Court Report - September 2014

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

UCB Inc. et al. v. Watson Laboratories Inc. (NV) et al.
1:14-cv-01083; filed August 21, 2014 in the District Court of Delaware

• Plaintiffs:  UCB Inc.; UCB Manufacturing Ireland Ltd.; UCB Pharma GmbH; LTS Lohmann Therapie-Systeme AG
• Defendants:  Watson Laboratories Inc. (NV); Watson Laboratories Inc. (DE)

Infringement of U.S. Patent Nos. 6,699,498 ("Transdermal Therapeutic Systems Having Improved Stabilty and Their Production," issued March 2, 2004), 6,884,434 ("Transdermal Therapeutic System Which Contains a D2 Agonist and Which is Provided for Treating Parkinsonism, and a Method for the Production Thereof," issued April 26, 2005), 7,413,747 ("Transdermal Therapeutic System for Treating Parkinsonism," issued August 19, 2008), 8,246,979 ("Transdermal Delivery System for the Administration of Rotigotine," issued August 21, 2012), 8,246,980 ("Transdermal Delivery System," issued August 21, 2012), and 8,617,591 ("Transdermal Delivery System for the Administration of Rotigotine," issued December 31, 2013) following a Paragraph IV certification as part of Watson's filing of an ANDA to manufacture a generic version of UCB's Neupro® (rotigotine transdermal systm, used to treat the signs and symptoms of idiopathic Parkinson's disease and moderate-to-severe Restless Legs Syndrome).  View the complaint here.

Mallinckrodt LLC et al. v. Hi-Tech Pharmacal Co. Inc. et al.
1:14-cv-01084; filed August 21, 2014 in the District Court of Delaware

• Plaintiffs:  Mallinckrodt LLC; Mallinckrodt Inc.; Nuvo Research Inc.
• Defendants:  Hi-Tech Pharmacal Co. Inc.; Akorn Pharmaceuticals Inc.; Akorn Ophthalmics Inc.; Akorn Inc.

Infringement of U.S. Patent Nos. 8,217,078 ("Treatment of Pain with Topical Diclofenac," issued July 10, 2012), 8,546,450 (same title, issued October 1, 2013), 8,618,164 (same title, issued December 31, 2013), and 8,741,956 (same title, issued June 3, 2014) following a Paragraph IV certification as part of Hi-Tech's filing of an ANDA to manufacture a generic version of Mallinckrodt's Pennsaid® (diclofenac sodium topical solution, used for the treatment of signs and symptoms of osteoarthritis of the knee(s)).  View the complaint here.

Novartis Pharmaceuticals Corp. et al. v. Dr. Reddy's Laboratories, Ltd. et al.
2:14-cv-05260; filed August 21, 2014 in the District Court of New Jersey

• Plaintiffs:  Novartis Pharmaceuticals Corp.; Novartis AG
• Defendants:  Dr. Reddy's Laboratories, Ltd.; Dr. Reddy's Laboratories, Inc.

Novartis Pharmaceuticals Corp. et al. v. Dr. Reddy's Laboratories Ltd. et al.
1:14-cv-01076; filed August 20, 2014 in the District Court of Delaware

• Plaintiffs:  Novartis Pharmaceuticals Corp.; Novartis AG
• Defendants:  Dr. Reddy's Laboratories Ltd.; Dr. Reddy's Laboratories Inc.

The complaints in these cases are substantially identical.  Infringement of U.S. Patent Nos. 6,894,051 ("Crystal Modification of a N-phenyl-2-pyrimidineamine Derivative, Processes for Its Manufacture and Its Use," issued May 17, 2005) and RE43,932 ("Crystal Modification of a N-phenyl-2-pyrimidineamine Derivative, Processes for Its Manufacture and Its Use," issued January 15, 2013) following a Paragraph IV certification as part of Dr. Reddy's filing of an ANDA to manufacture a generic version of Novartis' Gleevec® (imatinib mesylate, used for various indications, including treatment of myeloid leukemia).  View the Delaware complaint here.

Janssen Products LP et al. v. Cipla Ltd. et al.
1:14-cv-01056; filed August 15, 2014 in the District Court of Delaware

• Plaintiffs:  Janssen Products LP; Janssen R&D Ireland
• Defendants:  Cipla Ltd.; Cipla USA Inc.

Infringement of U.S. Patent Nos. 7,700,645 ("Pseudopolymorphic Forms of a HIV Protease Inhibitor," issued April 20, 2010), 7,126,015 ("Method for the Preparation of Hexahydro-furo-[2,3-b]furan-3-ol," issued October 24, 2006), 7,595,408 ("Methods for the Preparation of (3R,3aS,6aR)hexahydro-furo[2,3-b]furan-3-ol," issued September 29, 2009), and 8,518,987 ("Pseudopolymorphic Forms of a HIV Protease Inhibitor," issued August 27, 2013) following a Paragraph IV certification as part of Cipla's filing of an ANDA to manufacture a generic version of Janssen's Prezista® (darunavir, used to treat human immunodeficiency virus (HIV-1) infection).  View the complaint here.

