Trazimera® (trastuzumab-qyyp)

aBL 761081

Trazimera® (trastuzumab-qyyp)

aBL 761081

U.S. License Holder:

Pfizer Inc.

Date of License:

March-11-2019

Last Update:

Nov-15-2024

FDA-Approved Indications

TRAZIMERA (trastuzumab-qyyp) 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. Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product.

Approved Foreign Follow-On Biologics / Biosimilars

Biosimilars Approved In Canada

Trazimera® (Pfizer) (August-2019)

Biosimilars Approved In The E.U.

Trazimera® (Pfizer) (July-2018)

Biosimilars Approved In Australia

Trazimera® (Pfizer) (August-2019)

Inter Partes Review Proceedings

PTAB Portal

IPR Case No(s):

IPR2016-01837

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

IPR2017-00731

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)

IPR2017-00737

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)

IPR2017-00739

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

IPR2017-00804

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

IPR2017-00805

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

IPR2017-01488

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)

IPR2017-01489

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)

IPR2017-01726

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

IPR2017-01727

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

IPR2017-02019

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

IPR2017-02020

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

IPR2017-02063

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)

IPR2018-00016

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

IPR2018-00330

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

IPR2018-00331

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):

1:17-cv-01672 (D. Del.)

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

Trazimera® (trastuzumab-qyyp)

Trazimera® (trastuzumab-qyyp)

FDA-Approved Indications

Approved Foreign Follow-On Biologics / Biosimilars

Biosimilars Approved In Canada

Biosimilars Approved In The E.U.

Biosimilars Approved In Australia

Inter Partes Review Proceedings

IPR Case No(s):

IPR2016-01837

IPR2017-00731

IPR2017-00737

IPR2017-00739

IPR2017-00804

IPR2017-00805

IPR2017-01488

IPR2017-01489

IPR2017-01726

IPR2017-01727

IPR2017-02019

IPR2017-02020

IPR2017-02063

IPR2018-00016

IPR2018-00330

IPR2018-00331

U.S. Patent Litigations

Case No(s):

1:17-cv-01672 (D. Del.)

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