IPR decision (Feb. 15, 2018):
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AIA Review
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Filing Date
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Institution Date
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Petitioner
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Patent No.
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Status
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IPR2016-01542
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08/05/2016
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02/17/2017
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Apotex Inc.
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US 8,952,138
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(Claims 1–17,
19–24 are unpatentable AND claim 18 is patentable)
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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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