In one of the major development, the US District Court for the Southern District of New York has ruled that Mylan’s 10mg and 20mg generic version of omeprazole delayed-release capsules do not infringe AstraZeneca’s blockbuster Prilosec Orange Book listed patents, preventing Mylan from paying triple damages to AstraZeneca. Mylan launched its omeprazole generic products on August 04, 2003 despite the patent infringement litigation, which at the time was unprecedented in the generic pharmaceutical industry. However, the Court also found that Apotex and Impax generic omeprazole products do infringe the same patents asserted against Mylan. Earlier in December 2002, Schwarz/Kudco launched their generic version of omeprazole capsules after District Court Judge Barbara S. Jones ruled that Schwarz’s formulation did not infringe AstraZeneca’s Orange Book listed patents, the decision later appealed by AstraZeneca which subsequently in December 2003 affirmed by the US Court of Appeals for the Federal Circuit.
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