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:

Nov-15-2024

approved_indications FDA-Approved Indications

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

approved_indications Approved Foreign Follow-On Biologics / Biosimilars

Biosimilars Approved In South Korea

Eydenzelt (Celltrion) (May-2024)

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: Claims 1, 8-12

Claim Types Challenged Under § 102
Method of Treatment

§ 102 Challenge Instituted
Y (Joined)

§ 103 challenge
Y: Claims 1, 8-12

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 Voluntarily Dismissed

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: Claims 1, 3-11, 13-14, 16-24, 26

Claim Types Challenged Under § 102
Method of Treatment

§ 102 Challenge Instituted
Y (Joined)

§ 103 challenge
Y: Claims 1, 3-11, 13-14, 16-24, 26

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 Voluntarily Dismissed

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: Claims 1-18

Claim Types Challenged Under § 102
Formulation

§ 102 Challenge Instituted
Y

§ 103 challenge
Y: Claims 1-18

Claim Types Challenged Under § 103
Formulation

§ 103 Challenge Instituted
Y

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

IPR Status
Adverse Judgment After Disclaimer

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: Claims 1, 3-11, 13-14, 16-24, 26

Claim Types Challenged Under § 102
Method of Treatment

§ 102 Challenge Instituted
Y (Joined)

§ 103 challenge
Y: Claims 1, 3-11, 13-14, 16-24, 26

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
Y (Joined)

Final Written Decision Issued
y

Federal Circuit Appeal(s)
24-1564 (lead appeal, conslidated with 24-1567)

IPR Status
Joined with IPR2022-01225; Final Written Decision (All Challenged Claims Unpatentable); Federal Circuit Appeal Voluntarily Dismissed

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: Claims 1-9, 34-39, 41-43, 45

Claim Types Challenged Under § 102
Method of Treatment

§ 102 Challenge Instituted
Y (Joined)

§ 103 challenge
Y: Claims 1-9, 34-39, 41-43, 45

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
Y (Joined)

Final Written Decision Issued
y

Federal Circuit Appeal(s)
24-1567 (consolidated with lead appeal 24-1564)

IPR Status
Joined with IPR2022-01226; Final Written Decision (All Challenged Claims Unpatentable); Federal Circuit Appeal Voluntarily Dismissed

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: Claims 1-4

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

IPR2024-00260

U.S. Patent No.
11,253,572 (Use of a VEGF Antagonist to Treat Angiogenic Eye Disorders)

Patent Owner
Regeneron Pharmaceuticals, Inc.

Petitioner(s)
Celltrion, Inc.

§ 102 Challenge
Y: Claims 1-5, 8-11, 15-17, 20-21, 24, 26-30

Claim Types Challenged Under § 102
Method of Treatment

§ 102 Challenge Instituted
Y (Joined)

§ 103 challenge
Y: Claims 1-14, 16-23, 25-30

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
Y (Joined)

Settled / Challenged Claims Disclaimed / Challenge Terminated
Y (Adverse Judgment Due to Disclaimer)

IPR Status
Joined with IPR2023-00884; Adverse Judgment After Institution Due to Disclaimer

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: Claims 1-4, 6-11, 18-21, 27-32, 41-45, 58-59

Claim Types Challenged Under § 103
Formulation

§ 103 Challenge Instituted
N

IPR Status
Challenges Include Written Description (Claims 1-11, 17-21, 27-32, 41-53, 58-67), Enablement (Claims 1-11, 17-21, 27-32, 41-53, 58-67), and Indefiniteness (Claims 1-11, 17-21, 27-32, 41-53, 58-67); Institution Denied

approved_indications U.S. Patent Litigations

PACER

Case No(s):

1:23-cv-00089 (N.D.W. Va.) / MDL 1:24-md-03103 (N.D.W. Va.)

