Eylea® (aflibercept)

BL 125387

Eylea® (aflibercept)

BL 125387

U.S. License Holder:

Regeneron Pharmaceuticals

Date of License:

November-18-2011

Last Update:

Apr-08-2024

approved_indications FDA-Approved Indications


EYLEA (aflibercept) is a vascular endothelial growth factor (VEGF) inhibitor indicated for the treatment of patients with:

Neovascular (Wet) Age-Related Macular Degeneration (AMD);

Macular Edema Following Retinal Vein Occlusion (RVO);

Diabetic Macular Edema (DME);

Diabetic Retinopathy (DR);

Retinopathy of Prematurity (ROP).

approved_indications aBLA / 505(b)(2) Activity


aBLA / 505(b)(2) Accepted by FDA

M710: Biocon (Mylan) / Momenta (October-2021) CT-P42: Celltrion (June-2023) FYB203: Formycon / Klinge Biopharma (August-2023) ABP 938: Amgen (October-2023) SB15: Samsung Bioepis (Filing Date Undisclosed)

approved_indications Approved Foreign Follow-On Biologics / Biosimilars


Biosimilars Approved In The E.U.

Yesafili® (Biocon) (September-2023 in the EU; November-2023 in the UK)

Biosimilars Approved In South Korea

Afilivu (Samsung Bioepis / Samil) (February-2024)

approved_indications Inter Partes Review Proceedings

PTAB Portal

IPR Case No(s):

U.S. Patent No.
9,220,631 (Syringe)

Patent Owner
Novartis Pharma AG; Novartis Pharmaceuticals Corporation; Novartis Technology LLC

Petitioner(s)
Regeneron Pharmaceuticals, Inc.

§ 102 Challenge
N

§ 103 challenge
Y: Claims 1-26

Claim Types Challenged Under § 103
Method of Treatment Other

§ 103 Challenge Instituted
N

IPR Status
IPR Not Instituted; Request for Rehearing Withdrawn

U.S. Patent No.
9,220,631 (Syringe)

Patent Owner
Novartis Pharma AG; Novartis Pharmaceuticals Corporation; Novartis Technology LLC

Petitioner(s)
Regeneron Pharmaceuticals, Inc.

§ 102 Challenge
N

§ 103 challenge
Y: Claims 1-26

Claim Types Challenged Under § 103
Method of Treatment Other

§ 103 Challenge Instituted
Terminated Prior to Institution Decision

Settled / Challenged Claims Disclaimed / Challenge Terminated
Y (Terminated Prior to Institution Decision at Petitioner's Request)

IPR Status
Terminated Prior to Institution Decision at Petitioner's Request

U.S. Patent No.
9,220,631 (Syringe)

Patent Owner
Novartis Pharma AG; Novartis Pharmaceuticals Corporation; Novartis Technology LLC

Petitioner(s)
Regeneron Pharmaceuticals, Inc.

§ 102 Challenge
N

§ 103 challenge
Y: Claims 1-26

Claim Types Challenged Under § 103
Method of Treatment Other

§ 103 Challenge Instituted
No Decision

IPR Status
Administratively Closed, No Decision

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

Patent Owner
Regeneron Pharmaceuticals, Inc.

Petitioner(s)
Chengdu Kanghong Biotechnology Co., Ltd.; Bejing Kanghong Biomedical Co. Ltd.; Chengdu Kanghong Pharmaceutical Group Co. Ltd.

§ 102 Challenge
Y: Claims 1-18

Claim Types Challenged Under § 102
Formulation

§ 102 Challenge Instituted
Terminated Prior to Institution Decision

§ 103 challenge
Y: Claims 1-18

Claim Types Challenged Under § 103
Formulation

§ 103 Challenge Instituted
Terminated Prior to Institution Decision

IPR Status
Terminated Prior to Institution Decision (Petitioner Requested Dismissal)

U.S. Patent No.
9,220,631 (Syringe)

Patent Owner
Novartis Pharma AG; Novartis Pharmaceuticals Corporation; Novartis Technology LLC

Petitioner(s)
Regeneron Pharmaceuticals, Inc.

§ 102 Challenge
N

§ 103 challenge
Y: Claims 1-26

Claim Types Challenged Under § 103
Method of Treatment Other

§ 103 Challenge Instituted
Y

Final Written Decision Issued
Y

Federal Circuit Appeal(s)
23-1334

IPR Status
Final Written Decision (All Challenged Claims Unpatentable); Federal Circuit Appeal Pending

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

Patent Owner
Regeneron Pharmaceuticals, Inc.

