Kadcyla® (ado-trastuzumab emtansine)

BL 125427

Kadcyla® (ado-trastuzumab emtansine)

BL 125427

U.S. License Holder:

Genentech

Date of License:

February-22-2013

Last Update:

Dec-15-2024

approved_indications FDA-Approved Indications

KADCYLA (ado-trastuzumab emtansine) is a HER2-targeted antibody and microtubule inhibitor conjugate indicated, as a single agent for:

The treatment of patients with HER2-positive, metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination. Patients should have either: Received prior therapy for metastatic disease, or developed disease recurrence during or within six months of completing adjuvant therapy;

The adjuvant treatment of patients with HER2-positive early breast cancer who have residual invasive disease after neoadjuvant taxane and trastuzumab-based treatment.

approved_indications Inter Partes Review Proceedings

PTAB Portal

IPR Case No(s):

IPR2014-00676

U.S. Patent No.
8,337,856 (Methods of Treatment Using Anti-ERbB Antibody-Maytansinoid Conjugates)

Patent Owner
Genentech, Inc.; Immunogen, Inc.

Petitioner(s)
Phigenix, Inc.

§ 102 Challenge
N

§ 103 challenge
Y: Claims 1-8

Claim Types Challenged Under § 103
Composition of Matter

§ 103 Challenge Instituted
Y

Final Written Decision Issued
Y

Federal Circuit Appeal(s)
16-1544

IPR Status
Final Written Decision (No Instituted Claim Found Unpatentable); Federal Circuit Appeal Dismissed for Lack of Standing

IPR2014-00842

U.S. Patent No.
7,575,748 (Methods of Treatment Using Anti-ERbB Antibody-Maytansinoid Conjugates)

Patent Owner
Genentech, Inc.; Immunogen, Inc.

Petitioner(s)
Phigenix, Inc.

§ 102 Challenge
N

§ 103 challenge
Y: Claims 1-20, 25-27

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
N

IPR Status
IPR Not Instituted

approved_indications U.S. Patent Litigations

PACER

Case No(s):

1:14-cv-00287 (N.D. Ga.)

U.S. Patent Nos.
8,080,534 (Targeting PAX2 for the Treatment of Breast Cancer)

Plaintiffs
Phigenix, Inc.; MUSC Foundation For Research Development

Defendants
Genentech, Inc.

Status
Case Transferred to N.D. Cal. (5:15-cv-01238 (N.D. Cal.))

BPCIA
N

5:15-cv-01238 (N.D. Cal.)

U.S. Patent Nos.
8,080,534 (Targeting PAX2 for the Treatment of Breast Cancer)

Plaintiffs
Phigenix, Inc.; MUSC Foundation For Research Development

Defendants
Genentech, Inc.

Federal Circuit Appeal(s)
17-2617; 18-1042 (Cross Appeal)

Status
Summary Judgment of Noninfringement; Federal Circuit Affirmed

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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