About Court Report: Each week we will report briefly on recently filed biotech and pharma cases.
Otsuka Pharmaceutical Co., Ltd. v. Sandoz Inc. et al.
1:15-cv-01716; filed March 9, 2015 in the District Court of New Jersey
• Plaintiff: Otsuka Pharmaceutical Co., Ltd.; Sandoz Inc.
• Defendants: Sandoz Private Ltd.; Sandoz International GmbH
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 Sandoz'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.
Allergan Sales, LLC v. Sandoz, Inc.
2:15-cv-00347; filed March 9, 2015 in the Eastern District of Texas
Infringement of U.S. Patent Nos. 7,030,149 ("Combination of Brimonidine Timolol For Topical Ophthalmic Use," issued April 18, 2006), 7,320,976 (same title, issued January 22, 2008), 7,642,258 (same title, issued January 5, 2010), and 8,748,425 (same title, issued June 10, 2014) following a Paragraph IV certification as part of Sandoz's amendment of its ANDA to manufacture a generic version of Allergan's Combigan® (brimonidine tartrate/timolol maleate ophthalmic solution, used to treat glaucoma). View the complaint here.
Baxter Healthcare Corp. et al. v. Sagent Pharmaceuticals Inc.
1:15-cv-02076; filed March 9, 2015 in the Northern District of Illinois
• Plaintiffs: Baxter Healthcare Corp.; Baxter International Inc.; Baxter Healthcare S.A.
• Defendant: Sagent Pharmaceuticals Inc.
Baxter Healthcare Corp. et al. v. Sagent Pharmaceuticals Inc.
1:15-cv-01684; filed March 6, 2015 in the District Court of New Jersey
• Plaintiffs: Baxter Healthcare Corp.; Baxter International Inc.; Baxter Healthcare S.A.
• Defendant: Sagent Pharmaceuticals Inc.
The complaints in these cases are substantially identical. Infringement of U.S. Patent Nos. 6,310,094 ("Ready-to-Use Esmolol Solution," issued October 30, 2001) and 6,528,540 ("Esmolol Formulation," issued March 4, 2003) following a Paragraph IV certification as part of Sagent's filing of an ANDA to manufacture a generic version of Baxter's Brevibloc® (esmolol hydrochloride, used for the rapid control of the heart rate in patients with atrial fibrillation or atrial flutter in perioperative, postoperative, or other emergent circumstances where short term control of the heart rate with a short-acting agent is desirable). View the New Jersey complaint here.
Otsuka Pharmaceutical Co., Ltd. v. Wockhardt Bio AG et al.
3:15-cv-01690; filed March 6, 2015 in the District Court of New Jersey
• Plaintiff: Otsuka Pharmaceutical Co., Ltd.
• Defendants: Wockhardt Bio AG; Wockhardt USA LLC; Wockhardt Ltd.
Infringement of U.S. Patent Nos. 8,759,350 ("Carbostyril Derivatives and Serotonin Reuptake Inhibitors for Treatment of Mood Disorders," issued June 24, 2014) and 7,053,092 ("5-HT1A Receptor Subtype Agonist," issued May 30, 2006) following a Paragraph IV certification as part of Wockhardt'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.
Biomarin Pharmaceutical Inc. et al. v. Par Pharmaceutical, Inc.
3:15-cv-01706; filed March 6, 2015 in the District Court of New Jersey
• Plaintiffs: Biomarin Pharmaceutical Inc.; Merck & Cie
• Defendant: Par Pharmaceutical, Inc.
Infringement of U.S. Patent Nos. 7,566,462 ("Stable Tablet Formulation," issued July 28, 2009), 7,566,714 ("Methods and Compositions for the Treatment of Metabolic Disorders," issued July 28, 2009), 7,612,073 ("Methods of Administering Tetrahydrobiopterin, Associated Compositions, and Methods of Measuring," issued November 3, 2009), 7,727,987 (""Crystalline Forms of (6R)-L-Erythro-Tetrahydrobiopterin Dihydrochloride," issued June 1, 2010), 8,003,126 ("Stable Table Formulation," issued August 23, 2011), 8,067,416 ("Methods and Compositions for the Treatment of Metabolic Disorders," issued November 29, 2011), RE43,797 ("Methods of Administering Tetrahydrobiopterin," issued November 6, 2012), and 8,318,745 ("Crystalline Forms of (6R)-L-Erythro-Tetrahydrobiopterin Dihydrochloride," issued November 27, 2012) following a Paragraph IV certification as part of Par's filing of an ANDA to manufacture a generic version of BioMarin's Kuvan® (sapropterin dihydrochloride, used to reduce blood phenylalanine levels in patients with hyperphenylalaninemia due to tetrahydrobiopterin- (BH4-) responsive phenylketonuria). View the complaint here.
