Myozyme® / Lumizyme® (alglucosidase alfa)

BL 125141 / BL 125291

Myozyme® / Lumizyme® (alglucosidase alfa)

BL 125141 / BL 125291

U.S. License Holder:

Genzyme

Date of License:

April-28-2006 (Myozyme®)

May-24-2010 (Lumizyme®)

Last Update:

Dec-15-2024

approved_indications FDA-Approved Indications

MYOZYME (alglucosidase alfa) is a lysosomal glycogen-specific enzyme indicated for use in patients with Pompe disease (GAA deficiency).

LUMIZYME (alglucosidase alfa) is a hydrolytic lysosomal glycogen-specific enzyme indicated for patients with Pompe disease (GAA deficiency).

approved_indications Inter Partes Review Proceedings

PTAB Portal

IPR Case No(s):

IPR2013-00534

U.S. Patent No.
7,351,410 (Treatment of Pompe's Disease)

Patent Owner
Genzyme Therapeutics Products Limited Partnership

Petitioner(s)
BioMarin Pharmaceutical Inc.

§ 102 Challenge
N

§ 103 challenge
Y: Claim 1

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
Y

Final Written Decision Issued
Y

Federal Circuit Appeal(s)
15-1721 (Consolidated with 15-1720)

IPR Status
Final Written Decision (All Instituted Claims Found Unpatentable); Federal Circuit Affirmed

IPR2013-00535

U.S. Patent No.
7,056,712 (Treatment of Glycogen Storage Disease Type II)

Patent Owner
Genzyme Corp.; Duke University; Synpac Venture Capital, L.P.

Petitioner(s)
BioMarin Pharmaceutical Inc.

§ 102 Challenge
Y: Claims 1-9, 11, 12, 15, 20, 21

Claim Types Challenged Under § 102
Method of Treatment

§ 102 Challenge Instituted
Y

§ 103 challenge
Y: Claims 1-9, 11, 12, 15, 18-21

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
Y

Final Written Decision Issued
Y

Federal Circuit Appeal(s)
16-1106 18-1696

Supreme Court Appeal(s)
19-1475

IPR Status
Final Written Decision (All Instituted Claims Found Unpatentable); Federal Circuit Appeal Affirmed-in-part, Reversed-in-part, Vacated-in-part, and Remanded; Remanded Claim Found Unpatentable; Federal Circuit Affirmed Remand Decision; Petition for En Banc Rehearing Denied; Petition for Certiorari Denied

IPR2013-00537

U.S. Patent No.
7,655,226 (Treatment of Pompe's Disease)

Patent Owner
Genzyme Therapeutic Products Limited Partnership

Petitioner(s)
BioMarin Pharmaceutical Inc.

§ 102 Challenge
Y: Claims 1, 3

Claim Types Challenged Under § 102
Method of Treatment

§ 102 Challenge Instituted
N

§ 103 challenge
Y: Claims 1, 3-6

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
Y

Final Written Decision Issued
Y

Federal Circuit Appeal(s)
15-1720 (Consolidated with 15-1721)

IPR Status
Final Written Decision (All Instituted Claims Found Unpatentable); Federal Circuit Affirmed

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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