Genentech Cabilly

Genentech Cabilly

U.S. License Holder:

Genentech

Date of License:

N/A

Last Update:

November-30-2018

approved_indications FDA-Approved Indications


N/A

approved_indications Inter Partes Review Proceedings

PTAB Portal

IPR Case No(s):

U.S. Patent No.
6,331,415 (Methods of Producing Immunoglobulins, Vectors and Transformed Host Cells for Use Therein)

Patent Owner
Genentech, Inc.; City of Hope

Petitioner(s)
Regeneron Pharmaceuticals, Inc.; Sanofi; Sanofi-Aventis US LLC

§ 102 Challenge
Y

Claim Types Challenged Under § 102
Manufacturing Other (Vector, Host Cell)

§ 102 Challenge Instituted
N

§ 103 challenge
Y

Claim Types Challenged Under § 103
Manufacturing Other (Host Cell)

§ 103 Challenge Instituted
Y

Settled / Challenged Claims Disclaimed / Challenge Terminated
Y- Settled After Institution

IPR Status
Settled After Institution

U.S. Patent No.
6,331,415 (Methods of Producing Immunoglobulins, Vectors and Transformed Host Cells for Use Therein)

Patent Owner
Genentech, Inc.; City of Hope

Petitioner(s)
Genzyme Corp.; Sanofi

§ 102 Challenge
Y

Claim Types Challenged Under § 102
Manufacturing Other (Vector, Host Cell)

§ 102 Challenge Instituted
N

§ 103 challenge
Y

Claim Types Challenged Under § 103
Manufacturing Other (Vector, Host Cell)

§ 103 Challenge Instituted
N

IPR Status
IPR Not Instituted

U.S. Patent No.
6,331,415 (Methods of Producing Immunoglobulins, Vectors and Transformed Host Cells for Use Therein)

Patent Owner
Genentech, Inc.; City of Hope

Petitioner(s)
Genzyme Corp.; Sanofi

§ 102 Challenge
Y

Claim Types Challenged Under § 102
Manufacturing Other (Vector, Host Cell)

§ 102 Challenge Instituted
N

§ 103 challenge
Y

Claim Types Challenged Under § 103
Manufacturing Other (Host Cell)

§ 103 Challenge Instituted
Y

Settled / Challenged Claims Disclaimed / Challenge Terminated
Y- Settled After Institution

IPR Status
Joined with IPR2015-01624; Settled After Institution

U.S. Patent No.
6,331,415 (Methods of Producing Immunoglobulins, Vectors and Transformed Host Cells for Use Therein)

Patent Owner
Genentech, Inc.; City of Hope

Petitioner(s)
Biocon Ltd.; Biocon Research Ltd.; Mylan FmbH; Mylan Inc.; Mylan Institutional LLC; Mylan NV; Mylan Pharmaceuticals Inc.; (Joined - Merck Sharp & Dohme Corp.)

§ 102 Challenge
N

§ 103 challenge
Y

Claim Types Challenged Under § 103
Manufacturing

§ 103 Challenge Instituted
Y

Settled / Challenged Claims Disclaimed / Challenge Terminated
Y- Settled After Institution

IPR Status
Settled After Institution

U.S. Patent No.
6,331,415 (Methods of Producing Immunoglobulins, Vectors and Transformed Host Cells for Use Therein)

Patent Owner
Genentech, Inc.; City of Hope

Petitioner(s)
Merck Sharp and Dohme Corp.

§ 102 Challenge
N

§ 103 challenge
Y

Claim Types Challenged Under § 103
Manufacturing Other (Vector, Host Cell)

§ 103 Challenge Instituted
N

IPR Status
IPR Not Instituted

U.S. Patent No.
6,331,415 (Methods of Producing Immunoglobulins, Vectors and Transformed Host Cells for Use Therein)

Patent Owner
Genentech, Inc.; City of Hope

Petitioner(s)
Merck Sharp and Dohme Corp.

§ 102 Challenge
N

§ 103 challenge
Y

Claim Types Challenged Under § 103
Manufacturing

§ 103 Challenge Instituted
Y

IPR Status
IPR Trial Ongoing; Joined with IPR2016-00710

approved_indications U.S. Patent Litigations

PACER

Case No(s):

U.S. Patent Nos.
4,816,567 (Recombinant Immunoglobin Preparations)

Plaintiffs
Human Genome Sciences Inc.

Defendants
City Of Hope; Genentech, Inc.

Status
Transferred (2:11-cv-06519 (C.D. Cal.))

