Hemgenix® (etranacogene dezaparvovec-drlb)

BL 125772

Hemgenix® (etranacogene dezaparvovec-drlb)

BL 125772

U.S. License Holder:

CSL Behring LLC

Date of License:

November-22-2022

Last Update:

Sep-30-2024

approved_indications FDA-Approved Indications

HEMGENIX (etranacogene dezaparvovec-drlb) is an adeno-associated virus vector-based gene therapy indicated for the treatment of adults with Hemophilia B (congenital Factor IX deficiency) who:

Currently use Factor IX prophylaxis therapy, or

Have current or historical life-threatening hemorrhage, or

Have repeated, serious spontaneous bleeding episodes.

approved_indications Inter Partes Review Proceedings

PTAB Portal

IPR Case No(s):

IPR2020-00388

U.S. Patent No.
9,249,405 (Factor IX Polypeptide Mutant, Its Uses and a Method for its Production)

Patent Owner
uniQure BioPharma BV

Petitioner(s)
Pfizer Inc.

§ 102 Challenge
Y: Claims 6, 9-15

Claim Types Challenged Under § 102
Composition of Matter Formulation Manufacturing Method of Treatment

§ 102 Challenge Instituted
Y

§ 103 challenge
Y: Claims 6, 9-15

Claim Types Challenged Under § 103
Composition of Matter Formulation Manufacturing Method of Treatment

§ 103 Challenge Instituted
Y

Settled / Challenged Claims Disclaimed / Challenge Terminated
Y (Patent Owner Requested Adverse Judgment After Institution)

IPR Status
Terminated After Institution - Patent Owner Request for Adverse Judgment

IPR2021-00925

U.S. Patent No.
9,982,248 (Factor IX Polypeptide Mutant, Its Uses and Method for Its Production)

Patent Owner
uniQure BioPharma BV; CSL Behring LLC

Petitioner(s)
Pfizer Inc.

§ 102 Challenge
Y: Claims 1, 3, 7-10, 14-16, 19, 20

Claim Types Challenged Under § 102
Method of Treatment

§ 102 Challenge Instituted
Y

§ 103 challenge
Y: Claims 1, 3, 7-10, 14-16, 19, 20

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
Y

Final Written Decision Issued
Y

Federal Circuit Appeal(s)
23-1404 (lead) (consolidated with 23-1405, 23-1406)

IPR Status
Final Written Decision (All Instituted Claims Unpatentable); Federal Circuit Appeal Pending

IPR2021-00926

U.S. Patent No.
9,982,248 (Factor IX Polypeptide Mutant, Its Uses and Method for Its Production)

Patent Owner
uniQure BioPharma BV; CSL Behring LLC

Petitioner(s)
Pfizer Inc.

§ 102 Challenge
Y: Claims 2, 5, 6, 11-13

Claim Types Challenged Under § 102
Method of Treatment

§ 102 Challenge Instituted
Y

§ 103 challenge
Y: Claims 2, 4-6, 11-13, 17, 18

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
Y

Final Written Decision Issued
Y

Federal Circuit Appeal(s)
23-1405 (consolidated with lead appeal 23-1404)

IPR Status
Final Written Decision (All Instituted Claims Unpatentable); Federal Circuit Appeal Pending

IPR2021-00928

U.S. Patent No.
10,465,180 (Factor IX Polypeptide Mutant, Its Uses and Method for Its Production)

Patent Owner
uniQure BioPharma BV; CSL Behring LLC

Petitioner(s)
Pfizer Inc.

§ 102 Challenge
Y: Claims 1-6

Claim Types Challenged Under § 102
Composition of Matter Formulation

§ 102 Challenge Instituted
Y

§ 103 challenge
Y: Claims 1-6

Claim Types Challenged Under § 103
Composition of Matter Formulation

§ 103 Challenge Instituted
Y

Final Written Decision Issued
Y

Federal Circuit Appeal(s)
23-1406 (consolidated with lead appeal 23-1404)

IPR Status
Final Written Decision (All Instituted Claims Unpatentable); Federal Circuit Appeal Pending

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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