Elevidys® (delandistrogene moxeparvovec-rokl)

BL 125781

Elevidys® (delandistrogene moxeparvovec-rokl)

BL 125781

U.S. License Holder:

Sarepta Therapeutics

Date of License:

June-22-2023

Last Update:

Apr-15-2024

approved_indications FDA-Approved Indications

ELEVIDYS (delandistrogene moxeparvovec-rokl) is an adeno-associated virus vector-based gene therapy indicated for the treatment of ambulatory pediatric patients aged 4 through 5 years with Duchenne muscular dystrophy (DMD) with a confirmed mutation in the DMD gene.

approved_indications Inter Partes Review Proceedings

PTAB Portal

IPR Case No(s):

IPR2024-00580

U.S. Patent No.
11,680,274 (Method of Increasing the Function of an AAV Vector)

Patent Owner
Trustees of the University of Pennsylvania; REGENXBIO Inc.

Petitioner(s)
Sarepta Therapeutics, Inc.

§ 102 Challenge
N

§ 103 challenge
Y: Claims 1, 3-6, 8

Claim Types Challenged Under § 103
Composition of Matter Formulation

§ 103 Challenge Instituted
Awaiting Institution Decision

IPR Status
Awaiting Institution Decision

approved_indications U.S. Patent Litigations

PACER

Case No(s):

1:19-cv-02316 (D. Del.)

U.S. Patent Nos.
8,697,443 (Cell Culture Methods and Devices Utilizing Gas Permeable Materials) 9,441,192 (Cell Culture Methods and Devices Utilizing Gas Permeable Materials)

Plaintiffs
Wilson Wolf Manufacturing Corporation

Defendants
Sarepta Therapeutics, Inc.

Status
Stayed

BPCIA
N

1:20-cv-01226 (D. Del.)

U.S. Patent Nos.
10,526,617 (Method of Detecting and/or Identifying Adeno-Associated Virus (AAV) Sequences and Isolating Novel Sequences Identified Thereby)

Plaintiffs
REGENXBIO Inc.; Trustees of the University of Pennsylvania

Defendants
Sarepta Therapeutics, Inc.; Sarepta Therapeutics Three, LLC; Catalent, Inc.

Federal Circuit Appeal(s)
24-1408

Status
Summary Judgment: Patent Invalid- Ineligible Subject Matter under Section 101; Federal Circuit Appeal Pending

BPCIA
N

1:23-cv-00667 (D. Del.)

U.S. Patent Nos.
11,680,274 (Method of Increasing the Function of an AAV Vector)

Plaintiffs
REGENXBIO Inc.; Trustees of the University of Pennsylvania

Defendants
Sarepta Therapeutics, Inc.; Sarepta Therapeutics Three, LLC; Catalent, Inc.

Status
Stayed Pending IPR2024-00580

BPCIA
N

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Methodology

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