By Sherri Oslick --
About Court Report: Each week we will report briefly on recently filed biotech and pharma cases.
Glycobiosciences Inc. v. Dara Biosciences, Inc. et al.
1:14-cv-01281; filed July 28, 2014 in the District Court of the District of Columbia
• Plaintiff: Glycobiosciences Inc.
• Defendants: Dara Biosciences, Inc.; Helsinn Healthcare SA
Infringement of U.S. Patent No. 6,335,035 ("Sustained Release Delivery System," issued January 1, 2002) based on defendants' manufacture and sale of its Gelclair product, a bioadherent oral rinse gel for management of mucositis. View the complaint here.
Warner Chilcott Co. LLC et al. v. Aurobindo Pharma Ltd. et al.
1:14-cv-00990; filed July 28, 2014 in the District Court of Delaware
• Plaintiffs: Warner Chilcott Co. LLC; Hoffmann-La Roche Inc.
• Defendants: Aurobindo Pharma Ltd.; Aurobindo Pharma USA Inc.
Infringement of U.S. Patent Nos. 6,165,513 ("Film-Coated Tablet For Improved Upper Gastrointestinal Tract Safety," issued December 26, 2000), 7,192,938 ("Method of Treatment Using Bisphosphonic Acid," issued March 20, 2007), and 7,718,634 (same title, issued May 18, 2010) following a Paragraph IV certification as part of Teva's filing of an ANDA to manufacture a generic version of Warner Chilcott's Actonel® (risedronate sodium, used to treat and prevent postmenopausal osteoporosis). View the complaint here.
Taro Pharmaceuticals USA Inc. et al. v. Perrigo Israel Pharmaceuticals Ltd.
1:14-cv-00989; filed July 28, 2014 in the District Court of Delaware
• Plaintiffs: Taro Pharmaceuticals USA Inc.; Taro Pharmaceuticals North America Inc.
• Defendant: Perrigo Israel Pharmaceuticals Ltd.
Infringement of U.S. Patent Nos. 8,277,780 ("Stable Liquid Desoximetasone Compositions with Reduced Oxidized Impurity" issued October 2, 2012) and 8,715,624 (same title, issued May 6, 2014) following a Paragraph IV certification as part of Perrigo's filing of an ANDA to manufacture a generic version of Taro's Topicort® (desoximetasone topical spray, used for the treatment of plaque psoriasis). View the complaint here.
Enteris Biopharma, Inc. v. Clinical Pharmacology of Miami, Inc.
1:14-cv-22770; filed July 28, 2014 in the Southern District of Florida
Infringement of U.S. Patent Nos. 6,086,918 ("Oral Peptide Pharmaceutical Products," issued July 11, 2000) and 8,377,863 ("Peptide Pharmaceutical for Oral Delivery," issued February 19, 2013) based on defendant having conducted a Phase I clinical trial relating to the development of Steath Peptide's BendaviaTM, after termination of plaintiff's clinical manufacturing service agreement with Steath, in which plaintiff's oral formulations of BendaviaTM were used. Also, various claims sounding in state law. View the complaint here.
IPXpharma, LLC v. Millennium Pharamaceuticals, Inc.
3:14-cv-01545; filed July 28, 2014 in the Middle District of Tennessee
Infringement of U.S. Patent No. 6,171,786 ("Methods for Preventing Multidrug Resistance in Cancer Cells," issued January 9, 2001) based on Millennium's manufacture and sale of its Velcade® product (bortezomib, used to treat multiple myeloma). View the complaint here.
Novartis Pharmaceuticals Corp. et al. v. Breckenridge Pharmaceutical, Inc.
9:14-cv-80990; filed July 28, 2014 in the Southern District of Florida
• Plaintiffs: Novartis Pharmaceuticals Corp.; Novartis AG
• Defendant: Breckenridge Pharmaceutical, Inc.
Novartis Pharmaceuticals Corp, et al. v. Breckenridge Pharmaceutical, Inc.
