment in favor of innovator Astra

Astra has announced that the US District Court of New Jersey has granted the company's Motion for Summary Judgment with respect to no intent and materiality of Inequitable Conduct. AstraZeneca had sued Teva and Sandoz, for infringement of AstraZeneca's Product patent of Seroquel (R) (Quetiapine fumarate) US4879288 (Expiry: Sep 26, 2011) as a result of Teva's and Sandoz's filings of Abbreviated New Drug Applications (ANDAs) for 25, 50, 100, 150, 200 and 400mg tablets. Since the Court granted AstraZeneca's motion for Summary Judgment of No Inequitable Conduct in its entirety, trial is unnecessary. Teva and Sandoz had already conceded infringement and the validity of AstraZeneca's patent. Thus, only the inequitable conduct contentions remained to be resolved. The Court had previously set a date for trial beginning on August 11, 2008. This drug was approved by USFDA on September 26, 1997 and no generic player has got any final or tentative approval for this product.So now the generic can be launched after the expiry of ‘288 patent. Further, there will be no First to File exclusivity of 180 days for any generic player for this product