Court Report - January 2016 #3

by McDonnell Boehnen Hulbert & Berghoff LLP
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About Court Report:  Each week we will report briefly on recently filed biotech and pharma cases.

Merck Sharp & Dohme B.V. v. Teva Pharmaceuticals USA Inc.
1:15-cv-00806; filed September 11, 2015 in the District Court of Delaware

• Plaintiff:  Merck Sharp & Dohme B.V.
• Defendants:  Teva Pharmaceuticals USA Inc.; Teva Pharmaceutical Industries Ltd.

Infringement of U.S. Patent No. 5,989,581 ("Drug Delivery System for Two or More Active Substances," issued November 23, 1999) following a Paragraph IV certification as part of Teva's filing of an ANDA to manufacture a generic version of Merck's NuvaRing® drug product (ethinyl estradiol and etonogestrel vaginal ring, used for contraception).  View the complaint here.

Kowa Co., Ltd. et al. v. Zydus Pharmacueticals (USA) Inc. et al.
3:15-cv-06792; filed September 11, 2015 in the District Court of New Jersey

• Plaintiffs:  Kowa Co., Ltd.; Kowa Pharmaceuticals America, Inc.; Nissan Chemical Industries, Ltd.
• Defendants:  Zydus Pharmacueticals (USA) Inc.; Cadila Healthcare Ltd.

Infringement of U.S. Patent No. 6,465,477 ("Stable Pharmaceutical Composition," issued October 15, 2002) following a Paragraph IV certification as part of Zydus' filing of an NDA (under § 505(b)(2) of the Food, Drug and Cosmetic Act) to manufacture a generic version of Kowa's Livalo® (pitavastatin, used as an adjunctive therapy to diet to reduce elevated total cholesterol, lowdensity lipoprotein cholesterol, apolipoprotein B, triglycerides, and to increase high-density lipoprotein cholesterol).  View the complaint here.

Depomed, Inc. et al. v. Actavis Elizabeth LLC et al.
2:15-cv-06797; filed September 11, 2015 in the District Court of New Jersey

• Plaintiffs:  Depomed, Inc.; Grunenthal GmbH
• Defendants:  Actavis Elizabeth LLC; Actavis LLC; Actavis Inc.

Infringement of U.S. Patent No. 8,536,130 (""Use of 1 Phenyl-3-Dimethylamino-Propane Compounds for Treating Neuropathic Pain," issued September 17, 2013) following a Paragraph IV certification as part of Actavis' filing of an ANDA to manufacture a generic version of Depomed's Nucynta ER® (tapentadol hydrochloride, used for the management of moderate to severe acute pain in adults).  View the complaint here.

Millennium Pharmaceuticals Inc. v. Hospira, Inc.
1:15-cv-00804; filed September 10, 2015 in the District Court of Delaware

Infringement of U.S. Patent Nos. 6,713,446 ("Formulation of Boronic Acid Compounds," issued March 30, 2004) and 6,958,319 (same title, issued October 25, 2005), licensed exclusively to Millennium, following a Paragraph IV certification as part of Hospira's filing of an ANDA to manufacture a generic version of Millenium's Velcade® (bortezomib, used to treat multiple myeloma).  View the complaint here.

Janssen Pharmaceutica N.V. et al. v. Apotex Inc. et al.
1:15-cv-07121; filed September 10, 2015 in the Southern District of New York

• Plaintiffs:  Janssen Pharmaceutica N.V.; Janssen Pharmaceuticals, Inc.; Janssen Research & Development, LLC
• Defendants:  Apotex Inc.; Apotex Corp.

Infringement of U.S. Patent No. 6,407,079 ("Pharmaceutical Compositions Containing Drugs Which Are Instable or Sparingly Soluble in Water and Methods for Their Preparation," issued June 18, 2002) following a Paragraph IV certification as part of Apotex's filing of an ANDA to manufacture a generic version of Janssen's Sporanox® (itraconazole, used for the treatment of certain fungal infections).  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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