Mylan Inc. announced today that the U.S. Court of Appeals for the Federal Circuit has affirmed a May 2007 District Court ruling stating that Mylan's 10 mg and 20 mg Omeprazole delayed-release capsules do not infringe patents asserted against Mylan by AstraZeneca. Omeprazole is the generic version of AstraZeneca LP's Prilosec(R).
Mylan and others challenged Astrazeneca’s patents on grounds that their generic formulations do not infringe two Astra’s listed patents. TheDistrict of New York court agreed that the generic formulation do not infringe. On appeal was the question of whether the generic versions contained an “alkaline reacting compound” (ARC) as required by the claims.
Astra argued that the talc used by the generic products included an ARC. The CAFC agreed that the lower court had properly rejected that argument based in part on language in the specification. Specifically, the nearly identical specifications listed several different ARCs but did not include talc on the list. “In contrast, the specifications also lists a number of ordinary excipients, among which one of them is talc. The specifications themselves indicate that ARCs do not include talc.”
Mylan launched its Omeprazole products on August 4, 2003, despite the patent infringement litigation, which at the time was unprecedented in the generic pharmaceutical industry.
