PB006 (natalizumab)

PB006 Approval Pending

PB006 (natalizumab)

PB006 Approval Pending

U.S. License Holder:

Sandoz / Polpharma

Date of License:

aBLA accepted by FDA July-2022

Last Update:

March-23-2023

approved_indications FDA-Approved Indications

PB006 (natalizumab) is not FDA-approved. An aBLA has been accepted by the FDA.

approved_indications Inter Partes Review Proceedings

PTAB Portal

IPR Case No(s):

PGR2022-00054

U.S. Patent No.
11,292,845 (Methods of Treating Inflammatory and Autoimmune Diseases with Natalizumab)

Patent Owner
Biogen MA, Inc.

Petitioner(s)
Sandoz, Inc.; Polpharma SA

§ 102 Challenge
N

§ 103 challenge
Y

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
N

IPR Status
Challenges Also Include Ineligible Subject Matter and Written Description. PGR Not Instituted

approved_indications U.S. Patent Litigations

PACER

Case No(s):

1:22-cv-01190 (D. Del.)

U.S. Patent Nos.
7,157,276 (Use of Depth Filtration in Series with Continuous Centrifugation to Clarify Mammalian Cell Cultures) 7,759,117 (Use of Depth Filtration in Series with Continuous Centrifugation to Clarify Mammalian Cell Cultures) 8,124,350 (Methods and Products for Evaluating an Immune Response to a Therapeutic Protein) 8,318,416 (Nutrient Monitoring and Feedback Control for Increased Bioproduct Production) 8,809,049 (Methods for Producing Mammalian Cells) 8,871,449 (Methods and Products for Evaluating an Immune Response to a Therapeutic Protein) 9,005,926 (Methods of Preventing and Removing Trisulfide Bonds) 9,096,879 (Method of Supplementing Culture Media to Prevent Undesirable Amino Acid Substitutions) 9,109,015 (Method of Isolating Biomacromolecules Using Low pH and Divalent Cations) 9,212,379 (Nutrient Monitoring and Feedback Control for Increased Bioproduct Production) 9,316,641 (Assay for JC Virus Antibodies) 9,493,567 (Methods of Treating Inflammatory and Autoimmune Diseases with Natalizumab) 9,562,252 (Methods of Preventing and Removing Trisulfide Bonds) 9,696,307 (Methods for the Detection of JC Polyoma Virus) 9,709,575 (Methods and Products for Evaluating an Immune Response to a Therapeutic Protein) 9,790,533 (Methods of Preventing and Removing Trisulfide Bonds) 10,119,976 (Method of Assessing Risk of PML) 10,233,245 (Methods of Treating Inflammatory and Autoimmune Diseases with Natalizumab) 10,308,706 (Methods of Preventing and Removing Trisulfide Bonds) 10,444,234 (Assay for JC Virus Antibodies) 10,590,454 (Methods of Preventing and Removing Trisulfide Bonds) 10,677,803 (Method of Assessing Risk of PML) 10,705,095 (Methods and Products for Evaluating an Immune Response to a Therapeutic Protein) 10,844,416 (Manganese Supplementation for Control of Glycosylation in Mammalian Cell Culture Process) 11,268,119 (Copper Supplementation for Control of Glycosylation in Mammalian Cell Culture Process) 11,280,794 (Method of Assessing Risk of PML) 11,287,423 (Assay for JC Virus Antibodies) 11,292,845 (Methods of Treating Inflammatory and Autoimmune Diseases with Natalizumab)

Plaintiffs
Biogen, Inc.; Biogen MA Inc.

Defendants
Sandoz Inc.; Polpharma Biologics SA

Status
Case Ongoing

BPCIA
Y

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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