Opuviz (aflibercept-yszy)

aBL 761350

Opuviz (aflibercept-yszy)

aBL 761350

U.S. License Holder:

Samsung Bioepis

Date of License:

May-20-2024 (Interchangeable)

Last Update:

Nov-15-2024

approved_indications FDA-Approved Indications

OPUVIZ (aflibercept-yszy) 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 South Korea

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

approved_indications Inter Partes Review Proceedings

PTAB Portal

IPR Case No(s):

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: 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

IPR Status
Final Written Decision (All Challenged Claims Unpatentable)

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: 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

IPR2023-00739

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: 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 (Disclaimed In Part- Claims 13-14, 22, 29-30 Disclaimed Prior to Petition Filing; Claims 15-16, 20

IPR Status
Claims 13-14, 22, 29-30 Disclaimed Prior to Petition Filing; Claims 15-16, 20, 23-24, 31-32, 46-47 Disclaimed Prior to Institution Decision; Adverse Judgment After Institution Due to Disclaimer of Claims 10-12, 17-19, 21, 25-28, 33

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: 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

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

IPR Status
Adverse Judgment After Institution Due to Disclaimer

IPR2023-01312

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

approved_indications U.S. Patent Litigations

PACER

Case No(s):

1:23-cv-00094 (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) 9,562,238 (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.

Federal Circuit Appeal(s)
Preliminary Injunction: 24-1966, 24-2083 (both consolidated with 24-1965 lead)

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

BPCIA
Y

1:23-cv-00106 (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) 9,562,238 (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.

Federal Circuit Appeal(s)
Preliminary Injunction: 24-1965 (lead); 24-2082 (consolidated)

Status
Case Ongoing, Preliminary Injunction Granted, Federal Circuit Appeals 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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