U.S. License Holder:
Genentech
Date of License:
September-25-1998
Last Update:
Nov-15-2024
FDA-Approved Indications
HERCEPTIN (trastuzumab) is a HER2/neu receptor antagonist indicated in adults for:
The treatment of HER2 overexpressing breast cancer;
The treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. Select patients for therapy based on an FDA-approved companion diagnostic for Herceptin.
aBLA / 505(b)(2) Activity
aBLA / 505(b)(2) Approved by FDA
Ogivri®: Mylan / Biocon (December-2017) Herzuma®: Teva / Celltrion (December-2018) Ontruzant®: Samsung Bioepis (January-2019) Trazimera®: Pfizer (March-2019) Kanjinti® (ABP 980): Amgen / Allergan (June-2019) Hercessi: Accord BioPharma / Shanghai Henlius Biotech (April-2024)
aBLA / 505(b)(2) Accepted by FDA
TX-05: Tanvex (October-2021, CRL August-2022, Resubmitted July-2024) EG12014: Sandoz / EirGenix (December-2021)
Approved Foreign Follow-On Biologics / Biosimilars
Biosimilars Approved In Canada
Adheroza (Intas / Shanghai Henlius Biotech) (August-2024)Herzuma® (Celltrion / Teva) (September-2019) Kanjinti® (Amgen) (February-2020) Ogivri® (Mylan / Biocon) (May-2019) Ontruzant® (Samsung Bioepis) (February-2022) Trazimera® (Pfizer) (August-2019)
Biosimilars Approved In The E.U.
Herwenda® (EirGenix / Sandoz) (November-2023) Herzuma® (Celltrion) (February-2018) Kanjinti® (Amgen / Allergan) (May-2018) Ogivri® (Mylan / Biocon) (December-2018) Ontruzant® (Samsung Bioepis) (November-2017) Trazimera® (Pfizer) (July-2018) Tuznue (Prestige BioPharma) (September-2024)Zercepac (Shanghai Henlius Biotech / Accord Healthcare Ltd.) (July-2020)
Biosimilars Approved In Australia
Herzuma® / Hertuzu® / Simabtra® (Celltrion) (August-2018) Kanjinti® (Amgen) (May-2019) Ogivri® (Mylan / Biocon) (December-2018) Ontruzant® (Samsung Bioepis) (January-2019) Trazimera® (Pfizer) (August-2019) Tuzucip® / Trastucip® (Shanghai Henlius Biotech / Cipla) (July-2022)
Biosimilars Approved In Japan
CT-P6 (Celltrion / Nippon Kayaku) (August-2018) Trastuzumab BS (Daiichi Sankyo) (September-2018)
Biosimilars Approved In South Korea
Herzuma® (Celltrion) (January-2014) Ogivri® (Alvogen Korea) (August-2020)Samfenet (Samsung Bioepis) (November-2017)
Inter Partes Review Proceedings
PTAB Portal
IPR Case No(s):
U.S. Patent No.
6,407,213 (Method for Making Humanized Antibodies)
Patent Owner
Genentech, Inc.
Petitioner(s)
Mylan Pharmaceuticals, Inc.
§ 102 Challenge
Y: Claims 1, 2, 4, 25, 29, 62-66, 71, 72, 75, 76, 78, 80, 81
Claim Types Challenged Under § 102
Composition of Matter
§ 102 Challenge Instituted
Terminated Prior to Institution Decision
§ 103 challenge
Y: Claims 1, 2, 4, 12, 25, 29-31, 33, 42, 60, 62-67, 69, 71-81
Claim Types Challenged Under § 103
Composition of Matter
§ 103 Challenge Instituted
Terminated Prior to Institution Decision
Settled / Challenged Claims Disclaimed / Challenge Terminated
Y (Settled Prior to Institution Decision)
IPR Status
Settled Prior to Institution Decision
U.S. Patent No.
6,407,213 (Method for Making Humanized Antibodies)
Patent Owner
Genentech, Inc.
Petitioner(s)
Mylan Pharmaceuticals, Inc.
§ 102 Challenge
N
§ 103 challenge
Y: Claims 1, 2, 4, 12, 25, 29-31, 33, 42, 60, 62-67, 69, 71-81
Claim Types Challenged Under § 103
Composition of Matter
§ 103 Challenge Instituted
Terminated Prior to Institution Decision
Settled / Challenged Claims Disclaimed / Challenge Terminated
Y (Settled Prior to Institution Decision)
IPR Status
Settled Prior to Institution Decision
U.S. Patent No.
