Adcetris® (brentuximab vedotin)

BL 125388

Adcetris® (brentuximab vedotin)

BL 125388

U.S. License Holder:

Seattle Genetics

Date of License:

August-19-2011

Last Update:

Nov-30-2023

approved_indications FDA-Approved Indications

ADCETRIS (brentuximab vedotin) is a CD30-directed antibody and microtubule inhibitor conjugate indicated for treatment of:

Adult patients with previously untreated Stage III or IV classical Hodgkin lymphoma (cHL), in combination with doxorubicin, vinblastine, and dacarbazine;

Pediatric patients 2 years and older with previously untreated high risk classical Hodgkin lymphoma (cHL), in combination with doxorubicin, vincristine, etoposide, prednisone, and cyclophosphamide;

Adult patients with classical Hodgkin lymphoma (cHL) at high risk of relapse or progression as post-autologous hematopoietic stem cell stransplantation (auto-HSCT) consolidation;

Adult patients with classical Hodgkin lymphoma after failure of auto-HSCT or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not auto-HSCT candidates;

Adult patients with previously untreated systemic anaplastic large cell lymphoma (sALCL) or other CD30-expressing peripheral T-cell lymphomas (PTCL), including angioimmunoblastic T-cell lymphoma and PTCL not otherwise specified, in combination with cyclophosphamide, doxorubicin, and prednisone;

Adult patients with systemic anaplastic large cell lymphoma (sALCL) after failure of at least one prior multi-agent chemotherapy regimen;

Adult patients with primary cutaneous anaplastic large cell lymphoma (pcALCL) or CD30-expressing mycosis fungoides (MF) who have received prior systemic therapy.

approved_indications Inter Partes Review Proceedings

PTAB Portal

IPR Case No(s):

PGR2021-00030

U.S. Patent No.
10,808,039 (Monomethylvaline Compounds Capable of Conjugation to Ligands)

Patent Owner
Seagen Inc.

Petitioner(s)
Daiichi Sankyo, Inc.; Daiichi Sankyo Co., Ltd.; AstraZeneca Pharmaceuticals LP; AstraZeneca UK Limited

§ 102 Challenge
Y: Claims 1-5, 9, 10

Claim Types Challenged Under § 102
Composition of Matter

§ 102 Challenge Instituted
Y (On Rehearing), N (On 2nd Rehearing), Y (On 3rd Rehearing)

§ 103 challenge
N

IPR Status
Challenges Also Include Written Description (Claims 1-5, 9, 10), Enablement (Claims 1-5, 9, 10), and Failure to Set Forth Subject Matter Regarded as the Invention (Claims 1-5, 9, 10). PGR Not Instituted (initially), 1st Request for Rehearing Granted and PGR Instituted; 2nd Request for Rehearing Granted and Institution Denied; Third Request for Rehearing Granted and PGR Instituted, Pending; POP Requests Denied

PGR2021-00042

U.S. Patent No.
10,808,039 (Monomethylvaline Compounds Capable of Conjugation to Ligands)

Patent Owner
Seagen Inc.

Petitioner(s)
Daiichi Sankyo, Inc.; Daiichi Sankyo Co., Ltd.; AstraZeneca Pharmaceuticals LP; AstraZeneca UK Limited

§ 102 Challenge
Y: Claims 6-8

Claim Types Challenged Under § 102
Composition of Matter

§ 102 Challenge Instituted
Y (On Rehearing)

§ 103 challenge
N

Settled / Challenged Claims Disclaimed / Challenge Terminated
Y (All Challenged Claims Disclaimed After Institution)

IPR Status
Challenges Also Include Written Description (Claims 6-8), Enablement (Claims 6-8), and Failure to Set Forth Subject Matter Regarded as the Invention (Claims 6-8). PGR Not Instituted (initially), Request for Rehearing Granted and PGR Instituted; Terminated After Institution (Adverse Judgment - Claims Disclaimed)

approved_indications U.S. Patent Litigations

PACER

Case No(s):

1:20-cv-01524 (D. Del.)

U.S. Patent Nos.
10,808,039 (Monomethylvaline Compounds Capable of Conjugation to Ligands)

Plaintiffs
Daiichi Sankyo, Inc.; Daiichi Sankyo Co., Ltd.; AstraZeneca Pharmaceuticals LP

Defendants
Seagen Inc.

Status
Stayed

BPCIA
N

2:12-cv-01734 (W.D. Wash.)

U.S. Patent Nos.
5,635,483 (Tumor Inhibiting Tetrapeptide Bearing Modified Phenethyl Amides)

Plaintiffs
Seattle Genetics, Inc.

Defendants
Arizona State University; Arizona Technology Enterprises; The Arizona Board of Regents

Status
Dismissed

BPCIA
N

2:14-cv-00653 (D. Ariz.)

U.S. Patent Nos.
5,635,483 (Tumor Inhibiting Tetrapeptide Bearing Modified Phenethyl Amides)

Plaintiffs
The Arizona Board of Regents

Defendants
Seattle Genetics, Inc.

Federal Circuit Appeal(s)
15-1998

Status
Case Terminated

BPCIA
N

2:20-cv-00337 (E.D. Tex.)

U.S. Patent Nos.
10,808,039 (Monomethylvaline Compounds Capable of Conjugation to Ligands)

Plaintiffs
Seagen Inc.

Defendants
Daiichi Sankyo Co., Ltd.; AstraZeneca Pharmaceuticals LP; AstraZeneca UK Limited

Federal Circuit Appeal(s)
23-2424 (Lead); 24-1176 (consolidated)

Status
Jury Verdict (Claims Valid and Infringed); Bench Trial Verdict (Not Unenforceable); Motion for JMOL Denied; Federal Circuit Appeals Pending

BPCIA
N

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Methodology

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