SB3 (trastuzumab)

SB3 Approval Pending

SB3 (trastuzumab)

SB3 Approval Pending

U.S. License Holder:

Samsung Bioepsis Co. Ltd.

Date of License:

aBLA accepted by FDA December-2017

Last Update:

December-09-2018

approved_indications FDA-Approved Indications


SB3 (trastuzumab) is not FDA-approved. An aBLA has been accepted by the FDA.

approved_indications Inter Partes Review Proceedings

PTAB Portal

IPR Case No(s):

U.S. Patent No.
6,627,196 (Dosages for Treatment with Anti-ErbB2 Antibodies)

Patent Owner
Genentech, Inc.

Petitioner(s)
Samsung Bioepis, Co., Ltd.

§ 102 Challenge
N

§ 103 challenge
Y

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
Y; Joined with IPR2017-00804

Final Written Decision Issued
Y

Federal Circuit Appeal(s)
19-1174

IPR Status
Joined with IPR2017-00804; Final Written Decision (No Instituted Claim Found Unpatentable); Federal Circuit Appeal Pending

U.S. Patent No.
7,371,379 (Dosages for Treatment with Anti-ErbB2 Antibodies)

Patent Owner
Genentech, Inc.

Petitioner(s)
Samsung Bioepis, Co., Ltd.

§ 102 Challenge
N

§ 103 challenge
Y

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
Y; Joined with IPR2017-00805

Final Written Decision Issued
Y

Federal Circuit Appeal(s)
19-1173

IPR Status
IPR Trial Ongoing; Joined with IPR2017-00805; Final Written Decision (No Instituted Claim Found Unpatentable); Federal Circuit Appeal Pending

U.S. Patent No.
7,892,549 (Treatment with Anti-ErbB2 Antibodies)

Patent Owner
Genentech, Inc.

Petitioner(s)
Samsung Bioepis, Co., Ltd.

§ 102 Challenge
N

§ 103 challenge
Y

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
Y; Joined with IPR2017-00737

Final Written Decision Issued
Y

IPR Status
Joined with IPR2017-00737; Final Written Decision (All Instituted Claims Found Unpatentable)

U.S. Patent No.
6,407,213 (Method for Making Humanized Antibodies)

Patent Owner
Genentech, Inc.

Petitioner(s)
Samsung Bioepis, Co., Ltd.

§ 102 Challenge
Y

Claim Types Challenged Under § 102
Composition of Matter

§ 102 Challenge Instituted
Y; Joined with IPR2017-01488

§ 103 challenge
Y

Claim Types Challenged Under § 103
Composition of Matter

§ 103 Challenge Instituted
Y; Joined with IPR2017-01488

Final Written Decision Issued
Y

IPR Status
Joined with IPR2017-01488; Final Written Decision (Some Instituted Claims Found Unpatentable)

U.S. Patent No.
6,407,213 (Method for Making Humanized Antibodies)

Patent Owner
Genentech, Inc.

Petitioner(s)
Samsung Bioepis, Co., Ltd.

§ 102 Challenge
N

§ 103 challenge
Y

Claim Types Challenged Under § 103
Composition of Matter

§ 103 Challenge Instituted
Y; Joined with IPR2017-01489

IPR Status
IPR Trial Ongoing; Joined with IPR2017-01489

U.S. Patent No.
7,846,441 (Treatment with Anti-ERBB2 Antibodies)

Patent Owner
Genentech, Inc.

Petitioner(s)
Samsung Bioepis, Co., Ltd.

§ 102 Challenge
N

§ 103 challenge
Y

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
N

IPR Status
IPR Not Instituted

approved_indications U.S. Patent Litigations

PACER

Case No(s):

U.S. Patent Nos.
6,331,415 (Methods of Producing Immunoglobulins, Vectors and Transformed Host Cells for Use Therein) 6,339,142 (Protein Purification) 6,407,213 (Method for Making Humanized Antibodies) 6,417,335 (Protein Purification) 6,610,516 (Cell Culture Process) 6,627,196 (Dosages for Treatment with Anti-ErbB2 Antibodies) 7,371,379 (Dosages for Treatment with Anti-ErbB2 Antibodies) 7,390,660 (Methods for Growing Mammalian Cells In Vitro) 7,485,704 (Reducing Protein A Leaching During Protein A Affinity Chromatography) 7,807,799 (Reducing Protein A Leaching During Protein A Affinity Chromatography) 7,846,441 (Treatment with Anti-ERBB2 Antibodies) 7,892,549 (Treatment with anti-ErbB2 antibodies) 7,923,221 (Methods of Making Antibody Heavy and Light Chains having Specificity for a Desired Antigen) 7,993,834 (Detection of ErbB2 Gene Amplification to Increase the Likelihood of the Effectiveness of ErbB2 Antibody Breast Cancer Therapy) 8,076,066 (Gene Detection Assay for Improving the Likelihood of an Effective Response to a HER2 Antibody Cancer Therapy) 8,425,908 (Treatment with Anti-ErbB2 Antibodies) 8,440,402 (Gene Detection Assay for Improving the Likelihood of an Effective Response to a HER2 Antibody Cancer Therapy) 8,512,983 (Production of Proteins in Glutamine-Free Cell Culture Media) 8,574,869 (Prevention of Disulfide Bond Reduction During Recombinant Production of Polypeptides) 9,249,218 (Protein Purification) 9,714,293 (Production of Proteins in Glutamine-free Cell Culture Media)

Plaintiffs
City of Hope; Genentech, Inc.

Defendants
Samsung Bioepis Co., Ltd.

Status
Case Ongoing

BPCIA
Y

Methodology

Information contained in the Venable Fitzpatrick 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 Fitzpatrick BiologicsHQ database.

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