7,807,799 (Reducing Protein A Leaching During Protein A Affinity Chromatography)
Patent Owner
Genentech, Inc.
Petitioner(s)
Hospira, Inc.
§ 102 Challenge
Y: Claims 1, 2, 5
Claim Types Challenged Under § 102
Manufacturing
§ 102 Challenge Instituted
Y
§ 103 challenge
Y: Claims 1-3, 5-11
Claim Types Challenged Under § 103
Manufacturing
§ 103 Challenge Instituted
Y
Final Written Decision Issued
Y
Federal Circuit Appeal(s)
18-1933
IPR Status
Final Written Decision (All Instituted Claims Found Unpatentable); Federal Circuit Affirmed
U.S. Patent No.
7,846,441 (Treatment with anti-ErbB2 antibodies)
Patent Owner
Genentech, Inc.
Petitioner(s)
Hospira, Inc.; Pfizer Inc.
§ 102 Challenge
N
§ 103 challenge
Y: Claims 1-14
Claim Types Challenged Under § 103
Method of Treatment
§ 103 Challenge Instituted
Y (On Request for Rehearing)
Final Written Decision Issued
Y
Federal Circuit Appeal(s)
19-1263 (lead case, consolidated with 19-1267)
IPR Status
Final Written Decision (All Instituted Claims Found Unpatentable); Federal Circuit Appeal Terminated as to Hospira and Pfizer, Affirmed (with US as Intervenor)
U.S. Patent No.
7,892,549 (Treatment with anti-ErbB2 antibodies)
Patent Owner
Genentech, Inc.
Petitioner(s)
Hospira, Inc.; Pfizer Inc.
§ 102 Challenge
N
§ 103 challenge
Y: Claims 1-17
Claim Types Challenged Under § 103
Method of Treatment
§ 103 Challenge Instituted
Y
Final Written Decision Issued
Y
Federal Circuit Appeal(s)
19-1265 (lead case, consolidated with 19-1270)
IPR Status
Final Written Decision (All Instituted Claims Found Unpatentable); Federal Circuit Appeal Dismissed for Hospira, Motion for Samsung Bioepis to Withdraw as a Party Granted, Affirmed (with US as Intervenor)
U.S. Patent No.
7,892,549 (Treatment with Anti-ErbB2 Antibodies)
Patent Owner
Genentech, Inc.
Petitioner(s)
Hospira, Inc.; Pfizer Inc.
§ 102 Challenge
Y: Claims 1-11, 14-17
Claim Types Challenged Under § 102
Method of Treatment
§ 102 Challenge Instituted
N
§ 103 challenge
N
IPR Status
IPR Not Instituted
U.S. Patent No.
6,627,196 (Dosages for Treatment with Anti-ErbB2 Antibodies)
Patent Owner
Genentech, Inc.
Petitioner(s)
Hospira, Inc.; Pfizer Inc.
§ 102 Challenge
N
§ 103 challenge
Y: Claims 1-3, 5, 7, 9-11, 17-33
Claim Types Challenged Under § 103
Method of Treatment
§ 103 Challenge Instituted
Y
Final Written Decision Issued
Y
Federal Circuit Appeal(s)
19-1174
IPR Status
Final Written Decision (No Instituted Claim Found Unpatentable); Federal Circuit Appeal Dismissed
U.S. Patent No.
7,371,379 (Dosages for Treatment with Anti-ErbB2 Antibodies)
Patent Owner
Genentech, Inc.
Petitioner(s)
Hospira, Inc.; Pfizer Inc.
§ 102 Challenge
N
§ 103 challenge
Y: Claims 1-3, 5, 7, 9-11, 16-28, 30-40
Claim Types Challenged Under § 103
Method of Treatment
§ 103 Challenge Instituted
Y
Federal Circuit Appeal(s)
19-1173
IPR Status
Final Written Decision (No Instituted Claim Found Unpatentable); Federal Circuit Appeal Dismissed
U.S. Patent No.
8,591,897 (Anti-ErbB2 Antibody Adjuvant Therapy)
Patent Owner
Genentech, Inc.
Petitioner(s)
Celltrion, Inc.
