Inter Partes Review Proceedings
PTAB Portal
IPR Case No(s):
U.S. Patent No.
8,952,138 (Refolding Proteins Using a Chemically Controlled Redox State)
Patent Owner
Amgen Inc.; Amgen Manufacturing Ltd.
Petitioner(s)
Apotex Inc.; Apotex Corp.
§ 102 Challenge
Y
Claim Types Challenged Under § 102
Manufacturing
§ 102 Challenge Instituted
N
§ 103 challenge
Y
Claim Types Challenged Under § 103
Manufacturing
§ 103 Challenge Instituted
Y
Final Written Decision Issued
Y
Federal Circuit Appeal(s)
19-2171
Supreme Court Appeal(s)
20-74
IPR Status
Final Written Decision (Most Challenged Claims Unpatentable, 1 Claim Not Unpatentable); Request for Rehearing Determined All Claims Unpatentable; Petition for Writ of Certiorari Granted, Vacating and Remanding to the Federal Circuit for Consideration in Light of Arthrex; Federal Circuit Vacated and Remanded Due to Arthrex; Joint Motion to Terminate Remand Pending; Request for Director Review Denied; Federal Circuit Reversed (No Claims Found Unpatentable)
U.S. Patent No.
8,940,878 (Capture Purification Processes for Proteins Expressed in a Non-Mammalian System)
Patent Owner
Amgen Inc.
Petitioner(s)
Kashiv BioSciences, LLC; Amneal Pharmaceuticals, Inc.; Amneal Pharmaceuticals LLC
§ 102 Challenge
Y
Claim Types Challenged Under § 102
Manufacturing
§ 102 Challenge Instituted
Y
§ 103 challenge
Y
Claim Types Challenged Under § 103
Manufacturing
§ 103 Challenge Instituted
Y
Settled / Challenged Claims Disclaimed / Challenge Terminated
Y (Settled After Institution)
IPR Status
Settled After Institution Decision
U.S. Patent No.
9,643,997 (Capture Purification Processes for Proteins Expressed in a Non-Mammalian System)
Patent Owner
Amgen Inc.
Petitioner(s)
Kashiv BioSciences, LLC; Amneal Pharmaceuticals, Inc.; Amneal Pharmaceuticals LLC
§ 102 Challenge
Y
Claim Types Challenged Under § 102
Manufacturing
§ 102 Challenge Instituted
Y
§ 103 challenge
Y
Claim Types Challenged Under § 103
Manufacturing
§ 103 Challenge Instituted
Y
Settled / Challenged Claims Disclaimed / Challenge Terminated
Y (Settled After Institution)
IPR Status
Settled After Institution Decision
U.S. Patent No.
9,856,287 (Refolding Proteins Using a Chemically Controlled Redox State)
Patent Owner
Amgen Inc.; Amgen Manufacturing Ltd.
Petitioner(s)
Fresenius Kabi USA, LLC; Fresenius Kabi AG; Fresenius Kabi Deutschland GmbH; Fresenius Kabi Pharmaceuticals Holding, Inc.; Fresenius Kabi SwissBioSim GmbH; Fresenius SE & Co. KGaA; Dr. Reddy's Laboratories Inc.; Dr. Reddy's Laboratories, Ltd.; Dr. Reddy's Laboratories, SA
§ 102 Challenge
Y
Claim Types Challenged Under § 102
Manufacturing
§ 102 Challenge Instituted
N
§ 103 challenge
Y
Claim Types Challenged Under § 103
Manufacturing
§ 103 Challenge Instituted
N
IPR Status
IPR Not Instituted
U.S. Patent No.
9,643,997 (Capture Purification Processes for Proteins Expressed in a Non-Mammalian System)
Patent Owner
Amgen Inc.
