Herceptin® (trastuzumab)

BL 103792

Herceptin® (trastuzumab)

BL 103792

U.S. License Holder:

Genentech

Date of License:

September-25-1998

Last Update:

December-09-2018

approved_indications FDA-Approved Indications


HERCEPTIN (trastuzumab) is a HER2/neu receptor antagonist indicated for:

The treatment of HER2 overexpressing breast cancer;

The treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.

approved_indications aBLA / 505(b)(2) Activity


aBLA / 505(b)(2) Approved by FDA

Ogivri: Mylan / Biocon (December-2017)

aBLA / 505(b)(2) Accepted by FDA

ABP 980: Amgen / Allergan (Submitted July-2017; Complete Response Letter June-2018) Herzuma®: Teva / Celltrion (Submitted July-2017; Complete Response Letter April-2018; Resubmitted June-2018) PF-05280014: Pfizer (Accepted August-2017; Complete Response Letter April-2018) SB3: Samsung Bioepis (Accepted December-2017)

approved_indications Approved Foreign Follow-On Biologics / Biosimilars


Biosimilars Approved In The E.U.

Herzuma® (Celltrion) (February- 2018)
Kanjinti (Amgen) (May-2018);
Ontruzant (Samsung Bioepis) (November-2017)
Trazimera (Pfizer) (July-2018)

Biosimilars Approved In Australia

Herzuma® (Celltrion) (August-2018)

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)
Samfenet (Samsung Bioepis) (November-2017)

approved_indications 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

Claim Types Challenged Under § 102
Composition of Matter

§ 102 Challenge Instituted
Terminated Prior to Institution Decision

§ 103 challenge
Y

Claim Types Challenged Under § 103
Composition of Matter

§ 103 Challenge Instituted
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

Claim Types Challenged Under § 103
Composition of Matter

§ 103 Challenge Instituted
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

Claim Types Challenged Under § 102
Manufacturing

§ 102 Challenge Instituted
Y

§ 103 challenge
Y

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 Appeal Pending

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

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

IPR Status
Final Written Decision (All Instituted Claims Found Unpatentable); Federal Circuit Appeal Pending

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

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
Y

Final Written Decision Issued
Y

Federal Circuit Appeal(s)
19-1265

IPR Status
Final Written Decision (All Instituted Claims Found Unpatentable); Federal Circuit Appeal Pending

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

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

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 Terminated as to Hospiral and Pfizer

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

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 Terminated as to Hospiral and Pfizer

U.S. Patent No.
8,591,897 (Anti-ErbB2 Antibody Adjuvant Therapy)

Patent Owner
Genentech, Inc.

Petitioner(s)
Celltrion, Inc.

§ 102 Challenge
Y

Claim Types Challenged Under § 102
Method of Treatment

§ 102 Challenge Instituted
N/A

§ 103 challenge
Y

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
N/A

Settled / Challenged Claims Disclaimed / Challenge Terminated
Y- Patent Owner Requested Adverse Judgment and Claim Cancellation 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

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
Y

Final Written Decision Issued
Y

Federal Circuit Appeal(s)
19-1267

IPR Status
Final Written Decision (All Instituted Claims Found Unpatentable); Federal Circuit Appeal Pending

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

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
Y

Final Written Decision Issued
Y

Federal Circuit Appeal(s)
19-1270

IPR Status
Final Written Decision (All Instituted Claims Found Unpatentable); Federal Circuit Appeal Pending

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

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
Y

Final Written Decision Issued
Y

Federal Circuit Appeal(s)
19-1258

IPR Status
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)
Celltrion, Inc.; Celltrion Healthcare Co., Ltd.; Teva Pharmaceuticals International GmbH

§ 102 Challenge
N

§ 103 challenge
Y

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
Y

Final Written Decision Issued
Y

Federal Circuit Appeal(s)
19-1259

IPR Status
Final Written Decision (No Instituted Claim Found Unpatentable); Federal Circuit Appeal Pending

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

Claim Types Challenged Under § 103
Composition of Matter

§ 103 Challenge Instituted
Y

IPR Status
IPR Trial Ongoing

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

Claim Types Challenged Under § 102
Composition of Matter

§ 102 Challenge Instituted
Y

§ 103 challenge
Y

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

Claim Types Challenged Under § 102
Composition of Matter

§ 102 Challenge Instituted
Y

§ 103 challenge
Y

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

Claim Types Challenged Under § 103
Composition of Matter

§ 103 Challenge Instituted
Y

IPR Status
IPR Trial Ongoing

U.S. Patent No.
8,591,897 (Anti-ErbB2 Antibody Adjuvant Therapy)

Patent Owner
Genentech, Inc.

Petitioner(s)
Pfizer, Inc.

§ 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

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

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

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.
6,339,142 (Protein Purification)

Patent Owner
Genentech, Inc.

Petitioner(s)
Pfizer, Inc.

§ 102 Challenge
Y

Claim Types Challenged Under § 102
Composition of Matter Formulation

§ 102 Challenge Instituted
Y

§ 103 challenge
Y

Claim Types Challenged Under § 103
Composition of Matter Formulation

§ 103 Challenge Instituted
Y

IPR Status
Joint Motion to Terminated Filed

U.S. Patent No.
9,249,218 (Protein Purification)

Patent Owner
Genentech, Inc.

Petitioner(s)
Pfizer, Inc.

§ 102 Challenge
Y

Claim Types Challenged Under § 102
Formulation

§ 102 Challenge Instituted
Y

§ 103 challenge
Y

Claim Types Challenged Under § 103
Formulation

§ 103 Challenge Instituted
Y

IPR Status
Joint Motion to Terminated Filed

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

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

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)
Pfizer, Inc.

§ 102 Challenge
N

§ 103 challenge
Y

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

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

Claim Types Challenged Under § 102
Composition of Matter Formulation

§ 102 Challenge Instituted
N

§ 103 challenge
Y

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

Claim Types Challenged Under § 102
Formulation

§ 102 Challenge Instituted
N

§ 103 challenge
Y

Claim Types Challenged Under § 103
Formulation

§ 103 Challenge Instituted
N

IPR Status
IPR Not Instituted; Motion for Joinder with IPR2017-02020 Denied

approved_indications 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)

Plaintiffs
Genentech, Inc.; City of Hope

Defendants
Pfizer, Inc.

Status
Dismissed (Settled)

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
Case Ongoing

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)

Plaintiffs
City of Hope; Genentech, Inc.

Defendants
Amgen Inc.

Status
Case Ongoing

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
Case Ongoing; Consolidated with lead case 1:18-cv-00095 (D. Del.)

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
Case Ongoing

BPCIA
Y

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.
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 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

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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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