Court Report - February 2016 #2

by McDonnell Boehnen Hulbert & Berghoff LLP

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

Salix Pharmaceuticals, Inc. et al. v. Apotex, Inc. et al.
1:15-cv-00880; filed September 30, 2015 in the District Court of Delaware

• Plaintiffs:  Salix Pharmaceuticals, Inc.; Glycyx Pharmaceuticals, Ltd.; Valeant Pharmaceuticals Int'l; Valeant Pharmaceuticals Luxembourg S.A.R.L.
• Defendants:  Apotex Inc.; Apotex Corp.

Infringement of U.S. Patent Nos. 6,197,341 ("Formulations of Balsalazide and Its Derivatives," issued March 6, 2001) and 8,497,256 ("Formulations and Uses of 2-Hydroxy-5-Phenylazobenzoic Acid Derivatives for the Treatment of Males," issued July 30, 2013) following a Paragraph IV certification as part of Apotex's filing of an ANDA to manufacture a generic version of Salix's Giazo® (balsalazide disodium, used for the treatment of mildly to moderately active ulcerative colitis in male patients 18 years of age and older).  View the complaint here.

Rutgers, The State University of New Jersey v. Qiagen N.V. et al.
3:15-cv-07187; filed September 30, 2015 in the District Court of New Jersey

• Plaintiff:  Rutgers, The State University of New Jersey
• Defendants:  Qiagen N.V.; Qiagen, Inc.

Infringement of U.S. Patent Nos. 7,579,141 ("Proteins Expressed By Mycobacterium tuberculosis And Not By BCG and Their Use as Diagnostic Reagents and Vaccines," issued August 25, 2009), 8,021,832 (same title, issued September 20, 2011), and 8,974,800 (same title, issued March 10, 2015) based on Qiangen's manufacture and sale of its QFT and QFT-Plus in vitro diagnostic kits for the detection of TB infection.  View the complaint here.

Dana-Farber Cancer Institute, Inc. v. Ono Pharmaceutical Co., Ltd. et al.
1:15-cv-13443; filed September 25, 2015 in the District Court of Massachusetts

• Plaintiff:  Dana-Farber Cancer Institute, Inc.
• Defendants:  Ono Pharmaceutical Co., Ltd.; Tasuku Honjo; E.R. Squibb & Sons, LLC; Bristol-Myers Squibb Co.

Correction of inventorship of U.S. Patents Nos. 7,595,048 ("Method for Treatment of Cancer by Inhibiting the Immunosuppressive Signal Inducted by PD-1," issued September 29, 2009), 8,168,179 ("Treatment Method Using Anti-PD-L1 Antibody," issued May 1, 2012), 8,728,474 ("Immunopotentiative Composition," issued May 20, 2014), 9,067,999 (same title, issued June 30, 2015), and 9,073,994 (same title, issued July 7, 2015).  View the complaint here.

Helsinn Healthcare S.A. et al. v. Fresenius Kabi USA, LLC
1:15-cv-00865; filed September 24, 2015 in the District Court of Delaware

• Plaintiffs:  Helsinn Healthcare S.A.; Roche Palo Alto LLC
• Defendant:  Helsinn Healthcare S.A.; Roche Palo Alto LLC

Helsinn Healthcare S.A. et al. v. Fresenius Kabi USA, LLC et al.
3:15-cv-07015; filed September 23, 2015 in the District Court of New Jersey

• Plaintiffs:  Helsinn Healthcare S.A.; Roche Palo Alto LLC
• Defendants:  Fresenius Kabi USA, LLC; Emcure Pharmaceuticals Ltd.; Emcure Pharmaceuticals USA, Inc.

The complaints in these cases are substantially identical.  Infringement of U.S. Patent Nos. 7,947,724 ("Liquid Pharmaceutical Formulations of Palonosetron," issued May 24, 2011), 7,947,725 (same title, issued May 24, 2011), 7,960,424 (same title, issued June 14, 2011), 8,598,219 (same title, issued December 3, 2013), and 8,729,094 (same title, issued May 20, 2014) following a Paragraph IV certification as part of Fesenius' filing of an ANDA to manufacture a generic version of Helsinn's Aloxi® (palonosetron hydrochloride intravenous solution, used to prevent chemotherapy induced nausea and vomiting).  View the New Jersey complaint here.

Rigel Pharmaceuticals, Inc. v. Novartis Pharmaceuticals Corp.
5:15-cv-04370; filed September 23, 2015 in the Northern District of California

Infringement of U.S. Patent Nos. 8,188,276 ("2,4-Pyrimidinediamine Compounds and Their Uses," issued May 29, 2012), 8,835,430 (same title, issued September 16, 2014), and 9,018,204 (same title, issued April 28, 2015) based on Novartis' manufacture and sale of its Zykadia® product (ceritinib, used to treat anaplastic lymphoma kinase-positive metastatic non-small cell lung cancer in people whose cancer progressed while taking, or who couldn't tolerate, crizotinib).  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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