Court Report - December 2014

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

Reckitt Benckiser Pharmaceuticals Inc. et al. v. Teva Pharmaceuticals USA Inc.
1:14-cv-01451; filed December 2, 2014 in the District Court of Delaware

• Plaintiffs:  Reckitt Benckiser Pharmaceuticals Inc.; RB Pharmaceuticals Ltd.; MonoSol Rx LLC
• Defendant:  Teva Pharmaceuticals USA Inc.

Infringement of U.S. Patent Nos. 8,475,832 ("Sublingual and Buccal Film Compositions," issued July 2, 2013), 8,017,150 ("Polyethylene Oxide-Based Films and Drug Delivery Systems Made Therefrom," issued on September 13, 2011), and 8,603,514 ("Uniform Films for Rapid Dissolve Dosage Form Incorporating Taste-Masking Compositions," issued December 10, 2013) following a Paragraph IV certification as part of Teva's filing of an ANDA to manufacture a generic version of Reckitt Benckiser's Suboxone® (buprenorphine hydrochloride and naloxone hydrochloride sublingual film, used for the maintenance treatment of opioid dependence).  View the complaint here.

Meda Pharmaceuticals Inc. et al. v. Apotex Inc. et al.
1:14-cv-01453; filed December 2, 2014 in the District Court of Delaware

• Plaintiffs:  Meda Pharmaceuticals Inc.; Cipla Ltd.
• Defendants:  Apotex Inc.; Apotex Corp.

Infringement of U.S. Patent Nos. 8,163,723 ("Combination of Azelastine and Steroids," issued April 24, 2012) and 8,168,620 (same title, issued May 1, 2012), licensed to Meda, following a Paragraph IV certification as part of Apotex's filing of an ANDA to manufacture a generic version of Meda's Dymista® (azelastine hydrochloride and fluticasone prioionate combination nasal spray.  View the complaint here.

Helsinn Healthcare S.A. et al. v. Exela Pharma Sciences LLC et al.
1:14-cv-01444; filed December 1, 2014 in the District Court of Delaware

• Plaintiffs:  Helsinn Healthcare S.A.; Roche Palo Alto LLC
• Defendants:  Exela Pharma Sciences LLC; Excela PharmSci Inc.; Exela Holdings Inc.

Infringement of U.S. Patent Nos. 8,518,981 ("Liquid Pharmaceutical Formulations of Palonosetron," issued August 27, 2013) and 8,598,218 (same title, issued December 3, 2013) following a Paragraph IV certification as part of Exela'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.

Otsuka Pharmaceutical Co., Ltd. v. Alembic Pharmaceuticals Ltd. et al.
1:14-cv-07405; filed November 26, 2014 in the District Court of New Jersey

• Plaintiff:  Otsuka Pharmaceutical Co., Ltd.
• Defendants:  Alembic Pharmaceuticals Ltd.; Alembic Ltd.; Alembic Global Holding SA; Alembic Pharmaceuticals Inc.

Infringement of U.S. Patent No. 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 Alembic'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.

Bausch & Lomb Inc. et al. v. Micro Labs USA, Inc. et al.
1:14-cv-07406; filed November 26, 2014 in the District Court of New Jersey

• Plaintiffs:  Bausch & Lomb Inc.; Bausch & Lomb Pharma Holdings Corp.; Senju Pharmaceutical Co., Ltd.
• Defendants:  Micro Labs USA, Inc.; Micro Labs Ltd,

Infringement of U.S. Patent No. 8,784,789 ("Aqueous Liquid Preparations and Light-Stabilized Aqueous Liquid Preparations," issued July 22, 2014) following a Paragraph IV certification as part of Micro's filing of an ANDA to manufacture a generic version of Bausch & Lomb's Bepreve® (bepotastine besilate ophthalmic solution, used for the treatment of itching associated with allergic conjunctivitis).  View the complaint here.

Noven Therapeutics, LLC v. Prinston Pharmaceutical Inc. et al.
2:14-cv-07400; filed November 26, 2014 in the District Court of New Jersey

• Plaintiff:  Noven Therapeutics, LLC
• Defendants:  Prinston Pharmaceutical Inc.; Solco Healthcare U.S., LLC; Huahai US Inc.

Infringement of U.S. Patent Nos. 5,874,447 ("4-Phenylpiperidine Compounds for Treating Depression," issued February 23, 1999), 7,598,271 ("Crystalline Paroxetine Methane Sulfonate," issued October 6, 2009), and 8,658,663 ("Method of Treating Thermoregulatory Dysfunction with Paroxetine," issued February 25, 2014) following a Paragraph IV certification as part of Prinston's filing of an ANDA to manufacture a generic version of Noven's Brisdelle® (paroxetine mesylate, used for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause).  View the complaint here.

Supernus Pharmaceuticals, Inc. v. Zydus Pharmaceuticals (USA) Inc. et al.
2:14-cv-07272; filed November 21, 2014 in the District Court of New Jersey

• Plaintiff:  Supernus Pharmaceuticals, Inc.
• Defendants:  Zydus Pharmaceuticals (USA) Inc.; Cadila Healthcare Ltd.

Infringement of U.S. Patent Nos. 8,298,576 ("Sustained-Release Formulations of Topiramate," issued October 30, 2012,), 8,298,580 (same title, issued October 30, 2012), and 8,663,683 (same title, issued March 4, 2014) following a Paragraph IV certification as part of Zydus' filing of an ANDA to manufacture a generic version of Supernus' Trokendi XR® (topiramate extended-release, used to treat certain types of seizures).  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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