Zolgensma® (onasemnogene abeparvovec-xioi)

BL 125694

Zolgensma® (onasemnogene abeparvovec-xioi)

BL 125694

U.S. License Holder:

Novartis Gene Therapies, Inc.

Date of License:

May-24-2019

Last Update:

May-15-2024

approved_indications FDA-Approved Indications


ZOLGENSMA (onasemnogene abeparvovec-xioi) is an adeno-associated virus (AAV) vector-based gene therapy indicated for the treatment of pediatric patients less than 2 years of age with spinal muscular atrophy (SMA) with bi-allelic mutations in the survival motor neuron 1 (SMN1) gene.

approved_indications Inter Partes Review Proceedings

PTAB Portal

IPR Case No(s):

U.S. Patent No.
9,051,542 (Compositions and Methods to Prevent AAV Vector Aggregation)

Patent Owner
Genzyme Corporation; Aventis, Inc.; Sanofi

Petitioner(s)
Novartis Gene Therapies, Inc.; Novartis Pharmaceuticals Corporation

§ 102 Challenge
N

§ 103 challenge
Y: Claims 1, 2, 5, 6

Claim Types Challenged Under § 103
Formulation

§ 103 Challenge Instituted
N

Settled / Challenged Claims Disclaimed / Challenge Terminated
Y (Patent Owner Disclaimed Claims 1 and 2 Prior to Institution Decision)

IPR Status
IPR Not Instituted; Patent Owner Disclaimed Claims 1 and 2 Prior to Institution Decision

U.S. Patent No.
9,051,542 (Compositions and Methods to Prevent AAV Vector Aggregation)

Patent Owner
Genzyme Corporation; Aventis, Inc.; Sanofi

Petitioner(s)
Novartis Gene Therapies, Inc.; Novartis Pharmaceuticals Corporation

§ 102 Challenge
N

§ 103 challenge
Y: Claims 1, 2, 5, 6

Claim Types Challenged Under § 103
Formulation

§ 103 Challenge Instituted
N

Settled / Challenged Claims Disclaimed / Challenge Terminated
Y (Patent Owner Disclaimed Claims 1 and 2 Prior to Institution Decision)

IPR Status
IPR Not Instituted; Patent Owner Disclaimed Claims 1 and 2 Prior to Institution Decision

U.S. Patent No.
10,429,288 (Analytical Ultracentrifugation for Characterization of Recombinant Viral Particles)

Patent Owner
Genzyme Corporation; Aventis, Inc.; Sanofi

Petitioner(s)
Novartis Gene Therapies, Inc.; Novartis Pharmaceuticals Corporation

§ 102 Challenge
Y: Claims 1, 17, 18, 20, 21, 23, 32, 33

Claim Types Challenged Under § 102
Manufacturing

§ 102 Challenge Instituted
Y

§ 103 challenge
Y: Claims 1-3, 17-34

Claim Types Challenged Under § 103
Manufacturing

§ 103 Challenge Instituted
Y

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

IPR Status
Terminated After Institution Due to Settlement

U.S. Patent No.
10,429,288 (Analytical Ultracentrifugation for Characterization of Recombinant Viral Particles)

Patent Owner
Genzyme Corporation; Aventis, Inc.; Sanofi

Petitioner(s)
Novartis Gene Therapies, Inc.; Novartis Pharmaceuticals Corporation

§ 102 Challenge
Y: Claims 4-8, 10-15

Claim Types Challenged Under § 102
Manufacturing

§ 102 Challenge Instituted
Y (in part): Claims 5-8, 15; Claims 4, 10-14 Disclaimed

§ 103 challenge
Y: Claims 4-16

Claim Types Challenged Under § 103
Manufacturing

§ 103 Challenge Instituted
Y (in part): Claims 5-9, 15, 16; Claims 4, 10-14 Disclaimed

Settled / Challenged Claims Disclaimed / Challenge Terminated
Y (Patent Owner Disclaimed Claims 4 and 10-14 Prior to Institution Decision; Settled After Instituti

IPR Status
Patent Owner Disclaimed Claims 4 and 10-14 Prior to Institution Decision, Terminated After Institution Due to Settlement

approved_indications U.S. Patent Litigations

PACER

Case No(s):

U.S. Patent Nos.
6,596,535 (Metabolically Activated Recombinant Viral Vectors and Methods for the Preparation and Use) 7,125,717 (Metabolically Activated Recombinant Viral Vectors and Methods for the Preparation and Use) 7,785,888 (Metabolically Activated Recombinant Viral Vectors and Methods for the Preparation and Use) 7,846,729 (Metabolically Activated Recombinant Viral Vectors and Methods for the Preparation and Use) 8,093,054 (Metabolically Activated Recombinant Viral Vectors and Methods for the Preparation and Use) 9,051,542 (Compositions and Methods to Prevent AAV Vector Aggregation)

Plaintiffs
Genzyme Corp.; Aventis, Inc.

Defendants
Novartis Gene Therapies, Inc.; Novartis Pharmaceuticals Corp.; Novartis AG

Status
Stipulated Dismissal

BPCIA
N

U.S. Patent Nos.
10,429,288 (Analytical Ultracentrifugation for Characterization of Recombinant Viral Particles)

Plaintiffs
Genzyme Corp.; Aventis, Inc.

Defendants
Novartis Gene Therapies, Inc.; Novartis Pharmaceuticals Corp.

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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