Court Report - April 2015 #2

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

Supernus Pharmaceuticals, Inc. v. Actavis Inc. et al.
1:15-cv-02499; filed April 7, 2015 in the District Court of New Jersey

• Plaintiff:  Supernus Pharmaceuticals, Inc.
• Defendants:  Actavis Inc.; Actavis Laboratories FL, Inc.; Activis Pharma, Inc.; Watson Laboratories, Inc.; Anda, Inc.

Infringement of U.S. Patent No. 8,821,930 ("Modified Release Preparations Containing Oxcarbazepine and Derivatives Thereof," issued September 2, 2014) following a Paragraph IV certification as part of Actavis' filing of an ANDA to manufacture a generic version of Supernus' Oxtellar XR® (oxcarbazepine extended-release tablets, used for adjunctive therapy in the treatment of partial seizures in adults and in children 6 to 17 years of age).  View the complaint here.

Merial Inc et al. v. Ceva Sante Animale SA et al.
3:15-cv-00039; filed April 6, 2015 in the Middle District of Georgia

• Plaintiffs:  Merial Inc; Merial SAS
• Defendants:  Ceva Sante Animale SA; Horizon Valley Generics Inc; Trurx LLC

Infringement of U.S. Patent No. 6,096,329 ("Insecticidal Combination to Control Mammal Fleas, in Particular Fleas on Cats and Dogs," issued August 1, 2000), licensed to Merial in the animal health field, based on Ceva's manufacture and sale of its PetAction Plus and PetLock Plus flea and tick products .  View the complaint here.

Sanofi-Aventis U.S. LLC et al. v. Accord Healthcare, Inc.
3:15-cv-02520; filed April 6, 2015 in the District Court of New Jersey

• Plaintiffs:  Sanofi-Aventis U.S. LLC; Aventis Pharma S.A.; Sanofi
• Defendant:  Accord Healthcare, Inc.

Sanofi-Aventis U.S. LLC et al. v. BPI Labs, LLC et al.
3:15-cv-02521; filed April 6, 2015 in the District Court of New Jersey

• Plaintiffs:  Sanofi-Aventis U.S. LLC; Aventis Pharma S.A.; Sanofi
• Defendants:  BPI Labs, LLC; Belcher Pharmaceuticals, LLC

Sanofi-Aventis U.S. LLC et al. v. Dr. Reddy's Laboratories, Inc. et al.
3:15-cv-02522; filed April 6, 2015 in the District Court of New Jersey

• Plaintiffs:  Sanofi-Aventis U.S. LLC; Aventis Pharma S.A.; Sanofi
• Defendants:  Dr. Reddy's Laboratories, Inc.; Dr. Reddy's Laboratories, Ltd.

Sanofi-Aventis U.S. LLC et al. v. Glenmark Generics Inc. et al.
3:15-cv-02523; filed April 6, 2015 in the District Court of New Jersey

• Plaintiffs:  Sanofi-Aventis U.S. LLC; Aventis Pharma S.A.; Sanofi
• Defendants:  Glenmark Generics Inc.; Glenmark Pharmaceuticals Ltd.

The complaints in these cases are substantially identical.  Infringement of U.S. Patent No. 8,927,592 ("Antitumoral Use Of Cabazitaxel," issued January 6, 2015) following a Paragraph IV certification as part of defendants' filing of an ANDA and/or an NDA (under § 505(b)(2) of the Food, Drug and Cosmetic Act) to manufacture a generic version of Sanofi's Jevtana® (cabazitaxel injection, used in combination with prednisone for the treatment of patients with hormonerefractory metastatic prostate cancer previously treated with a docetaxel-containing treatment regimen).  View the Accord complaint here.

Purdue Pharma L.P. et al. v. Acura Pharmaceuticals Inc. et al.
1:15-cv-00292; filed April 3, 2015 in the District Court of Delaware

• Plaintiffs:  PF Laboratories Inc.; Purdue Pharma LP; Purdue Pharmaceuticals LP
• Defendants:  Acura Pharmaceuticals Inc.; Egalet Corp.; Egalet US Inc.

Declaratory judgment of infringement of U.S. Patent No. 8,389,007 ("Pharmaceutical Composition Containing Gelling Agent," issued March 5, 2013) based on Acura's anticipated marketing and sale of Oxaydo® (formerly Oxecta®, oxycodone hydrochloride, used for the management of acute and chronic moderate to severe pain where the use of an opioid analgesic is appropriate).  View the complaint here.

Gilead Sciences, Inc. et al. v. Watson Laboratories, Inc. et al.
2:15-cv-02350; filed April 3, 2015 in the District Court of New Jersey

• Plaintiffs:  Gilead Sciences, Inc.; Royalty Pharma Collection Trust
• Defendants:  Watson Laboratories, Inc.; Actavis, Inc.; Actavis PLC

Infringement of U.S. Patent No. RE42,462 ("Carboxylic Acid Derivatives, Their Preparation and Use," issued June 14, 2011) following a Paragraph IV certification as part of Watson's filing of an ANDA to manufacture a generic version of Gilead's Letairis® (ambrisentan, used to treat pulmonary arterial hypertension).  View the complaint here.

Elan Pharma International Ltd. v. Actavis Laboratories UT Inc. et al.
1:15-cv-00291; filed April 2, 2015 in the District Court of Delaware

• Plaintiff:  Elan Pharma International Ltd.
• Defendants:  Actavis Laboratories UT Inc.; Actavis Inc.; Actavis plc

Infringement of U.S. Patent No. 6,899,890 ("Bioadhesive Drug Delivery System," issued May 31, 2005) following a Paragraph IV certification as part of Actavis' filing of an ANDA to manufacture a generic version of Elan's Clindesse®(clindamycin phosphate vaginal cream, used to treat bacterial vaginosis).  View the complaint here.

Merck Sharp & Dohme Corp. v. Apotex Inc. et al.
3:15-cv-02384; filed April 2, 2015 in the District Court of New Jersey

• Plaintiff:  Merck Sharp & Dohme Corp.
• Defendants:  Apotex Inc.; Apotex Corp.

Infringement of U.S. Patent No. 6,127,353 ("Mometasone Furoate Monohydrate, Process for Making Same and Pharmaceutical Compositions," issued October 3, 2000) following a Paragraph IV certification as part of Apotex's filing of an ANDA to manufacture a generic version of Merck's Nasonex® (mometasone furoate monohydrate metered nasal spray, used to treat diseases of the upper airways, including allergic and nonallergic rhinitis).  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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