Court Report - Part I

by McDonnell Boehnen Hulbert & Berghoff LLP
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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. Teva Pharmaceuticals USA Inc. et al.
1:13-cv-01148; filed June 28, 2013 in the District Court of Delaware

• Plaintiffs:  UCB Inc.; UCB Pharma GmbH; Research Corporation Technologies Inc.; Harris FRC Corp.
• Defendants:  Teva Pharmaceuticals USA Inc.; Teva Pharmaceutical Industries Ltd.

UCB, Inc. et al. v. Zydus Pharmaceuticals (USA), Inc. et al.
1:13-cv-04021; filed June 28, 2013 in the District Court of New Jersey

• Plaintiffs:  UCB, Inc.; UCB Pharma GmbH; Research Corporation Technologies, Inc.; Harris FRC Corp.
• Defendants:  Zydus Pharmaceuticals (USA), Inc.; Cadila Healthcare Ltd.

The complaints in these cases are substantially identical.  Infringement of U.S. Patent No. RE38,551 (""Anticonvulsant Enantiomeric Amino Acid Derivatives," issued July 6, 2004) following a Paragraph IV certification as part of defendants' filing of an ANDA to manufacture a generic version of UCB's Vimpat® (lacosamide, used as adjunctive therapy in the treatment of partial-onset seizures in people with epilepsy aged 17 years and older).  View the Teva complaint here.

Pfizer Inc. et al. v Lupin Ltd
1:13-cv-01153; filed June 28, 2013 in the District Court of Delaware

• Plaintiffs:  Pfizer Inc.; UCB Pharma GmbH
• Defendant:  Lupin Ltd.

Pfizer Inc. et al. v Zydus Pharmaceuticals (USA) Inc.
1:13-cv-01154; filed June 28, 2013 in the District Court of Delaware

• Plaintiffs:  Pfizer Inc.; UCB Pharma GmbH
• Defendant:  Zydus Pharmaceuticals (USA) Inc.

Pfizer Inc. et al. v Accord Healthcare Inc. USA
1:13-cv-01155; filed June 28, 2013 in the District Court of Delaware

• Plaintiffs:  Pfizer Inc.; UCB Pharma GmbH
• Defendant:  Accord Healthcare Inc. USA

Pfizer Inc. et al. v. Amerigen Pharmaceuticals Inc., et al.
1:13-cv-01156; filed June 28, 2013 in the District Court of Delaware

• Plaintiffs:  Pfizer Inc.; UCB Pharma GmbH
• Defendants:  Amerigen Pharmaceuticals Inc.; Amerigen Pharmaceuticals Ltd.

Pfizer Inc. et al. v. Amneal Pharmaceuticals LLC
1:13-cv-01157; filed June 28, 2013 in the District Court of Delaware

• Plaintiffs:  Pfizer Inc.; UCB Pharma GmbH
• Defendant:  Amneal Pharmaceuticals LLC

Pfizer Inc. et al. v. Impax Laboratories Inc.
1:13-cv-01158; filed June 28, 2013 in the District Court of Delaware

• Plaintiffs:  Pfizer Inc.; UCB Pharma GmbH
• Defendant:  Impax Laboratories Inc.

The complaints in these cases are substantially identical.  Infringement of U.S. Patent Nos. 6,858,650 ("Stable Salts of Novel Derivatives of 3,3-Diphenylpropylamines," issued February 22, 2005), 7,384,980 ("Derivatives of 3,3-Diphenylpropylamines," issued June 10, 2008), 7,855,230 (same title, issued December 21, 2010), 7,985,772 (same title, issued July 26, 2011), and 8,338,478 (same title, issued December 25, 2012) following a Paragraph IV certification as part of defendants' filing of an ANDA to manufacture a generic version of Pfizer's Toviaz® (fesoterodine fumarate, used to treat the symptoms of overactive bladder).  View the Lupin complaint here.

Astrazeneca AB et al. v. Mylan Pharmaceuticals et al.
3:13-cv-04022; filed June 28, 2013 in the District Court of New Jersey

• Plaintiffs:  Astrazeneca AB; Astrazeneca LP; KBI-E Inc.; Pozen, Inc.
• Defendants:  Mylan Pharmaceuticals; Mylan Laboratories Ltd.; Mylan, Inc.

Infringement of U.S. Patent Nos. 5,714,504 ("Compositions," issued February 3, 1988), 6,369,085 ("Form of S-omeprazole," issued April 9, 2002), 6,875,872 ("Compounds," issued April 5, 2005), 7,411,070 ("Form of S-omeprazole," issued August 12, 2008), 7,745,466 (same title, issued June 29, 2010), 5,948,789 ("Process For Synthesis Of Substituted Sulphoxides," issued September 7, 1999), and 6,926,907 ("Pharmaceutical Compositions for the Coordinated Delivery of NSAIDs," issued August 9, 2005) following a Paragraph IV certification as part of Mylan's filing of an ANDA to manufacture a generic version of AstraZeneca's Vimovo® (naproxen and esomeprazole magnesium, used to relieve the signs and symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis, and to decrease the risk of stomach (gastric) ulcers in patients at risk of developing stomach ulcers from treatment with non-steroidal anti-inflammatory drugs (NSAIDs)).  View the complaint here.

Merck, Sharp & Dohme Corp. et al. v. Cipla USA, Inc. et al.
1:13-cv-04017; filed June 27, 2013 in the District Court of New Jersey

• Plaintiffs:  Merck, Sharp & Dohme Corp.; Bristol-Myers Squibb Co.
• Defendants:  Cipla USA, Inc.; Cipla Ltd.

Infringement of U.S. Patent Nos. 6,639,071 ("Crystal Forms of (-)-6-chloro-4-cyclopropylethynyl-4-trifluoromethyl-1,4-dihydro-2H-3,1-benzoxazin-2-one," issued October 28, 2003) and 6,939,964 (same title, issued September 6, 2005) following a Paragraph IV certification as part of Cipla's filing of an ANDA to manufacture a generic version of BMS' Sustiva® (efavirenz, used to treat HIV infection).  View the complaint here.

Par Pharmaceutical, Inc. et al. v. Breckenridge Pharmaceutical, Inc.
2:13-cv-04000; filed June 27, 2013 in the District Court of New Jersey

• Plaintiffs:  Par Pharmaceutical, Inc.; Alkermes Pharma Ireland Ltd.
• Defendants:  Breckenridge Pharmaceutical, Inc.

Infringement of U.S. Patent Nos. 6,592,903 ("Nanoparticulate Dispersions Comprising a Synergistic Combination of a Polymeric Surface Stabilizer and Dioctyl Sodium Sulfosuccinate," issued July 15, 2003) and 7,101,576 ("Nanoparticulate Megestrol Formulations," issued September 5, 2006) following a Paragraph IV certification as part of Breckenridge's filing of an ANDA to manufacture a generic version of Par's Megace ES® (megestrol acetate, used for the treatment of appetite loss, severe malnutrition, or unexplained, significant weight loss in AIDS patients).  View the complaint here.

United States Department of Health and Human Services et al. v. Lupin Ltd.
2:13-cv-04039; filed June 27, 2013 in the District Court of New Jersey

• Plaintiffs:  United States Department of Health and Human Services; Board of Trustees of the University of Illinois
• Defendant:  Lupin Ltd.

Infringement of U.S. Patent No. 7,470,506 ("Fitness Assay and Associated Methods," issued December 30, 2008), licensed to Janssen following a Paragraph IV certification as part of Lupin'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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