Yesafili (aflibercept-jbvf)

aBL 761274

Yesafili (aflibercept-jbvf)

aBL 761274

U.S. License Holder:

Biocon Biologics Inc.

Date of License:

May-20-2024 (Interchangeable)

Last Update:

Dec-15-2024

approved_indications FDA-Approved Indications

YESAFILI (aflibercept-jbvf) 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).

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)

approved_indications Inter Partes Review Proceedings

PTAB Portal

IPR Case No(s):

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: 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 Voluntarily Dismissed

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: 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 Voluntarily Dismissed

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: 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 Voluntarily Dismissed

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: 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 Voluntarily Dismissed

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: 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

IPR2024-00201

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)

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

IPR Status
Joined with IPR2023-00739; Adverse Judgment After Institution Due to Disclaimer

IPR2024-00298

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)

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

approved_indications U.S. Patent Litigations

PACER

Case No(s):

1:22-cv-00061 (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) 9,669,069 (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); 24-2002 (Permanent Injunction)

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 Dismissed Due to Lack of Jurisdiction. Summary Judgment of Noninfringement Due to Disclaimer: 10,406,226, 10,464,992, and 10,857,205 Patents; Permanent Injunction Issued, Federal Circuit Appeal 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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