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:

September-23-2022

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 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

related articles Related News Articles

Venable Fitzpatrick’s BiologicsHQ Monthly Injection – July 2022 April Breyer Menon; Damineh Morsali, Ph.D.; Robert S. Schwartz, Ph.D.; Ha Kung Wong August 5, 2022
Venable Fitzpatrick’s BiologicsHQ Monthly Injection – May 2022 April Breyer Menon; Damineh Morsali, Ph.D.; Robert S. Schwartz, Ph.D.; Ha Kung Wong June 7, 2022
Venable Fitzpatrick’s BiologicsHQ Monthly Injection – April 2022 April Breyer Menon; Damineh Morsali, Ph.D.; Robert S. Schwartz, Ph.D.; Ha Kung Wong May 9, 2022
Venable Fitzpatrick’s BiologicsHQ Monthly Injection – July 2021 April Breyer Menon; Damineh Morsali, Ph.D.; Robert S. Schwartz, Ph.D.; Ha Kung Wong August 11, 2021
Venable Fitzpatrick’s BiologicsHQ Monthly Injection – June 2021 April Breyer Menon; Damineh Morsali, Ph.D.; Robert S. Schwartz, Ph.D.; Ha Kung Wong July 13, 2021
Venable Fitzpatrick’s BiologicsHQ Monthly Injection – January 2021 April Breyer Menon; Damineh Morsali, Ph.D.; Robert S. Schwartz, Ph.D.; Ha Kung Wong February 8, 2021
Venable Fitzpatrick’s BiologicsHQ Monthly Injection – December 2020 April Breyer Menon; Damineh Morsali, Ph.D.; Robert S. Schwartz, Ph.D.; Ha Kung Wong January 12, 2021
Venable Fitzpatrick’s BiologicsHQ Monthly Injection – November 2020 April Breyer Menon; Damineh Morsali, Ph.D.; Robert S. Schwartz, Ph.D.; Ha Kung Wong December 9, 2020
Venable Fitzpatrick’s BiologicsHQ Monthly Injection – December 2019 April Breyer Menon; Corinne E. Atton; Robert S. Schwartz, Ph.D.; Ha Kung Wong January 7, 2020

Methodology

Information contained in the Venable Fitzpatrick 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 Fitzpatrick BiologicsHQ database.

Disclaimer

The individuals who maintain this site work for Venable LLP. The information, comments and links posted on this site do not constitute legal advice. No attorney-client relationship has been or will be formed by any communication(s) to, from or with the site and/or the author. For legal advice, contact an attorney at Venable LLP or an attorney actively practicing in your jurisdiction. Do not send any confidential or privileged information to the author; neither Venable LLP nor the author will assume any liability or responsibility for it. If you send any information, documents or materials to the site, you give permission for the author to include them on or in the site. No information, documents or materials you send to the site will be considered confidential or privileged by Venable LLP or its lawyers. Also, no such information, documents or materials will be returned to you. All decisions relating to the content belong to the author.

Subscribe for Future Updates

    captcha