Opdivo® (nivolumab)

BL 125554 [BL 125527]

Opdivo® (nivolumab)

BL 125554 [BL 125527]

U.S. License Holder:

Bristol-Myers Squibb

Date of License:

December-22-2014 [March-04-2015]

Last Update:

Dec-15-2024

approved_indications FDA-Approved Indications

BL 125554: OPDIVO (nivolumab) is a programmed death receptor-1 (PD-1) blocking antibody indicated for the treatment of:

Melanoma: Adult and pediatric (12 years and older) patients with unresectable or metastatic melanoma, as a single agent or in combination with ipilimumab; For the adjuvant treatment of adult and pediatric patients 12 years and older with completely resected Stage IIB, Stage IIC, Stage III, or Stage IV melanoma;

Non-Small Cell Lung Cancer (NSCLC): Adult patients with resectable (tumors greater than or equal to 4 cm or node positive) non-small cell lung cancer in the neoadjuvant setting, in combination with platinum-doublet chemotherapy; Adult patients with resectable (tumors greater than or equal to 4 cm or node positive) non-small cell lung cancer and no known EGFR mutations or ALK rearrangements, for neoadjuvant treatment, in combination with platinum-doublet chemotherapy, followed by single-agent Opdivo as adjuvant treatment after surgery; Adult patients with metastatic non-small cell lung cancer expressing PD-L1 (greater than or equal to 1 percent) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations, as first-line treatment in combination with ipilimumab; Adult patients with metastatic or recurrent non-small cell lung cancer with no EGFR or ALK genomic tumor aberrations as first-line treatment, in combination with ipilimumab and 2 cycles of platinum-doublet chemotherapy; Adult patients with metastatic non-small cell lung cancer and progression on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving Opdivo;

Malignant Pleural Mesothelioma: Adult patients with unresectable malignant pleural mesothelioma, as first-line treatment in combination with ipilimumab;

Renal Cell Carcinoma (RCC): Adult patients with intermediate or poor risk advanced renal cell carcinoma, as a first-line treatment in combination with ipilimumab; Adult patients with advanced renal cell carcinoma, as a first-line treatment in combination with cabozantinib; Adult patients with advanced renal cell carcinoma who have received prior anti-angiogenic therapy;

Classical Hodgkin Lymphoma (cHL): Adult patients with classical Hodgkin lymphoma that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin, or 3 or more lines of systemic therapy that includes autologous HSCT;

Squamous Cell Carcinoma of the Head and Neck (SCCHN): Adult patients with recurrent or metastatic squamous cell carcinoma of the head and neck with disease progression on or after a platinum-based therapy;

Urothelial Carcinoma: Adjuvant treatment of adult patients with urothelial carcinoma (UC) who are at high risk of recurrence after undergoing radical resection of UC; Adult patients with unresectable or metastatic urothelial carcinoma, as firstline treatment in combination with cisplatin and gemcitabine; Adult patients with locally advanced or metastatic urothelial carcinoma who: have disease progression during or following platinum-containing chemotherapy; have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy;

Colorectal Cancer: Adult and pediatric (12 years and older) patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan as a single agent or in combination with ipilimumab;

Hepatocellular Carcinoma (HCC): Adult patients with hepatocellular carcinoma who have been previously treated with sorafenib in combination with ipilimumab;

Esophageal Cancer: Adult patients with completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease, who have received neoadjuvant chemoradiotherapy (CRT); Adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma as first-line treatment in combination with fluoropyrimidine- and platinum-containing chemotherapy; Adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma as first-line treatment in combination with ipilimumab; Adult patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine-and platinum-based chemotherapy;

Gastric Cancer, Gastroesophageal Junction Cancer, and Esophageal Adenocarcinoma: Adult patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma in combination with fluoropyrimidine- and platinum-containing chemotherapy.

BL 125527: OPDIVO (nivolumab) is a programmed death receptor-1 (PD-1) blocking antibody indicated for the treatment of patients with:

Unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor;

Metastatic squamous non-small cell lung cancer with progression on or after platinum-based chemotherapy.

approved_indications Inter Partes Review Proceedings

PTAB Portal

IPR Case No(s):

IPR2016-01217

U.S. Patent No.
9,067,999 (Immunopotentiative Composition)

Patent Owner
Bristol-Myers Squibb Co.; ER Squibb and Sons, LLC; Ono Pharmaceutical Co., Ltd.; Tasuku Honjo

Petitioner(s)
Merck Sharp and Dohme Corp.

