By Sherri Oslick —
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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