Court Report -- January 06, 2014

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Gavel About Court Report:  Each week we will report briefly on recently filed biotech and pharma cases.

Cephalon Inc. v. Sandoz Inc.
1:13-cv-02104; filed December 31, 2014 in the District Court of Delaware

Cephalon Inc. v. Hospira Inc.
1:13-cv-02094; filed December 26, 2014 in the District Court of Delaware

Cephalon Inc. v. Accord Healthcare Inc. et al.
1:13-cv-02095; filed December 26, 2014 in the District Court of Delaware

• Plaintiff:  Cephalon Inc.
• Defendants:  Accord Healthcare Inc.; Intas Pharmaceuticals Ltd.

Cephalon Inc. v. Sun Pharma Global FZE et al.
1:13-cv-02096; filed December 26, 2014 in the District Court of Delaware

• Plaintiff:  Cephalon Inc.
• Defendants:  Sun Pharma Global FZE; Sun Pharmaceutical Industries Ltd.; Sun Pharmaceutical Industries Inc.

The complaints in these cases are substantially identical.  Infringement of U.S. Patent Nos. 8,445,524 ("Solid Forms of Bendamustine Hydrochloride," issued May 21, 2013) and 8,436,190 ("Bendamustine Pharmaceutical Compositions," issued May 7, 2013) following a Paragraph IV certification as part of defendants' filing of an ANDA to manufacture a generic version of Cephalon's Treanda® (bendamustine hydrochloride, used to treat chronic lymphocytic leukemia and non-Hodgkin's lymphoma).  View the Hospira complaint here.

Helsinn Healthcare S.A. et al. v. Accord Healthcare Inc. et al.
1:13-cv-02101; filed December 27, 2014 in the District Court of Delaware

• Plaintiffs:  Helsinn Healthcare S.A.; Roche Palo Alto LLC
• Defendants:  Accord Healthcare Inc.; Intas Pharmaceuticals Ltd.

Infringement of U.S. Patent Nos. 8,598,218 ("Liquid Pharmaceutical Formulations of Palonosetron," issued December 3, 2013) and 8,598,219 (same title, issued December 3, 2013) following a Paragraph IV certification as part of Accord's filing of an ANDA to manufacture a generic version of Helsinn's Aloxi® (palonosetron hydrochloride intravenous solution, used to prevent chemotherapy induced nausea and vomiting).  View the complaint here.

Jazz Pharmaceuticals, Inc. v. Par Pharmaceutical, Inc.
2:13-cv-07884; filed December 27, 2013 in the District Court of New Jersey

Infringement of U.S. Patent Nos. 6,472,431 ("Microbiologically Sound and Stable Solutions of Gamma-Hydroxybutyrate Salt for the Treatment of Narcolepsy," issued October 29, 2002), 6,780,889 (same title, issued August 24, 2004), 7,262,219 (same title, issued August 28, 2007), 7,851,506 (same title, issued December 14, 2010 ("Sensitive Drug Distribution System and Method" issued February 22, 2011), 8,263,650 ("Microbiologically Sound and Stable Solutions of Gamma-Hydroxybutyrate Salt for the Treatment of Narcolepsy,"  issued September 11, 2012), 8,324,275 (same title,  issued December 4, 2012), 8,461,203 ("Microbiologically Sound and Stable Solutions of Gamma-Hydroxybutyrate Salt for the Treatment of Narcolepsy," issued June 11, 2013), 7,668,730 ("Sensitive Drug Distribution System and Method," issued February 23, 2010), 7,765,106 (same title, issued July 27, 2010), 7,765,107 (same title, issued July 27, 2010), 7,895,059 (same title, issued February 22, 2011), 8,457,988 (same title, issued June 4, 0213), and 8,589,182 (same title, issued November 19, 2013) following a Paragraph IV certification as part of Par's filing of an ANDA to manufacture a generic version of Jazz's Xyrem® (sodium oxybate, used to treat narcolepsy).  View the complaint here.

Novartis Pharmaceuticals Corp. v. Fresenius USA, LLC
2:13-cv-07914; filed December 27, 2013 in the District Court of New Jersey

Infringement of U.S. Patent No. 8,324,189 ("Use of Zolendronate for the Manufacture of a Medicament for the Treatment of Bone Metabolism Diseases," issued December 4, 2012) following a Paragraph IV certification as part of Fesenius' filing of an ANDA to manufacture a generic version of Novartis' Zometa® (zoledronic acid, used for the prevention of skeletal-related complications associated with cancer).  View the complaint here.

Cephalon Inc. v. Glenmark Pharmaceuticals Ltd. et al.
1:13-cv-02093; filed December 26, 2014 in the District Court of Delaware

• Plaintiff:  Cephalon Inc.
• Defendants:  Glenmark Pharmaceuticals Ltd.; Glenmark Generics Ltd.; Glenmark Generics S.A.; Glenmark Generics Inc. USA

Infringement of U.S. Patent No. 8,445,524 ("Solid Forms of Bendamustine Hydrochloride," issued May 21, 2013) following a Paragraph IV certification as part of Glenmark's filing of an ANDA to manufacture a generic version of Cephalon's Treanda® (bendamustine hydrochloride, used to treat chronic lymphocytic leukemia and non-Hodgkin's lymphoma).  View the complaint here.

 

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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