In a significant decision, the U.S. District Court for the District of Delaware has declared the Orange Book listed patents of innovator Santarus (who has got licensed on the patents from University of Missouri) for Omeprazole + Sodium Bicarbinate (Zegerid) 20 mg; 1.1 g and 40 mg ;1.1 g Capsules and 20 mg/PACKET;1.68 g/PACKET and 40 mg/PACKET;1.68 g/PACKET powder for oral suspension were declared invalid due to obviousness in the light of prior publications. The following Orange Book listed patents were opposed by the generic player Par Pharma and court declared the patent invalid:
US6,489,346 (Expiry: Jul 16, 2016): Invalid due to Obviousness
US6,645,988 (Expiry: Jul 16, 2016): Invalid due to Obviousness
US 6,699,885 (Expiry: Jul 16, 2016): Invalid due to Obviousness
US6,780,882 (Expiry: Jul 16, 2016): Listed for suspension only, Invalid due to Obviousness
US7,399,772(Expiry: Jul 16, 2016): Invalid due to lack of written description as per 35 USC 112
Earlier, generic player Par filed ANDA with Para IV in 2007 for capsules and oral suspension. Subsequently, innovator sued Par for the infringement of above patents.
The patent invalidty attack of Par (in the light of well searched and debated arguments) resulted into invalidation of above key patents. Also, court found that the patent are not invalid due to inequitable conduct and refused attorney fees to Par.
As per press release by innovator (Here), Santarus is currently assessing the potential timing and impact of launch of a generic version of ZEGERID. Par has not yet received final FDA approval for any of its ANDA submissions, and Santarus is not aware of any other companies that have submitted ANDAs for generic versions of ZEGERID. As a result, the timing of a launch of a generic version of ZEGERID is uncertain.
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