§ 102 Challenge
Y: Claims 1-13
Claim Types Challenged Under § 102
Method of Treatment
§ 102 Challenge Instituted
Terminated Prior to Institution Decision
§ 103 challenge
Y: Claims 1-13
Claim Types Challenged Under § 103
Method of Treatment
§ 103 Challenge Instituted
Terminated Prior to Institution Decision
Settled / Challenged Claims Disclaimed / Challenge Terminated
Y (All Challenged Claims Cancelled Before Institution Decision)
IPR Status
IPR Terminated Prior to Institution Decision (Patent Owner Requested Adverse Judgment and Claim Cancellation)
U.S. Patent No.
7,846,441 (Treatment with Anti-ERBB2 Antibodies)
Patent Owner
Genentech, Inc.
Petitioner(s)
Celltrion, Inc.; Celltrion Healthcare Co., Ltd.; Teva Pharmaceuticals International GmbH
§ 102 Challenge
N
§ 103 challenge
Y: Claims 1-14
Claim Types Challenged Under § 103
Method of Treatment
§ 103 Challenge Instituted
Y
Final Written Decision Issued
Y
Federal Circuit Appeal(s)
19-1267 (consolidated with lead case 19-1263)
IPR Status
Final Written Decision (All Instituted Claims Found Unpatentable); Federal Circuit Appeal Terminated Due to Settlement with Celltrion and Teva, Affirmed (with US as Intervenor)
U.S. Patent No.
7,892,549 (Treatment with Anti-ERBB2 Antibodies)
Patent Owner
Genentech, Inc.
Petitioner(s)
Celltrion, Inc.; Celltrion Healthcare Co., Ltd.; Teva Pharmaceuticals International GmbH
§ 102 Challenge
N
§ 103 challenge
Y: Claims 1-11, 14-17
Claim Types Challenged Under § 103
Method of Treatment
§ 103 Challenge Instituted
Y
Final Written Decision Issued
Y
Federal Circuit Appeal(s)
19-1270 (consolidated with lead case 19-1265)
IPR Status
Final Written Decision (All Instituted Claims Found Unpatentable); Federal Circuit Appeal Terminated Due to Settlement with Celltrion and Teva, Affirmed (with US as Intervenor)
U.S. Patent No.
6,627,196 (Dosages for Treatment with Anti-ErbB2 Antibodies)
Patent Owner
Genentech, Inc.
Petitioner(s)
Celltrion, Inc.; Celltrion Healthcare Co., Ltd.; Teva Pharmaceuticals International GmbH
§ 102 Challenge
N
§ 103 challenge
Y: Claims 1-3, 5, 7, 9-11, 13-15, 17-33
Claim Types Challenged Under § 103
Method of Treatment
§ 103 Challenge Instituted
Y
Final Written Decision Issued
Y
Federal Circuit Appeal(s)
19-1258 (consolidated with 19-1259)
IPR Status
Final Written Decision (No Instituted Claim Found Unpatentable); Federal Circuit Appeal Dismissed
U.S. Patent No.
7,371,379 (Dosages for Treatment with Anti-ErbB2 Antibodies)
Patent Owner
Genentech, Inc.
Petitioner(s)
Celltrion, Inc.; Celltrion Healthcare Co., Ltd.; Teva Pharmaceuticals International GmbH
§ 102 Challenge
N
§ 103 challenge
Y: Claims 1-3, 5, 7, 9-11, 13-28, 30-40
Claim Types Challenged Under § 103
Method of Treatment
§ 103 Challenge Instituted
Y
Final Written Decision Issued
Y
Federal Circuit Appeal(s)
19-1259 (consolidated with lead case 19-1258)
IPR Status
Final Written Decision (No Instituted Claim Found Unpatentable); Federal Circuit Appeal Dismissed
U.S. Patent No.
6,407,213 (Method for Making Humanized Antibodies)
Patent Owner
Genentech, Inc.
Petitioner(s)
Celltrion Healthcare Co., Ltd.; Celltrion Inc.; Teva Pharmaceuticals International GmbH
§ 102 Challenge
N
§ 103 challenge
Y: Claims 1, 2, 4, 12, 25, 29-31, 33, 42, 60, 62-67, 69, 71-81
Claim Types Challenged Under § 103
Composition of Matter
§ 103 Challenge Instituted
Y
Final Written Decision Issued
Y
IPR Status
Final Written Decision (Some Instituted Claims Unpatentable)
U.S. Patent No.
6,407,213 (Method for Making Humanized Antibodies)
Patent Owner
Genentech, Inc.
