Tuesday, 29 September 2009

Quetiapine fumarate (Seroquel): CAFC upholds the validity of key patent

Innovator AstraZeneca announced (in a press release Here ) that the US Court of Appeals for the Federal Circuit has affirmed the Summary Judgment decision of No Inequitable Conduct in patent litigation involving Seroquel (quetiapine fumarate) tablets.


Earlier in July 2008, the US District Court for the District of New Jersey granted the company's Motion for Summary Judgment of No Inequitable Conduct during prosecution of key patent US4879288 (Expiry: March, 2012), which covers Quetiapine as product.


In a separate press release Here generic player Teva pharma announced that, Teva expects to market its generic version of AstraZeneca's antipsychotic agent Seroquel® (Quetiapine Fumarate) Tablets no later than March 2012, when the patent is otherwise set to expire.

Earlier, generic players Teva and Sandoz challenged ‘288 by filing Para IV against said patent with invalidation grounds. Also, generic players alleged that innovator during prosecution of ‘288 patent had not disclosed test data on the closely related compounds to USPTO.

The generic players alleged that the said data would have been material to the patentability of ‘288 patent. The CAFC affirmed US District Court for the District of New Jersey decision that there wasn’t sufficient evidence which can clearly show that during prosecution of ‘288 patent application in the USPTO, innovator Astra Zeneca made a misrepresentation of material fact or an omission of material fact to the USPTO, with intent to deceive or mislead the patent examiner into granting the patent.

The CAFC opinion Here

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Disclaimer: "IP Pharma Doc" blog is published for information purpose only. "IP Pharma Doc" blog contains no legal advice. I assume no legal responsibility for the views/information expressed here. “IP Pharma Doc” blog is my personal website and not edited by my employer, accordingly, no part of my blog should be attributed to my employer. All information on the present blog should be double checked for its accuracy and applicability. © Dr. Sarwal (2007)
 
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