Court Report -- Part II: August 2014

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

Medicines Company v. Accord Healthcare, Inc. et al.
1:14-cv-00626; filed July 24, 2014 in the Middle District of North Carolina

• Plaintiff:  The Medicines Company
• Defendants:  Accord Healthcare, Inc.; Intas Pharmaceuticals Ltd.

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 Accord'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.

Bristol-Myers Squibb et al. v. Lupin Ltd.
2:14-cv-00795; filed July 24, 2014 in the Eastern District of Texas

• Plaintiffs:  Bristol-Myers Squibb; Gilead Sciences, LLC
• Defendant:  Lupin Ltd.

Infringement of U.S. Patent No. 8,598,185 ("Unitary Pharmaceutical Dosage Form," issued December 3, 2013) following a Paragraph IV certification 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.

Gilead Sciences, Inc. v. Lupin Ltd.
2:14-cv-00796; filed July 24, 2014 in the Eastern District of Texas

Infringement of U.S. Patent Nos. 8,592,397 ("Compositions and Methods for Combination Antiviral Therapy," issued November 26, 2013) and 8,716,264 (same title, issued May 6, 2014) following a Paragraph IV certification 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.

Prometheus Laboratories Inc. v. Amneal Pharmaceuticals LLC et al.
1:14-cv-00968; filed July 23, 2014 in the District Court of Delaware

• Plaintiff:  Prometheus Laboratories Inc.
• Defendants:  Amneal Pharmaceuticals LLC; Amneal Pharmaceuticals of New York LLC; Amneal Pharmaceuticals Co. India Pvt. Ltd.

Infringement of U.S. Patent No. 6,284,770 ("Medicaments for the Treatment of Non-Constipated Female Irritable Bowel Syndrome," issued September 4, 2001) following a Paragraph IV certification as part of Amneal's filing of an ANDA to manufacture a generic version of Prometheus' Lotronex® (alosetron hydrochloride, used to treat women with severe diarrhea-predominant irritable bowel syndrome).  View the complaint here.

Alcon Pharmaceuticals Ltd et al. v. Watson Laboratories Inc. et al.
1:14-cv-00970; filed July 23, 2014 in the District Court of Delaware

• Plaintiffs:  Alcon Pharmaceuticals Ltd; Alcon Research Ltd.
• Defendants:  Watson Laboratories Inc.; Actavis, Inc.; Actavis Pharma Inc.

Infringement of U.S. Patent Nos. 6,716,830 ("Ophthalmic Antibiotic Compositions Containing Moxifloxacin," issued April 6, 2004), 7,671,070 ("Method of Treating Ophthalmic Infections with Moxifloxacin Compositions," issued March 2, 2010), and 8,450,311 ("Pharmaceutical Compositions Containing a Fluoroquinolone Antibiotic Drug," issued May 28, 2013) following a Paragraph IV certification as part of Watson's filing of an ANDA to manufacture a generic version of Alcon's Alcon's Moxeza® (moxifloxacin hydrochloride, used to treat bacterial conjunctivitis).  View the complaint here.

Janssen Pharmaceuticals, Inc. et al. v. Watson Laboratories, Inc.
2:14-cv-04617; filed July 23, 2014 in the District Court of New Jersey

• Plaintiffs:  Janssen Pharmaceuticals, Inc.; Grunenthal GmbH
• Defendant:  Watson Laboratories, Inc.

Infringement of U.S. Patent Nos. RE39,593 ("1-Phenyl-3-Dimethylaminopropane Compounds With a Pharmacological Effects," issued April 24, 2007) and 7,994,364 ("Crystalline Forms of (-)-(1R,2R)-3-(3-Dimethylamino-1-Ethyl-2-Methylpropyl)-Phenol Hydrochloride," issued August 9, 2011), licensed to Janssen, following a Paragraph IV certification as part of Watson's filing of an ANDA to manufacture a generic version of Janssen's Nucynta® (tapentadol hydrochloride, used for the management of moderate to severe acute pain in adults).  View the complaint here.

Janssen Products, L.P. et al. v. Mylan Pharmaceuticals Inc. et al.
2:14-cv-04550; filed July 18, 2014 in the District Court of New Jersey

• Plaintiffs:  Janssen Products, L.P.; Janssen R&D Ireland
• Defendants:  Mylan Pharmaceuticals Inc.; Mylan Inc.

Infringement of U.S. Patent No. 8,153,829 ("Methods for the Preparation of Hexahydrofuro[2,3-b]furan-3-ol," issued April 10, 2012) in conjunction with Mylan's filing of an ANDA to manufacture a generic version of Janssen's Prezista® (darunavir, used to treat human immunodeficiency virus (HIV-1) infection).  View the complaint here.

AbbVie Inc. v. Aurobindo Pharma Ltd. et al.
1:14-cv-00959; filed July 18, 2014 in the District Court of Delaware

• Plaintiff:  AbbVie Inc.
• Defendants:  Aurobindo Pharma Ltd.; Aurobindo Pharma USA Inc.

Infringement of U.S. Patent Nos. 7,148,359 ("Polymorph of a Pharmaceutical," issued December 12, 2006), 7,364,752 ("Solid Dispersion Pharmaceutical Formulations," issued April 29, 2008), 8,399,015 ("Solid Pharmaceutical Dosage Form," issued March 19, 2013), and 8,691,878 (same title, issued April 8, 2014) following a Paragraph IV certification as part of Aurobindo's filing of an ANDA to manufacture a generic version of AbbVie's Norvir® (ritonavir, used to treat human immunodeficiency virus (HIV) infection).  View the complaint here.

Acorda Therapeutics Inc. et al. v. Apotex Corp. et al.
1:14-cv-00955; filed July 18, 2014 in the District Court of Delaware

• Plaintiffs:  Acorda Therapeutics Inc.; Alkermes Pharma Ireland Ltd.
• Defendants:  Apotex Corp.; Apotex Inc.

Acorda Therapeutics Inc. et al. v. Teva Pharmaceuticals USA Inc.
1:14-cv-00941; filed July 17, 2014 in the District Court of Delaware

• Plaintiffs:  Acorda Therapeutics Inc.; Alkermes Pharma Ireland Ltd.
• Defendant:  Teva Pharmaceuticals USA 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 Teva complaint here.

Salix Pharmaceuticals Ltd. et al. v. Par Pharmaceutical Companies Inc. et al.
1:14-cv-00946; filed July 17, 2014 in the District Court of Delaware

• Plaintiffs:  Salix Pharmaceuticals Ltd.; Salix Pharmaceuticals Inc.; Glycyx Pharmaceuticals Ltd.
• Defendants:  Par Pharmaceutical Companies Inc.; Par Pharmaceutical Inc.

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 Par'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.

 

Topics:  Biotechnology, Patent Infringement, Patent Litigation, Patents, Pharmaceutical, Pharmaceutical Patents

Published In: Civil Procedure Updates, Intellectual Property Updates, Science, Computers & Technology Updates

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.

© McDonnell Boehnen Hulbert & Berghoff LLP | Attorney Advertising

Don't miss a thing! Build a custom news brief:

Read fresh new writing on compliance, cybersecurity, Dodd-Frank, whistleblowers, social media, hiring & firing, patent reform, the NLRB, Obamacare, the SEC…

…or whatever matters the most to you. Follow authors, firms, and topics on JD Supra.

Create your news brief now - it's free and easy »

CONNECT

At McDonnell Boehnen Hulbert & Berghoff LLP ("MBHB"), we provide creative, pragmatic business... View Profile »


Follow McDonnell Boehnen Hulbert & Berghoff LLP:

Reporters on Deadline