Court Report

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

Bristol-Myers Squibb Company v. Apotex Inc. et al.
1:14-cv-00351; filed March 19, 2014 in the District Court of Delaware

• Plaintiff:  Bristol-Myers Squibb Co.
• Defendants:  Apotex Inc.; Apotex Corp.

Infringement of U.S. Patent No. 5,206,244 ("Hydroxymethyl (Methylenecyclopentyl) Purines and Pyrimidines," issued April 27, 1993) following a Paragraph IV certification as part of Apotex's filing of an ANDA to manufacture a generic version of BMS's Baraclude® (entecavir, used to treat chronic hepatitis B virus infectrion).  View the complaint here.

Sanofi et al. v. Alkem Laboratories, Ltd. et al.
1:14-cv-01957; filed March 19, 2014 in the Northern District of Illinois

• Plaintiffs:  Sanofi; Sanofi-Aventis U.S. LLC
• Defendants:  Alkem Laboratories, Ltd.; Ascend Laboratories, LLC

Sanofi et al. v. Sun Pharma Global FZE et al.
1:14-cv-01844; filed March 14, 2014 in the Northern District of Illinois

• Plaintiffs:  Sanofi; Sanofi-Aventis U.S. LLC
• Defendants:  Sun Pharma Global FZE; Sun Pharmaceutical Industries Ltd.; Caraco Pharmaceutical Laboratories, Ltd.

The complaints in these cases are substantially identical.  Infringement of U.S. Patent Nos. 7,323,493 ("Solid Pharmaceutical Composition Containing Benzofuran Derivatives," issued January 29, 2008), 8,318,800 ("Solid Pharmaceutical Compositions Containing Benzofuran Derivatives," issued November 27, 2012), 8,410,167 ("Use of Dronedarone for the Preparation of a Medicament for Use in the Prevention of Cardiovascular Hospitalization or of Mortality," issued April 2, 2013), and 8,602,215 ("Methods for Reducing the Risk of an Adverse Dronedarone/Beta-Blockers Interaction in a Patient Suffering from Atrial Fibrillation," issued December 10, 2013) following a Paragraph IV certification as part of Sun's filing of an ANDA to manufacture a generic version of Sanofi's Multaq® (dronedarone, used to reduce the risk of hospitalization for atrial fibrillation in patients in sinus rhythm with a history of paroxysmal or persistent atrial fibrillation).  View the Sun complaint here.

Pfizer Inc. et al. v. Torrent Pharmaceuticals Limited et al.
3:14-cv-01704; filed March 17, 2014 in the District Court of New Jersey

• Plaintiffs:  Pfizer Inc.; Pfizer Ltd.; Pfizer Ireland Pharmaceuticals
• Defendants:  Torrent Pharmaceuticals Ltd.; Torrent Pharma Inc.

Pfizer Inc. et al. v. Torrent Pharmaceuticals Limited et al.
1:14-cv-01831; filed March 17, 2014 in the Southern District of New York

• Plaintiffs:  Pfizer Inc.; Pfizer Ltd.; Pfizer Ireland Pharmaceuticals
• Defendants:  Torrent Pharmaceuticals Ltd.; Torrent Pharma Inc.

The complaints in these cases are substantially identical.  Infringement of U.S. Patent No. 6,469,012 ("Pyrazolopyrimidinones for the Treatment of Impotence," issued October 22, 2002) following a Paragraph IV certification as part of Torrent's filing of an ANDA to manufacture a generic version of Pfizer's Viagra® (sildenafil citrate, used to treat erectile dysfunction).  View the New Jersey complaint here.

Cephalon, Inc. v. Emcure Pharmaceuticals Ltd. et al.
3:14-cv-01705; filed March 17, 2014 in the District Court of New Jersey

• Plaintiff:  Cephalon, Inc.
• Defendants:  Emcure Pharmaceuticals Ltd.; Emcure Pharmaceuticals USA, Inc.

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 Emcure'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.

Otsuka Pharmaceutical Co., Ltd. v. Amneal Pharmaceuticals, LLC et al.
3:14-cv-01688; filed March 14, 2014 in the District Court of New Jersey

• Plaintiff:  Otsuka Pharmaceutical Co., Ltd.
• Defendants:  Amneal Pharmaceuticals, LLC; Amneal Pharmaceuticals of New York, LLC; Amneal Pharmaceuticals Co. India Private Ltd.

Infringement of U.S. Patent No. 7,053,092 ("5-HT1A Receptor Subtype Agonist," issued May 30, 2006) following a Paragraph IV certification as part of Amneal's filing of an ANDA to manufacture a generic version of Otsuka's Abilify® (aripiprazole, used to treat bipolar disorder and schizophrenia).  View the complaint here.

Astellas US LLC et al. v. Emcure Pharmaceuticals USA, Inc. et al.
2:14-cv-01665; filed March 14, 2014 in the District Court of New Jersey

• Plaintiffs:  Astellas US LLC; Astellas Pharma US, Inc.; Item Development AB
• Defendants:  Emcure Pharmaceuticals USA, Inc.; Emcure Pharmaceuticals, Ltd.

Infringement of U.S. Patent No. 5,731,296 ("Selective Vasodilation by Continuous Adenosine Infusion," issued March 24, 1998), licensed to Astellas, following a Paragraph IV certification as part of Emcure's filing of an ANDA to manufacture a generic version of Astellas' Adenoscan® product (adenosine injection, used as a diagnostic for myocardial reperfusion injury).  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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