BPCIA
N

U.S. Patent Nos.
7,923,221 (Methods of Making Antibody Heavy and Light Chains having Specificity for a Desired Antigen)

Plaintiffs
Human Genome Sciences Inc.

Defendants
City Of Hope; Genentech, Inc.

Status
Transferred (2:11-cv-06594 (C.D. Cal.))

BPCIA
N

U.S. Patent Nos.
6,054,297 (Humanized Antibodies and Methods for Making Them) 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) 6,586,206 (Methods for Making Recombinant Proteins Using Apoptosis Inhibitors) 6,620,918 (Separation of Polypeptide Monomers) 6,870,034 (Protein Purification) 6,884,879 (Anti-VEGF Antibodies) 7,060,269 (Anti-VEGF Antibodies) 7,169,901 (Anti-VEGF Antibodies) 7,375,193 (Anti-VEGF Antibodies) 7,622,115 (Treatment With Anti-VEGF Antibodies) 7,807,799 (Reducing Protein A Leaching During Protein A Affinity Chromatography) 7,923,221 (Methods of Making Antibody Heavy and Light Chains having Specificity for a Desired Antigen) 8,044,017 (Protein Purification) 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) 8,710,196 (Protein Purification) 9,441,035 (Cell Culture Media and Methods of Antibody Production) 9,487,809 (Decreasing Lactate Level and Increasing Polypeptide Production by Downregulating the Expression of Lactate Dehydrogenase and Pyruvate Dehydrogenase Kinase) 9,795,672 (Treatment with Anti-VEGF Antibodies)

Plaintiffs
Genentech, Inc.; City of Hope

Defendants
Amgen Inc.

Status
Case Ongoing; Consolidated with 1:17-cv-01471 (D. Del.)

BPCIA
Y

U.S. Patent Nos.
6,054,297 (Humanized Antibodies and Methods for Making Them) 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) 6,586,206 (Methods for Making Recombinant Proteins Using Apoptosis Inhibitors) 6,620,918 (Separation of Polypeptide Monomers) 6,870,034 (Protein Purification) 6,884,879 (Anti-VEGF Antibodies) 7,060,269 (Anti-VEGF Antibodies) 7,169,901 (Anti-VEGF Antibodies) 7,297,334 (Anti-VEGF Antibodies) 7,375,193 (Anti-VEGF Antibodies) 7,622,115 (Treatment With Anti-VEGF Antibodies) 7,807,799 (Reducing Protein A Leaching During Protein A Affinity Chromatography) 7,923,221 (Methods of Making Antibody Heavy and Light Chains having Specificity for a Desired Antigen) 8,044,017 (Protein Purification) 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) 8,710,196 (Protein Purification) 9,441,035 (Cell Culture Media and Methods of Antibody Production) 9,487,809 (Decreasing Lactate Level and Increasing Polypeptide Production by Downregulating the Expression of Lactate Dehydrogenase and Pyruvate Dehydrogenase Kinase) 9,795,672 (Treatment with Anti-VEGF Antibodies)

Plaintiffs
Genentech, Inc.; City of Hope

Defendants
Amgen Inc.

Status
Case Ongoing; Consolidated with Lead Case 1:17-cv-01407 (D. Del.)

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) 8,044,017 (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
Case Ongoing

BPCIA
Y

U.S. Patent Nos.
6,121,428 (Protein Recovery) 6,331,415 (Methods of Producing Immunoglobulins, Vectors and Transformed Host Cells for Use Therein) 6,489,447 (Protein Purification) 6,610,516 (Cell Culture Process) 6,620,918 (Separation of Polypeptide Monomers) 6,870,034 (Protein Purification) 7,381,560 (Expression and Use of Anti-CD20 Antibodies) 7,485,704 (Reducing Protein A Leaching During Protein A Affinity Chromatography) 7,807,799 (Reducing Protein A Leaching During Protein A Affinity Chromatography) 7,820,161 (Treatment of Autoimmune Diseases) 7,923,221 (Methods of Making Antibody Heavy and Light Chains having Specificity for a Desired Antigen) 7,976,838 (Therapy of Autoimmune Disease in a Patient with an Inadequate Response to a TNF-alpha Inhibitor) 8,206,711 (Treatment of Chronic Lymphocytic Leukemia Using Anti-CD20 Antibodies) 8,314,225 (Heavy Chain Mutant Leading to Improved Immunoglobulin Production) 8,329,172 (Combination Therapies For B-Cell Lymphomas Comprising Administration of Anti-CD20 Antibody) 8,512,983 (Production of Proteins in Glutamine-Free Cell Culture Media) 8,545,843 (Treatment of Vasculitis) 8,557,244 (Treatment of Aggressive Non-Hodgkins Lymphoma with Anti-CD20 Antibody) 8,574,869 (Prevention of Disulfide Bond Reduction During Recombinant Production of Polypeptides) 8,710,196 (Protein Purification) 8,821,873 (Treatment of Diffuse Large-Cell Lymphoma With Anti-CD20 Antibody) 9,296,821 (Combination Therapies for B-Cell Lymphomas Comprising Administration of Anti-CD20 Antibodies) 9,504,744 (Treatment of Diffuse Large-Cell Lymphoma with Anti-CD20 Antibody) 9,714,293 (Production of Proteins in Glutamine-free Cell Culture Media)

