Court Report - September 9, 2013

by McDonnell Boehnen Hulbert & Berghoff LLP

Gavel About Court Report:  Each week we will report briefly on recently filed biotech and pharma cases.

Senju Pharmaceutical Co., Ltd. et al. v. Akorn, Inc.
1:13-cv-06080; filed August 28, 2013 in the Southern District of New York

• Plaintiffs:  Senju Pharmaceutical Co., Ltd.; Bausch & Lomb, Inc.; Bausch & Lomb Pharma Holdings Corp.
• Defendant:  Akorn, Inc.

Infringement of U.S. Patent No. 6,335,335 ("Prolonged-Action Eye Drop," issued January 1, 2002) following a Paragraph IV certification as part of Akorn's filing of an ANDA to manufacture a generic version of Senju's Istalol® (timolol maleate ophthalmic solution, 0.5%, used treat elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma).  View the complaint here.

Horizon Pharma AG et al. v. Watson Laboratories, Inc. - Florida et al.
0:13-cv-61868; filed August 28, 2013 in the Southern District of Florida

• Plaintiffs:  Horizon Pharma AG; Jagoteg AG
• Defendants:  Watson Laboratories, Inc. – Florida; Actavis Pharma, Inc.; Andrx Corp. (A Delaware Corporation); Actavis, Inc.

Horizon Pharma AG et al. v. Watson Laboratories, Inc. - Florida et al.
1:13-cv-05124; filed August 26, 2013 in the District Court of New Jersey

• Plaintiffs:  Horizon Pharma AG; Jagotec AG
• Defendants:  Watson Laboratories, Inc. – Florida; Actavis Pharma, Inc.; Andrx Corp.; Actavis, Inc.

The complaints in these cases are substantially identical.  Infringement of U.S. Patent Nos. 6,488,960 ("Corticosteroid Formulation" issued December 3, 2002), 6,677,326 ("Corticosteroid Formulation Comprising Less Than 2.5 mg Prednisolone for Once Daily Administration," issued January 13, 2004), 8,309,124 ("Delayed Release Tablet with Defined Core Geometry," issued November 13, 2012), 8,168,218 (same title, issued May 1, 2012), and 8,394,407 (same title, issued March 12, 2013) following a Paragraph IV certification as part of Watson's filing of an ANDA to manufacture a generic version of Horizon's Rayos® (prednisone delayed-release tablets, used as an anti-inflammatory or immunosuppressive agent for certain allergic, dermatologic, gastrointestinal, hematologic, ophthalmologic, nervous system, renal respiratory, rheumatologic, specific infectious diseases or conditions and organ transplantation; for the treatment of certain endocrine conditions; and for palliation of certain neoplastic conditions).  View the New Jersey complaint here.

Novartis Pharmaceuticals Corp. v. Akorn, Inc. et al.
2:13-cv-05125; filed August 26, 2013 in the District Court of New Jersey

• Plaintiff:  Novartis Pharmaceuticals Corp.
• Defendants:  Akorn, Inc.; Strides, Inc.; Agila Specialties Private Ltd.; USV North America, Inc.

Infringement of U.S. Patent Nos. 8,324,189 ("Use of Zolendronate for the Manufacture of a Medicament for the Treatment of Bone Metabolism Diseases," issued December 4, 2012), 8,052,987 ("Method of Administering Bisphosphonates," issued November 8, 2011), and 7,932,241 ("Pharmaceutical Products Comprising Bisphosphonates," issued April 26, 2011) based on Akorn's filing of an ANDA to manufacture a generic version of Novartis' Zometa® (zoledronic acid, used for the prevention of skeletal-related complications associated with cancer) and Reclast® (zoledronic acid, used to treat osteoporosis and Paget's disease).  View the complaint here.

Intelgenx Corp. v. Wockhardt Bio, AG et al.
2:13-cv-05074; filed August 23, 2013 in the District Court of New Jersey

• Plaintiff:  Intelgenx Corp.
• Defendants:  Wockhardt Bio, AG; Wockhardt Limited; Wockhardt USA, LLC

Infringement of U.S. Patent No. 7,674,479 ("Sustained-Release Bupropion and Bupropion/Mecamylamine Tablets," issued March 9, 2010) following a Paragraph IV certification as part of Wockhardt's filing of an ANDA to manufacture a generic version of IntelGenx's FORFIVO® XL (bupropion hydrochloride extended-release tablets, used for the treatment of major depressive disorder).  View the complaint here.

Novartis Pharmaceuticals Corp. et al. v. Par Pharmaceutical Inc.
1:13-cv-01467; filed August 22, 2013 in the District Court of Delaware

• Plaintiffs:  Novartis Pharmaceuticals Corp.; Novartis AG; Novartis Pharma AG; Novartis International Pharmaceutical Ltd.; LTS Lohmann Therapie-Systeme AG
• Defendant:  Par Pharmaceutical Inc.

Infringement of U.S. Patent No. 6,335,031 ("TTS Containing an Antioxidant," issued January 1, 2002) following a Paragraph IV certification as part of Par's filing of an ANDA to manufacture a generic version of Novartis' Exelon® Patch (rivastigmine tartrate, used to treat mild to moderate dementia of the Alzheimer's type, and mild to moderate dementia associated with Parkinson's disease).  View the 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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