Court Report -- June 30, 2013

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.

Alpex Pharma S A et al. v. Zydus Pharmaceuticals USA Inc. et al.
1:13-cv-01143; filed June 26, 2013 in the District Court of Delaware

• Plaintiffs:  Alpex Pharma S A; Citius Pharmaceuticals LLC; Prenzamax LLC
• Defendants:  Zydus Pharmaceuticals USA Inc.; Cadila Healthcare Ltd.

Infringement of U.S. Patent No. 6,149,938 ("Process for the Preparation of a Granulate Suitable to the Preparation of Rapidly Disintegrable Mouth-Soluble Tablets and Compositions Obtained Thereby," issued November 21, 2000) following a Paragraph IV certification as part of Zydus' filing of an ANDA to manufacture a generic version of Alpex's Suprenza® (phentermine hydrochloride, used to treat obesity).  View the complaint here.

Alza Corp. et al. v. Osmotica Kereskedelmi es Szolgaltato Kft
1:13-cv-04668; filed June 26, 2013 in the Northern District of Illinois

• Plaintiffs: Alza Corp.; Janssen Pharmaceuticals, Inc.
• Defendant: Osmotica Kereskedelmi es Szolgaltato Kft

Alza Corporation et al. v. Osmotica Kereskedelmi es Szolgaltato Kft et al.
1:13-cv-01126; filed June 24, 2013 in the District Court of Delaware

• Plaintiffs: Alza Corp.; Janssen Pharmaceuticals Inc.
• Defendants: Osmotica Kereskedelmi es Szolgaltato Kft; Osmotica Pharmaceutical Corp.; Norwich Pharmaceuticals Inc.

The complaints in these cases are substantially identical.  Infringement of U.S. Patent No. 8,163,798 ("Methods and Devices for Providing Prolonged Drug Therapy," issued April 24, 2012) following a Paragraph IV certification as part of Osmotica's filing of an ANDA to manufacture a generic version of Alza's Concerta® (methylphenidate hydrochloride, used to treat attention deficit hyperactivity disorder).  View the Delaware complaint here.

Sandoz Inc. v. Amgen Inc. et al.
3:13-cv-02904; filed June 24, 2013 in the Northern District of California

• Plaintiff:  Sandoz Inc.
• Defendants:  Amgen Inc.; Hoffman-La Roche Inc.

Declaratory judgment of non-infringement, invalidity, and unenforceability of U.S. Patent Nos. 8,063,182 ("Human TNF Receptor Fusion Protein," issued November 22, 2011) and 8,163,522 ("Human TNF Receptor," issued April 24, 2012) based on Sandoz's development of a biologic drug containing etanercept that would compete with Amgen's Enbrel® (etanercept, used to treat rheumatoid Arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, and plaque psoriasis).  View the complaint here.

Pegasus Laboratories, Inc. v. Wedgewood Village Pharmacy, Inc.
4:13-cv-00630; filed June 24, 2013 in the Western District of Missouri

• Plaintiff:  Pegasus Laboratories, Inc.
• Defendants:  Wedgewood Village Pharmacy, Inc.

Infringement of U.S. Patent Nos. 5,747,476 ("Treatment of Equine Protozoal Myeloencephalitis" issued May 5, 1998), 6,255,308 (same title, issued July 3, 2001), and 6,448,252 (same title, issued September 10, 2002), licensed to Pegasus, based on Wedgewood's marketing and sale of a sulfadiazine and pyrimethamine product for treating horses with Equine Protozoal Myeloencephalitis caused by sarcocystic neurona.  View the complaint here.

Janssen Products, L.P. et al. v. Lupin Ltd. et al.
2:13-cv-03891; filed June 24, 2013 in the District Court of New Jersey

• Plaintiffs:  Janssen Products, L.P.; Janssen R&D Ireland
• Defendants:  Lupin Ltd.; Lupin Pharmaceuticals 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), and 7,595,408 ("Methods for the Preparation of (3R,3aS,6aR)hexahydro-furo[2,3-b]furan-3-ol," issued September 29, 2009) 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.

Pfizer et al. vs. Alkem Laboratories, LTD
1:13-cv-04628; filed June 24, 2013 in the Northern District of Illinois

• Plaintiffs:  Pfizer Inc.; UCB Pharma GmbH
• Defendant:  Alkem Laboratories, Ltd.

Pfizer Inc. et al. v. Alkem Laboratories Ltd.
1:13-cv-01110; filed June 21, 2013 in the District Court of Delaware

• Plaintiffs:  Pfizer Inc.; UCB Pharma GmbH
• Defendants:  Alkem Laboratories Ltd.

Pfizer Inc. et al. v. Sandoz Inc.
1:13-cv-01111; filed June 21, 2013 in the District Court of Delaware

• Plaintiffs:  Pfizer Inc.; UCB Pharma GmbH
• Defendants:  Sandoz 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 Alkem's 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 Delaware Alkem complaint here.

Par Pharmaceutical Inc. et al. v Breckenridge Pharmaceutical Inc.
1:13-cv-01114; filed June 21, 2013 in the District Court of Delaware

• Plaintiffs:  Par Pharmaceutical Inc.; Alkermes Pharma Ireland Ltd.
• Defendant:  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.

Endo Pharmaceuticals Inc. v. Ranbaxy Laboratories Ltd. et al.
1:13-cv-04343; filed June 21, 2013 in the Southern District of New York

• Plaintiff:  Endo Pharmaceuticals Inc.
• Defendants:  Ranbaxy Laboratories Ltd.; Ranbaxy Inc.; Ranbaxy Pharmaceuticals Inc.

Infringement of U.S. Patent Nos. 7,851,482 ("Method for Making Analgesics," issued December 14, 2010), 8,309,122 ("Oxymorphone Controlled Release Formulations," issued November 13, 2012), and 8,329,216 (same title, issued December 11, 2012) following a Paragraph IV certification as part of Ranbaxy's filing of an ANDA to manufacture a generic version of Endo's Opana® ER CRF (oxymorphone hydrochloride, crush-resistant formulation, used to treat moderate to severe pain in patients requiring continuous, around-the-clock opioid treatment for an extended period of time).  View the complaint here.

Kremers Urban Pharmaceuticals, Inc. v. Rea et al.
3:13-cv-00399; filed June 21, 2013 in the Eastern District of Virginia

• Plaintiff:  Kremers Urban Pharmaceuticals, Inc.
• Defendants:  Teresa Stanek Rea; United States Patent and Trademark Office

Reversal of the revival by the U.S. Patent and Trademark Office of the application that granted as U.S. Patent No. 6,469,035 ("Methods of Pretreating Hyperlipidemic Individuals with a Flush Inhibiting Agent Prior to the Start of Single Daily Dose Nicotinic Acid Therapy to Reduce Flushing Provoked by Nicotinic Acid," issued October 22, 2002), listed in the Orange Book for AbbVie's Niaspan® (niacin extended-release tablets, used to treat hypercholesterolemia), and therefore a declaration that the patent is invalid.  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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