§ 102 Challenge
Y: Claims 1, 6-14, 19-20, 24-26, 29-30

Claim Types Challenged Under § 102
Method of Treatment

§ 102 Challenge Instituted
Settled Prior to Institution Decision

§ 103 challenge
Y: Claims 1, 6-14, 19-20, 24-27, 29-30

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
Settled Prior to Institution Decision

Settled / Challenged Claims Disclaimed / Challenge Terminated
Y (Settled Prior to Institution Decision)

IPR Status
Settled Prior to Institution Decision

IPR2016-01218

U.S. Patent No.
9,067,999 (Immunopotentiative Composition)

Patent Owner
Bristol-Myers Squibb Co.; ER Squibb and Sons, LLC; Ono Pharmaceutical Co., Ltd.; Tasuku Honjo

Petitioner(s)
Merck Sharp and Dohme Corp.

§ 102 Challenge
Y: Claims 1, 6-14, 19-20, 24-25

Claim Types Challenged Under § 102
Method of Treatment

§ 102 Challenge Instituted
Settled Prior to Institution Decision

§ 103 challenge
Y: Claims 1, 6-14, 19-20, 24-27, 29-30

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
Settled Prior to Institution Decision

Settled / Challenged Claims Disclaimed / Challenge Terminated
Y (Settled Prior to Institution Decision)

IPR Status
Settled Prior to Institution Decision

IPR2016-01219

U.S. Patent No.
9,073,994 (Immunopotentiative Composition)

Patent Owner
Bristol-Myers Squibb Co.; ER Squibb and Sons, LLC; Ono Pharmaceutical Co., Ltd.; Tasuku Honjo

Petitioner(s)
Merck and Co., Inc.; Merck Sharp and Dohme Corp.

§ 102 Challenge
Y: Claims 1-3, 8-9, 14-15, 19-22, 25

Claim Types Challenged Under § 102
Method of Treatment

§ 102 Challenge Instituted
Settled Prior to Institution Decision

§ 103 challenge
Y: Claims 1-3, 8-9, 14-15, 19-22, 25-26

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
Settled Prior to Institution Decision

Settled / Challenged Claims Disclaimed / Challenge Terminated
Y (Settled Prior to Institution Decision)

IPR Status
Settled Prior to Institution Decision

IPR2016-01221

U.S. Patent No.
9,073,994 (Immunopotentiative Composition)

Patent Owner
Bristol-Myers Squibb Co.; ER Squibb and Sons, LLC; Ono Pharmaceutical Co., Ltd.; Tasuku Honjo

Petitioner(s)
Merck Sharp and Dohme Corp.

§ 102 Challenge
Y: Claims 1-3, 8-9, 14-15, 19-22

Claim Types Challenged Under § 102
Method of Treatment

§ 102 Challenge Instituted
Settled Prior to Institution Decision

§ 103 challenge
Y: Claims 1-3, 8-9, 14-15, 19-22, 25-26

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
Settled Prior to Institution Decision

Settled / Challenged Claims Disclaimed / Challenge Terminated
Y (Settled Prior to Institution Decision)

IPR Status
Settled Prior to Institution Decision

IPR2023-00249

U.S. Patent No.
10,323,092 (Cancer Immunotherapy by Disrupting PD-1/PD-L1 Signaling)

Patent Owner
Bristol-Myers Squibb Co.

Petitioner(s)
Dana-Farber Cancer Institute, Inc.

§ 102 Challenge
N

§ 103 challenge
Y: Claims 1-25

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
Settled Prior to Institution Decision

Settled / Challenged Claims Disclaimed / Challenge Terminated
Y (Settled Prior to Institution Decision)

IPR Status
Settled Prior to Institution Decision

IPR2023-00252

U.S. Patent No.
10,138,299 (Cancer Immunotherapy by Disrupting PD-1/PD-L1 Signaling)

Patent Owner
Bristol-Myers Squibb Co.

Petitioner(s)
Dana-Farber Cancer Institute, Inc.

§ 102 Challenge
N

§ 103 challenge
Y: Claims 1-24

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
Settled Prior to Institution Decision

Settled / Challenged Claims Disclaimed / Challenge Terminated
Y (Settled Prior to Institution Decision)

IPR Status
Settled Prior to Institution Decision

IPR2023-00501

U.S. Patent No.
8,008,449 (Human Monoclonal Antibodies to Programmed Death 1 (PD-1) and Methods for Treating Cancer Using Anti-PD-1 Antibodies Alone or in Combination with Other Immunotherapeutics)

Patent Owner
ER Squibb & Sons, LLC; Ono Pharmaceutical Co., Ltd.

Petitioner(s)
Dana-Farber Cancer Institute, Inc.