Petitioner(s)
Celltrion Healthcare Co., Ltd.; Celltrion Inc.; Teva Pharmaceuticals International GmbH
§ 102 Challenge
Y: Claims 1, 2, 4, 25, 29, 62-64, 66, 71, 75, 76, 78, 80, 81
Claim Types Challenged Under § 102
Composition of Matter
§ 102 Challenge Instituted
Y
§ 103 challenge
Y: Claims 1, 2, 4, 12, 25, 29-31, 33, 42, 60, 62-67, 69, 71-81
Claim Types Challenged Under § 103
Composition of Matter
§ 103 Challenge Instituted
Y
Final Written Decision Issued
Y
IPR Status
Final Written Decision (Some Instituted Claims Unpatentable)
U.S. Patent No.
6,407,213 (Method for Making Humanized Antibodies)
Patent Owner
Genentech, Inc.
Petitioner(s)
Pfizer, Inc.
§ 102 Challenge
Y: Claims 1, 2, 4, 25, 29, 62-64, 66, 67, 71, 72, 75, 76, 80, 81
Claim Types Challenged Under § 102
Composition of Matter
§ 102 Challenge Instituted
Y
§ 103 challenge
Y: Claims 1, 2, 4, 12, 25, 29-31, 33, 42, 60, 62-67, 69, 71-81
Claim Types Challenged Under § 103
Composition of Matter
§ 103 Challenge Instituted
Y
Final Written Decision Issued
Y
IPR Status
Final Written Decision (Some Instituted Claims Unpatentable)
U.S. Patent No.
6,407,213 (Method for Making Humanized Antibodies)
Patent Owner
Genentech, Inc.
Petitioner(s)
Pfizer, Inc.
§ 102 Challenge
N
§ 103 challenge
Y: Claims 1, 2, 4, 12, 25, 29-31, 33, 42, 60, 62-67, 69, 71-81
Claim Types Challenged Under § 103
Composition of Matter
§ 103 Challenge Instituted
Y
Final Written Decision Issued
Y
IPR Status
Final Written Decision (Some Instituted Claims Unpatentable)
U.S. Patent No.
8,591,897 (Anti-ErbB2 Antibody Adjuvant Therapy)
Patent Owner
Genentech, Inc.
Petitioner(s)
Pfizer, Inc.
§ 102 Challenge
Y: Claims 1-13
Claim Types Challenged Under § 102
Method of Treatment
§ 102 Challenge Instituted
N
§ 103 challenge
Y: Claims 1-13
Claim Types Challenged Under § 103
Method of Treatment
§ 103 Challenge Instituted
N
IPR Status
IPR Not Instituted
U.S. Patent No.
8,591,897 (Anti-ErbB2 Antibody Adjuvant Therapy)
Patent Owner
Genentech, Inc.
Petitioner(s)
Pfizer, Inc.
§ 102 Challenge
N
§ 103 challenge
Y: Claims 1-13
Claim Types Challenged Under § 103
Method of Treatment
§ 103 Challenge Instituted
N
IPR Status
IPR Not Instituted
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: Claims 1-3, 5, 7, 9-11, 17-33
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 Dismissed
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: Claims 1-3, 5, 7, 9-11, 16-28, 30-40
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
Joined with IPR2017-00805; Final Written Decision (No Instituted Claim Found Unpatentable); Federal Circuit Appeal Dismissed
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: Claims 1-17
Claim Types Challenged Under § 103
Method of Treatment
§ 103 Challenge Instituted
Y; Joined with IPR2017-00737
Final Written Decision Issued
Y
Federal Circuit Appeal(s)
19-1265
IPR Status
Joined with IPR2017-00737; Final Written Decision (All Instituted Claims Found Unpatentable); Federal Circuit Appeal Terminated as to Hospira, Motion for Samsung Bioepis to Withdraw as a Party Granted, Ongoing with USPTO Director as Intervenor
U.S. Patent No.
6,339,142 (Protein Purification)
Patent Owner
Genentech, Inc.
Petitioner(s)
Pfizer, Inc.
§ 102 Challenge
Y: Claims 1-3
Claim Types Challenged Under § 102
Composition of Matter Formulation
§ 102 Challenge Instituted
Y
§ 103 challenge
Y: Claims 1-3
Claim Types Challenged Under § 103
Composition of Matter Formulation
§ 103 Challenge Instituted
Y
Settled / Challenged Claims Disclaimed / Challenge Terminated
Y (Settled After Institution)
IPR Status
Terminated after Institution due to Settlement
U.S. Patent No.
9,249,218 (Protein Purification)
Patent Owner
Genentech, Inc.
Petitioner(s)
Pfizer, Inc.