Plaintiffs
Biogen, Inc.; City of Hope; Genentech, Inc.

Defendants
Sandoz GmbH; Sandoz Inc.; Sandoz International GmbH

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

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) 6,417,335 (Protein Purification) 6,455,043 (Combination Therapies for B-Cell Lymphomas Comprising Administration of Anti-CD20 Antibody) 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) 6,716,602 (Metabolic Rate Shifts in Fermentations Expressing Recombinant Proteins) 7,381,560 (Expression and Use of Anti-CD20 Antibodies) 7,390,660 (Methods for Growing Mammalian Cells In Vitro) 7,485,704 (Reducing Protein A Leaching During Protein A Affinity Chromatography) 7,682,612 (Treatment of Hematologic Malignancies Associated with Circulating Tumor Cells Using Chimeric Anti-CD20 Antibody) 7,807,799 (Reducing Protein A Leaching During Protein A Affinity Chromatography) 7,820,161 (Treatment of Autoimmune Diseases) 7,923,221 (Methods of Making Antibody Heavy and Light Chains having Specificity for a Desired Antigen) 7,976,838 (Therapy of Autoimmune Disease in a Patient with an Inadequate Response to a TNF-alpha Inhibitor) 8,044,017 (Protein Purification) 8,206,711 (Treatment of Chronic Lymphocytic Leukemia Using Anti-CD20 Antibodies) 8,329,172 (Combination Therapies For B-Cell Lymphomas Comprising Administration of Anti-CD20 Antibody) 8,357,301 (Chromatography Equipment Characterization) 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) 8,545,843 (Treatment of Vasculitis) 8,557,244 (Treatment of Aggressive Non-Hodgkins Lymphoma with Anti-CD20 Antibody) 8,574,869 (Prevention of Disulfide Bond Reduction During Recombinant Production of Polypeptides) 8,633,302 (Variable Tangential Flow Filtration) 8,710,196 (Protein Purification) 8,771,988 (Protein Expression from Multiple Nucleic Acids) 8,821,873 (Treatment of Diffuse Large-Cell Lymphoma With Anti-CD20 Antibody) 8,822,655 (Pre-filtration Adjustment of Buffer Solutes) 9,047,438 (Chromatography Equipment Characterization) 9,080,183 (Promoter) 9,296,821 (Combination Therapies for B-Cell Lymphomas Comprising Administration of Anti-CD20 Antibodies) 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) 9,504,744 (Treatment of Diffuse Large-Cell Lymphoma with Anti-CD20 Antibody) 9,714,293 (Production of Proteins in Glutamine-free Cell Culture Media)

Plaintiffs
Biogen, Inc.; 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
Requested 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) 6,407,213 (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

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.
6,331,415 (Methods of Producing Immunoglobulins, Vectors and Transformed Host Cells for Use Therein) 6,489,447 (Protein Purification) 6,610,516 (Cell Culture Process) 6,620,918 (Separation of Polypeptide Monomers) 7,381,560 (Expression and Use of Anti-CD20 Antibodies) 7,485,704 (Reducing Protein A Leaching During Protein A Affinity Chromatography) 7,807,799 (Reducing Protein A Leaching During Protein A Affinity Chromatography) 7,820,161 (Treatment of Autoimmune Diseases) 7,923,221 (Methods of Making Antibody Heavy and Light Chains having Specificity for a Desired Antigen) 7,976,838 (Therapy of Autoimmune Disease in a Patient with an Inadequate Response to a TNF-alpha Inhibitor) 8,206,711 (Treatment of Chronic Lymphocytic Leukemia Using Anti-CD20 Antibodies) 8,329,172 (Combination Therapies For B-Cell Lymphomas Comprising Administration of Anti-CD20 Antibody) 8,545,843 (Treatment of Vasculitis) 8,557,244 (Treatment of Aggressive Non-Hodgkins Lymphoma with Anti-CD20 Antibody) 8,574,869 (Prevention of Disulfide Bond Reduction During Recombinant Production of Polypeptides) 8,821,873 (Treatment of Diffuse Large-Cell Lymphoma With Anti-CD20 Antibody) 9,296,821 (Combination Therapies for B-Cell Lymphomas Comprising Administration of Anti-CD20 Antibodies) 9,504,744 (Treatment of Diffuse Large-Cell Lymphoma with Anti-CD20 Antibody)

