Court Report - August 2015 #4

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

Bristol-Myers Squibb Co. et al. v. Merck & Co., Inc. et al.
1:15-cv-00572; filed July 7, 2015 in the District Court of Delaware

• Plaintiffs:  Bristol-Myers Squibb Co.; E. R. Squibb & Sons, L.L.C.; Ono Pharmaceutical Co., Ltd.; Tasuku Honjo
• Defendants:  Merck & Co., Inc.; Merck Sharp & Dohme Corp.

Infringement of U.S. Patent No. 9,073,994 ("Immunopotentiative Composition," issued July 7, 2015) based on Merck's manufacture and sale of its Keytruda® product (pembrolizumab, an anti-PD-1 antibody, used to treat metastatic melanoma).  View the complaint here.

Prinston Pharmaceutical, Inc. v. Noven Therapeutics, LLC
2:15-cv-05308; filed July 2, 2015 in the District Court of New Jersey

Declaratory judgment of non-infringement and invalidity of U.S. Patent No. 8,946,251 (("Method of Treating Thermoregulatory Dysfunction with Paroxetine," issued February 3, 2015) in conjunction with 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.

Otsuka Pharmaceutical Co., Ltd. v. Macleods Pharmaceuticals Ltd. et al.
1:15-cv-05109; filed July 2, 2015 in the District Court of New Jersey

• Plaintiff:  Otsuka Pharmaceutical Co., Ltd.
• Defendants:  Macleods Pharmaceuticals Ltd.; Macleods Pharma USA, 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 Macleods' 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.

Gilead Sciences, Inc. et al. v. Sigmapharm Laboratories, LLC
1:15-cv-04898; filed June 30, 2015 in the District Court of New Jersey

• Plaintiffs:  Gilead Sciences, Inc.; Royalty Pharma Collection Trust
• Defendant:  Sigmapharm Laboratories, LLC

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 SigmaPharm'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.

Horizon Pharma Ireland Ltd. et al. v. Taro Pharmaceuticals USA, Inc. et al.
1:15-cv-05021; filed June 30, 2015 in the District Court of New Jersey

• Plaintiffs:  Horizon Pharma Ireland Ltd.; HZNP Ltd.; Horizon Pharma USA, Inc.
• Defendants:  Taro Pharmaceuticals USA, Inc.; Taro Pharmaceutical Industries, Ltd.

Horizon Pharma Ireland Ltd. et al. v. IGI Laboratories, Inc.
1:15-cv-05022; filed June 30, 2015 in the District Court of New Jersey

• Plaintiffs:  Horizon Pharma Ireland Ltd.; HZNP Ltd.; Horizon Pharma USA, Inc.
• Defendant:  IGI Laboratories, Inc.

Horizon Pharma Ireland Ltd. et al. v. Amneal Pharmaceuticals LLC
1:15-cv-05024; filed June 30, 2015 in the District Court of New Jersey

• Plaintiffs:  Horizon Pharma Ireland Ltd.; HZNP Ltd.; Horizon Pharma USA, Inc.
• Defendant:  Amneal Pharmaceuticals LLC

Horizon Pharma Ireland Ltd. et al. v. Actavis Laboratories UT, Inc. et al.
1:15-cv-05025; filed June 30, 2015 in the District Court of New Jersey

• Plaintiffs:  Horizon Pharma Ireland Ltd.; HZNP Ltd.; Horizon Pharma USA, Inc.
• Defendants:  Actavis Laboratories UT, Inc.; Actavis, Inc.; Allergan PLC

Horizon Pharma Ireland Ltd. et al. v. Lupin Ltd. et al.
1:15-cv-05027; filed June 30, 2015 in the District Court of New Jersey

• Plaintiffs:  Horizon Pharma Ireland Ltd.; HZNP Ltd.; Horizon Pharma USA, Inc.
• Defendants:  Lupin Ltd.; Lupin Pharmaceuticals Inc.

The complaints in these cases are substantially identical.  Infringement of U.S. Patent No. 9,066,913 ("Diclofenac Topical Formulation," issued June 30, 2015) in conjunction with defendants' filing of an ANDA to manufacture a generic version of Horizon's Pennsaid® (diclofenac sodium topical solution, used for the treatment of signs and symptoms of osteoarthritis of the knee(s)).  View the Taro 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. Attorney Advertising.

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