Court Report - February 09, 2014

by McDonnell Boehnen Hulbert & Berghoff LLP

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

Novartis Pharmaceuticals Corp. et al. v. Dr. Reddy's Laboratories Ltd. et al.
1:14-cv-00157; filed February 5, 2014 in the District Court of Delaware

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

Infringement of U.S. Patent No. 6,894,051 ("Crystal Modification of a N-phenyl-2-pyrimidineamine Derivative, Processes for Its Manufacture and Its Use," issued May 17, 2005) 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 complaint here.

Monsanto Co. et al. v. Ponder et al.
7:14-cv-00013 filed February 5, 2014 in the Middle District of Georgia

• Plaintiffs:  Monsanto Co.; Monsanto Technology LLC
• Defendants:  Christopher Ponder; Chris Ponder Farms LLC

Infringement of U.S. Patent Nos. 6,949,696 ("Chimeric Figwort Mosaic Virus-Elongation Factor 1 a Promoters and Methods of Using Them," issued September 27, 2005) and 7,064,249 ("Plants Transformed to Express CRY2A d-Endotoxins," issued June 20, 2006) based on defendant's use of cotton seed produced from earlier planted Roundup Ready® Flex, Bollgard II®, and/or Roundup Ready® Flex with Bollgard II® cotton seed, or combinations thereof.  View the complaint here.

Teijin Ltd. et al. v. Ranbaxy Laboratories Ltd. et al.
1:14-cv-00117; filed January 31, 2014 in the District Court of Delaware

• Plaintiffs:  Teijin Ltd.; Teijin Pharma Ltd.; Takeda Pharmaceuticals U.S.A., Inc.
• Defendants:  Ranbaxy Laboratories Ltd.; Ranbaxy Pharmaceuticals Inc.; Ranbaxy Inc.

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 Ranbaxy'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.

Cephalon Inc. v. Actavis LLC et al.
1:14-cv-00122; filed January 31, 2014 in the District Court of Delaware

• Plaintiff:  Cephalon Inc.
• Defendants:  Actavis LLC; Actavis Elizabeth LLC

Infringement of U.S. Patent Nos. 8,445,524 ("Solid Forms of Bendamustine Hydrochloride," issued May 21, 2013) and 8,436,190 ("Bendamustine Pharmaceutical Compositions," issued May 7, 2013) following a Paragraph IV certification as part of Actavis' filing of an ANDA to manufacture a generic version of Cephalon's Treanda® (bendamustine hydrochloride, used to treat chronic lymphocytic leukemia and non-Hodgkin's lymphoma).  View the complaint here.

Forest Laboratories Inc. et al. v. Teva Pharmaceuticals USA Inc. et al.
1:14-cv-00121; filed January 31, 2014 in the District Court of Delaware

• Plaintiffs:  Forest Laboratories Inc.; Forest Laboratories Holdings Ltd.; Merz Pharma GmbH & Co. KGaA; Merz Pharmaceuticals GmbH; Adamas Pharmaceuticals Inc.
• Defendant:  Teva Pharmaceuticals USA Inc.; Wockhardt USA LLC; Wockhardt Bio AG; Wockhardt Ltd.; Sun Pharma Global FZE; Sun Pharmaceutical Industries, Ltd.

Infringement of U.S. Patent Nos. 5,061,703 ("Adamantane Derivatives in the Prevention and Treatment of Cerebral Ischemia," issued on October 29, 1991), 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.

Phigenix, Inc. v. Genentech, Inc.
1:14-cv-00287; filed January 31, 2014 in the Northern District of Georgia

Infringement of U.S. Patent No. 8,080,534 ("Targeting PAX2 for the Treatment of Breast Cancer," issued December 20, 2011) based on Genentech's manufacture and sale of its Kadcyla® (ado-trastuzumab emtansine, used to treat patients with HER2-positive, metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination).  View the complaint here.

Senju Pharmaceutical Co., Ltd. et al. v. Lupin, Ltd. et al.
1:14-cv-00667; filed January 31, 2014 in the District Court of New Jersey

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

Infringement of U.S. Patent No. 8,129,431 ("Aqueous Liquid Preparation Containing 2-amino-3-(4-bromobenzoyl)phenylacetic acid," issued March 6, 2012) 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.

Sanofi-Aventis U.S. LLC et al. v. Eli Lilly and Company
1:14-cv-00113; filed January 30, 2014 in the District Court of Delaware

• Plaintiffs:  Sanofi-Aventis U.S. LLC; Sanofi-Aventis Deutschland GmbH
• Defendant:  Eli Lilly and Company

Infringement of U.S. Patent Nos. 8,556,864 ("Drive Mechanisms Suitable for Use in Drug Delivery Devices," issued October 15, 2013), 8,603,044 ("Pen-Type Injector," issued December 10, 2013), 7,476,652 ("Acidic Insulin Preparations Having Improved Stability," issued January 13, 2009), and 7,713,930 (same title, issued May 11, 2010) following a Paragraph IV certification as part of Lilly's filing of an NDA (under § 505(b)(2) of the Food, Drug and Cosmetic Act) to manufacture an insulin glargine for injection in a prefilled insulin delivery device, comparable to Sanofi's Lantus® and Lantus® SoloSTAR® products (insulin glargine [rDNA origin] for injection, used to treat diabetes).  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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