Court Report - June 2015 #3

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

Mayne Pharma International Pty Ltd. v. Merck & Co., Inc., et al.
1:15-cv-00438; filed May 29, 2015 in the District Court of Delaware

• Plaintiff:  Mayne Pharma International Pty Ltd.
• Defendants:  Merck & Co., Inc.; Merck Sharp & Dohme Corp.; N.V. Organon

Infringement of U.S. Patent No. 6,881,745 ("Pharmaceutical Compositions for Poorly Soluble Drugs," issued April 18, 2005) based on Merck's manufacture and sale of its Noxafil® (posaconazole, used in the prophylaxis of fungal infections in immunocompromised patients, and in the treatment of oropharyngeal candidiasis).  View the complaint here.

Novartis Pharmaceuticals Corp. v. Apotex, Inc. et al.
2:15-cv-03634; filed May 29, 2015 in the District Court of New Jersey

• Plaintiff:  Novartis Pharmaceuticals Corp.
• Defendants:  Apotex, Inc; Apotex Corp.

Infringement of U.S. Patent No. 8,324,189 ("Use of Zolendronate for the Manufacture of a Medicament for the Treatment of Bone Metabolism Diseases," issued December 4, 2012) following a Paragraph IV certification as part of Apotex's filing of an ANDA to manufacture a generic version of Novartis' Zometa® (zoledronic acid, used for the prevention of skeletal-related complications associated with cancer).  View the complaint here.

Fresenius Kabi USA, LLC v. Fera Pharmaceuticals, LLC
2:15-cv-03654; filed May 29, 2015 in the District Court of New Jersey

Fresenius Kabi USA, LLC v. Innopharma Licensing, LLC et al.
2:15-cv-03655; filed May 29, 2015 in the District Court of New Jersey

• Plaintiff:  Fresenius Kabi USA, LLC
• Defendants:  Innopharma Licensing, LLC; Innopharma Licensing, Inc.; Innopharma, LLC; Innopharma, Inc.

The complaints in these cases are substantially identical.  Infringement of U.S. Patent No. 9,006,689 ("Levothyroxine Formulations," issued on April l4, 2015) following a Paragraph IV certification as part of Fera's filing of an ANDA to manufacture a generic version of Fresenius' Levothyroxine Sodium (levothyroxine sodium for injection, used to treat myxedema coma).  View the Fera complaint here.

Mylan Pharmaceuticals Inc. v. Janssen Pharmaceuticals, Inc.
2:15-cv-02990; filed May 29, 2015 in the Eastern District of Pennsylvania

Declaratory judgment of invalidity and non-infringement of U.S. Patent No. 8,629,179 ("Methods and Devices for Providing Prolonged Drug Therapy," issued January 14, 2014) in conjunction with Mylan's filing of an ANDA to manufacture a generic version of Alza's Concerta® (methylphenidate hydrochloride, used to treat attention deficit hyperactivity disorder).  View the Delaware complaint here.  View the complaint here.

Forest Laboratories LLC et al. v. Amneal Pharmaceuticals LLC et al.
1:15-cv-00430; filed May 28, 2015 in the District Court of Delaware

• Plaintiffs:  Forest Laboratories LLC; Forest Laboratories Holdings Ltd.
• Defendants:  Amneal Pharmaceuticals LLC; Amneal Pharmaceuticals of New York LLC; Amneal Pharmaceuticals Co. India Pvt. Ltd.

Infringement of U.S. Patent No. 5,763,476 ("Sublingual or Buccal Pharmaceutical Composition," issued June 9, 1998) following a Paragraph IV certification as part of Amneal's filing of an ANDA to manufacture a generic version of Forest's Saphris® (asenapine maleate, sublingual, used to treat schizophrenia and manic or mixed episodes associated with bipolar I disorder).  View the complaint here.

Warner Chilcott Co., LLC v. Amneal Pharmaceuticals LLC
3:15-cv-03590; filed May 28, 2015 in the District Court of New Jersey

Infringement of U.S. Patent No. 6,667,050 ("Chewable Oral Contraceptive," issued December 23, 2003) following a Paragraph IV certification as part of Amneal's filing of an ANDA to manufacture a generic version of Warner Chilcott's Minastrin® 24 Fe (ethinyl estradiol and norethindrone acetate, used for oral contraception).  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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