About Court Report: Each week we will report briefly on recently filed biotech and pharma cases.
Otsuka Pharmaceutical Co. Ltd. v. Apotex Inc. et al.
1:15-cv-00109; filed January 29, 2015 in the District Court of Delaware
• Plaintiff: Otsuka Pharmaceutical Co. Ltd.
• Defendants: Apotex Inc.; Apotex Corp.
Infringement of U.S. Patent Nos. 5,753,677 ("Benzoheterocyclic Compounds," issued May 19, 1998) and 8,501,730 ("Process for Preparing Bezazepine Compounds or Salts Thereof," issued August 6, 2013) following a Paragraph IV certification as part of Apotex's filing of an ANDA to manufacture a generic version of Otsuka's Samsca® (tolvaptan, used to treat hyponatremia). View the complaint here.
Pfizer Inc. et al. v. Mylan Pharmaceuticals Inc.
1:15-cv-00013; filed January 27, 2015 in the Northern District of West Virginia
• Plaintiffs: Pfizer Inc.; UCB Pharma GmbH
• Defendant: Mylan Pharmaceuticals Inc.
Pfizer Inc. et al. v. Mylan Pharmaceuticals Inc.
1:15-cv-00079; filed January 23, 2015 in the District Court of Delaware
• Plaintiffs: Pfizer Inc.; UCB Pharma GmbH
• Defendant: Mylan Pharmaceuticals Inc.
The complaints in these cases are substantially identical. Infringement of U.S. Patent Nos. 6,858,650 ("Stable Salts of Novel Derivatives of 3,3-Diphenylpropylamines," issued February 22, 2005), 7,384,980 ("Derivatives of 3,3-Diphenylpropylamines," issued June 10, 2008), 7,855,230 (same title, issued December 21, 2010), 7,985,772 (same title, issued July 26, 2011), and 8,338,478 (same title, issued December 25, 2012) following a Paragraph IV certification as part of Mylan's filing of an ANDA to manufacture a generic version of Pfizer's Toviaz® (fesoterodine fumarate, used to treat the symptoms of overactive bladder). View the Delaware complaint here.
Senju Pharmaceutical Co. Ltd. et al. v. Paddock Laboratories LLC et al.
1:15-cv-00087; filed January 26, 2015 in the District Court of Delaware
• Plaintiffs: Senju Pharmaceutical Co. Ltd.; Bausch & Lomb Inc.; Bausch & Lomb Pharma Holdings Corp.
• Defendants: Paddock Laboratories LLC; L Perrigo Company; Perrigo Co.
Infringement of U.S. Patent Nos. 8,129,431 ("Aqueous Liquid Preparation Containing 2-amino-3-(4-bromobenzoyl)phenylacetic acid," issued March 6, 2012), 8,669,290 (same title, issued March 1, 2014), 8,754,131 (same title, issued June 17, 2014), 8,871,813 (same title, issued October 28, 2014), and 8,927,606 (same title, issued January 6, 2015) following a Paragraph IV certification as part of Paddock's filing of an ANDA to manufacture a generic version of B&L's Prolensa® (bromfenac ophthalmic solution, used to treat postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery). View the complaint here.
AstraZeneca Pharmaceuticals LP et al. v. Glenmark Pharmaceuticals Ltd. et al.
1:15-cv-00615; filed January 26, 2015 in the District Court of New Jersey
• Plaintiffs: AstraZeneca Pharmaceuticals LP; AstraZeneca UK Ltd.; AstraZeneca AB
• Defendants: Glenmark Pharmaceuticals Ltd.; Glenmark Generics Ltd.; Glenmark Generics Inc., USA
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 Glenmark'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.
Acorda Therapeutics Inc. et al. v. Actavis Laboratories FL, Inc.
1:15-cv-00077; filed January 23, 2015 in the District Court of Delaware
• Plaintiffs: Acorda Therapeutics Inc.; Alkermes Pharma Ireland Ltd.
• Defendant: Actavis Laboratories FL, Inc.
