Validity of certain patent claims covering Santarus' Zegerid capsule and powder upheld

6 September 2012

US drugmaker Santarus (Nasdaq: SNTS) saw its shares leap 14.2% to $7.06 in regular trading on September 4, adding a further 2.8% after hours, after the company said that the US Court of Appeals for the Federal Circuit reversed in part a lower court decision of invalidity involving certain asserted patent claims covering Zegerid (omeprazole/sodium bicarbonate) capsules and powder for oral suspension.

The Federal Circuit found that certain claims of asserted US Patent numbers 6,780,882 and 7,399,772, which fellow US drug firm Par Pharmaceutical had been found to infringe, were not invalid due to obviousness. The Federal Circuit also upheld the District Court’s finding that there was no inequitable conduct. The case will be remanded back to the US District Court for the District of Delaware for further proceedings consistent with the appellate decision.

These patents were the subject of lawsuits brought by Santarus in 2007 against Par for patent infringement associated with Par’s submission of Abbreviated New Drug Applications to the US Food and Drug Administration. The patents at issue expire in July 2016. In July 2010, following the District Court decision that five patents covering Zegerid were invalid due to obviousness, Prasco, under a distribution and supply agreement with Santarus, and Par launched generic versions of Zegerid capsules.

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