Enhertu® (fam-trastuzumab deruxtecan-nxki)

BL 761139

Enhertu® (fam-trastuzumab deruxtecan-nxki)

BL 761139

U.S. License Holder:

Daiichi Sankyo

Date of License:

December-20-2019

Last Update:

January-23-2023

approved_indications FDA-Approved Indications

ENHERTU (fam-trastuzumab deruxtecan-nxki) is a HER2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of:

Adult patients with unresectable or metastatic HER2-positive breast cancer who have received a prior anti-HER2-based regimen either: in the metastatic setting, or in the neoadjuvant or adjuvant setting and have developed disease recurrence during or within six months of completing therapy;

Adult patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer, as determined by an FDA-approved test, who have received a prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy;

Adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, as detected by an FDA-approved test, and who have received a prior systemic therapy;

Adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who have received a prior trastuzumab-based regimen.

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

Claim Types Challenged Under § 102
Composition of Matter

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

§ 103 challenge
N

IPR Status
Challenges Also Include Written Description, Enablement, and Failure to Set Forth Subject Matter Regarded as the Invention. IPR Not Instituted (initially), Request for Rehearing Granted and IPR Instituted; Second Request for Rehearing Granted and Institution Denied; Third Request for Rehearing Pending

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

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, Enablement, and Failure to Set Forth Subject Matter Regarded as the Invention. IPR Not Instituted (initially), Request for Rehearing Granted and IPR 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

2:20-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

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

BPCIA
N

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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