About Court Report: Each week we will report briefly on recently filed biotech and pharma cases.
Fresenius Kabi USA, LLC et al. v. Mylan Laboratories Ltd. et al.
1:15-cv-00942; filed October 19, 2015 in the District Court of Delaware
• Plaintiffs: Fresenius Kabi USA, LLC; Fresenius Kabi Deutschland GmbH
• Defendants: Mylan Laboratories Ltd.; Mylan Inc.; Agila Specialties Inc.; Mylan Pharmaceuticals Inc.
Fresenius Kabi USA, LLC et al. v. Mylan Laboratories Ltd. et al.
1:15-cv-00185; filed October 19, 2015 in the Northern District of West Virginia
• Plaintiffs: Fresenius Kabi USA, LLC; Fresenius Kabi Deutschland GMBH
• Defendants: Mylan Laboratories Ltd.; Mylan Inc.; Agila Specialties Inc.; Mylan Pharmaceuticals Inc.
The complaints in these cases are substantially identical. Infringement of U.S. Patent Nos. 7,828,787 ("Connector for Packaging Containing Medical Fluids and Packaging for Medical Fluids," issued November 9, 2010), 7,857,802 ("Connector for Medical Liquid-Containing Packages and Medical Liquid-Containing Packages," issued December 28, 2010), 8,118,802 ("Connector for Packaging Containing Medical Fluids and Packaging for Medical Fluids," issued February 21, 2012), and 8,162,915 ("Connector for Packings Containing Medical Liquids, and Corresponding Packing for Medical Liquids," issued April 24, 2012) following Mylan's filing of an ANDA to manufacture a generic version of Fresenius' Naropin® (ropivacaine hydrochloride injection product, used for the production of regional or local anesthesia for surgery and for acute pain management). View the Delaware complaint here.
Jazz Pharmaceuticals, Inc. et al. v. Par Pharmaceutical, Inc.
2:15-cv-07580; filed October 19, 2015 in the District Court of New Jersey
• Plaintiffs: Jazz Pharmaceuticals, Inc.; Jazz Pharmaceuticals Ireland Ltd.
• Defendant: Par Pharmaceutical, Inc.
Infringement of U.S. Patent No. 9,050,302 ("Method of Administration of Gamma Hydroxybutyrate with Monocarboxylate Transporters," issued June 9, 2015) following a Paragraph IV certification as part of Par's filing of an ANDA to manufacture a generic version of Jazz's Xyrem® (sodium oxybate, used to treat narcolepsy). View the complaint here.
Horizon Therapeutics, Inc. v. Lupin Ltd. et al.
1:15-cv-07624; filed October 19, 2015 in the District Court of New Jersey
• Plaintiff: Horizon Therapeutics, Inc.
• Defendants: Lupin Ltd.; Lupin Pharmaceuticals Inc.
Infringement of U.S. Patent Nos. 8,404,215 ("Methods of Therapeutic Monitoring of Nitrogen Scavenging Drugs," issued March 26, 2013), 8,642,012 ("Methods of Treatment Using Ammonia-Scavenging Drugs," issued February 4, 2014), and 9,095,559 ("Methods of Therapeutic Monitoring of Nitrogen Scavenging Drugs," issued August 4, 2015) following Lupin's filing of an ANDA to manufacture a generic version of Horizon's Ravicti® (glycerol phenylbutyrate oral liquid, used as a nitrogen binding agent for chronic management of adult and pediatric patients ≥ 2 years of age with urea cycle disorders that cannot be managed by dietary protein restriction and/or amino acid supplementation alone). View the complaint here.
Otsuka Pharmaceutical Co., Ltd. v. Aurobindo Pharma Ltd. et al.
1:15-cv-07584; filed October 19, 2015 in the District Court of New Jersey
• Plaintiff: Otsuka Pharmaceutical Co., Ltd.
• Defendants: Aurobindo Pharma Ltd.; Aurobindo Pharma USA, Inc.; Aurolife Pharma LLC
Infringement of U.S. Patent No. 9,089,567 ("Method of Treating Cognitive Impairments and Schizophrenias," issued July 28, 2015) following Aurobindon'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. [NB: The complaint was later voluntarily dismissed.
Purdue Pharma LP et al. v. Alvogen Pine Brook LLC et al.
1:15-cv-00940; filed October 16, 2015 in the District Court of Delaware
• Plaintiffs: Purdue Pharma LP; Purdue Pharmaceuticals LP
• Defendant: Alvogen Pine Brook Inc.; Alvogen Pine Brook LLC
Infringement of U.S. Patent Nos. 9,084,816 ("Tamper Resistant Dosage Forms," issued July 21, 2015), 9,095,614 (same title, issued August 4, 2015), and 9,095,615 (same title, issued August 4, 2015) following a Paragraph IV certification as part of Alvogen's filing of an ANDA to manufacture a generic version of Purdue's Hysingla® ER (hydrocodone bitartrate, used for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate). View the complaint here.
Astrazeneca Pharmaceuticals LP et al. v. Mylan Pharmaceuticals Inc. et al.
1:15-cv-00183; filed October 15, 2015 in the Northern District of West Virginia
• Plaintiffs: Astrazeneca Pharmaceuticals LP; Astrazeneca UK Ltd.; AstraZeneca AB
• Defendants: Mylan Pharmaceuticals Inc.; Mylan Laboratories Ltd.; Mylan 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 Mylan'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.