U.S. Patent Nos.
7,070,959 (Modified Chimeric Polypeptides with Improved Pharmacokinetic Properties) 9,222,106 (Enhanced Expression and Stability Regions) 9,254,338 (Use of a VEGF Antagonist to Treat Angiogenic Eye Disorders) 9,315,281 (System and Methods for Use in Dispensing Biopharmaceutical Materials) 9,816,110 (CHO Integration Sites and Uses Thereof) 10,130,681 (Use of a VEGF Antagonist to Treat Angiogenic Eye Disorders) 10,415,055 (Enhanced Expression and Stability Regions) 10,464,992 (VEGF Antagonist Formulations Suitable for Intravitreal Administration) 10,669,594 (Compositions and Methods for Detecting a Biological Contaminant) 10,828,345 (Use of a VEGF Antagonist to Treat Angiogenic Eye Disorders) 10,888,601 (Use of a VEGF Antagonist to Treat Angiogenic Eye Disorders) 10,927,342 (Taurine Supplemented Cell Culture Medium and Methods of Use) 11,053,280 (Anti-VEGF Protein Compositions and Methods for Producing the Same) 11,066,458 (VEGF Antagonist Formulations Suitable for Intravitreal Administration) 11,084,865 (VEGF Antagonist Formulations Suitable for Intravitreal Administration) 11,104,715 (Methods for Producing Aflibercept in Chemically Defined Media Having Reduced Aflibercept Variants) 11,174,283 (Anti-VEGF Protein Compositions and Methods for Producing the Same) 11,253,572 (Use of a VEGF Antagonist to Treat Angiogenic Eye Disorders) 11,299,532 (Anti-VEGF Protein Compositions and Methods for Producing the Same) 11,306,135 (Anti-VEGF Protein Compositions and Methods for Producing the Same) 11,312,936 (Taurine Supplemented Cell Culture Medium and Methods of Use) 11,332,771 (Serum-Free Cell Culture Medium) 11,459,374 (Anti-VEGF Protein Compositions and Methods for Producing the Same) 11,472,861 (Methods for Producing Aflibercept in Chemically Defined Media Having Reduced Aflibercept Variants) 11,485,770 (Anti-VEGF Protein Compositions and Methods for Producing the Same) 11,505,593 (Anti-VEGF Protein Compositions and Methods for Producing the Same) 11,525,833 (Hydrophobic Interaction Chromatography-Coupled Native Mass Spectrometry for Antibody Analysis) 11,535,663 (Methods for Producing Aflibercept in Chemically Defined Media Having Reduced Aflibercept Variants) 11,542,317 (Anti-VEGF Protein Compositions and Methods for Producing the Same) 11,548,932 (Anti-VEGF Protein Compositions and Methods for Producing the Same) 11,555,176 (Cell Culture Medium for Eukaryotic Cells) 11,559,564 (Use of a VEGF Antagonist to Treat Angiogenic Eye Disorders) 11,707,506 (Use of a VEGF Antagonist to Treat Angiogenic Eye Disorders) 11,732,024 (VEGF Antagonist Formulations Suitable for Intravitreal Administration) 11,753,459 (Anti-VEGF Protein Compositions and Methods for Producing the Same) 11,769,597 (Methods of Associating Genetic Variants with a Clinical Outcome in Patients Suffering from Age-Related Macular Degeneration Treated with Anti-VEGF) 11,788,102 (CHO Integration Sites and Uses Thereof) 11,793,926 (Medical Device Packaging and Related Methods)

Plaintiffs
Regeneron Pharmaceuticals, Inc.

Defendants
Celltrion, Inc.

Federal Circuit Appeal(s)
Preliminary Injunction: 24-2058 (lead), 24-2147 (consolidated)

Status
Case Ongoing, Preliminary Injunction Granted, Federal Circuit Appeals Ongoing

BPCIA
Y

1:24-cv-00053 (N.D.W. Va.) / MDL 1:24-md-03103 (N.D.W. Va.)

U.S. Patent Nos.
9,222,106 (Enhanced Expression and Stability Regions) 9,254,338 (Use of a VEGF Antagonist to Treat Angiogenic Eye Disorders) 9,315,281 (System and Methods for Use in Dispensing Biopharmaceutical Materials) 9,816,110 (CHO Integration Sites and Uses Thereof) 10,130,681 (Use of a VEGF Antagonist to Treat Angiogenic Eye Disorders) 10,415,055 (Enhanced Expression and Stability Regions) 10,669,594 (Compositions and Methods for Detecting a Biological Contaminant) 10,828,345 (Use of a VEGF Antagonist to Treat Angiogenic Eye Disorders) 10,888,601 (Use of a VEGF Antagonist to Treat Angiogenic Eye Disorders) 10,927,342 (Taurine Supplemented Cell Culture Medium and Methods of Use) 11,066,458 (VEGF Antagonist Formulations Suitable for Intravitreal Administration) 11,084,865 (VEGF Antagonist Formulations Suitable for Intravitreal Administration) 11,253,572 (Use of a VEGF Antagonist to Treat Angiogenic Eye Disorders) 11,312,936 (Taurine Supplemented Cell Culture Medium and Methods of Use) 11,332,771 (Serum-Free Cell Culture Medium) 11,505,593 (Anti-VEGF Protein Compositions and Methods for Producing the Same) 11,525,833 (Hydrophobic Interaction Chromatography-Coupled Native Mass Spectrometry for Antibody Analysis) 11,555,176 (Cell Culture Medium for Eukaryotic Cells) 11,559,564 (Use of a VEGF Antagonist to Treat Angiogenic Eye Disorders) 11,707,506 (Use of a VEGF Antagonist to Treat Angiogenic Eye Disorders) 11,732,024 (VEGF Antagonist Formulations Suitable for Intravitreal Administration) 11,753,459 (Anti-VEGF Protein Compositions and Methods for Producing the Same) 11,769,597 (Methods of Associating Genetic Variants with a Clinical Outcome in Patients Suffering from Age-Related Macular Degeneration Treated with Anti-VEGF) 11,788,102 (CHO Integration Sites and Uses Thereof) 11,793,926 (Medical Device Packaging and Related Methods)

Plaintiffs
Regeneron Pharmaceuticals, Inc.

Defendants
Celltrion, Inc.

Status
Case Ongoing

BPCIA
Y

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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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