Petitioner(s)
Mylan Pharmaceuticals Inc.; Mylan Inc.; Viatris Inc.; Momenta Pharmaceuticals, Inc.; Johnson & Johnson

§ 102 Challenge
Y: Claims 1, 8-12

Claim Types Challenged Under § 102
Method of Treatment

§ 102 Challenge Instituted
Y

§ 103 challenge
Y: Claims 1, 8-12

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
Y

Final Written Decision Issued
Y

Federal Circuit Appeal(s)
23-1395

IPR Status
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)
Mylan Pharmaceuticals Inc.; Mylan Inc.; Viatris Inc.; Momenta Pharmaceuticals, Inc.; Johnson & Johnson

§ 102 Challenge
Y: Claims 1, 3-11, 13-14, 16-24, 26

Claim Types Challenged Under § 102
Method of Treatment

§ 102 Challenge Instituted
Y

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

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
Y

Final Written Decision Issued
Y

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

IPR Status
Final Written Decision (All Challenged Claims Unpatentable); Fed. Cir. Appeal Pending

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 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: 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 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)
Apotex Inc.; Apotex Corp.; Apotex Pharmaceutical Holdings Inc.; Aposhem Delaware Holdings Corporation

§ 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 Pending

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

Patent Owner
Regeneron Pharmaceuticals, Inc.

Petitioner(s)
Apotex Inc.; Apotex Corp.; Apotex Pharmaceutical Holdings Inc.; Aposhem Delaware Holdings Corporation

§ 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 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)
Mylan Pharmaceuticals Inc.; Mylan Inc.; Viatris Inc.; Momenta Pharmaceuticals, Inc.; Johnson & Johnson; Janssen Research & Development LLC

§ 102 Challenge
Y: Claims 1, 3-11, 13-14, 16-24, 26

Claim Types Challenged Under § 102
Method of Treatment

§ 102 Challenge Instituted
Y

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

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
Y

Final Written Decision Issued
Y

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

IPR Status
Final Written Decision (All Challenged Claims Unpatentable); Federal Circuit Appeal Pending

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

Patent Owner
Regeneron Pharmaceuticals, Inc.

Petitioner(s)
Mylan Pharmaceuticals Inc.; Mylan Inc.; Viatris Inc.; Momenta Pharmaceuticals, Inc.; Johnson & Johnson; Janssen Research & Development LLC

§ 102 Challenge
Y: Claims 1-9, 34-39, 41-43, 45

Claim Types Challenged Under § 102
Method of Treatment

§ 102 Challenge Instituted
Y

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

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
Y

Final Written Decision Issued
Y

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

IPR Status
Final Written Decision (All Challenged Claims Unpatentable); Federal Circuit Appeal Pending

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

Patent Owner
Regeneron Pharmaceuticals, Inc.

Petitioner(s)
Apotex Inc.; Apotex Corp.; Apotex Pharmaceutical Holdings Inc.; Aposhem Delaware Holdings Corporation

§ 102 Challenge
Y: Claims 1-5, 8-11, 14, 26-30

Claim Types Challenged Under § 102
Method of Treatment

§ 102 Challenge Instituted
N

§ 103 challenge
Y: Claims 6, 7, 12, 13

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
N

IPR Status
IPR Not Instituted

U.S. Patent No.
10,857,205 (Use of a VEGF Antagonist to Treat Angiogenic Eye Disorders)

Patent Owner
Regeneron Pharmaceuticals, Inc.

Petitioner(s)
Mylan Pharmaceuticals Inc.; Mylan Inc.; Viatris Inc.; Momenta Pharmaceuticals, Inc.; Johnson & Johnson; Janssen Research & Development LLC

§ 102 Challenge
Y: Claims 1-3

Claim Types Challenged Under § 102
Method of Treatment

§ 102 Challenge Instituted
N

§ 103 challenge
Y: Claims 1-3

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
N

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

IPR Status
IPR Not Instituted Due to Disclaimer

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

Patent Owner
Regeneron Pharmaceuticals, Inc.

Petitioner(s)
Samsung Bioepis Co., Ltd.

§ 102 Challenge
N

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

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
Y

IPR Status
Instituted, 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: 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

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 Pending

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 Pending

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

Patent Owner
Regeneron Pharmaceuticals, Inc.

Petitioner(s)
Samsung Bioepis Co., Ltd.

§ 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

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

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

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

Patent Owner
Regeneron Pharmaceuticals, Inc.

Petitioner(s)
Samsung Bioepis Co., Ltd.