§ 102 Challenge
Y: Claims 1, 5-7
Claim Types Challenged Under § 102
Formulation
§ 102 Challenge Instituted
Y
§ 103 challenge
Y: Claims 1, 5-7
Claim Types Challenged Under § 103
Formulation
§ 103 Challenge Instituted
Y
Settled / Challenged Claims Disclaimed / Challenge Terminated
Y (Settled After Institution)
IPR Status
Terminated After Institution due to Settlement
U.S. Patent No.
7,846,441 (Treatment with Anti-ERBB2 Antibodies)
Patent Owner
Genentech, Inc.
Petitioner(s)
Pfizer, Inc.
§ 102 Challenge
N
§ 103 challenge
Y: Claims 1-14
Claim Types Challenged Under § 103
Method of Treatment
§ 103 Challenge Instituted
Y; Joined with IPR2017-01121
Final Written Decision Issued
Y
IPR Status
Joined with IPR2017-01121; 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: Claims 1, 2, 4, 25, 29, 62-64, 66, 67, 71, 72, 75, 76, 80, 81
Claim Types Challenged Under § 102
Composition of Matter
§ 102 Challenge Instituted
Y; Joined with IPR2017-01488
§ 103 challenge
Y: Claims 1, 2, 4, 12, 25, 29-31, 33, 42, 60, 62-67, 69, 71-81
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: Claims 1, 2, 4, 12, 25, 29-31, 33, 42, 60, 62-67, 69, 71-81
Claim Types Challenged Under § 103
Composition of Matter
§ 103 Challenge Instituted
Y; Joined with IPR2017-01489
Final Written Decision Issued
Y
IPR Status
Joined with IPR2017-01489; Final Written Decision (Some Instituted Claims Unpatentable)
U.S. Patent No.
7,846,441 (Treatment with Anti-ERBB2 Antibodies)
Patent Owner
Genentech, Inc.
Petitioner(s)
Pfizer, Inc.
§ 102 Challenge
N
§ 103 challenge
Y: Claims 1-14
Claim Types Challenged Under § 103
Method of Treatment
§ 103 Challenge Instituted
N
IPR Status
IPR Not Instituted
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: Claims 1-14
Claim Types Challenged Under § 103
Method of Treatment
§ 103 Challenge Instituted
N
IPR Status
IPR Not Instituted
U.S. Patent No.
6,339,142 (Protein Purification)
Patent Owner
Genentech, Inc.
Petitioner(s)
Pfizer, Inc.
§ 102 Challenge
Y: Claims 1-3
Claim Types Challenged Under § 102
Composition of Matter Formulation
§ 102 Challenge Instituted
N
§ 103 challenge
Y: Claims 1-3
Claim Types Challenged Under § 103
Composition of Matter Formulation
§ 103 Challenge Instituted
N
IPR Status
IPR Not Instituted; Motion for Joinder with IPR2017-02019 Denied
U.S. Patent No.
9,249,218 (Protein Purification)
Patent Owner
Genentech, Inc.
Petitioner(s)
Pfizer, Inc.
§ 102 Challenge
Y: Claims 1, 5-7
Claim Types Challenged Under § 102
Formulation
§ 102 Challenge Instituted
N
§ 103 challenge
Y: Claims 1, 5-7
Claim Types Challenged Under § 103
Formulation
§ 103 Challenge Instituted
N
IPR Status
IPR Not Instituted; Motion for Joinder with IPR2017-02020 Denied
U.S. Patent Litigations
PACER
Case No(s):
U.S. Patent Nos.
RE40,070 (Antibody Purification) RE41,555 (Antibody Purification)
Plaintiffs
GlaxoSmithKline LLC
Defendants
Genentech, Inc.; Roche Holding Ltd
Status
Dismissed
BPCIA
N
U.S. Patent Nos.
