On Sep 06, 2016, The District Court for the Southern District of Florida ruled that Apotex’s proposed filgrastim and pegfilgrastim products will not infringe the asserted claims of Amgen’s ’138 patent (U.S. Patent. No. 8,952,138). The ‘138 Patent is entitled “Refolding Proteins Using a Chemically Controlled Redox State.”
Board after considering the facts ruled that Amgen has not met its burden to show that Apotex’s refolding process, as defined by Apotex’s aBLAs, infringes the asserted claims of the ‘138 Patent, either literally or under the doctrine of equivalents. Specifically, Amgen has not established by a preponderance of the evidence that Apotex’s process has: (1) a “high protein concentration” at or above about 1 g/L; and (2) a redox component having a redox buffer strength of 2 to 100 mM.
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