§ 102 Challenge
Y: Claims 13-16, 20, 22-24, 29-32, 46-47

Claim Types Challenged Under § 102
Method of Treatment

§ 102 Challenge Instituted
N (Claims Disclaimed)

§ 103 challenge
Y: Claims 10-33

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
Y: Claims 10-12, 17-19, 21, 25-28, 33 (Other Claims Disclaimed)

Settled / Challenged Claims Disclaimed / Challenge Terminated
Y (In Part- Claims 13-14, 22, 29-30 Disclaimed Prior to Petition Filing; Claims 15-16, 20, 23-24, 31

IPR Status
Instituted (Claims 10-12, 17-19, 21, 25-28, 33), Pending; Claims 13-16, 20, 22-24, 29-32, 46-47 Disclaimed

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

Patent Owner
Regeneron Pharmaceuticals, Inc.

Petitioner(s)
Samsung Bioepis Co., Ltd.

§ 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

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

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
Y

IPR Status
Instituted, Pending

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

Patent Owner
Regeneron Pharmaceuticals, Inc.

Petitioner(s)
Samsung Bioepis Co., Ltd.

§ 102 Challenge
Y: Claims 1-18

Claim Types Challenged Under § 102
Formulation

§ 102 Challenge Instituted
Y (Joined)

§ 103 challenge
Y: Claims 1-18

Claim Types Challenged Under § 103
Formulation

§ 103 Challenge Instituted
Y (Joined)

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

IPR Status
Joined with IPR2023-00462; Adverse Judgment After Disclaimer

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

Patent Owner
Regeneron Pharmaceuticals, Inc.

Petitioner(s)
Biocon Biologics Inc.; Biocon Biologics Limited; Biocon Biologics UK Limited; Biocon Limited; Biosimilar Collaborations Ireland Limited; Janssen Research & Development, LLC; Johnson & Johnson; Momenta Pharmaceuticals, Inc.; Mylan Inc.; Mylan Pharmaceuticals Inc.; Viatris Inc.

§ 102 Challenge
N

§ 103 challenge
Y: Claims 10-12, 17-19, 21, 25-28, 33

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
Y (Joined)

IPR Status
Instituted, Pending; Joined with IPR2023-00739

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)

IPR Status
Instituted, Pending; Joined with IPR2023-00884

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

Patent Owner
Regeneron Pharmaceuticals, Inc.

Petitioner(s)
Biocon Biologics Inc.; Biocon Biologics Limited; Biocon Biologics UK Limited; Biocon Limited; Biosimilar Collaborations Ireland Limited; Janssen Research & Development, LLC; Johnson & Johnson; Momenta Pharmaceuticals, Inc.; Mylan Inc.; Mylan Pharmaceuticals Inc.; Viatris 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)

IPR Status
Instituted, Pending; Joined with IPR2023-00884

U.S. Patent No.
10,828,345 (Use of a VEGF Antagonsit to Treat Angiogenic Eye Disorders)

Patent Owner
Regeneron Pharmaceuticals, Inc.

Petitioner(s)
Chengdu Kanghong Biotechnology Co., Ltd.; Bejing Kanghong Biomedical Co. Ltd.; Chengdu Kanghong Pharmaceutical Group Co. Ltd.

§ 102 Challenge
Y: Claims 1-11

Claim Types Challenged Under § 102
Method of Treatment

§ 102 Challenge Instituted
Terminated Prior to Institution Decision

§ 103 challenge
Y: Claims 1-11

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
Terminated Prior to Institution Decision

Settled / Challenged Claims Disclaimed / Challenge Terminated
Y (Petitioner Requested Dismissal)

IPR Status
Terminated Prior to Institution Decision (Petitioner Requested Dismissal)

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):

U.S. Patent Nos.
5,688,688 (Vector for Expression of a Polypeptide in a Mammalian Cell)

Plaintiffs
Novartis Vaccines and Diagnostics, Inc.; Novartis Pharma AG; Grifols Worldwide Operations Limited

Defendants
Regeneron Pharmaceuticals, Inc.

Status
Judgment of Non-Infringement and Order of Dismissal

BPCIA
N

U.S. Patent Nos.
9,220,631 (Syringe)

Plaintiffs
Novartis Pharma AG; Novartis Pharmaceuticals Corporation; Novartis Technology LLC

Defendants
Regeneron Pharmaceuticals, Inc.

Status
Case Stayed Pending Federal Circuit Appeal of Decision in IPR2021-00816

BPCIA
N

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) 9,669,069 (Use of a VEGF Antagonist to Treat Angiogenic Eye Disorders) 9,816,110 (CHO Integration Sites and Uses Thereof) 10,130,681 (Use of a VEGF Antagonist to Treat Angiogenic Eye Disorders) 10,406,226 (Method of Manufacturing VEGF Antagonist Fusion Proteins) 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) 10,857,205 (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) 10,973,879 (Use of a VEGF Antagonist to Treat Angiogenic Eye Disorders) 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) 11,186,625 (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) 11,332,771 (Serum-Free Cell Culture Medium)

Plaintiffs
Regeneron Pharmaceuticals, Inc.