Plaintiffs
Biogen, Inc.; 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
Requested Dismissal due to Settlement

BPCIA
Y

U.S. Patent Nos.
4,816,567 (Recombinant Immunoglobulin Preparations) 6,171,586 (Antibody Formulation) 6,331,415 (Methods of Producing Immunoglobulins, Vectors and Transformed Host Cells for Use Therein) 6,333,398 (Protein Purification) 6,417,335 (Protein Purification) 6,870,034 (Protein Purification)

Plaintiffs
Centocor Ortho Biotech, Inc.

Defendants
City of Hope; Genentech, Inc.

Status
Dismissed

BPCIA
N

U.S. Patent Nos.
7,923,221 (Methods of Making Antibody Heavy and Light Chains having Specificity for a Desired Antigen)

Plaintiffs
City Of Hope; Genentech, Inc.

Defendants
Glaxo Group Ltd; GlaxoSmithKline LLC; Human Genome Sciences Inc.; Lonza Biologics Inc.; Lonza Biologics PLC

Status
Dismissed

BPCIA
N

U.S. Patent Nos.
4,816,567 (Recombinant Immunoglobin Preparations) 6,331,415 (Methods of Producing Immunoglobulins, Vectors and Transformed Host Cells for Use Therein)

Plaintiffs
Human Genome Sciences Inc.; Glaxo Group Ltd; GlaxoSmithKline LLC

Defendants
City Of Hope; Genentech, Inc.

Status
Dismissed

BPCIA
N

U.S. Patent Nos.
7,923,221 (Methods of Making Antibody Heavy and Light Chains having Specificity for a Desired Antigen)

Plaintiffs
GlaxoSmithKline LLC; Human Genome Sciences Inc.

Defendants
City Of Hope; Genentech, Inc.

Status
Dismissed

BPCIA
N

U.S. Patent Nos.
6,331,415 (Methods of Producing Immunoglobulins, Vectors and Transformed Host Cells for Use Therein) 7,923,221 (Methods of Making Antibody Heavy and Light Chains having Specificity for a Desired Antigen)

Plaintiffs
Bristol-Myers Squibb Co.

Defendants
City of Hope; Genentech, Inc.

Status
Dismissed

BPCIA
N

U.S. Patent Nos.
6,331,415 (Methods of Producing Immunoglobulins, Vectors and Transformed Host Cells for Use Therein) 7,923,221 (Methods of Making Antibody Heavy and Light Chains having Specificity for a Desired Antigen)

Plaintiffs
Eli Lilly and Co.; ImClone Systems LLC

Defendants
City of Hope; Genentech, Inc.

Status
Dismissed

BPCIA
N

U.S. Patent Nos.
7,923,221 (Methods of Making Antibody Heavy and Light Chains having Specificity for a Desired Antigen)

Plaintiffs
Regeneron Pharmaceuticals, Inc.; Sanofi-Aventis US LLC

Defendants
City of Hope; Genentech, Inc.

Status
Dismissed

BPCIA
N

U.S. Patent Nos.
7,923,221 (Methods of Making Antibody Heavy and Light Chains Having Specificity for a Desired Antigen)

Plaintiffs
Genzyme Corp.

Defendants
City of Hope; Genentech, Inc.

