About Court Report: Each week we will report briefly on recently filed biotech and pharma cases.
Eli Lilly and Company et al. v. Accord Healthcare Inc., USA et al.
1:14-cv-00389; filed March 12, 2014 in the Southern District of Indiana
• Plaintiffs: Eli Lilly and Company; Daiichi Sankyo Co., Ltd.; Daiichi Sankyo Co., Ltd.; Ube Industries, Ltd.
• Defendants: Accord Healthcare Inc., USA; Accord Healthcare, Inc.; Intas Pharmaceuticals Ltd.; Amneal Pharmaceuticals LLC; Amneal Pharmaceuticals of New York, LLC; Amneal Pharmaceuticals Co. India Pvt. Ltd.; Aurobindo Pharma Limited; Aurobindo Pharma USA Inc.; Dr. Reddy's Laboratories, Ltd.; Dr. Reddy's Laboratories, Inc.; Glenmark Generics Inc., USA; Glenmark Generics Ltd.; Glenmark Pharmaceuticals Ltd.; Hetero USA Inc.; Hetero Labs Limited; Hetero Labs Limited Unit V; Hetero Drugs Ltd.; Mylan Pharmaceuticals Inc.; Mylan Inc.; Mylan Laboratories Limited; Par Pharmaceutical Companies, Inc.; Par Pharmaceutical, Inc.; Sun Pharma Global FZE; Caraco Pharmaceutical Laboratories, Ltd.; Sun Pharma Global, Inc.; Sun Pharmaceutical Industries Ltd.; Teva Pharmaceuticals USA, Inc.; Teva Pharmaceutical Industries Ltd.; Watson Laboratories, Inc.; Actavis PLC; Zydus Pharmaceuticals USA, Inc.; Cadila Healthcare Ltd.; Actavis Inc.; Actavis Pharma, Inc.
Infringement of certain of U.S. Patent Nos. 5,288,726 ("Tetrahydrothienopyridine Derivatives, Furo and Pyrrolo Analogs Thereof and Their Preparation and Uses for Inhibiting Blood Platelet Aggregation," issued February 22, 1994), 8,404,703 ("Medicinal Compositions Containing Aspirin," issued March 26, 2013) and 8,569,325 ("Method of Treatment with Coadministration of Aspirin and Prasugrel," issued October 29, 2013) following a Paragraph IV certification as part of defendants' filing of an ANDA to manufacture a generic version of Lilly's Effient® (prasugrel hydrochloride, to be used in combination with aspirin for the reduction of thrombotic cardiovascular events in certain patients with acute coronary syndrome (ACS) who are to be managed with percutaneous coronary intervention). View the complaint here.
Medac Pharma, Inc. et al. v. Antares Pharma, Inc. et al.
1:14-cv-01498; filed March 7, 2014 in the District Court of New Jersey
• Plaintiffs: Medac Pharma, Inc.; Medac Gesellschaft fur klinische Spezialpraparate GmbH
• Defendants: Antares Pharma, Inc.; Leo Pharma A/S; Leo Pharma Inc.
Infringement of U.S. Patent No. 8,664,231 ("Concentrated Methotrexate Solutions," issued March 4, 2014) based on defendants' manufacture, sale, and offer for sale of its OTREXUP product ((methotrexate) injection, used in the management of patients with severe, active rheumatoid arthritis and polyarticular juvenile idiopathic arthritis, who are intolerant of or had an inadequate response to first-line therapy and in the symptomatic control of severe, recalcitrant, disabling psoriasis in adults who are not adequately responsive to other forms of therapy). View the complaint here.
Sanofi et al. v. Alkem Laboratories Ltd. et al.
1:14-cv-00292; filed March 6, 2014 in the District Court of Delaware
• Plaintiffs: Sanofi; Sanofi-Aventis US LLC
• Defendants: Alkem Laboratories Ltd.; Ascend Laboratories LLC
Sanofi et al. v. Sun Pharma Global FZE et al.
1:14-cv-00294; filed March 6, 2014 in the District Court of Delaware
• Plaintiffs: Sanofi; Sanofi-Aventis US LLC
• Defendants: Sun Pharma Global FZE; Sun Pharmaceutical Industries Ltd.; Caraco Pharmaceutical Laboratories Ltd.
The complaints in these cases are substantially identical. Infringement of U.S. Patent Nos. 7,323,493 ("Solid Pharmaceutical Composition Containing Benzofuran Derivatives," issued January 29, 2008), 8,318,800 ("Solid Pharmaceutical Compositions Containing Benzofuran Derivatives," issued November 27, 2012), 8,410,167 ("Use of Dronedarone for the Preparation of a Medicament for Use in the Prevention of Cardiovascular Hospitalization or of Mortality," issued April 2, 2013), and 8,602,215 ("Methods for Reducing the Risk of an Adverse Dronedarone/Beta-Blockers Interaction in a Patient Suffering from Atrial Fibrillation," issued December 10, 2013) following a Paragraph IV certification as part of defendants' filing of an ANDA to manufacture a generic version of Sanofi's Multaq® (dronedarone, used to reduce the risk of hospitalization for atrial fibrillation in patients in sinus rhythm with a history of paroxysmal or persistent atrial fibrillation). View the Alkem complaint here.
Sanofi et al. v. First Time US Generics LLC
1:14-cv-00293; filed March 6, 2014 in the District Court of Delaware
• Plaintiffs: Sanofi; Sanofi-Aventis US LLC
• Defendant: First Time US Generics LLC
Infringement of U.S. Patent Nos. 8,318,800 ("Solid Pharmaceutical Compositions Containing Benzofuran Derivatives," issued November 27, 2012), 8,410,167 ("Use of Dronedarone for the Preparation of a Medicament for Use in the Prevention of Cardiovascular Hospitalization or of Mortality," issued April 2, 2013), and 8,602,215 ("Methods for Reducing the Risk of an Adverse Dronedarone/Beta-Blockers Interaction in a Patient Suffering from Atrial Fibrillation," issued December 10, 2013) following a Paragraph IV certification as part of defendants' filing of an ANDA to manufacture a generic version of Sanofi's Multaq® (dronedarone, used to reduce the risk of hospitalization for atrial fibrillation in patients in sinus rhythm with a history of paroxysmal or persistent atrial fibrillation). View the complaint here.
Janssen Products, L.P. et al. v. Lupin Ltd. et al.
2:14-cv-01370; filed March 4, 2014 in the District Court of New Jersey
• Plaintiffs: Janssen Products, L.P.; Janssen R&D Ireland
• Defendants: Lupin Ltd.; Lupin Pharmaceuticals Inc.
Infringement of U.S. Patent No. 8,518,987 ("Pseudopolymorphic Forms of a HIV Protease Inhibitor," issued August 27, 2013) following a Paragraph IV certification as part of Lupin's filing of an ANDA to manufacture a generic version of Janssen's Prezista® (darunavir, used to treat human immunodeficiency virus (HIV-1) infection). View the complaint here.
