Court Report -- November 24, 2013

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Gavel 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.

 

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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