Court Report - July 2016 #2

by McDonnell Boehnen Hulbert & Berghoff LLP

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

Genzyme Corp. et al. v. Zydus Pharmaceuticals (USA) Inc.
1:16-cv-00540; filed June 29, 2016 in the District Court of Delaware

Plaintiffs:  Genzyme Corp.; Sanofi-Aventis U.S. LLC
Defendant:  Zydus Pharmaceuticals (USA) Inc.

Infringement of U.S. Patent Nos. 7,897,590 ("Methods to mobilize progenitor/stem cells" issued March 1, 2011) and 6,987,102 ("Methods to mobilize progenitor/stem cells" issued January 17, 2006) following a Paragraph IV certification as part of Zydus' filing of an ANDA to manufacture a generic version of Genzyme's Mozobil® (plerixafor solution for injection, used in combination with granulocyte-colony stimulating factor to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with non-Hodgkin's lymphoma and multiple myeloma).  View the complaint here.

Janssen Pharmaceutica N.V. v. Xellia Pharmaceuticals ApS
1:16-cv-00554; filed June 29, 2016 in the District Court of Delaware

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 Xellia’s filing of an NDA (under § 505(b)(2) of the Food, Drug and Cosmetic Act) to manufacture a generic injectable voriconazole product, which relies upon the NDA filed for Janssen's Sporanox® (itraconazole, used for the treatment of certain fungal infections).  View the complaint here.

BTG International Ltd. et al. v. Glenmark Pharmaceuticals Inc., USA et al.
2:16-cv-03743; filed June 24, 2016 in the District Court of New Jersey

Plaintiffs:  BTG International Ltd.; Janssen Biotech, Inc.; Janssen Oncology, Inc.; Janssen Research & Development, LLC
Defendants:  Glenmark Pharmaceuticals Inc., USA; Glenmark Pharmaceuticals SA; Glenmark Pharmaceuticals Ltd.

Infringement of U.S. Patent No. 8,822,438 ("Methods and Compositions for Treating Cancer," issued September 2, 2014) following a Paragraph IV certification as part of Glenmark’s filing of an ANDA to manufacture a generic version of Janssen's Zytiga® (abiraterone acetate, used in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer).  View the complaint here.

Gilead Sciences, Inc. et al. v. Aurobindo Pharma Ltd. et al.
1:16-cv-03722; filed June 23, 2016 in the District Court of New Jersey

Plaintiffs:  Gilead Sciences, Inc.; Emory University
Defendants:  Aurobindo Pharma Ltd.; Aurobindo Pharma USA Inc.

Infringement of U.S. Patent Nos. 6,642,245 ("Antiviral Activity and Resolution of 2-Hydroxymethyl-5-(5-fluorocytosin-1-yl)-l,3-oxathiolane," issued November 4, 2003) and 6,703,396 ("Method of Resolution and Antiviral Activity of 1,3-Oxathiolane Nucleoside Enantiomers," issued March 9, 2004) following a Paragraph IV certification as part of Aurobindo’s filing of an ANDA to manufacture a generic version of Gilead's Emtriva® (emtricitabine, used for the treatment of HIV-1 infection in adults).  View the complaint here.

Abbvie Inc. et al. v. Medimmune Ltd.
2:16-cv-00322; filed June 22, 2016 in the Eastern District of Virginia

Declaratory judgment of invalidity of U.S. Patent No. 6,248,516 ("Single Domain Ligands, Receptors Comprising Said Ligands Methods for Their Production, and Use of Said Ligands and Receptors," issued June 19, 2001) relating to AbbVie's marketing and sale of its Humira® product (adalimumab, used to treat rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease and plaque psoriasis).  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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