Court Report

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.

Cephalon Inc. v. Uman Pharma Inc.
1:14-cv-00568; filed April 30, 2014 in the District Court of Delaware

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 Uman's 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.

Celgene Corp. et al. v. Fresenius Kabi USA LLC
1:14-cv-00571; filed April 30, 2014 in the District Court of Delaware

• Plaintiffs:  Celgene Corp.; Astellas Pharma Inc.
• Defendant:  Fresenius Kabi USA LLC

Infringement of U.S. Patent Nos. 7,608,280 ("Method of Producing FR901228," issued October 27, 2009) and 7,611,724 (same title, issued November 3, 2009) following a Paragraph IV certification as part of Fesenius' filing of an ANDA to manufacture a generic version of Celgene's Istodax® (romidepsin for injection, used to treatment of peripheral and cutaneous T-cell lymphoma).  View the complaint here.

Amarin Pharma, Inc. et al. v. Dr. Reddy's Laboratories, Inc. et al.
3:14-cv-02760; filed April 30, 2014 in the District Court of New Jersey

• Plaintiffs:  Amarin Pharma, Inc.; Amarin Pharmaceuticals Ireland Ltd.
• Defendants:  Dr. Reddy's Laboratories, Inc.; Dr. Reddy's Laboratories, Ltd.

Amarin Pharma, Inc. et al. v. Roxane Laboratories, Inc.
1:14-cv-00901; filed April 25, 2014 in the Northern District of Ohio

• Plaintiffs:  Amarin Pharma, Inc.; Amarin Pharmaceuticals Ireland Ltd.
• Defendant:  Roxane Laboratories, Inc.

The complaints in these cases are substantially identical.  Infringement of U.S. Patent Nos. 8,293,728 ("Methods of Treating Hypertriglyceridemia," issued October 23, 2012), 8,318,715 (same title, issued November 27, 2012), 8,357,677 (same title, issued January 22, 2013), 8,367,652 (same title, issued February 5, 2013), 8,377,920 (same title, issued February 19, 2013), 8,399,446 (same title, issued March 19, 2013), 8,415,335 (same title, issued April 9, 2013), 8,426,399 (same title, issued April 23, 2013), 8,431,560 (same title, issued April 30, 2013), 8,440,650 (same title, issued May 14, 2013), 8,501,225 ("Stable Pharmaceutical Composition and Methods of Using Same," issued August 6, 2013), 8,518,929 ("Methods of Treating Hypertriglyceridemia," issued August 27, 2013), 8,524,698 (same title, issued September 3, 2013), 8,546,372 (same title, issued October 1, 2013), 8,551,521 ("Stable Pharmaceutical Composition and Methods of Using Same," issued October 8, 2013), and 8,617,594 (same title, issued December 31, 2013) following a Paragraph IV certification as part of defendants' filing of an ANDA to manufacture a generic version of Amarin's Vascepa® (icosapent ethyl, used as an adjunct to diet to reduce triglyceride levels in adult patients with severe hypertriglyceridemia).  View the Dr. Reddy's complaint here.

Otsuka Pharmaceutical Co., Ltd. v. Amneal Pharmaceuticals, LLC et al.
3:14-cv-02700; filed April 28, 2014 in the District Court of New Jersey

• Plaintiff:  Otsuka Pharmaceutical Co., Ltd.
• Defendants:  Amneal Pharmaceuticals, LLC; Amneal Pharmaceuticals of New York, LLC; Amneal Pharmaceuticals Co. India Private Ltd.

Infringement of U.S. Patent No. 8,642,600 ("Method of Treating Autism," issued February 4, 2014) following a Paragraph IV certification as part of Amneal's filing of an ANDA to manufacture a generic version of Otsuka's Abilify® (aripiprazole, used to treat bipolar disorder, schizophrenia, and austistic disorder, and as an adjunctive treatment of major depressive disorder).  View the complaint here.

Medicines Company v. Exela Pharma Sciences, LLC et al.
5:14-cv-00058; filed April 25, 2014 in the Western District of North Carolina

• Plaintiff:  Medicines Company
• Defendants:  Exela Pharma Sciences, LLC; Exela Pharmsci, Inc.; Exela Holdings, Inc.

Infringement of U.S. Patent Nos. 7,582,727 ("Pharmaceutical Formulations of Bivalirudin and Process of Making the Same," issued September 1, 2009) and 7,598,343 (same title, issued October 6, 2009) following a Paragraph IV certification as part of Exela's filing of an ANDA to manufacture a generic version of The Medicines Company's Angiomax® (bivalirudin, used as an anticoagulant in patients with unstable angina undergoing percutaneous translurninal coronary angioplasty).  View the complaint here.

Dow Pharmaceutical Sciences, Inc. et al. v. Actavis, Inc. et al.
2:14-cv-02661; filed April 25, 2014 in the District Court of New Jersey

• Plaintiffs:  Dow Pharmaceutical Sciences, Inc.; Valeant Pharmaceuticals North America LLC
• Defendants:  Actavis, Inc.; Watson Laboratories, Inc.; Andrx Corp.; Watson Pharma, Inc.

Infringement of U.S. Patent No. 8,663,699 ("Topical Pharmaceutical Formulations Containing a Low Concentration of Benzoyl Peroxide in Suspension in Water and a Water-Miscible Organic Solvent," issued March 4, 2014) following a Paragraph IV certification as part of Actavis' filing of an ANDA to manufacture a generic version of Dow's Acanya® (clindamycin phosphate and benzoyl peroxide gel, 1.2%/2.5%, used to treat acne).  View the complaint here.

AbbVie Inc. et al. v. Hetero USA Inc. et al.
1:14-cv-00543; filed April 24, 2014 in the District Court of Delaware

• Plaintiffs:  AbbVie Inc.; Abbvie Deutschland GmbH & Co. KG
• Defendants:  Hetero USA Inc.; Hetero Labs Ltd.; Hetero Labs Ltd.; Hetero USA Inc.

Infringement of U.S. Patent Nos. 8,470,347 ("Self-Emulsifying Active Substance Formulation and Use of This Formulation," issued June 25, 2013) and 8,399,015 ("Solid Pharmaceutical Dosage Form," issued March 19, 2013) following a Paragraph IV certification as part of Hetero's  amendment of its ANDA to manufacture a generic version of AbbVie's Norvir® (ritonavir, used to treat human immunodeficiency virus (HIV) 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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