Court Report - May 2014

by McDonnell Boehnen Hulbert & Berghoff LLP

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

Kowa Co. et al. v. Orient Pharma Co.
1:14-cv-03336; filed May 7, 2014 in the Northern District of Illinois

• Plaintiffs:  Kowa Co.; Kowa Pharmaceuticals America, Inc.; Nissan Chemical Industries, Ltd.
• Defendant:  Orient Pharma Co.

Infringement of U.S. Patent Nos. 5,856,336 ("Quinoline Type Mevalonolactones," issued January 5, 1999), 6,465,477 ("Stable Pharmaceutical Composition," issued October 15, 2002), and 8,557,993 ("Crystalline Forms of Pitavastatin Calcium," issued October 15, 2013) following a Paragraph IV certification as part of defendants' filing of an ANDA 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 Mylan complaint here.

Genmark Diagnostics, Inc. v. Vironovative BV
3:14-cv-01140; filed May 6, 2014 in the Southern District of California

Declaratory judgment of non-infringement and invalidity of U.S. Patent Nos. 7,449,324 ("Metapneumovirus Strains and Their Use in Vaccine Formulations and as Vectors for Expression of Antigenic Sequences," issued November 11, 2008), 7,531,342 (same title, issued May 12, 2009), 7,704,720 ("Metapneumovirus Strains and Their Use in Vaccine Formulations and as Vectors for Expression of Antigenic Sequences and Methods for Propagating Virus," issued April 27, 2010) and 8,715,922 ("Virus Causing Respiratory Tract Illness in Susceptible Mammals," issued May 6, 2014) based on Genmark's manufacture and sale of its Respiratory Viral Panel (RVP) assay.  View the complaint here.

Monsanto Co. et al. v. Omega Farm Supply, Inc.
4:14-cv-00870; filed May 6, 2014 in the Eastern District of Missouri

• Plaintiffs:  Monsanto Co.; Monsanto Technology, LLC
• Defendant:  Omega Farm Supply, Inc.

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.

Senju Pharmaceutical Co. et al. v. Aurobindo Pharma Ltd. et al.
1:14-cv-00579; filed May 2, 2014 in the District Court of Delaware

• Plaintiffs:  Senju Pharmaceutical Co.; Kyorin Pharmaceutical Co.; Allergan Inc.
• Defendants:  Aurobindo Pharma Ltd.; Aurobindo Pharma USA Inc.

Infringement of U.S. Patent No. 6,333,045 ("Aqueous Liquid Pharmaceutical Composition Comprised of Gatifloxacin," issued December 25, 2001) following a Paragraph IV certifications as part of Aurobindo's filing of an ANDA to manufacture a generic version of Allergan's Zymar® (0.3 w/v % gatifloxacin ophthalmic solution, used for the treatment of bacterial conjunctivitis) and of Allergan's Zymaxid® (0.5 w/v % gatifloxacin ophthalmic solution, used to treat bacterial conjunctivitis).  View the complaint here.

Cephalon, Inc. v. Uman Pharma Inc.
1:14-cv-03114; filed May 1, 2014 in the Southern District of New York

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.

Roxane Laboratories, Inc. v. Lee et al.
3:14-cv-00313; filed April 29, 2014 in the Eastern District of Virginia

• Plaintiff:  Roxane Laboratories, Inc.
• Defendants:  Michelle K. Lee; U.S. Patent and Trademark Office

Declaratory judgment to vacate the USPTO's decision to revive U.S. Patent Application No. 09/709,829, which later issued as U.S. Patent No. 7,364,752 ("Solid Dispersion Pharmaceutical Formulations," issued April 29, 2008), assigned to AbbVie and currently asserted against Roxane in its ANDA litigation relating to 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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