Status
Dismissed

BPCIA
N

U.S. Patent Nos.
6,054,297 (Humanized Antibodies and Methods for Making Them) 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) 6,586,206 (Methods for Making Recombinant Proteins Using Apoptosis Inhibitors) 6,610,516 (Cell Culture Process) 6,620,918 (Separation of Polypeptide Monomers) 6,870,034 (Protein Purification) 6,884,879 (Anti-VEGF Antibodies) 7,060,269 (Anti-VEGF Antibodies) 7,169,901 (Anti-VEGF Antibodies) 7,297,334 (Anti-VEGF Antibodies) 7,323,553 (Non-Affinity Purification of Proteins) 7,375,193 (Anti-VEGF Antibodies) 7,622,115 (Treatment With Anti-VEGF Antibodies) 7,807,799 (Reducing Protein A Leaching During Protein A Affinity Chromatography) 7,923,221 (Methods of Making Antibody Heavy and Light Chains having Specificity for a Desired Antigen) 8,044,017 (Protein Purification) 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) 8,710,196 (Protein Purification) 9,441,035 (Cell Culture Media and Methods of Antibody Production) 9,487,809 (Decreasing Lactate Level and Increasing Polypeptide Production by Downregulating the Expression of Lactate Dehydrogenase and Pyruvate Dehydrogenase Kinase)

Plaintiffs
Amgen Inc.

Defendants
Genentech, Inc.; City of Hope

Status
Dismissed

BPCIA
Y

U.S. Patent Nos.
6,331,415 (Methods of Producing Immunoglobulins, Vectors and Transformed Host Cells for Use Therein) 7,923,221 (Methods of Making Antibody Heavy and Light Chains having Specificity for a Desired Antigen)

Plaintiffs
Bristol-Myers Squibb Co.

Defendants
City of Hope; Genentech, Inc.

Status
Transferred and Consolidated with 2:13-cv-05400 (N.D. Cal.); Case Terminated

BPCIA
N

U.S. Patent Nos.
6,331,415 (Methods of Producing Immunoglobulins, Vectors and Transformed Host Cells for Use Therein) 7,923,221 (Methods of Making Antibody Heavy and Light Chains having Specificity for a Desired Antigen)

Plaintiffs
Eli Lilly and Co.; ImClone Systems LLC

Defendants
City of Hope; Genentech, Inc.

Federal Circuit Appeal(s)
13-0164

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.
6,331,415 (Methods of Producing Immunoglobulins, Vectors and Transformed Host Cells for Use Therein) 6,417,335 (Protein Purification) 6,455,043 (Combination Therapies for B-Cell Lymphomas Comprising Administration of Anti-CD20 Antibody) 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) 6,716,602 (Metabolic Rate Shifts in Fermentations Expressing Recombinant Proteins) 7,390,660 (Methods for Growing Mammalian Cells In Vitro) 7,485,704 (Reducing Protein A Leaching During Protein A Affinity Chromatography) 7,682,612 (Treatment of Hematologic Malignancies Associated with Circulating Tumor Cells Using Chimeric Anti-CD20 Antibody) 7,807,799 (Reducing Protein A Leaching During Protein A Affinity Chromatography) 7,820,161 (Treatment of Autoimmune Diseases) 7,923,221 (Methods of Making Antibody Heavy and Light Chains having Specificity for a Desired Antigen) 7,976,838 (Therapy of Autoimmune Disease in a Patient with an Inadequate Response to a TNF-alpha Inhibitor) 8,044,017 (Protein Purification) 8,206,711 (Treatment of Chronic Lymphocytic Leukemia Using Anti-CD20 Antibodies) 8,329,172 (Combination Therapies For B-Cell Lymphomas Comprising Administration of Anti-CD20 Antibody) 8,357,301 (Chromatography Equipment Characterization) 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) 8,545,843 (Treatment of Vasculitis) 8,557,244 (Treatment of Aggressive Non-Hodgkins Lymphoma with Anti-CD20 Antibody) 8,574,869 (Prevention of Disulfide Bond Reduction During Recombinant Production of Polypeptides) 8,633,302 (Variable Tangential Flow Filtration) 8,710,196 (Protein Purification) 8,771,988 (Protein Expression from Multiple Nucleic Acids) 8,821,873 (Treatment of Diffuse Large-Cell Lymphoma With Anti-CD20 Antibody) 8,822,655 (Pre-filtration Adjustment of Buffer Solutes) 9,047,438 (Chromatography Equipment Characterization) 9,080,183 (Promoter) 9,296,821 (Combination Therapies for B-Cell Lymphomas Comprising Administration of Anti-CD20 Antibodies) 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) 9,504,744 (Treatment of Diffuse Large-Cell Lymphoma with Anti-CD20 Antibody) 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
Biogen, Inc.; City of Hope; Genentech, Inc.; Hoffmann-La Roche Inc.

Federal Circuit Appeal(s)
18-2161 (Consolidated with 18-2160; 18-2160 is Lead Appeal)

Status
Dismissed for Failure to State a Claim; Federal Circuit Appeal Dismissed

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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