6,121,428 (Protein Recovery) 6,242,177 (Methods and Compositions for Secretion of Heterologous Polypeptides) 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) 6,489,447 (Protein Purification) 6,586,206 (Methods for Making Recombinant Proteins Using Apoptosis Inhibitors) 6,610,516 (Cell Culture Process) 6,620,918 (Separation of Polypeptide Monomers) 6,627,196 (Dosages for Treatment with Anti-ErbB2 Antibodies) 6,716,602 (Metabolic Rate Shifts in Fermentations Expressing Recombinant Proteins) 7,371,379 (Dosages for Treatment with Anti-ErbB2 Antibodies) 7,390,660 (Methods for Growing Mammalian Cells In Vitro) 7,449,184 (Fixed Dosing of HER Antibodies) 7,485,704 (Reducing Protein A Leaching During Protein A Affinity Chromatography) 7,501,122 (Treatment with Anti-ErbB2 Antibody Combinations) 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) 8,044,017 (Protein Purification) 8,076,066 (Gene Detection Assay for Improving the Likelihood of an Effective Response to a HER2 Antibody Cancer Therapy) 8,314,225 (Heavy Chain Mutant Leading to Improved Immunoglobulin Production) 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) 8,460,895 (Method for Producing Recombinant Proteins with a Constant Content of pCO2 in the Medium) 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) 8,633,302 (Variable Tangential Flow Filtration) 8,691,232 (Extending Time to Disease Progression or Survival in Cancer Patients) 8,710,196 (Protein Purification) 8,771,988 (Protein Expression from Multiple Nucleic Acids) 8,822,655 (Pre-filtration Adjustment of Buffer Solutes) 9,249,218 (Protein Purification) 9,428,766 (Protein Expression from Multiple Nucleic Acids) 9,487,809 (Decreasing Lactate Level and Increasing Polypeptide Production by Downregulating the Expression of Lactate Dehydrogenase and Pyruvate Dehydrogenase Kinase) 9,493,744 (Methods for Viral Inactivation and Other Adventitious Agents) 9,714,293 (Production of Proteins in Glutamine-free Cell Culture Media) 9,868,760 (Protein Purification)
Plaintiffs
Genentech, Inc.; City of Hope
Defendants
Pfizer, Inc.
Status
Dismissed due to Settlement
BPCIA
Y
U.S. Patent Nos.
6,121,428 (Protein Recovery) 6,242,177 (Methods and Compositions for Secretion of Heterologous Polypeptides) 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) 6,489,447 (Protein Purification) 6,586,206 (Methods for Making Recombinant Proteins Using Apoptosis Inhibitors 6,610,516 (Cell Culture Process) 6,620,918 (Separation of Polypeptide Monomers) 6,627,196 (Dosages for Treatment with Anti-ErbB2 Antibodies) 6,716,602 (Metabolic Rate Shifts in Fermentations Expressing Recombinant Proteins) 7,371,379 (Dosages for Treatment with Anti-ErbB2 Antibodies) 7,390,660 (Methods for Growing Mammalian Cells In Vitro) 7,449,184 (Fixed Dosing of HER Antibodies) 7,485,704 (Reducing Protein A Leaching During Protein A Affinity Chromatography) 7,501,122 (Treatment with Anti-ErbB2 Antibody Combinations) 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) 8,357,301 (Chromatography Equipment Characterization) 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) 8,460,895 (Method for Producing Recombinant Proteins with a Constant Content of pCO2 in the Medium) 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) 8,633,302 (Variable Tangential Flow Filtration) 8,691,232 (Extending Time to Disease Progression or Survival in Cancer Patients) 8,771,988 (Protein Expression from Multiple Nucleic Acids) 8,822,655 (Pre-filtration Adjustment of Buffer Solutes) 9,047,438 (Chromatography Equipment Characterization) 9,080,183 (Promoter) 9,249,218 (Protein Purification) 9,428,548 (Enhanced Protein Purification Through a Modified Protein A Elution) 9,428,766 (Protein Expression from Multiple Nucleic Acids) 9,487,809 (Decreasing Lactate Level and Increasing Polypeptide Production by Downregulating the Expression of Lactate Dehydrogenase and Pyruvate Dehydrogenase Kinase) 9,714,293 (Production of Proteins in Glutamine-free Cell Culture Media)
Plaintiffs
City of Hope; Genentech, Inc.; Hoffmann-La Roche Inc.
Defendants
Celltrion Healthcare Co., Ltd.; Celltrion, Inc.; Teva Pharmaceuticals International GmbH; Teva Pharmaceuticals USA, Inc.
Status
Dismissed due to Settlement
BPCIA
Y
U.S. Patent Nos.
