CT-P42 (aflibercept)

CT-P42 Approval Pending

CT-P42 (aflibercept)

CT-P42 Approval Pending

U.S. License Holder:

Celltrion

Date of License:

aBLA submitted to FDA June-2023

Last Update:

Sep-23-2023

approved_indications FDA-Approved Indications

CT-P42 (aflibercept) is not FDA-approved. An aBLA has been submitted to the FDA.

approved_indications Inter Partes Review Proceedings

PTAB Portal

IPR Case No(s):

IPR2022-00257

U.S. Patent No.
9,669,069 (Use of a VEGF Antagonist to Treat Angiogenic Eye Disorders)

Patent Owner
Regeneron Pharmaceuticals, Inc.

Petitioner(s)
Celltrion, Inc.; Celltrion Healthcare Co., Ltd.; Celltrion Healthcare USA, Inc.

§ 102 Challenge
Y

Claim Types Challenged Under § 102
Method of Treatment

§ 102 Challenge Instituted
Y; Joined

§ 103 challenge
Y

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
Y; Joined

Final Written Decision Issued
Y

Federal Circuit Appeal(s)
23-1395

IPR Status
Joined with IPR2021-00880; Final Written Decision (All Challenged Claims Unpatentable); Fed. Cir. Appeal Pending

IPR2022-00258

U.S. Patent No.
9,254,338 (Use of a VEGF Antagonist to Treat Angiogenic Eye Disorders)

Patent Owner
Regeneron Pharmaceuticals, Inc.

Petitioner(s)
Celltrion, Inc.; Celltrion Healthcare Co., Ltd.; Celltrion Healthcare USA, Inc.

§ 102 Challenge
Y

Claim Types Challenged Under § 102
Method of Treatment

§ 102 Challenge Instituted
Y; Joined

§ 103 challenge
Y

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
Y; Joined

Final Written Decision Issued
Y

Federal Circuit Appeal(s)
23-1396 (consolidated with lead appeal 23-1395)

IPR Status
Joined with IPR2021-00881; Final Written Decision (All Challenged Claims Unpatentable); Fed. Cir. Appeal Pending

IPR2023-00462

U.S. Patent No.
10,464,992 (VEGF Antagonist Formulations Suitable for Intravitreal Administration)

Patent Owner
Regeneron Pharmaceuticals, Inc.

Petitioner(s)
Celltrion, Inc.; Celltrion Healthcare Co., Ltd.; Celltrion Healthcare USA, Inc.

§ 102 Challenge
Y

Claim Types Challenged Under § 102
Formulation

§ 102 Challenge Instituted
Y

§ 103 challenge
Y

Claim Types Challenged Under § 103
Formulation

§ 103 Challenge Instituted
Y

IPR Status
Instituted, Pending

IPR2023-00532

U.S. Patent No.
10,130,681 (Use of a VEGF Antagonist to Treat Angiogenic Eye Disorders)

Patent Owner
Regeneron Pharmaceuticals, Inc.

Petitioner(s)
Celltrion, Inc.; Celltrion Healthcare Co., Ltd.; Celltrion Healthcare USA, Inc.

§ 102 Challenge
Y

Claim Types Challenged Under § 102
Method of Treatment

§ 102 Challenge Instituted
Y (Joined)

§ 103 challenge
Y

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
Y (Joined)

IPR Status
Instituted, Pending; Joined with IPR2022-01225

IPR2023-00533

U.S. Patent No.
10,888,601 (Use of a VEGF Antagonist to Treat Angiogenic Eye Disorders)

Patent Owner
Regeneron Pharmaceuticals, Inc.

Petitioner(s)
Celltrion, Inc.; Celltrion Healthcare Co., Ltd.; Celltrion Healthcare USA, Inc.

§ 102 Challenge
Y

Claim Types Challenged Under § 102
Method of Treatment

§ 102 Challenge Instituted
Y (Joined)

§ 103 challenge
Y

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
Y (Joined)

IPR Status
Instituted, Pending; Joined with IPR2022-01226

IPR2023-00620

U.S. Patent No.
10,406,226 (Method of Manufacturing VEGF Antagonist Fusion Proteins)

Patent Owner
Regeneron Pharmaceuticals, Inc.

Petitioner(s)
Celltrion, Inc.

§ 102 Challenge
N

§ 103 challenge
Y

Claim Types Challenged Under § 103
Manufacturing

§ 103 Challenge Instituted
N

Settled / Challenged Claims Disclaimed / Challenge Terminated
Y (Patent Owner Disclaimed All Challenged Claims Prior to Institution Decision)

IPR Status
Institution Denied Due to Disclaimer of All Challenged Claims

PGR2021-00117

U.S. Patent No.
10,857,231 (Formulations of VEG Antagonist Fusion Proteins and Method of Manufacturing Them)

Patent Owner
Regeneron Pharmaceuticals, Inc.

Petitioner(s)
Celltrion, Inc.; Celltrion Healthcare Co., Ltd.; Celltrion Healthcare USA, Inc.

§ 102 Challenge
N

§ 103 challenge
Y

Claim Types Challenged Under § 103
Formulation

§ 103 Challenge Instituted
N

IPR Status
Challenges Include Written Description, Enablement, and Indefiniteness; Institution Denied

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