About Court Report: Each week we will report briefly on recently filed biotech and pharma cases.
Teva Pharmaceuticals USA, Inc. et al. v. Mylan Pharmaceuticals Inc. et al.
1:14-cv-00167; filed October 7, 2014 in the Northern District of West Virginia
• Plaintiffs: Teva Pharmaceuticals USA, Inc.; Teva Pharmaceutical Industries, Ltd.; Teva Neuroscience, Inc.; Yeda Research and Development Co., Ltd.
• Defendants: Mylan Pharmaceuticals Inc.; Mylan Inc.; Natco Pharma Ltd.
Teva Pharmaceuticals USA Inc. et al. v. Mylan Pharmaceuticals Inc. et al.
1:14-cv-01278; filed October 6, 2014 in the District Court of Delaware
• Plaintiffs: Teva Pharmaceuticals USA Inc.; Teva Pharmaceuticals Industries Ltd.; Teva Neuroscience Inc; Yeda Research and Development Co., Ltd.
• Defendants: Mylan Pharmaceuticals Inc.; Mylan Inc.; Natco Pharma Ltd.
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 Mylan's 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 Delaware complaint here.
Takeda Pharmaceuticals U.S.A., Inc. v. West-Ward Pharmaceutical Corp. et al.
1:14-cv-01268; filed October 3, 2014 in the District Court of Delaware
• Plaintiff: Takeda Pharmaceuticals U.S.A., Inc.
• Defendants: West-Ward Pharmaceutical Corp.; Hikma Americas Inc.; Hikma Pharmaceuticals PLC
Infringement of U.S. Patent Nos. 7,964,647 ("Colchicine Compositions and Methods," issued June 21, 2011), 7,964,648 ("Methods for Concomitant Administration of Colchicine and a Second Active Agent," issued June 21, 2011), 7,981,938 ("Colchicine Compositions and Methods," issued July 19, 2011), 8,097,655 ("Methods for Concomitant Administration of Colchicine and Macrolide Antibiotics," issued January 17, 2012), and 8,440,722 ("Methods for Concomitant Administration of Colchicine and a Second Active Agent," issued May 14, 2013) based on Hikma's anticipated manufacture, sale, and offer for sale (following the FDA's approval of Himka's NDA) of its Mitigare product (colchicine, used for the prophylaxis of gout flares). View the complaint here.
Forest Laboratories et al. v. Amerigen Pharmaceuticals Inc. et al.
1:14-cv-01271; filed October 3, 2014 in the District Court of Delaware
• Plaintiffs: Forest Laboratories LLC; Forest Laboratories Holdings Ltd.; Adamas Pharmaceuticals Inc.
• Defendants: Amerigen Pharmaceuticals Inc.; Amerigen Pharmaceuticals Ltd.
Infringement of U.S. Patent Nos. 8,039,009 ("Modified Release Formulations of Memantine Oral dosage Forms," issued October 18, 2011), 8,168,209 ("Method and Composition for Administering an NMDA Receptor Antagonist to a Subject," issued May 1, 2012), 8,173,708 (same title, issued May 8, 2012), 8,283,379 ("Method and Compositions for the Treatment of CNS-Related Conditions," issued October 9, 2012), 8,329,752 ("Composition for Administering an NMDA Receptor Antagonist to a Subject," issued December 11, 2012), 8,362,085 ("Method for Administering an NMDA Receptor Antagonist to a Subject," issued January 29, 2013), and 8,598,233 (same title, issued December 3, 2013) following a Paragraph IV certification as part of Amerigen's filing of an ANDA to manufacture a generic version of Forest's Namenda XR® (memantine hydrochloride extended release, used for the treatment of moderate to severe dementia of the Alzheimer's type). View the complaint here.
Forest Laboratories, LLC et al. v. Hikma Pharmaceuticals LLC et al.
1:14-cv-01266; filed October 2, 2014 in the District Court of Delaware
• Plaintiffs: Forest Laboratories, LLC; Forest Laboratories Holdings Ltd.
• Defendants: Hikma Pharmaceuticals LLC; Hikma Pharmaceuticals PLC; West-Ward Pharmaceutical Corp.
Infringement of U.S. Patent Nos. 7,741,358 ("Crystal Form of Asenapine Maleate," issued June 22, 2010) and 8,022,228 (same title, issued September 20, 2011) following a Paragraph IV certification as part of Hikma'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.
Jazz Pharmaceuticals, Inc. et al. v. Par Pharmaceutical, Inc.
2:14-cv-06150; filed October 2, 2014 in the District Court of New Jersey
• Plaintiffs: Jazz Pharmaceuticals, Inc.; Jazz Pharmaceuticals Ireland Ltd.
• Defendant: Par Pharmaceutical, Inc.
Jazz Pharmaceuticals, Inc. et al. v. Ranbaxy Laboratories Ltd. et al.
2:14-cv-06151; filed October 2, 2014 in the District Court of New Jersey
• Plaintiffs: Jazz Pharmaceuticals, Inc.; Jazz Pharmaceuticals Ireland Ltd.
• Defendants: Ranbaxy Laboratories Ltd.; Ranbaxy Inc.
The complaints in these cases are substantially identical. Infringement of U.S. Patent No. 8,772,306 ("Method of Administration of Gamma Hydroxybutyrate with Monocarboxylate Transporters," issued July 8, 2014) following a Paragraph IV certification as part of defendants' filing of an ANDA to manufacture a generic version of Jazz's Xyrem® (sodium oxybate, used to treat narcolepsy). View the Par complaint here.
Otsuka Pharmaceutical Co., Ltd. v. Intas Pharmaceuticals Ltd. et al.
1:14-cv-06158; filed October 2, 2014 in the District Court of New Jersey
• Plaintiff: Otsuka Pharmaceutical Co., Ltd.
• Defendants: Intas Pharmaceuticals Ltd.; Accord Healthcare, Inc.; Accord Healthcare Ltd.; Astron Research Ltd.; Hetero Labs Ltd.
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 Intas' 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.