Defendants
Mylan Pharmaceuticals Inc.; Biocon Biologics Inc.; Amgen USA, Inc. (Intervenor)

Federal Circuit Appeal(s)
24-1402 (lead); 24-1405 (cross)

Status
Judgment: Claims 4, 7, 9, 11, 14-17 of U.S. Patent No. 11,084,865 valid and infringed; Claims 6 and 25 of U.S. Patent No. 11,253,572 and Claims 11 and 19 of U.S. Patent No. 10,888,601 invalid and infringed; Federal Circuit Appeals Pending. Summary Judgment of Noninfringement Due to Disclaimer: 10,406,226, 10,464,992, and 10,857,205 Patents

BPCIA
Y

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.

Status
Case Ongoing, Motion for Preliminary Injunction Pending

BPCIA
Y

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) 9,562,238 (Enhanced Expression and Stability Regions) 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) 10,905,786 (Sterilisation Method) 10,918,754 (Sterilisation Method) 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) 11,472,861 (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) 11,535,663 (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)

Plaintiffs
Regeneron Pharmaceuticals, Inc.

Defendants
Samsung Bioepis Co., Ltd.

Status
Case Ongoing, Motion for Preliminary Injunction Pending

BPCIA
Y

U.S. Patent Nos.
7,070,959 (Modified Chimeric Polypeptides with Improved Pharmacokinetic Properties) 7,771,997 (Enhanced Expression and Stability Regions) 9,222,106 (Enhanced Expression and Stability Regions) 9,254,338 (Use of a VEGF Antagonist to Treat Angiogenic Eye Disorders) 9,562,238 (Enhanced Expression and Stability Regions) 9,816,110 (CHO Integration Sites and Uses Thereof) 9,932,605 (Enhanced Expression and Stability Regions) 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) 11,268,109 (CHO Integration Sites and Uses Thereof) 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) 11,472,861 (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) 11,535,663 (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) 11,549,154 (Compositions and Methods for Detecting a Biological Contaminant) 11,555,176 (Cell Culture Medium for Eukaryotic Cells) 11,559,564 (Use of a VEGF Antagonist to Treat Angiogenic Eye Disorders) 11,680,930 (Methods and Systems for Chromatography Data Analysis) 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)

Plaintiffs
Regeneron Pharmaceuticals, Inc.

Defendants
Formycon AG

Status
Case Ongoing, Motion for Preliminary Injunction Pending

BPCIA
Y

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) 9,562,238 (Enhanced Expression and Stability Regions) 9,816,110 (CHO Integration Sites and Uses Thereof) 10,130,681 (Use of a VEGF Antagonist to Treat Angiogenic Eye Disorders) 10,182,969 (Aseptic Piercing System and Method) 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) 10,905,786 (Sterilisation Method) 10,918,754 (Sterilisation Method) 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) 11,103,552 (High Concentration VEGF Receptor Fusion Protein Containing Formulations) 11,104,715 (Methods for Producing Aflibercept in Chemically Defined Media Having Reduced Aflibercept Variants) 11,160,918 (Medical Device Packaging and Related Methods) 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) 11,433,186 (Devices and Methods for Precision Dose Delivery) 11,439,758 (Devices and Methods for Precision Dose Delivery) 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) 11,478,588 (Needle Shield Grip Devices and Related Methods) 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) 11,535,663 (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) 11,577,025 (Devices and Methods for Overfilling Drug Containers) 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) D858,754 (Syringe Cap) D906,102 (Packaging) D934,069 (Packaging) D961,376 (Packaging) D961,377 (Packaging)

Plaintiffs
Regeneron Pharmaceuticals, Inc.

Defendants
Samsung Bioepis Co., Ltd.

Status
Case Ongoing, Motion for Preliminary Injunction Pending

BPCIA
Y

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) 10,464,992 (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) 10,905,786 (Sterilisation Method) 10,918,754 (Sterilisation Method) 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) 11,160,918 (Medical Device Packaging and Related Methods) 11,253,572 (Use of a VEGF Antagonist to Treat Angiogenic Eye Disorders) 11,306,135 (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) 11,505,593 (Anti-VEGF Protein Compositions and Methods for Producing the Same) 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) 11,680,930 (Methods and Systems for Chromatography Data Analysis) 11,707,506 (Use of a VEGF Antagonist to Treat Angiogenic Eye Disorders) 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
Amgen, Inc.

Status
Case Ongoing

BPCIA
Y

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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