By Sherri Oslick --
About Court Report: Each week we will report briefly on recently filed biotech and pharma cases.
Shire LLC et al. v. Apotex Corp. et al.
1:13-cv-24236; filed November 21, 2013 in the Southern District of Florida
• Plaintiffs: Shire LLC; Shire Development LLC; Supernus Pharmaceuticals, Inc.
• Defendants: Apotex Corp.; Apotex, Inc.
Infringement of U.S. Patent Nos. 6,287,599 ("Sustained Release Pharmaceutical Dosage Forms with Minimized pH Dependent Dissolution Profiles," issued September 11, 2001) and 6,811,794 (same title, issued November 2, 2004) following a Paragraph IV certification as part of Apotex's filing of an ANDA to manufacture a generic version of Shire's Intuniv® (guanfacine, used to treat attention-deficit hyperactivity disorder). View the complaint here.
Teijin Ltd. et al. v. Alembic Pharmaceuticals Ltd.
1:13-cv-01939; filed November 19, 2013 in the District Court of Delaware
• Plaintiffs: Teijin Ltd.; Teijin Pharma Ltd.; Takeda Pharmaceuticals USA Inc.
• Defendant: Alembic Pharmaceuticals Ltd.
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 Alembic's 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 complaint here.
Millennium Pharmaceuticals, Inc. v. Apotex Corp. et al.
1:13-cv-08240; filed November 15, 2013 in the Northern District of Illinois
• Plaintiff: Millennium Pharmaceuticals, Inc.
• Defendants: Apotex Corp.; Apotex Inc.
Infringement of U.S. Patent Nos. 6,713,446 ("Formulation of Boronic Acid Compounds," issued March 30, 2004) and 6,958,319 (same title, issued October 25, 2005), licensed exclusively to Millennium, following a Paragraph IV certification as part of Apotex's filing of an ANDA to manufacture a generic version of Millenium's Velcade® (bortezomib, used to treat multiple myeloma). View the complaint here.
Dow Pharmaceutical Sciences, Inc. et al. v. Perrigo Company et al.
2:13-cv-06922; filed November 15, 2013 in the District Court of New Jersey
• Plaintiffs: Dow Pharmaceutical Sciences, Inc.; Valeant Pharmaceuticals North America LLC
• Defendants: Perrigo Company; Perrigo Israel Pharmaceuticals Ltd.
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 Perrigo's 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.
Janssen Pharmaceuticals, Inc. et al. v. Roxane Laboratories, Inc.
3:13-cv-00639; filed November 15, 2013 in the District Court of Nevada
• Plaintiffs: Janssen Pharmaceuticals, Inc.; Grunenthal GmbH
• Defendant: Roxane Laboratories, Inc.
Janssen Pharmaceuticals, Inc. et al. v. Sandoz Inc. et al.
2:13-cv-06929; filed November 14, 2013 in the District Court of New Jersey
• Plaintiffs: Janssen Pharmaceuticals, Inc.; Grunenthal GmbH
• Defendants: Sandoz Inc.; Roxane Laboratories, Inc.
The complaintis in these cases are substantially identical. Infringement of U.S. Patent Nos. RE39,593 ("1-Phenyl-3-Dimethylaminopropane Compounds With a Pharmacological Effects," issued April 24, 2007) and 7,994,364 ("Crystalline Forms of (-)-(1R,2R)-3-(3-Dimethylamino-1-Ethyl-2-Methylpropyl)-Phenol Hydrochloride," issued August 9, 2011), licensed to Janssen, following a Paragraph IV certification as part of defendants' filing of an ANDA to manufacture a generic version of Janssen's Nucynta® (tapentadol hydrochloride, used for the management of moderate to severe acute pain in adults). View the Sandoz complaint here.
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