6,121,428 (Protein Recovery) 6,242,177 (Methods and Compositions for Secretion of Heterologous Polypeptides) 6,331,415 (Methods of Producing Immunoglobulins, Vectors and Transformed Host Cells for Use Therein) 6,407,213 (Method for Making Humanized Antibodies) 6,417,335 (Protein Purification) 6,489,447 (Protein Purification) 6,586,206 (Methods for Making Recombinant Proteins Using Apoptosis Inhibitors 6,620,918 (Separation of Polypeptide Monomers) 6,627,196 (Dosages for Treatment with Anti-ErbB2 Antibodies) 6,870,034 (Protein Purification) 7,371,379 (Dosages for Treatment with Anti-ErbB2 Antibodies) 7,449,184 (Fixed Dosing of HER Antibodies) 7,501,122 (Treatment with Anti-ErbB2 Antibody Combinations) 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) 8,044,017 (Protein Purification) 8,076,066 (Gene Detection Assay for Improving the Likelihood of an Effective Response to a HER2 Antibody Cancer Therapy) 8,314,225 (Heavy Chain Mutant Leading to Improved Immunoglobulin Production) 8,357,301 (Chromatography Equipment Characterization) 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) 8,460,895 (Method for Producing Recombinant Proteins with a Constant Content of pCO2 in the Medium) 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) 8,691,232 (Extending Time to Disease Progression or Survival in Cancer Patients) 8,710,196 (Protein Purification) 8,771,988 (Protein Expression from Multiple Nucleic Acids) 9,047,438 (Chromatography Equipment Characterization) 9,080,183 (Promoter) 9,249,218 (Protein Purification) 9,428,766 (Protein Expression from Multiple Nucleic Acids) 9,487,809 (Decreasing Lactate Level and Increasing Polypeptide Production by Downregulating the Expression of Lactate Dehydrogenase and Pyruvate Dehydrogenase Kinase) 9,493,744 (Methods for Viral Inactivation and Other Adventitious Agents) 9,714,293 (Production of Proteins in Glutamine-free Cell Culture Media) 9,868,760 (Protein Purification) 10,160,811 (Treatment with Anti-ErbB2 Antibodies)
Plaintiffs
City of Hope; Genentech, Inc.
Defendants
Amgen Inc.
Federal Circuit Appeal(s)
19-2156 (TRO and PI)
Status
Federal Circuit Affirmed Denial of of Temporary Restraining Order and Preliminary Injunction; Stipulated Dismissal Due to Settlement
BPCIA
Y
U.S. Patent Nos.
6,121,428 (Protein Recovery) 6,242,177 (Methods and Compositions for Secretion of Heterologous Polypeptides) 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) 6,489,447 (Protein Purification) 6,586,206 (Methods for Making Recombinant Proteins Using Apoptosis Inhibitors 6,610,516 (Cell Culture Process) 6,620,918 (Separation of Polypeptide Monomers) 6,627,196 (Dosages for Treatment with Anti-ErbB2 Antibodies) 6,716,602 (Metabolic Rate Shifts in Fermentations Expressing Recombinant Proteins) 7,371,379 (Dosages for Treatment with Anti-ErbB2 Antibodies) 7,390,660 (Methods for Growing Mammalian Cells In Vitro) 7,449,184 (Fixed Dosing of HER Antibodies) 7,485,704 (Reducing Protein A Leaching During Protein A Affinity Chromatography) 7,501,122 (Treatment with Anti-ErbB2 Antibody Combinations) 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) 8,357,301 (Chromatography Equipment Characterization) 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) 8,460,895 (Method for Producing Recombinant Proteins with a Constant Content of pCO2 in the Medium) 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) 8,633,302 (Variable Tangential Flow Filtration) 8,691,232 (Extending Time to Disease Progression or Survival in Cancer Patients) 8,771,988 (Protein Expression from Multiple Nucleic Acids) 8,822,655 (Pre-filtration Adjustment of Buffer Solutes) 9,047,438 (Chromatography Equipment Characterization) 9,080,183 (Promoter) 9,249,218 (Protein Purification) 9,428,548 (Enhanced Protein Purification Through a Modified Protein A Elution) 9,428,766 (Protein Expression from Multiple Nucleic Acids) 9,487,809 (Decreasing Lactate Level and Increasing Polypeptide Production by Downregulating the Expression of Lactate Dehydrogenase and Pyruvate Dehydrogenase Kinase) 9,714,293 (Production of Proteins in Glutamine-free Cell Culture Media)
Plaintiffs
City of Hope; Genentech, Inc.; Hoffmann-La Roche Inc.
Defendants
Celltrion Healthcare Co., Ltd.; Celltrion, Inc.; Teva Pharmaceuticals International GmbH; Teva Pharmaceuticals USA, Inc.
Status
Consolidated with lead case 1:18-cv-00095 (D. Del.); Dismissed due to Settlement
BPCIA
Y
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
Settled
BPCIA
Y
U.S. Patent Nos.
