Filgrastim & Pegfilgrastim – USA

Filgrastim & Pegfilgrastim – USA

IPR decision: Jun. 23, 2020

 

AIA Review #

Filing Date

Institution Date

Petitioner

Patent

Respondent

STATUS

IPR2019-01183

06/08/2019

12/10/2019

Fresenius Kabi USA, LLC

9,643,997

Amgen Inc.

Terminated-Settled

On US’997, Kashiv bioscience filed IPR (IPR2019-00797) on 03/07/2019 which was terminated as parties settled.


US 9,643,997 (Amgen Inc.)


1. A method of purifying a protein expressed in a non-native soluble form in a non-mammalian expression system comprising: (a) lysing a non-mammalian cell in which the protein is expressed in a nonnative soluble form to generate a cell lysate; (b) contacting the cell lysate with a separation matrix under conditions suitable for the protein to associate with the separation matrix; (c) washing the separation matrix; and (d) eluting the protein from the separation matrix.

 

9. A method of purifying a protein expressed in a non-native limited solubility form in a non-mammalian expression system comprising: (a) solubilizing the expressed protein in a solubilization solution comprising one or more of the following: (i) a denaturant; (ii) a reductant; and (iii) a surfactant; (b) forming a refold solution comprising the solubilization solution and a refold buffer, the refold buffer comprising one or more of the following: (i) a denaturant; (ii) an aggregation suppressor; (iii) a protein stabilizer; and (iv) a redox component; (c) applying the refold solution to a separation matrix under conditions suitable for the protein to associate with the matrix; (d) washing the separation matrix; and (e) eluting the protein from the separation matrix.

 

 

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