§ 102 Challenge
Y: Claims 1, 7-8, 12-14, 21-23

Claim Types Challenged Under § 102
Composition of Matter Formulation

§ 102 Challenge Instituted
Settled Prior to Institution Decision

§ 103 challenge
Y: Claims 1, 7-9, 12-16, 21-23

Claim Types Challenged Under § 103
Composition of Matter Formulation

§ 103 Challenge Instituted
Settled Prior to Institution Decision

Settled / Challenged Claims Disclaimed / Challenge Terminated
Y (Settled Prior to Institution Decision)

IPR Status
Settled Prior to Institution Decision

approved_indications U.S. Patent Litigations

PACER

Case No(s):

1:14-cv-01131 (D. Del.)

U.S. Patent Nos.
8,728,474 (Immunopotentiative Composition)

Plaintiffs
Bristol-Myers Squibb Co.; E.R. Squibb and Sons LLC; Ono Pharmaceutical Co., Ltd.; Tasuku Honjo

Defendants
Merck and Co., Inc.; Merck Sharp and Dohme Corp.

Status
Settled

BPCIA
N

1:15-cv-00560 (D. Del.)

U.S. Patent Nos.
9,067,999 (Immunopotentiative Composition)

Plaintiffs
Bristol-Myers Squibb Co.; E.R. Squibb and Sons LLC; Ono Pharmaceutical Co., Ltd.; Tasuku Honjo

Defendants
Merck and Co., Inc.; Merck Sharp and Dohme Corp.

Status
Settled

BPCIA
N

1:15-cv-00572 (D. Del.)

U.S. Patent Nos.
9,073,994 (Immunopotentiative Composition)

Plaintiffs
Bristol-Myers Squibb Co.; E.R. Squibb and Sons LLC; Ono Pharmaceutical Co., Ltd.; Tasuku Honjo

Defendants
Merck and Co., Inc.; Merck Sharp and Dohme Corp.

Status
Settled

BPCIA
N

1:17-cv-01027 (D. Del.)

U.S. Patent Nos.
9,402,899 (Immunopotentiative Composition)

Plaintiffs
Bristol-Myers Squibb Co.; E.R. Squibb and Sons LLC; Ono Pharmaceutical Co., Ltd.; Tasuku Honjo

Defendants
Genentech, Inc.

Status
Stipulated Dismissal

BPCIA
N

1:17-cv-01028 (D. Del.)

U.S. Patent Nos.
9,402,899 (Immunopotentiative Composition)

Plaintiffs
Bristol-Myers Squibb Co.; E.R. Squibb and Sons LLC; Ono Pharmaceutical Co., Ltd.; Tasuku Honjo

Defendants
AstraZeneca Pharmaceuticals LP; AstraZeneca UK Limited

Status
Stipulated Dismissal

BPCIA
N

1:17-cv-01029 (D. Del.)

U.S. Patent Nos.
9,402,899 (Immunopotentiative Composition)

Plaintiffs
Bristol-Myers Squibb Co.; E.R. Squibb and Sons LLC; Ono Pharmaceutical Co., Ltd.; Tasuku Honjo

Defendants
EMD Serono, Inc.; Merck KGaA; Pfizer Inc.

Status
Stipulated Dismissal Due to Settlement

BPCIA
N

1:22-cv-00346 (D. Del.)

U.S. Patent Nos.
9,580,505 (Human Monoclonal Antibodies to Programmed Death Ligand 1 (PD-L1) 9,580,507 (Human Monoclonal Antibodies to Programmed Death Ligand 1 (PD-L1) 10,138,299 (Cancer Immunotherapy by Disrupting PD-1 / PD-L1 Signaling) 10,266,594 (Cancer Immunotherapy by Disrupting PD-1 / PD-L1 Signaling) 10,266,595 (Cancer Immunotherapy by Disrupting PD-1 / PD-L1 Signaling) 10,266,596 (Cancer Immunotherapy by Disrupting PD-1 / PD-L1 Signaling) 10,308,714 (Cancer Immunotherapy by Disrupting PD-1 / PD-L1 Signaling) 10,323,092 (Cancer Immunotherapy by Disrupting PD-1 / PD-L1 Signaling)

Plaintiffs
Bristol-Myers Squibb Co.; E.R. Squibb and Sons, LLC

Defendants
AstraZeneca Pharmaceuticals LP; AstraZeneca UK Limited

Status
Stipulated Dismissal

BPCIA
N

1:23-cv-00459 (D. Del.)

U.S. Patent Nos.
9,402,899 (Immuopotentiative Composition)

Plaintiffs
Bristol-Myers Squibb Co.; Dana-Farber Cancer Institute, Inc.; E.R. Squibb and Sons LLC; Ono Pharmaceutical Co., Ltd.; Tasuku Honjo

Defendants
AstraZeneca Pharmaceuticals LP; AstraZeneca UK Limited

Status
Consolidated with Lead Case 1:22-cv-00346 (D. Del.); Stipulated Dismissal

BPCIA
N

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