About Court Report: Each week we will report briefly on recently filed biotech and pharma cases.
Novartis Pharmaceuticals Corp. et al. v. Roxane Laboratories Inc.
1:15-cv-00128; filed February 5, 2015 in the District Court of Delaware
• Plaintiffs: Novartis Pharmaceuticals Corp.; Novartis AG
• Defendant: Roxane Laboratories 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 Roxane'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.
Orexo AB v. Actavis Laboratories FL, Inc. et al.
3:15-cv-00826; filed February 4, 2015 in the District Court of New Jersey
• Plaintiff: Orexo AB
• Defendants: Actavis Laboratories FL, Inc.; Andrx Corp.; Actavis, Inc.; Actavis Pharma, Inc.
Infringement of U.S. Patent Nos. 6,759,059 ("Fentanyl Composition for the Treatment of Acute Pain," issued July 6, 2004), 6,761,910 ("Pharmaceutical Composition For The Treatment Of Acute Disorders," issued July 13, 2004), and 7,910,132 (same title, issued March 22, 2011) following a Paragraph IV certification as part of Actavis' filing of an ANDA to manufacture a generic version of Orexo's Abstral® (fentanyl citrate sublingual tablets, used for the management of breakthrough pain in cancer patients). View the complaint here.
Medac Pharma Inc. et al. v. Antares Pharma Inc.
1:15-cv-00120; filed February 3, 2015 in the District Court of Delaware
• Plaintiffs: Medac Pharma Inc.; Medac Gesellschaft Fur Klinische Speziialpraparate GmbH
• Defendant: Antares Pharma Inc.
Declaratory judgment of noninfringement and invalidity of U.S. Patent No. 8,945,063 ("Hazardous Agent Injector System," issued February 3, 2015) based on Medac's manufacture and sale of its Rasuvo® Injector product (methotrexate injection, used to treat certain adults with severe, active rheumatoid arthritis, and children with active polyarticular juvenile idiopathic arthritis (pJIA), after treatment with other medicines including non‑steroidal anti‑inflammatory (NSAIDS) have been used and did not work well and to control the symptoms of severe, resistant, disabling psoriasis in adults when other types of treatment have been used and did not work well). View the complaint here.
Teva Pharmaceuticals USA Inc. et al. v. Amneal Pharmaceuticals LLC
1:15-cv-00124; filed February 3, 2015 in the District Court of Delaware
• Plaintiffs: Teva Pharmaceuticals USA Inc.; Teva Pharmaceutical Industries Ltd.; Teva Neuroscience Inc; Yeda Research and Development Co Ltd.
• Defendant: Amneal Pharmaceuticals LLC
Infringement of U.S. Patent Nos. 8,232,250 ("Low Frequency Glatiramer AcetateTherapy," issued July 31, 2012) and 8,399,413 (same title, issued March 19, 2013) following a Paragraph IV certification as part of Amneal's filing of an ANDA to manufacture a generic version of Teva's Copaxone® (glatiramer acetate injection, used for the reduction or frequency of relapses in patients with relapsing-remitting multiple sclerosis). View the complaint here.
Cephalon Inc. et al. v. Unimark Remedies Ltd.
1:15-cv-00117; filed February 2, 2015 in the District Court of Delaware
• Plaintiffs: Cephalon Inc.; Teva Sante SAS
• Defendant: Unimark Remedies Ltd.
Infringement of U.S. Patent No. 7,132,570 ("Method for the Production of Crystalline Forms of Optical Enantiomers of Modafinil," issued November 7, 2006) following a Paragraph IV certification as part of Unimark's filing of an ANDA to manufacture a generic version of Cephalon's Nuvigil® (armodafinil, used to improve wakefulness in patients with excessive sleepiness associated with obstructive sleep apnea/hypopnea syndrome, narcolepsy, and shift work sleep disorder). View the complaint here.
Cosmo Technologies Ltd. et al. v. Par Pharmaceutical Inc.
1:15-cv-00116; filed February 2, 2015 in the District Court of Delaware
• Plaintiffs: Cosmo Technologies Ltd.; Santarus Inc.
• Defendant: Par Pharmaceutical Inc.
Infringement of U.S. Patent Nos. 7,410,651 ("Controlled Release and Taste Masking Oral Pharmaceutical Composition," issued August 12, 2008), 7,431,943 (same title, issued October 7, 2008), 8,293,273 (same title, issued October 23, 2012), 8,784,888 (same title, issued July 22, 2014), 8,895,064 (same title, issued November 25, 2014), and RE43,799 (same title, issued November 13, 2012) following a Paragraph IV certification as part of Par's filing of an ANDA to manufacture a generic version of Santarus' Uceris® (budesonide, used to treat mildly to moderately active ulcerative colitis). View the complaint here.
Sanofi-Aventis U.S. LLC et al. v. Actavis LLC et al.
