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-15-2024

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

Final Written Decision Issued
Y

Federal Circuit Appeal(s)
24-1878

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; POP Requests Denied; Final Written Decision (All Challenged Claims Unpatentable), Request for Director Review Denied; Federal Circuit Appeal Pending, Motion to Intervene by USPTO Director Granted

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

Information contained in the Venable 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 BiologicsHQ database.

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