Zynteglo® (betibeglogene autotemcel)

BL 125717

Zynteglo® (betibeglogene autotemcel)

BL 125717

U.S. License Holder:

bluebird bio, Inc.

Date of License:

August-17-2022

Last Update:

Dec-15-2024

approved_indications FDA-Approved Indications

ZYNTEGLO (betibeglogene autotemcel) is an autologous hematopoietic stem cell-based gene therapy indicated for the treatment of adult and pediatric patients with beta-thalassemia who require regular red blood cell (RBC) transfusions.

approved_indications Inter Partes Review Proceedings

PTAB Portal

IPR Case No(s):

IPR2023-00070

U.S. Patent No.
7,541,179 (Vector Encoding Human Globin Gene and Use Thereof in Treatment of Hemoglobinopathies)

Patent Owner
Sloan Kettering Institute for Cancer Research; Memorial Sloan Kettering Cancer Center; San Rocco Therapeutics, LLC

Petitioner(s)
bluebird bio, Inc.; Third Rock Ventures, LLC

§ 102 Challenge
Y: Claims 1, 19, 22

Claim Types Challenged Under § 102
Composition of Matter

§ 102 Challenge Instituted
Y

§ 103 challenge
Y: Claims 1, 10, 19, 22

Claim Types Challenged Under § 103
Composition of Matter

§ 103 Challenge Instituted
Y

Final Written Decision Issued
Y

Federal Circuit Appeal(s)
24-2016 (consolidated with 24-2010 (lead))

IPR Status
Final Written Decision (No Challenged Claims Found Unpatentable); Federal Circuit Appeal Pending

IPR2023-00074

U.S. Patent No.
8,058,061 (Vector Encoding Human Globin Gene and Use Thereof in Treatment of Hemoglobinopathies)

Patent Owner
Sloan Kettering Institute for Cancer Research; Memorial Sloan Kettering Cancer Center; San Rocco Therapeutics, LLC

Petitioner(s)
bluebird bio, Inc.; Third Rock Ventures, LLC

§ 102 Challenge
Y: Claims 1, 2, 6, 7, 11

Claim Types Challenged Under § 102
Composition of Matter Manufacturing

§ 102 Challenge Instituted
Y

§ 103 challenge
Y: Claims 1, 2, 5-8, 11, 15

Claim Types Challenged Under § 103
Composition of Matter Manufacturing

§ 103 Challenge Instituted
Y

Final Written Decision Issued
Y

Federal Circuit Appeal(s)
24-2010 (lead), consolidated with 24-2016

IPR Status
Final Written Decision (No Challenged Claims Found Unpatentable); Federal Circuit Appeal Pending

approved_indications U.S. Patent Litigations

PACER

Case No(s):

1:21-cv-01478 (D. Del.)

U.S. Patent Nos.
7,541,179 (Vector Encoding Human Globin Gene and Use Thereof in Treatment of Hemoglobinopathies) 8,058,061 (Vector Encoding Human Globin Gene and Use Thereof in Treatment of Hemoglobinopathies)

Plaintiffs
San Rocco Therapeutics, LLC; Errant Gene Therapeutics, LLC

Defendants
bluebird bio, Inc.; Third Rock Ventures, LLC

Status
Case Ongoing

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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