Kymriah® (tisagenlecleucel)

BL 125646

Kymriah® (tisagenlecleucel)

BL 125646

U.S. License Holder:

Novartis Pharmaceuticals Corp.

Date of License:

August-30-2017

Last Update:

Dec-15-2024

approved_indications FDA-Approved Indications

KYMRIAH (tisagenlecleucel) is a CD19-directed genetically modified autologous T-cell immunotherapy indicated for the treatment of:

Patients up to 25 years of age with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse;

Adult patients with relapsed or refractory (r/r) large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, high grade B-cell lymphoma and DLBCL arising from follicular lymphoma. KYMRIAH is not indicated for treatment of patients with primary central nervous system lymphoma;

Adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.

approved_indications Inter Partes Review Proceedings

PTAB Portal

IPR Case No(s):

IPR2022-00852

U.S. Patent No.
9,518,123 (Compositions and Methods for Treatment of Cancer)

Patent Owner
Trustees of The University of Pennsylvania; Novartis Pharma AG

Petitioner(s)
Miltenyi Biomedicine GmbH; Miltenyi Biotec, Inc.

§ 102 Challenge
N

§ 103 challenge
Y: Claims 1-17, 19-24, 26

Claim Types Challenged Under § 103
Composition of Matter

§ 103 Challenge Instituted
Y

Settled / Challenged Claims Disclaimed / Challenge Terminated
Y (Settled After Institution)

IPR Status
Terminated After Institution Due to Settlement

IPR2022-00853

U.S. Patent No.
9,464,140 (Compositions and Methods for Treatment of Cancer)

Patent Owner
Trustees of The University of Pennsylvania; Novartis Pharma AG

Petitioner(s)
Miltenyi Biomedicine GmbH; Miltenyi Biotec, Inc.

§ 102 Challenge
N

§ 103 challenge
Y: Claims 1-19, 21-28

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
N

IPR Status
IPR Not Instituted; Request for Rehearing Denied

IPR2022-00855

U.S. Patent No.
9,540,445 (Compositions and Methods for Treatment of Cancer)

Patent Owner
Trustees of The University of Pennsylvania; Novartis Pharma AG

Petitioner(s)
Miltenyi Biomedicine GmbH; Miltenyi Biotec, Inc.

§ 102 Challenge
N

§ 103 challenge
Y: Claims 1-30

Claim Types Challenged Under § 103
Formulation

§ 103 Challenge Instituted
Y

Settled / Challenged Claims Disclaimed / Challenge Terminated
Y (Settled After Institution)

IPR Status
Terminated After Institution Due to Settlement

approved_indications U.S. Patent Litigations

PACER

Case No(s):

2:13-cv-01502 (E.D. Pa.)

U.S. Patent Nos.
8,399,645 (Chimeric Receptors with 4-1BB Stimulatory Signaling Domain)

Plaintiffs
Trustees of The University of Pennsylvania; Novartis Pharmaceuticals Corporation (Intervenor); Novartis Institutes for Biomedical Research, Inc. (Counter Defendant)

Defendants
St. Jude Children's Research Hospital, Inc.; Juno Therapeutics, Inc. (Intervenor- Exclusive Licensee)

Status
Stipulated Dismissal

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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