Betaseron® (interferon beta-1b)

BL 103471

Betaseron® (interferon beta-1b)

BL 103471

U.S. License Holder:

Bayer Healthcare Pharms

Date of License:

July-23-1993

Last Update:

Dec-15-2024

approved_indications FDA-Approved Indications

BETASERON (interferon beta-1b) is an interferon beta indicated for the treatment of relapsing forms of multiple sclerosis, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.

approved_indications U.S. Patent Litigations

PACER

Case No(s):

2:10-cv-02734 (D.N.J.)

U.S. Patent Nos.
7,588,755 (DNA Sequences, Recombinant DNA Molecules and Processes for Producing Human Fibroblast Interferon-Like Polypeptides)

Plaintiffs
Bayer HealthCare Pharmaceuticals Inc.; Consolidated Plaintiffs: Biogen IDEC, Inc.; Biogen MA, Inc.

Defendants
Biogen IDEC, Inc.; Biogen MA, Inc.; Ares Trading; Consolidated Defendants: Bayer HealthCare Pharmaceuticals Inc., EMD Serono Inc.; Novartis Pharmaceuticals Corp.; Pfizer Inc.

Federal Circuit Appeal(s)
19-1133; 21-117; 21-120

Supreme Court Appeal(s)
20-1604

Status
Jury Verdict (Claims infringed and anticipated); JMOL Motions Granted for New Trial; Federal Circuit Reversed and Remanded to Reinstate Jury Verdict, Petition for Panel Rehearing and En Banc Rehearing Denied; Final Judgment of Invalidity of Claim 1 Entered; Petitions for Writ of Mandamus Voluntarily Dismissed; Petition for Writ of Certiorari Denied; Voluntarily Dismissed

BPCIA
N

2:10-cv-02760 (D.N.J.)

U.S. Patent Nos.
7,588,755 (DNA Sequences, Recombinant DNA Molecules and Processes for Producing Human Fibroblast Interferon-Like Polypeptides)

Plaintiffs
Biogen MA, Inc.

Defendants
Bayer HealthCare Pharmaceuticals Inc.; EMD Serono, Inc.; Novartis Pharmaceuticals Corp.; Pfizer Inc.

Federal Circuit Appeal(s)
19-1133

Status
Consolidated with 2:10-cv-02734 (D.N.J.); Federal Circuit Reversed and Remanded to Reinstate Jury Verdict, Petition for Panel Rehearing and En Banc Rehearing Denied

BPCIA
N

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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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