Court Report - August 2014

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.

Roche Molecular Systems, Inc. v. Cepheid
3:14-cv-03228; filed July 16, 2014 in the Northern District of California

Infringement of U.S. Patent No. 5,643,723 ("Detection of a Genetic Locus Encoding Resistance to Rifampin in Mycobacterial Cultures and in Clinical Specimens," issued July 1, 1997) based on Cepheid's sale and offer for sale of its "Xpert® MTB/RIF Assay," an assay for detecting Mycobacterium tuberculosis (MTB) in a biological sample and identifying rifampicin-resistant MTB.  View the complaint here.

Gilead Sciences, Inc., et al. v. Lupin Ltd.
1:14-cv-05352; filed July 16, 2014 in the Southern District of New York

• Plaintiffs:  Gilead Sciences, Inc.; Emory University
• Defendant:  Lupin Ltd.

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 Paragraph IV certifications as part of Lupin's filing of an ANDA to manufacture a generic version of Gilead's Atripla® (efavirenz, emtricitabine, and tenofovir disoproxil, used for the treatment of HIV-1 infection) products.  View the complaint here.

Acorda Therapeutics Inc., et al. v. Mylan Pharmaceuticals Inc., et al.
1:14-cv-00935; filed July 16, 2014 in the District Court of Delaware

• Plaintiffs:  Acorda Therapeutics Inc.; Alkermes Pharma Ireland Ltd.
• Defendants:  Mylan Pharmaceuticals Inc.; Mylan Inc.

Acorda Therapeutics Inc. et al. v. Accord Healthcare Inc. et al.
1:14-cv-00932; filed July 15, 2014 in the District Court of Delaware

• Plaintiffs:  Acorda Therapeutics Inc.; Alkermes Pharma Ireland Ltd.
• Defendants:  Accord Healthcare Inc.; Intas Pharmaceuticals Ltd.

Acorda Therapeutics Inc. et al. v. Roxane Laboratories Inc. et al.
1:14-cv-00922; filed July 14, 2014 in the District Court of Delaware

• Plaintiffs:  Acorda Therapeutics Inc.; Alkermes Pharma Ireland Ltd.
• Defendants:  Roxane Laboratories Inc.; Boehringer Ingelheim Roxane Inc.

The complaints in these cases are substantially identical.  Infringement of U.S. Patent Nos. 5,540,938 ("Formulations and Their Use in the Treatment of Neurological Diseases," issued July 30, 1996), 8,007,826 ("Sustained Release Aminopyridine Composition," issued August 30, 2011), 8,354,437 ("Method of Using Sustained Release Aminopyridine Compositions," issued January 15, 2013), 8,440,703 (same title, issued May 14, 2013), and 8,663,685 ("Sustained Release Aminopyridine Composition," issued March 4, 2014) following a Paragraph IV certification as part of defendants' filing of an ANDA to manufacture a generic version of Acorda's Ampyra® (dalfampridine extended release, used to improve walking in patients with multiple sclerosis).  View the Roxane complaint here.

Alcon Pharmaceuticals Ltd et al. v. Aurobindo Pharma Ltd. et al.
1:14-cv-00930; filed July 15, 2014 in the District Court of Delaware

• Plaintiffs:  Alcon Pharmaceuticals Ltd; Alcon Research Ltd.
• Defendants:  Aurobindo Pharma Ltd.; Aurobindo Pharma USA Inc.

Infringement of U.S. Patent Nos. 6,716,830 ("Ophthalmic Antibiotic Compositions Containing Moxifloxacin," issued April 6, 2004) and 7,671,070 ("Method of Treating Ophthalmic Infections with Moxifloxacin Compositions," issued March 2, 2010) following a Paragraph IV certification as part of Aurobindo's filing of an ANDA to manufacture a generic version of Alcon's Vigamox® (moxifloxacin hydrochloride, used to treat bacterial conjunctivitis).  View the complaint here.

Jazz Pharmaceuticals, Inc. v. Ranbaxy Laboratories Ltd. et al.
2:14-cv-04467; filed July 15, 2014 in the District Court of New Jersey

• Plaintiff:  Jazz Pharmaceuticals, Inc.
• Defendants:  Ranbaxy Laboratories Ltd.; Ranbaxy Inc.

Infringement of U.S. Patent Nos. 6,472,431 ("Microbiologically Sound and Stable Solutions of Gamma-Hydroxybutyrate Salt for the Treatment of Narcolepsy," issued October 29, 2002), 6,780,889 (same title, issued August 24, 2004), 7,262,219 (same title, issued August 28, 2007), 7,851,506 (same title, issued December 14, 2010 ("Sensitive Drug Distribution System and Method" issued February 22, 2011), 8,263,650 ("Microbiologically Sound and Stable Solutions of Gamma-Hydroxybutyrate Salt for the Treatment of Narcolepsy,"  issued September 11, 2012), 8,324,275 (same title,  issued December 4, 2012), 8,461,203 ("Microbiologically Sound and Stable Solutions of Gamma-Hydroxybutyrate Salt for the Treatment of Narcolepsy," issued June 11, 2013), 7,668,730 ("Sensitive Drug Distribution System and Method," issued February 23, 2010), 7,765,106 (same title, issued July 27, 2010), 7,765,107 (same title, issued July 27, 2010), 7,895,059 (same title, issued February 22, 2011), 8,457,988 (same title, issued June 4, 0213), 8,589,182 (same title, issued November 19, 2013), and 8,731,963 (same title, issued May 20, 2014) following a Paragraph IV certification as part of Ranbaxy's filing of an ANDA to manufacture a generic version of Jazz's Xyrem® (sodium oxybate, used to treat narcolepsy).  View the complaint here.

Senju Pharmaceutical Co. Ltd. et al. v. Actavis Inc. et al.
1:14-cv-00923; filed July 14, 2014 in the District Court of Delaware

• Plaintiffs:  Senju Pharmaceutical Co. Ltd.; Kyorin Pharmaceutical Co. Ltd.; Allergan Inc.
• Defendants:  Actavis Inc.; Actavis Pharma Inc.; Watson Laboratories 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 Actavis' 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.

Eli Lilly and Company et al. v. First Time US Generics LLC
1:14-cv-01168; filed July 14, 2014 in the Southern District of Indiana

• Plaintiffs:  Eli Lilly and Company; Daiichi Sankyo Co., Ltd.; Daiichi Sankyo, Inc.; Ube Industries, Ltd.
• Defendant:  First Time US Generics LLC

Infringement of of U.S. Patent Nos. 8,404,703 ("Medicinal Compositions Containing Aspirin," issued March 26, 2013) and 8,569,325 ("Method of Treatment with Coadministration of Aspirin and Prasugrel," issued October 29, 2013) following a Paragraph IV certification as part of First Time's filing of an ANDA to manufacture a generic version of Lilly's Effient® (prasugrel hydrochloride, to be used in combination with aspirin for the reduction of thrombotic cardiovascular events in certain patients with acute coronary syndrome (ACS) who are to be managed with percutaneous coronary intervention).  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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