7,625,558 (Compositions and Methods of Treating Tumors)
Plaintiffs
Trustees of The University of Pennsylvania
Defendants
Genentech, Inc.
Status
Case Ongoing
BPCIA
N
U.S. Patent Nos.
5,849,522 (Enhancer for Eukaryotic Expression Systems) 6,218,140 (Enhancer for Eukaryotic Expression Systems)
Plaintiffs
Sanofi-Aventis Deutschland GmbH; Sanofi-Aventis U.S. LLC; Sanofi-Aventis U.S. Inc.
Defendants
Biogen IDEC, Inc.; Genentech, Inc.
Federal Circuit Appeal(s)
12-1454
Status
Case Terminated
BPCIA
N
U.S. Patent Nos.
5,849,522 (Enhancer for Eukaryotic Expression Systems) 6,218,140 (Enhancer for Eukaryotic Expression Systems)
Plaintiffs
Sanofi-Aventis Deutschland GmbH
Defendants
Biogen IDEC, Inc.; Genentech, Inc.
Federal Circuit Appeal(s)
12-1454
Status
Case Terminated
BPCIA
N
U.S. Patent Nos.
8,574,869 (Prevention of Disulfide Bond Reduction During Recombinant Production of Polypeptides) 10,662,237 (Method to Improve Virus Filtration Capacity) 10,808,037 (Prevention of Disulfide Bond Reduction During Recombinant Production of Polypeptides)
Plaintiffs
Genentech, Inc.
Defendants
Tanvex BioPharma USA, Inc.; Tanvex Biologics Corp.; Tanvex Biologics, Inc.; Tanvex Biopharma, Inc.
Status
Settled
BPCIA
Y
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) 6,489,447 (Protein Purification) 6,586,206 (Methods for Making Recombinant Proteins Using Apoptosis Inhibitors 6,610,516 (Cell Culture Process) 6,620,918 (Separation of Polypeptide Monomers) 6,627,196 (Dosages for Treatment with Anti-ErbB2 Antibodies) 6,716,602 (Metabolic Rate Shifts in Fermentations Expressing Recombinant Proteins) 7,371,379 (Dosages for Treatment with Anti-ErbB2 Antibodies) 7,390,660 (Methods for Growing Mammalian Cells In Vitro) 7,449,184 (Fixed Dosing of HER Antibodies) 7,485,704 (Reducing Protein A Leaching During Protein A Affinity Chromatography) 7,501,122 (Treatment with Anti-ErbB2 Antibody Combinations) 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) 8,357,301 (Chromatography Equipment Characterization) 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) 8,460,895 (Method for Producing Recombinant Proteins with a Constant Content of pCO2 in the Medium) 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) 8,633,302 (Variable Tangential Flow Filtration) 8,691,232 (Extending Time to Disease Progression or Survival in Cancer Patients) 8,771,988 (Protein Expression from Multiple Nucleic Acids) 8,822,655 (Pre-filtration Adjustment of Buffer Solutes) 9,047,438 (Chromatography Equipment Characterization) 9,080,183 (Promoter) 9,249,218 (Protein Purification) 9,428,548 (Enhanced Protein Purification Through a Modified Protein A Elution) 9,428,766 (Protein Expression from Multiple Nucleic Acids) 9,487,809 (Decreasing Lactate Level and Increasing Polypeptide Production by Downregulating the Expression of Lactate Dehydrogenase and Pyruvate Dehydrogenase Kinase) 9,714,293 (Production of Proteins in Glutamine-free Cell Culture Media)
Plaintiffs
Celltrion Healthcare Co., Ltd.; Celltrion, Inc.; Teva Pharmaceuticals International GmbH; Teva Pharmaceuticals USA, Inc.
Defendants
City of Hope; Genentech, Inc.; Hoffmann-La Roche Inc.
Federal Circuit Appeal(s)
18-2160 (Consolidated with 18-2161; 18-2160 is Lead Appeal)
Status
Dismissed for Failure to State a Claim; Federal Circuit Appeal Voluntarily Dismissed
BPCIA
Y
U.S. Patent Nos.
6,733,752 (Prevention of Tumors with Monoclonal Antibodies Against Neu)
Plaintiffs
Genentech, Inc.
Defendants
The Trustees Of The University Of Pennsylvania
Status
Dismissed
BPCIA
N
U.S. Patent Nos.
RE40,070 (Antibody Purification) RE41,555 (Antibody Purification)
Plaintiffs
Genentech, Inc.
Defendants
GlaxoSmithKline LLC
Status
Dismissed
BPCIA
N
