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:

November-30-2018

approved_indications FDA-Approved Indications


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

Patients with BRAF V600 wild-type unresectable or metastatic melanoma, as a single agent;

Patients with BRAF V600 mutation-positive unresectable or metastatic melanoma, as a single agent;

Patients with unresectable or metastatic melanoma, in combination with ipilimumab;

Patients with melanoma with lymph node involvement or metastatic disease who have undergone complete resection, in the adjuvant setting;

Patients with metastatic non-small cell lung cancer and progression on or after platinum-based chemotherapy;

Patients with metastatic small cell lung cancer with progression after platinum-based chemotherapy and at least one other line of therapy;

Patients with advanced renal cell carcinoma who have received prior anti-angiogenic therapy;

Patients with intermediate or poor risk, previously untreated advanced renal cell carcinoma, in combination with ipilimumab;

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;

Patients with recurrent or metastatic squamous cell carcinoma of the head and neck with disease progression on or after a platinum-based therapy;

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;

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;

Patients with hepatocellular carcinoma who have been previously treated with sorafenib.

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):

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

Claim Types Challenged Under § 102
Method of Treatment

§ 102 Challenge Instituted
Settled Prior to Institution Decision

§ 103 challenge
Y

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

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

Claim Types Challenged Under § 102
Method of Treatment

§ 102 Challenge Instituted
Settled Prior to Institution Decision

§ 103 challenge
Y

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

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

Claim Types Challenged Under § 102
Method of Treatment

§ 102 Challenge Instituted
Settled Prior to Institution Decision

§ 103 challenge
Y

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

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

Claim Types Challenged Under § 102
Method of Treatment

§ 102 Challenge Instituted
Settled Prior to Institution Decision

§ 103 challenge
Y

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

approved_indications U.S. Patent Litigations

PACER

Case No(s):

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

Plaintiffs
Bristol-Meyers 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

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

Plaintiffs
Bristol-Meyers 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

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

Plaintiffs
Bristol-Meyers 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

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

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

Defendants
Genentech, Inc.

Status
Case Ongoing

BPCIA
N

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

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

Defendants
AstraZeneca Pharmaceuticals LP; AstraZeneca UK Limited

Status
Case Ongoing

BPCIA
N

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

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

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

Status
Case Ongoing

BPCIA
N

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