Salix Pharmaceuticals Ltd. et al. v. Mylan Pharmaceuticals Inc.
1:14-cv-01055; filed August 15, 2014 in the District Court of Delaware

• Plaintiffs:  Salix Pharmaceuticals Ltd.; Salix Pharmaceuticals Inc.; Glycyx Pharmaceuticals Ltd.
• Defendant:  Mylan Pharmaceuticals Inc.

Infringement of U.S. Patent Nos. 6,197,341 ("Formulations of Balsalazide and Its Derivatives," issued March 6, 2001) and 8,497,256 ("Formulations and Uses of 2-Hydroxy-5-Phenylazobenzoic Acid Derivatives for the Treatment of Males," issued July 30, 2013) following a Paragraph IV certification as part of Mylan's filing of an ANDA to manufacture a generic version of Salix's Giazo® (balsalazide disodium, used for the treatment of mildly to moderately active ulcerative colitis in male patients 18 years of age and older).  View the complaint here.

Forest Laboratories, LLC et al. v. Lupin Ltd. et al.
1:14-cv-01058; filed August 15, 2014 in the District Court of Delaware

• Plaintiffs:  Forest Laboratories, LLC; Forest Laboratories Holdings Ltd.; Adamas Pharmaceuticals Inc.
• Defendants:  Lupin Ltd.; Lupin Pharmaceuticals Inc.; Par Pharmaceutical Inc.; Anchen Pharmaceuticals Inc.; Amerigen Pharmaceuticals Inc.; Amerigen Pharmaceuticals Ltd.

Infringement of U.S. Patent Nos. 8,039,009 ("Modified Release Formulations of Memantine Oral dosage Forms," issued October 18, 2011), 8,168,209 ("Method and Composition for Administering an NMDA Receptor Antagonist to a Subject," issued May 1, 2012), 8,173,708 (same title, issued May 8, 2012), 8,283,379 ("Method and Compositions for the Treatment of CNS-Related Conditions," issued October 9, 2012), 8,329,752 ("Composition for Administering an NMDA Receptor Antagonist to a Subject," issued December 11, 2012), 8,362,085 ("Method for Administering an NMDA Receptor Antagonist to a Subject," issued January 29, 2013), and 8,598,233 (same title, issued December 3, 2013) following a Paragraph IV certification as part of defendants' filing of an ANDA to manufacture a generic version of Forest's Namenda XR® (memantine hydrochloride extended release, used for the treatment of moderate to severe dementia of the Alzheimer's type).  View the complaint here.

Jazz Pharmaceuticals, Inc. v. Par Pharmaceutical, Inc.
2:14-cv-05139; filed August 15, 2014 in the District Court of New Jersey

Infringement of U.S. Patent No. 8,731,963 ("Sensitive Drug Distribution System and Method," issued May 20, 2014) following a Paragraph IV certification as part of Par's filing of an ANDA to manufacture a generic version of Jazz's Xyrem® (sodium oxybate, used to treat narcolepsy).  View the complaint here.

Senju Pharmaceutical Co., Ltd. et al. v. Lupin, Ltd. et al.
1:14-cv-05144; filed August 15, 2014 in the District Court of New Jersey

• Plaintiffs:  Senju Pharmaceutical Co., Ltd.; Bausch & Lomb, Inc.; Bausch & Lomb Pharma Holdings Corp.
• Defendants:  Lupin, Ltd.; Lupin Pharmaceuticals, Inc.

Infringement of U.S. Patent No. 8,754,131 ("Aqueous Liquid Preparation Containing 2-amino-3-(4-bromobenzoyl)phenylacetic acid," issued June 17, 2014) following a Paragraph IV certification as part of Lupin's filing of an ANDA to manufacture a generic version of B&L's Prolensa® (bromfenac ophthalmic solution, used to treat postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery).  View the complaint here.

United States Department of Health and Human Services et al. v. Cipla Ltd. et al.
2:14-cv-05135; filed August 15, 2014 in the District Court of New Jersey

• Plaintiffs:  United States Department of Health and Human Services; Board of Trustees of the University of Illinois
• Defendants:  Cipla Ltd.; Cipla USA, Inc.

Infringement of U.S. Patent Nos. 7,470,506 ("Fitness Assay and Associated Methods," issued December 30, 2008) and 8,597,876 ("Method of Treating HIV Infection," issued December 3, 2013), both licensed to Janssen, following a Paragraph IV certification as part of Cipla's filing of an ANDA to manufacture a generic version of Janssen's Prezista® (darunavir, used to treat human immunodeficiency virus (HIV-1) infection).  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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