About Court Report: Each week we will report briefly on recently filed biotech and pharma cases.
Teijin
Ltd. et al. v. Dr. Reddy's Laboratories Ltd., et al.
1:13-cv-01780;
filed October 30, 2013 in the District Court of Delaware
• Plaintiffs:
Teijin Ltd.; Teijin Pharma Ltd.; Takeda Pharmaceuticals USA, Inc.
• Defendants:
Dr. Reddy's Laboratories Ltd.; Dr. Reddy's Laboratories Inc.
Teijin
Ltd. et al.. v. Mylan Pharmaceuticals Inc.
1:13-cv-01781;
filed October 30, 2013 in the District Court of Delaware
• Plaintiffs:
Teijin Ltd.; Teijin Pharma Ltd.; Takeda Pharmaceuticals USA, Inc.
• Defendant:
Mylan Pharmaceuticals Inc.
The complaints in these cases are substantially identical. Infringement of U.S. Patent No. 6,225,474 ("Polymorphs of 2-(3-cyano-4-isobutyloxyphenyl)-4-methyl-5-thiazolecarboxylic acid and Method of Producing the Same," issued May 1, 2001) following a Paragraph IV certification as part of defendants' filing of an ANDA to manufacture a generic version of Takeda's Uloric® (febuxostat, used for the chronic management of hyperuricemia in patients with gout). View the Dr. Reddy's complaint here.
Warner
Chilcott Co., LLC v. Mylan Inc. et al.
3:13-cv-06560;
filed October 30, 2013 in the District Court of Delaware
• Plaintiff: Warner
Chilcott Co., LLC
• Defendants:
Mylan Inc.; Mylan Pharmaceuticals Inc.; Famy Care Ltd.
Infringement of U.S. Patent No. 7,704,984 ("Extended Estrogen Dosing Contraceptive Regimen" issued April 27, 2010) following a Paragraph IV certification as part of Mylan's filing of an ANDA to manufacture a generic version of Warner Chilcott's Lo Loestrin® Fe (norethindrone acetate and ethinyl estradiol tablets, and ethinyl estradiol and ferrous fumarate tablets, used for oral contraception). View the complaint here.
Reckitt
Benckiser Pharmaceuticals, Inc. et al. v. BioDelivery Sciences International,
Inc.
5:13-cv-00760;
filed October 29, 2013 in the Eastern District of North Carolina
• Plaintiffs:
Reckitt Benckiser Pharmaceuticals, Inc.; RB Pharmaceuticals Ltd.; MonoSol
Rx, LLC
• Defendant:
BioDelivery Sciences International, Inc.
Infringement of U.S. Patent No. 8,475,832 ("Sublingual and Buccal Film Compositions," issued July 2, 2013) in conjunction with BioDelivery's filing of an NDA (under § 505(b)(2) of the Food, Drug and Cosmetic Act) to manufacture its Bunavail product, comparable to Reckitt Benckiser's Suboxone® film (buprenorphine hydrochloride and naloxone hydrochloride sublingual film, used for the maintenance treatment of opioid dependence). View the complaint here.
Cipher
Pharmaceuticals, Inc. et al. v. Watson Laboratories, Inc.-Florida et al.
2:13-cv-06502;
filed October 29, 2013 in the District Court of New Jersey
• Plaintiffs:
Cipher Pharmaceuticals, Inc.; Galephar Pharmaceutical Research, Inc.; Ranbaxy,
Inc.; Ranbaxy Pharmaceuticals, Inc.
• Defendants:
Watson Laboratories, Inc.-Florida; Andrx Corp.; Actavis Pharma, Inc.; Actavis,
Inc.
Infringement of U.S. Patent No. 8,367,102 ("Pharmaceutical Semi-Solid Composition of Isotretinoin," issued February 5, 2013) following a Paragraph IV certification as part of Watson's filing of an ANDA to manufacture a generic version of Ranbaxy's Absorica® (isotretinoin, used for the treatment of severe recalcitrant nodular acne). View the complaint here.
Takeda
Pharmaceutical Co. et al. v. Wockhardt Bio AG et al.
