About Court Report: Each week we will report briefly on recently filed biotech and pharma cases.
Novartis Pharmaceuticals Corp. et al. v. Par Pharmaceutical Inc.
1:14-cv-01494; filed December 18 2014 in the District Court of Delaware
• Plaintiffs: Novartis Pharmaceuticals Corp.; Novartis AG
• Defendant: Par Pharmaceutical Inc.
Infringement of U.S. Patent Nos. 5,665,772 ("O-alkylated Rapamycin Derivatives and Their Use, Particularly as Immunosuppressants," issued September 9, 1997), 7,297,703 ("Macrolides," issued November 20, 2007), and 7,741,338 (same title, issued June 22, 2010) following a Paragraph IV certification as part of Par's filing of an ANDA to manufacture a generic version of Novartis' Afinitor® (everolimus, used for the treatment of: postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer in combination with exemestane after failure of treatment with letrozole or anastrozole; adults with progressive neuroendocrine tumors of pancreatic origin that are unresectable, locally advanced or metastatic; adults with advanced renal cell carcinoma after failure of treatment with sunitinib or sorafenib; adults with renal angiomyolipoma and tuberous sclerosis complex, not requiring immediate surgery; and pediatric and adult patients with tuberous sclerosis complex who have subependymal giant cell astrocytoma that requires therapeutic intervention but cannot be curatively resected). View the complaint here.
Novartis AG et al. v. Actavis Inc. et al.
1:14-cv-01487; filed December 16 2014 in the District Court of Delaware
• Plaintiffs: Novartis AG; Novartis Pharmaceuticals Corp.; Mitsubishi Tanabe Pharma Corp.; Mitsui Sugar Co. Ltd.
• Defendants: Actavis Inc.; Actavis Elizabeth LLC
Infringement of U.S. Patent No. 5,604,229 ("2-Amino-1,3-Propanediol Compound and Immunosuppressant," issued February 18, 1997) following a Paragraph IV certification as part of Actavis' filing of an ANDA to manufacture a generic version of Novartis' Gilenya® (fingolimod hydrochloride, used to reduce the frequency of clinical exacerbations and to delay the accumulation of physical disability in patients with relapsing forms of multiple sclerosis). View the complaint here.
Boehringer Ingelheim Pharma GmbH & Co. KG et al. v. Teva Pharmaceuticals USA, Inc. et al.
3:14-cv-07811; filed December 15, 2014 in the District Court of New Jersey
• Plaintiffs: Boehringer Ingelheim Pharma GmbH & Co. KG; Boehringer Ingelheim International GmbH; Boehringer Ingelheim Pharmaceuticals, Inc.
• Defendants: Teva Pharmaceuticals USA, INC.; Teva Pharmaceutical Industries, Ltd.; Alkem Laboratories, Ltd.; Mylan Phamaceuticals Inc.
Infringement of U.S. Patent No. 6,087,380 ("Disubstituted Bicyclic Heterocycles, the Preparations and the Use Thereof as Pharmaceutical Compositions," issued July 11, 2000) following a Paragraph IV certification as part of defendants' filing of an ANDA to manufacture a generic version of Boehringer's Pradaxa® (dabigatran etexilate mesylate, used to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation). View the complaint here.
AstraZeneca Pharmaceuticals LP et al. v. Teva Pharmaceuticals USA Inc. et al.
1:14-cv-01478; filed December 12, 2014 in the District Court of Delaware
• Plaintiffs: AstraZeneca Pharmaceuticals LP; AstraZeneca AB; Amylin Pharmaceuticals LLC
• Defendants: Teva Pharmaceuticals USA Inc.; Teva Pharmaceutical Industries Ltd.
Infringement of U.S. Patent Nos. 6,858,576 ("Methods for Regulating Gastrointestinal Motility," issued February 22, 2005), 6,872,700 ("Methods for Glucagon Suppression," issued March 29, 2005), 6,956,026 ("Use of Exendins for the Reduction of Food Intake," Issued October 8, 2005), 6,902,744 ("Exendin Agonist Formulations and Methods of Administration Thereof," issued June 7, 2005), and 7,521,423 ("Exendin Pharmaceutical Compositions," issued April 21, 2009) following a Paragraph IV certification as part of Teva's filing of an ANDA to manufacture a generic version of AstraZeneca's Byetta® (exenatide injection, used to improve blood sugar control in adults with Type II diabetes, when used with diet and exercise). View the complaint here.
Shire Development LLC et al. v. InvaGen Pharmaceuticals, Inc.
2:14-cv-07263; filed December 12, 2014 in the Eastern District of New York
• Plaintiffs: Shire Development LLC; Shire Canada Inc.; Shire International Licensing B.V.
• Defendant: InvaGen Pharmaceuticals, Inc.
Infringement of U.S. Patent Nos. 5,968,976 ("Pharmaceutical Composition Containing Selected Lanthanum Carbonate Hydrates," issued October 19, 1999), 7,381,428 ("Stabilized Lanthanum Carbonate Compositions," issued June 3, 2008), and 7,465,465 ("Pharmaceutical Formulation Comprising Lanthanum Compounds," issued December 16, 2008) following a Paragraph IV certification as part of InvaGen's filing of an ANDA to manufacture a generic version of Shire's Fosrenol® (lanthanum carbonate chewable tablets, used for the reduction of serum phosphate in patients with end stage renal disease). View the complaint here.