1:14-cv-05729; filed July 25, 2014 in the Southern District of New York
• Plaintiffs: Novartis Pharmaceuticals Corp.; Novartis AG
• Defendant: Breckenridge Pharmaceutical, Inc.
The complaints in these cases are substantially identical. Infringement of U.S. Patent Nos. 6,894,051 ("Crystal Modification of a N-phenyl-2-pyrimidineamine Derivative, Processes for Its Manufacture and Its Use," issued May 17, 2005) and RE43,932 ("Crystal Modification of a N-phenyl-2-pyrimidineamine Derivative, Processes for Its Manufacture and Its Use," issued January 15, 2013) following a Paragraph IV certification as part of Breckenridge's filing of an ANDA to manufacture a generic version of Novartis' Gleevec® (imatinib mesylate, used for various indications, including treatment of myeloid leukemia). View the SDNY complaint here.
Alkermes Pharma Ireland Ltd. v. Sun Pharma Global FZE et al.
1:14-cv-00986; filed July 25, 2014 in the District Court of Delaware
• Plaintiff: Alkermes Pharma Ireland Ltd.
• Defendants: Sun Pharma Global FZE; Sun Pharmaceutical Industries Inc.
Infringement of U.S. Patent No. 6,730,325 (same title, issued May 4, 2004), licensed to Novartis, following a Paragraph IV certification as part of Sun's filing of an ANDA to manufacture a generic version of Novartis' Focalin® XR (extended release dexmethylphenidate hydrochloride, used to treat attention deficit hyperactivity disorder). View the complaint here.
Unimed Pharmaceuticals LLC et al. v. Perrigo Co. et al.
1:14-cv-00985; filed July 25, 2014 in the District Court of Delaware
• Plaintiffs: Unimed Pharmaceuticals LLC; Besins Healthcare Inc.; Besins Healthcare Luxenbourg SARL
• Defendants: Perrigo Co.; Perrigo Israel Pharmaceuticals Ltd.; Perrigo UK FINCO Ltd. Partnership
Infringement of U.S. Patent Nos. 6,503,894 ("Pharmaceutical Composition and Method for Treating Hypogonadism," issued January 7, 2003), 8,466,136 ("Testosterone Gel and Method of Use," issued June 18, 2013), 8,466,137 (same title, issued June 18, 2013), 8,466,138 (same title, issued June 18, 2013), and 8,486,925 (same title, issued July 16, 2013) following a Paragraph IV certification as part of Perrigo's filing of an ANDA to manufacture a generic version of AbbVie's AndroGel® (testosterone gel, used to treat conditions associated with a deficiency or absence of endogenous testosterone). View the complaint here.
Impax Laboratories Inc. et al. v. Lannett Holdings Inc. et al.
1:14-cv-00984; filed July 25, 2014 in the District Court of Delaware
• Plaintiffs: Impax Laboratories Inc.; AstraZeneca AB
• Defendants: Lannett Holdings Inc.; Lannett Co. Inc.
Infringement of U.S. Patent Nos. 6,750,237 ("Pharmaceutical Formulations Containing Aolmitriptan," issued June 15, 2004) and 7,220,767 (same title, issued May 22, 2007), licensed to Impax, following a Paragraph IV certification as part of Lannett's filing of an ANDA to manufacture a generic version of Impax's Zomig® Nasal Spray (zolmitriptan nasal spray, used for the acute treatment of migraine with or without aura in adults). View the complaint here.
Otsuka Pharmaceutical Co., Ltd. v. Torrent Pharmaceuticals Ltd. et al.
1:14-cv-04671; filed July 25, 2014 in the District Court of New Jersey
• Plaintiff: Otsuka Pharmaceutical Co., Ltd.
• Defendants: Torrent Pharmaceuticals Ltd.; Torrent Pharma Inc.
Infringement of U.S. Patent No. 8,642,760 ("Low Hygroscopic Aripiprazole Drug Substance and Process for the Preparation Thereof," issued February 4, 2014) following a Paragraph IV certification as part of Torrent'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.
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