Filgrastim & Pegfilgrastim – USA

Filgrastim & Pegfilgrastim – USA

IPR decision (Feb. 15, 2018):

AIA Review
Filing Date
Institution Date
Patent No.
Apotex Inc.
US 8,952,138
(Claims 1–17, 19–24 are unpatentable AND claim 18 is patentable)
US 8,952,138 (Amgen; Jul 29, 2031)

1. A method of refolding a protein expressed in a non-mammalian expression system and present in a volume at a concentration of 2.0 g/L or greater comprising: (a) contacting the protein with a refold buffer comprising a redox component comprising a final thiol-pair ratio having a range of 0.001 to 100 and a redox buffer strength of 2 mM or greater and one or more of: (i) a denaturant; (ii) an aggregation suppressor; and (iii) a protein stabilizer; to form a refold mixture; (b) incubating the refold mixture; and (c) isolating the protein from the refold mixture.
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