Court Report - November 2014 #2

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

AstraZeneca Pharmaceuticals LP et al. v. Pharmadax USA, Inc. et al.
1:14-cv-07105; filed November 3, 2014 in the District Court of New Jersey

• Plaintiffs:  AstraZeneca Pharmaceuticals LP; AstraZeneca UK Ltd.
• Defendants:  Pharmadax USA, Inc.; Pharmadax Inc.; Pharmadax (Guangzhou) Inc.

Infringement of U.S. Patent No. 5,948,437 ("Pharmaceutical Compositions Using Thiazepine," issued September 7, 1999) following a Paragraph IV certification as part of Pharmadax's filing of an ANDA to manufacture a generic version of AstraZeneca's Seroquel® XR (quetiapine fumarate, used to treat schizophrenia and bipolar disorder).  View the complaint here.

Endo Pharmaceuticals Inc. et al. v. Actavis Inc., et al.
1:14-cv-01381; filed November 7, 2014 in the District Court of Delaware

• Plaintiffs:  Endo Pharmaceuticals Inc.; Mallinckrodt LLC
• Defendants:  Actavis Inc.; Actavis South Atlantic LLC

Endo Pharmaceuticals Inc. et al. v. Amneal Pharmaceuticals LLC, et al.
1:14-cv-01382; filed November 7, 2014 in the District Court of Delaware

• Plaintiffs:  Endo Pharmaceuticals Inc.; Mallinckrodt LLC
• Defendants:  Amneal Pharmaceuticals LLC; Amneal Pharmaceuticals of New York LLC

Endo Pharmaceuticals Inc. et al. v. Impax Laboratories Inc.
1:14-cv-01383; filed November 7, 2014 in the District Court of Delaware

• Plaintiffs:  Endo Pharmaceuticals Inc.; Mallinckrodt LLC
• Defendant:  Impax Laboratories Inc.

Endo Pharmaceuticals Inc. et al. v. Impax Laboratories Inc. et al.
1:14-cv-01384; filed November 7, 2014 in the District Court of Delaware

• Plaintiffs:  Endo Pharmaceuticals Inc.; Mallinckrodt LLC
• Defendants:  Impax Laboratories Inc.; ThoRx Laboratories Inc.

Endo Pharmaceuticals Inc. et al. v. Par Pharmaceutical Companies Inc. et al.
1:14-cv-01385; filed November 7, 2014 in the District Court of Delaware

• Plaintiffs:  Endo Pharmaceuticals Inc.; Mallinckrodt LLC
• Defendants:  Par Pharmaceutical Companies Inc.; Par Pharmaceutical Inc.

Endo Pharmaceuticals Inc. et al. v Ranbaxy Laboratories Ltd. et al.
1:14-cv-01386; filed November 7, 2014 in the District Court of Delaware

• Plaintiffs:  Endo Pharmaceuticals Inc.; Mallinckrodt LLC
• Defendants:  Ranbaxy Laboratories Ltd.; Ranbaxy Inc.; Ranbaxy Pharmaceuticals Inc.

Endo Pharmaceuticals Inc. et al. v. Roxane Laboratories Inc.
1:14-cv-01387; filed November 7, 2014 in the District Court of Delaware

• Plaintiffs:  Endo Pharmaceuticals Inc.; Mallinckrodt LLC
• Defendant:  Roxane Laboratories Inc.

Endo Pharmaceuticals Inc. et al. v. Sandoz Inc.
1:14-cv-01388; filed November 7, 2014 in the District Court of Delaware

• Plaintiffs:  Endo Pharmaceuticals Inc.; Mallinckrodt LLC
• Defendant:  Sandoz Inc.

Endo Pharmaceuticals Inc. et al. v. Teva Pharmaceuticals USA Inc. et al.
1:14-cv-01389; filed November 7, 2014 in the District Court of Delaware

• Plaintiffs:  Endo Pharmaceuticals Inc.; Mallinckrodt LLC
• Defendants:  Teva Pharmaceuticals USA Inc.; Teva Pharmaceutical Industries Ltd.; Barr Laboratories Inc.

The complaints in these cases are substantially identical.  Infringement of U.S. Patent Nos. 8,808,737 ("Method of Treating Pain Utilizing Controlled Release Oxymorphone Pharmaceutical Compositions and Instruction on Dosing for Renal Impairment," issued August 19, 2014) and 8,871,779 ("Process for Preparing Morphinan-6-One Products with Low Levels of α,β-Unsaturated Ketone Compounds," issued October 28, 2014) following a Paragraph IV certification as part of defendants' filing of an ANDA to manufacture a generic version of Endo's Opana® ER CRF (oxymorphone hydrochloride, crush-resistant formulation, used to treat moderate to severe pain in patients requiring continuous, around-the-clock opioid treatment for an extended period of time).  View the Actavis complaint here.

Otsuka Pharmaceutical Co., Ltd. v. Lupin Ltd. et al.
1:14-cv-07105; filed November 3, 2014 in the District Court of New Jersey

• Plaintiff:  Otsuka Pharmaceutical Co., Ltd.
• Defendants:  Lupin Ltd.; Atlantic Holding SA; Lupin Pharmaceuticals, Inc.

Infringement of U.S. Patent Nos. 8,017,615 ("Low Hygroscopic Aripiprazole Drug Substance and Process for the Preparation Thereof," issued September 13, 2011), 8,580,796 (same title, issued November 12, 2013), 8,642,760 (same title, issued February 4, 2014), and 8,759,350 ("Carbostyril Derivatives and Serotonin Reuptake Inhibitors for Treatment of Mood Disorders," issued June 24, 2014) following a Paragraph IV certification as part of Lupin'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.

 

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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