3:15-cv-00776; filed February 2, 2015 in the District Court of New Jersey
• Plaintiffs: Sanofi-Aventis U.S. LLC; Aventis Pharma S.A.; Sanofi
• Defendants: Actavis LLC; Actavis Elizabeth LLC
Infringement of U.S. Patent Nos. 5,847,170 ("Taxoids, Their Preparation and Pharmaceutical Compositions Containing Them" issued December 8, 1998) and 7,241,907 ("Acetone Solvate of Dimethoxy Docetaxel and its Process of Preparation" issued July 10, 2007) following a Paragraph IV certification as part of Actavis' filing of an NDA (under § 505(b)(2) of the Food, Drug and Cosmetic Act) (for another dosage form) to manufacture a generic version of Sanofi's Jevtana® (cabazitaxel injection, used in combination with prednisone for the treatment of patients with hormonerefractory metastatic prostate cancer previously treated with a docetaxel-containing treatment regimen). View the complaint here.
Bayer HealthCare LLC et al. v. Mylan Pharmaceuticals Inc. et al.
1:15-cv-00114; filed January 30, 2015 in the District Court of Delaware
• Plaintiffs: Bayer HealthCare LLC; Bayer HealthCare Pharmaceuticals Inc.; Onyx Pharmaceuticals Inc.
• Defendants: Mylan Pharmaceuticals Inc.; Mylan Inc.
Infringement of U.S. Patent Nos. 8,618,141 ("Aryl Ureas with Angiogenesis Inhibiting Activity," issued December 31, 2013) and 8,877,933 ("Thermodynamically Stable Form of a Toslyate Salt," issued November 4, 2014) following a Paragraph IV certification as part of Mylan's filing of an ANDA to manufacture a generic version of Bayer's Nexavar® (sorafenib tosylate, used to treat certain types of cancer). View the complaint here.
Celgene Corp. et al. v. Lannett Holdings, Inc. et al.
2:15-cv-00697; filed January 30, 2015 in the District Court of New Jersey
• Plaintiffs: Celgene Corp.; Children's Medical Center Corp.
• Defendants: Lannett Holdings, Inc.; Lannett Co., Inc.
Infringement of U.S. Patent Nos. 6,045,501 ("Methods for Delivering a Drug to a Patient While Preventing the Exposure of a Foetus or Other Contraindicated Individual to the Drug," issued April 4, 2000), 6,315,720 ("Methods for Delivering a Drug to a Patient While Avoiding the Occurrence of an Adverse Side Effect Known or Suspected of Being Caused by the Drug," issued November 13, 2001), 6,561,976 ("Methods for Delivering a Drug to a Patient While Preventing the Exposure of a Foetus or Other Contraindicated Individual to the Drug," issued May 13, 2003), 6,561,977 ("Methods for Delivering a Drug to a Patient While Restricting Access to the Drug by Patients for Whom the Drug May be Contraindicated," issued May 13, 2003), 6,755,784 (same title, issued June 29, 2004), 6,869,399 (same title, issued March 22, 2005), 7,141,018 (same title, issued November 28, 2006), 7,230,012 ("Pharmaceutical Compositions and Dosage Forms of Thalidomide," issued June 12, 2007), 7,435,745 ("Methods and Compositions for Inhibition of Angiogenesis," issued October 14, 2008), 7,874,984 ("Methods for Delivering a Drug to a Patient While Preventing the Exposure of a Foetus or Other Contraindicated Individual to the Drug," issued January 25, 2011), 7,959,566 ("Methods for Delivering a Drug to a Patient While Restricting Access to the Drug by Patients for Whom the Drug May be Contraindicated," issued June 14, 2011), 8,204,763 ("Methods for Delivering a Drug to a Patient While Preventing the Exposure of a Foetus or Other Contraindicated Individual to the Drug," issued June 19, 2012), 8,315,886 ("Methods for Delivering a Drug to a Patient While Restricting Access to the Drug by Patients for Whom the Drug May be Contraindicated," issued November 20, 2012), 8,589,188 ("Methods for Delivering a Drug to a Patient While Preventing the Exposure of a Foetus or Other Contraindicated Individual to the Drug," issued November 19, 2013), and 8,626,531 ("Methods for Delivering a Drug to a Patient While Restricting Access to the Drug by Patients for Whom the Drug May be Contraindicated," issued January 7, 2014) following a paragraph IV certification as part of Lannett's filing of an ANDA to manufacture a generic version of Celgene's Thalomid® (thalidomide, used to treat multiple myeloma and erythema nodosum leprosum). View the complaint here.
Shionogi & Co., Ltd. et al. v. Apotex Corp. et al.
3:15-cv-00668; filed January 30, 2015 in the District Court of New Jersey
• Plaintiffs: Shionogi & Co., Ltd.; Shionogi Inc.
• Defendants: Apotex Corp.; Apotex Inc.
Infringement of U.S. Patent No. 8,247,402 ("Crystal Form of Pyrrolidylthiocarbapenem Derivative," issued August 21, 2012) following a Paragraph IV certification as part of Apotex's filing of an ANDA to manufacture a generic version of Shionogi's Doribax® (doripenem injection, used to treat complicated intra-abdominal infections and complicated urinary tract infections, including pyelonephritis). View the complaint here.
