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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