Petitioner(s)
Fresenius Kabi USA, LLC; Fresenius Kabi AG; Fresenius Kabi Deutschland GmbH; Fresenius Kabi Pharmaceuticals Holding, Inc.; Fresenius Kabi Swiss BioSim GmbH; Fresenius SE & Co. KGaA; Dr. Reddy's Laboratories, Inc.; Dr. Reddy's Laboratories, Ltd.; Dr. Reddy's Laboratories, SA
§ 102 Challenge
Y
Claim Types Challenged Under § 102
Manufacturing
§ 102 Challenge Instituted
Y
§ 103 challenge
Y
Claim Types Challenged Under § 103
Manufacturing
§ 103 Challenge Instituted
Y
Settled / Challenged Claims Disclaimed / Challenge Terminated
Y (Settled After Institution)
IPR Status
Settled After Institution Decision
U.S. Patent No.
9,856,287 (Refolding Proteins Using a Chemically Controlled Redox State)
Patent Owner
Amgen Inc.; Amgen Manufacturing Ltd.
Petitioner(s)
Fresenius Kabi USA, LLC; Fresenius Kabi AG; Fresenius Kabi Deutschland GmbH; Fresenius Kabi Pharmaceuticals Holding, Inc.; Fresenius Kabi SwissBioSim GmbH; Fresenius SE & Co. KGaA; Dr. Reddy's Laboratories Inc.; Dr. Reddy's Laboratories, Ltd.; Dr. Reddy's Laboratories, SA
§ 102 Challenge
Y
Claim Types Challenged Under § 102
Manufacturing
§ 102 Challenge Instituted
Settled Prior to Institution Decision
§ 103 challenge
Y
Claim Types Challenged Under § 103
Manufacturing
§ 103 Challenge Instituted
Settled Prior to Institution Decision
Settled / Challenged Claims Disclaimed / Challenge Terminated
Y (Settled Prior to Institution Decision)
IPR Status
Settled Prior to Institution Decision
U.S. Patent No.
9,856,287 (Refolding Proteins Using a Chemically Controlled Redox State)
Patent Owner
Amgen Inc.
Petitioner(s)
Lupin Limited; Lupin Pharmaceuticals, Inc.; Lupin Inc.; Nanomi BV
§ 102 Challenge
Y
Claim Types Challenged Under § 102
Manufacturing
§ 102 Challenge Instituted
N
§ 103 challenge
Y
Claim Types Challenged Under § 103
Manufacturing
§ 103 Challenge Instituted
N
IPR Status
IPR Not Instituted
U.S. Patent No.
8,273,707 (Process for Purifying Proteins)
Patent Owner
Amgen Inc.
Petitioner(s)
Hospira, Inc.; Pfizer Inc.
§ 102 Challenge
Y
Claim Types Challenged Under § 102
Manufacturing
§ 102 Challenge Instituted
Y
§ 103 challenge
Y
Claim Types Challenged Under § 103
Manufacturing
§ 103 Challenge Instituted
Y
Settled / Challenged Claims Disclaimed / Challenge Terminated
Y (Settled After Institution)
IPR Status
Terminated After Institution Due to Settlement
U.S. Patent No.
9,856,287 (Refolding Proteins Using a Chemically Controlled Redox State)
Patent Owner
Amgen Inc.; Amgen Manufacturing Ltd.
Petitioner(s)
Adello Biologics, LLC; Amneal Pharmaceuticals, Inc.; Amneal Pharmaceuticals LLC; ApoPharma USA, Inc.; Apotex Corp.; Apotex Holdings, Inc.; Apotex Inc.; Apotex Pharmaceutical Holdings Inc.; Intas Pharmaceuticals Ltd.; Kashiv BioSciences, LLC
§ 102 Challenge
Y
Claim Types Challenged Under § 102
Manufacturing
§ 102 Challenge Instituted
Y
§ 103 challenge
Y
Claim Types Challenged Under § 103
Manufacturing
§ 103 Challenge Instituted
Y
Settled / Challenged Claims Disclaimed / Challenge Terminated
Y (Settled After Institution)
IPR Status
Challenges Also Include Indefiniteness, Written Description, and Enablement. Settled After Institution Decision