By Sherri Oslick --
About Court Report: Each week we will report briefly on recently filed biotech and pharma cases.
Millennium Pharmaceuticals Inc. v. Glenmark Pharmaceuticals Ltd. et al.
1:14-cv-01156; filed September 10, 2014 in the District Court of Delaware
• Plaintiff: Millennium Pharmaceuticals Inc.
• Defendants: Glenmark Pharmaceuticals Ltd.; Glenmark Generics Ltd.; Glenmark Generics Inc. USA
Infringement of U.S. Patent Nos. 6,713,446 ("Formulation of Boronic Acid Compounds," issued March 30, 2004) and 6,958,319 (same title, issued October 25, 2005), licensed exclusively to Millennium, following a Paragraph IV certification as part of Glenmarks' filing of an ANDA to manufacture a generic version of Millenium's Velcade® (bortezomib, used to treat multiple myeloma). View the complaint here.
Teva Pharmaceuticals USA Inc. et al. v. Sandoz Inc. et al.
1:14-cv-01171; filed September 10, 2014 in the District Court of Delaware
• Plaintiffs: Teva Pharmaceuticals USA Inc.; Teva Pharmaceutical Industries Ltd; Teva Neuroscience Inc; Yeda Research and Development Co Ltd.
• Defendants: Sandoz Inc.; Momenta Pharmaceuticals Inc.
Teva Pharmaceuticals USA Inc. et al. v. Dr Reddy's Laboratories Ltd et al.
1:14-cv-01172; filed September 10, 2014 in the District Court of Delaware
• Plaintiffs: Teva Pharmaceuticals USA Inc.; Teva Pharmaceutical Industries Ltd; Teva Neuroscience Inc; Yeda Research and Development Co Ltd.
• Defendants: Dr Reddy's Laboratories Ltd; Dr Reddy's Laboratories Inc.
The complaints in these cases are substantially identical. Infringement of U.S. Patent Nos. 8,232,250 ("Low Frequency Glatiramer AcetateTherapy," issued July 31, 2012) and 8,399,413 (same title, issued March 19, 2013) following a Paragraph IV certification as part of defendants' filing of an ANDA to manufacture a generic version of Teva's Copaxone® (glatiramer acetate injection, used for the reduction or frequency of relapses in patients with relapsing-remitting multiple sclerosis). View the Sandoz complaint here.
Fresenius Kabi USA, LLC v. Emcure Pharmaceuticals USA Inc. et al.
1:14-cv-01141; filed September 8, 2014 in the District Court of Delaware
• Plaintiff: Fresenius Kabi USA, LLC
• Defendants: Emcure Pharmaceuticals USA Inc.; Emcure Pharmaceuticals Ltd.
Fresenius Kabi USA, LLC v. Emcure Pharmaceuticals USA, Inc. et al.
1:14-cv-05584 filed September 8, 2014 in the District Court of New Jersey
• Plaintiff: Fresenius Kabi USA, LLC
• Defendants: Emcure Pharmaceuticals USA Inc.; Emcure Pharmaceuticals Ltd.
The complaints in these cases are substantially identical. Infringement of U.S. Patent No. 8,476,010 ("Propofol Formulations with Non-Reactive Container Closures," issued July 2, 2013) following a Paragraph IV certification as part of Emcure'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 Delaware complaint here.
Salix Pharmaceuticals, LTD et al. v. Mylan Pharmaceuticals Inc.
1:14-cv-00152; filed September 8, 2014 in the Northern District of West Virginia
• Plaintiffs: Salix Pharmaceuticals, LTD; Salix Pharmaceuticals, Inc; Glycyx Pharmaceuticals, LTD
• Defendant: Mylan Pharmaceuticals Inc.
Infringement of U.S. Patent Nos. 6,197,341 ("Formulations of Balsalazide and Its Derivatives," issued March 6, 2001) and 8,497,256 ("Formulations and Uses of 2-Hydroxy-5-Phenylazobenzoic Acid Derivatives for the Treatment of Males," issued July 30, 2013) following a Paragraph IV certification as part of Mylan's filing of an ANDA to manufacture a generic version of Salix's Giazo® (balsalazide disodium, used for the treatment of mildly to moderately active ulcerative colitis in male patients 18 years of age and older). View the complaint here.
AbbVie Inc. v. Hetero Labs Ltd. et al.
1:14-cv-01137; filed September 5, 2014 in the District Court of Delaware
• Plaintiff: AbbVie Inc.
• Defendants: Hetero Labs Ltd.; Hetero USA Inc.; Hetero Labs Ltd.; Hetero USA Inc.
Infringement of U.S. Patent No. 8,691,878 ("Solid Pharmaceutical Dosage Form," issued April 8, 2014) following a Paragraph IV certification as part of Hetero's filing of an ANDA to manufacture a generic version of AbbVie's Norvir® (ritonavir, used to treat human immunodeficiency virus (HIV) infection). View the complaint here.
Bristol-Myers Squibb Co. et al. v. Merck & Co Inc.
1:14-cv-01131; filed September 4, 2014 in the District Court of Delaware
• Plaintiffs: Bristol-Myers Squibb Co.; Ono Pharmaceutical Co., Ltd.
• Defendant: Merck & Co. Inc.
Infringement of U.S. Patent No. 8,728,474 ("Immunopotentiative Composition," issued May 20, 2014), licensed to BMS, based on Merck's anticipated manufacture and sale of pembrolizumab for the treatment of cancer. View the complaint here.
Otsuka Pharmaceutical Co., Ltd. V. Zhejiang Huahai Pharmaceutical Co., Ltd., et al.
1:14-cv-05537; filed September 4, 2014 in the District Court of New Jersey
• Plaintiff: Otsuka Pharmaceutical Co., Ltd.
• Defendants: Zhejiang Huahai Pharmaceutical Co., Ltd.; Huahai US Inc.; Prinston Pharmaceutical Inc.; Solco Healthcare U.S., LLC
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), and 8,642,760 (same title, issued February 4, 2014) following a Paragraph IV certification as part of Zhejiang Huahai'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.
Astrazeneca Pharmaceuticals LP et al. v. Sagent Pharmaceuticals, Inc.
1:14-cv-05539; filed September 2, 2014 in the District Court of New Jersey
• Plaintiffs: Astrazeneca Pharmaceuticals LP; Astrazeneca UK Ltd.; Astrazeneca AB
• Defendant: Sagent Pharmaceuticals, Inc.
Infringement of U.S. Patent Nos. 6,774,122 ("Formulation," issued August 10, 2004), 7,456,160 (same title, issued November 25, 2008), 8,329,680 (same title, issued December 11, 2012), and 8,466,139 (same title, issued June 18, 2013) following a Paragraph IV certification as part of Sagent's filing of an ANDA to manufacture a generic version of AstraZeneca's Faslodex® (fulvestrant injection, used to treat hormone receptor positive metastatic breast cancer in postmenopausal women with disease progression following antiestrogen therapy). View the complaint here.
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