Court Report - November 2015 #5

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

Merck Sharp & Dohme Corp. v. Savior Lifetec Corp.
5:15-cv-00415; filed August 21, 2015 in the Eastern District of North Carolina

Infringement of U.S. Patent No. 5,952,323 ("Carbapenem Antibiotic," issued September 14, 1999) following a Paragraph IV certification as part of Savior's filing of an ANDA to manufacture a generic version of Merck's Invanz® (ertapenem, used for the treatment of complicated intra-abdominal infections, complicated skin and skin structure infections, community acquired pneumonia, complicated urinary tract infections, and acute pelvic infections, and for the prophylaxis ofvsurgical site infection following elective colorectal surgery).  View the complaint here.

Otsuka Pharmaceutical Co., Ltd. v. Standard Chem. & Pharm. Co., Ltd et al.
1:15-cv-06353; filed August 21, 2015 in the District Court of New Jersey

• Plaintiff:  Otsuka Pharmaceutical Co., Ltd.
• Defendants:  Standard Chem. & Pharm. Co., Ltd; Stason Pharmaceuticals Inc.; Breckenridge Pharmaceutical, Inc.; Zhejiang Jinhua Conba Bio-Pharm Co. Ltd.; Tai Heng Industry Co., Ltd.

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 defendants' 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.

Par Pharmaceutical, Inc. et al. v. TWi Pharmaceuticals, Inc. et al.
1:15-cv-00710; filed August 18, 2015 in the District Court of Delaware

• Plaintiffs:  Par Pharmaceutical, Inc.; Alkermes Pharma Ireland Ltd.
• Defendants:  TWi Pharmaceuticals, Inc.; TWi Pharmaceuticals USA, Inc.

Infringement of U.S. Patent No. 9,107,827 ("Nonoparticulate Megestrol Formulations," issued August 18, 2015) in conjunction with Twi's filing of an ANDA to manufacture a generic version of Par's Megace ES® (megestrol acetate, used for the treatment of appetite loss, severe malnutrition, or unexplained, significant weight loss in AIDS patients).  View the complaint here.

Dr. Reddy's Laboratories, Inc. et al. v. Fresenius Kabi USA, LLC
1:15-cv-00714; filed August 18, 2015 in the District Court of Delaware

• Plaintiffs:  Dr. Reddy's Laboratories, Inc.; Dr. Reddy's Laboratories, Ltd.
• Defendant:  Fresenius Kabi USA, LLC

Declaratory judgment of non-infringement of U.S. Patent No. 8,476,010 ("Propofol Formulations with Non-Reactive Container Closures," issued July 2, 2013) in conjunction with Dr. Reddy's filing of an ANDA to manufacture a generic version of Fresenius' Diprivan® (propofol injectable emulsion, used for the induction and maintenance of general anesthesia and sedation in certain patient populations).  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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