Infringement of U.S. Patent No. 5,540,938 ("Formulations and Their Use in the Treatment of Neurological Diseases," issued July 30, 1996) following a Paragraph IV certification as part of Actavis' filing of an ANDA to manufacture a generic version of Acorda's Ampyra® (dalfampridine extended release, used to improve walking in patients with multiple sclerosis). View the complaint here.
Novartis Pharmaceuticals Corp. et al. v. Par Pharmaceutical Inc.
1:15-cv-00078; filed January 23, 2015 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.
Astellas Pharma Inc. et al. v. Fresenius Kabi USA LLC
1:15-cv-00080; filed January 23, 2015 in the District Court of Delaware
• Plaintiffs: Astellas Pharma Inc.; Astellas US LLC; Astellas Pharma US Inc.
• Defendant: Fresenius Kabi USA LLC
Infringement of U.S. Patent Nos. 6,107,458 ("Cyclic Hexapeptides Having Antibiotic Activity," issued August 22, 2000) and 6,774,104 ("Stabilized Pharmaceutical Composition in Lyophilized Form," issued August 10, 2004) following a Paragraph IV certification as part of Fesenius' filing of an ANDA to manufacture a generic version of Astellas' Mycamine® (micafungin sodium, used for the treatment of candidemia, acute disseminated candidiasis, Candida peritonitis and abscesses; esophageal candidiasis; and prophylaxis of Candida infections in hematopoietic stem cell transplant recipients). View the complaint here.
Eli Lilly and Company v. Fresenius Kabi USA, LLC
1:15-cv-00096; filed January 23, 2015 in the Southern District of Indiana
Infringement of U.S. Patent No. 7,772,209 ("Novel Antifolate Combination Therapies," issued August 10, 2010) following a Paragraph IV certification as part of Fesenius' filing of an ANDA to manufacture a generic version of Lilly's Alimta® (pemetrexed for injection, used to treat malignant pleural mesothelioma and locally advanced or metastatic non-small cell lung cancer). View the complaint here.
Spectrum Pharmaceuticals, Inc. et al. v. Amneal Pharmaceuticals LLC
2:15-cv-00139; filed January 23, 2015 in the District Court of Nevada
• Plaintiffs: Spectrum Pharmaceuticals, Inc.; University of Strathclyde
• Defendant: Amneal Pharmaceuticals LLC
Infringement of U.S. Patent No. 6,500,829 ("Substantially Pure Diastereoisomers of Tetrahydrofolate Derivatives," issued December 31, 2002) following a Paragraph IV certification as part of Amneal's filing of an ANDA to manufacture a generic version of Spectrum's Fusilev® (levoleucovorin, used to treat advanced metastatic colorectal cancer). View the complaint here.
Teva Pharmaceuticals USA, Inc. et al. v. Dr. Reddys Laboratories, Ltd. et al.
2:15-cv-00471; filed January 22, 2015 in the District Court of New Jersey
• Plaintiffs: Teva Pharmaceuticals USA, Inc.; Teva Pharmaceutical Industries Ltd.; Teva Neuroscience, Inc.; Yeda Research and Development Co., Ltd.
• Defendants: Dr. Reddys Laboratories, Ltd.; Dr. Reddys Laboratories, Inc.
Teva Pharmaceuticals USA, Inc. et al. v. Synthon Pharmaceuticals, Inc. et al.
2:15-cv-00472; filed January 22, 2015 in the District Court of New Jersey
• Plaintiffs: Teva Pharmaceuticals USA, Inc.; Teva Pharmaceutical Industries Ltd.; Teva Neuroscience, Inc.; Yeda Research and Development Co., Ltd.
• Defendants: Synthon Pharmaceuticals, Inc.; Synthon B.V.; Synthon S.R.O. Blansko
The complaints in these cases are substantially identical. Infringement of U.S. Patent No. 5,800,808 ("Copolymer-1 Improvements on Compositions of Copolymers," issued September 1, 1998) based on defendants' 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 Dr. Reddys complaint here.
