Eylea® (aflibercept)

BL 125387

Eylea® (aflibercept)

BL 125387

U.S. License Holder:

Regeneron Pharmaceuticals

Date of License:

November-18-2011

Last Update:

May-23-2023

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: Mylan / Momenta (October-2021)

approved_indications Inter Partes Review Proceedings

PTAB Portal

IPR Case No(s):

IPR2020-01317

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

Claim Types Challenged Under § 103
Method of Treatment Other

§ 103 Challenge Instituted
N

IPR Status
IPR Not Instituted; Request for Rehearing Withdrawn

IPR2020-01318

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

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

IPR2020-01320

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

Claim Types Challenged Under § 103
Method of Treatment Other

§ 103 Challenge Instituted
No Decision

IPR Status
Administratively Closed, No Decision

IPR2021-00402

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

Claim Types Challenged Under § 102
Formulation

§ 102 Challenge Instituted
Terminated Prior to Institution Decision

§ 103 challenge
Y

Claim Types Challenged Under § 103
Formulation

§ 103 Challenge Instituted
Terminated Prior to Institution Decision

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

IPR2021-00816

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

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

IPR2021-00880

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

Claim Types Challenged Under § 102
Method of Treatment

§ 102 Challenge Instituted
Y

§ 103 challenge
Y

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

IPR2021-00881

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

Claim Types Challenged Under § 102
Method of Treatment

§ 102 Challenge Instituted
Y

§ 103 challenge
Y

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

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

IPR2022-00298

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

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

IPR2022-00301

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

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

IPR2022-01225

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

Claim Types Challenged Under § 102
Method of Treatment

§ 102 Challenge Instituted
Y

§ 103 challenge
Y

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
Y

IPR Status
Instituted, Pending

IPR2022-01226

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

Claim Types Challenged Under § 102
Method of Treatment

§ 102 Challenge Instituted
Y

§ 103 challenge
Y

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
Y

IPR Status
Instituted, Pending

IPR2022-01524

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

Claim Types Challenged Under § 102
Method of Treatment

§ 102 Challenge Instituted
N

§ 103 challenge
Y

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
N

IPR Status
IPR Not Instituted

IPR2023-00099

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

Claim Types Challenged Under § 102
Method of Treatment

§ 102 Challenge Instituted
N

§ 103 challenge
Y

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

IPR2023-00442

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

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
Awaiting Institution Decision

IPR Status
Awaiting Institution Decision

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
Awaiting Institution Decision

§ 103 challenge
Y

Claim Types Challenged Under § 103
Formulation

§ 103 Challenge Instituted
Awaiting Institution Decision

IPR Status
Awaiting Institution Decision

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

IPR2023-00566

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

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
Awaiting Institution Decision

IPR Status
Awaiting Institution Decision

IPR2023-00739

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

Claim Types Challenged Under § 102
Method of Treatment

§ 102 Challenge Instituted
Awaiting Institution Decision

§ 103 challenge
Y

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
Awaiting Institution Decision

IPR Status
Awaiting Institution Decision

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)
Samsung Bioepis Co., Ltd.

§ 102 Challenge
Y

Claim Types Challenged Under § 102
Method of Treatment

§ 102 Challenge Instituted
Awaiting Institution Decision

§ 103 challenge
Y

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
Awaiting Institution Decision

IPR Status
Awaiting Institution Decision

PGR2021-00035

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

Claim Types Challenged Under § 102
Method of Treatment

§ 102 Challenge Instituted
Terminated Prior to Institution Decision

§ 103 challenge
Y

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
Terminated Prior to Institution Decision

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

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

approved_indications U.S. Patent Litigations

PACER

Case No(s):

1:18-cv-02434 (S.D.N.Y.)

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

1:20-cv-00690 (N.D.N.Y.)

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

1:22-cv-00061 (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) 9,669,069 (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.

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.

Disclaimer

The individuals who maintain this site work for Venable LLP. The information, comments and links posted on this site do not constitute legal advice. No attorney-client relationship has been or will be formed by any communication(s) to, from or with the site and/or the author. For legal advice, contact an attorney at Venable LLP or an attorney actively practicing in your jurisdiction. Do not send any confidential or privileged information to the author; neither Venable LLP nor the author will assume any liability or responsibility for it. If you send any information, documents or materials to the site, you give permission for the author to include them on or in the site. No information, documents or materials you send to the site will be considered confidential or privileged by Venable LLP or its lawyers. Also, no such information, documents or materials will be returned to you. All decisions relating to the content belong to the author.

Subscribe for Future Updates

    captcha