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: Claims 1-7, 10, 12-17, 19, 22-23

Claim Types Challenged Under § 102
Manufacturing

§ 102 Challenge Instituted
N

§ 103 challenge
Y: Claims 1-24

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.
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: Claims 1-4, 7-19, 22-3

Claim Types Challenged Under § 102
Manufacturing

§ 102 Challenge Instituted
Y

§ 103 challenge
Y: Claims 1-30

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 (Claims 1-15), Written Description (Claims 1-9, 16-25), and Enablement (Claims 1-30). Settled After Institution Decision