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):

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

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

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

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

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

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

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

Methodology

Information contained in the Venable BiologicsHQ database relates to FDA-approved drug products listed in the CDER Purple Book or on the FDA website (www.fda.gov). Information relating to FDA licensed products, FDA-approved indications, and aBLA and 505(b)(2) applications is obtained from public sources including the U.S. FDA website (www.fda.gov). Information relating to litigations is given only for cases active from January 31, 2010 onward. Information relating to foreign biosimilar / biologics follow-on products approved in Australia, Canada, the E.U., Japan and South Korea is from public sources. Statistics graphics are compiled from information contained in the Venable BiologicsHQ database.

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