3:13-cv-06427;
filed October 25, 2013 in the District Court of New Jersey
• Plaintiffs:
Takeda Pharmaceutical Co.; Takeda Pharmaceuticals U.S.A., Inc.;
Takeda Pharmaceuticals America, Inc.
• Defendants:
Wockhardt Bio AG; Wockhardt Ltd.; Wockhardt USA LLC.
Infringement of U.S. Patent Nos. 6,328,994 ("Orally Disintegrable Tablets," issued December 11, 2001), 7,431,942 ("Orally Disintegrable Tablets," issued October 7, 2008), 7,399,485 ("Rapidly Disintegrable Solid Preparation," issued July 15, 2008), and 7,875,292 ("Orally Disintegrable Tablets," issued January 25, 2011) following a Paragraph IV certification as part of Wockhardt's filing of an ANDA to manufacture a generic version of Takeda's Prevacid® SoluTab (lansoprazole delayed release orally disintegrating tablets, used to treat ulcers, gastroesophageal reflux disease, erosive esophagitis, and pathological hypersecretory conditions, including Zollinger-Ellison syndrome). View the complaint here.
Ferring B.V.
v. Apotex, Inc. et al.
3:13-cv-00595;
filed October 25, 2013 in the District Court of Nevada
• Plaintiff:
Ferring B.V.
• Defendants:
Apotex, Inc.; Apotex Corp.
Infringement of U.S. Patent No. 8,487,005 ("Tranexamic Acid Formulations," issued July 16, 2013), 7,947,739 (same title, issued May 24, 2011) following a Paragraph IV certification as part of Aptoex's filing of an ANDA to manufacture a generic version of Ferring's Lysteda® (tranexamic acid, used to treat heavy menstrual bleeding). View the complaint here.
Dow
Pharmaceutical Sciences, Inc. et al. v. Actavis, Inc. et al.
2:13-cv-06401;
filed October 24, 2013 in the District Court of New Jersey
• Plaintiffs:
Dow Pharmaceutical Sciences, Inc.; Valeant Pharmaceuticals North America LLC
• Defendants:
Actavis, Inc.; Watson Laboratories, Inc.; Andrx Corp.; Watson Pharma, Inc.
Infringement of U.S. Patent No. 8,288,434 ("Topical Pharmaceutical Formulations Containing a Low Concentration of Benzoyl Peroxide in Suspension in Water and a Water-Miscible Organic Solvent," issued October 16, 2012) following a Paragraph IV certification as part of defendants' filing of an ANDA to manufacture a generic version of Dow's Acanya® (clindamycin phosphate and benzoyl peroxide gel, 1.2%/2.5%, used to treat acne). View the complaint here.
Warner
Chilcott Co., LLC et al. v. Impax Laboratories, Inc.
2:13-cv-06403;
filed October 23, 2013; in the District
Court of New Jersey
• Plaintiffs:
Warner Chilcott Co., LLC; Warner Chilcott (US), LLC
• Defendant:
Impax Laboratories, Inc.
Infringement of U.S. Patent Nos. 7,645,459 ("Dosage Forms of Bisphosphonates," issued January 12, 2010), 7,645,460 ("Dosage Forms of Risedronate" issued January 12, 2010), and 8,246,989 ("Dosage Forms of Bisphosphonates" issued August 21, 2012) following a Paragraph IV certification as part of Impax's filing of an ANDA to manufacture a generic version of Warner Chilcott's Atelvia (risedronate sodium delayed-release, used to treat osteoporosis in women after menopause). View the complaint here.
Acella
Pharmaceuticals, LLC v. Chemo S.A. France
2:13-cv-00573;
filed October 22, 2013 in the Eastern District of Virginia
Declaratory judgment of invalidity of U.S. Patent No. 8,183,227 ("Compositions, Kits and Methods for Nutrition Supplementation," issued May 22, 2012), licensed to Everett Laboratories, Inc., relating to Everett's filing of a suit alleging infringement of the '227 patent based on Acella's manufacture and sale of its PNV-First product, an alleged copy of Everett's Vitafol®-One (prescription prenatal nutritional supplement). View the complaint here.
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