Court Report -- Part II: September 2014

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

Roxane Laboratories, Inc. v. Zydus Pharmaceuticals USA, Inc.
2:14-cv-05423; filed August 28, 2014 in the District Court of New Jersey

Roxane Laboratories, Inc. v. Amneal Pharmaceuticals, LLC
2:14-cv-05420; filed August 28, 2014 in the District Court of New Jersey

The complaints in these cases are substantially identical.  Infringement of U.S. Patent No. 8,563,032 ("Formulation and Manufacturing Process for Calcium Acetate Capsules," issued October 22, 2013) based on defendants' anticipated manufacture and sale of a generic calcium acetate capsule, having filed an ANDA to manufacture a generic version of Fresenius' PhosLo® Gelcaps (calcium acetate, used for the reduction of serum phosphorous in patients with end stage renal disease).  View the Zydus complaint here.

Novartis Pharmaceuticals Corp. et al. v. Zydus Noveltech Inc. et al.
2:14-cv-05405; filed August 28, 2014 in the District Court of New Jersey

• Plaintiffs:  Novartis Pharmaceuticals Corp.; Novartis AG; Novartis Pharma AG; LTS Lohmann Therapie-Systeme AG
• Defendants:  Zydus Noveltech Inc.; Zydus Pharmaceuticals (USA) Inc.; Cadila Healthcare Ltd.

Novartis Pharmaceuticals Corp. et al. v. Zydus Noveltech Inc. et al.
1:14-cv-01104; filed August 27, 2014 in the District Court of Delaware

• Plaintiffs:  Novartis Pharmaceuticals Corp.; Novartis AG; Novartis Pharma AG; LTS Lohmann Therapie-Systeme AG
• Defendants:  Zydus Noveltech Inc.; Zydus Pharmaceuticals (USA) Inc.; Cadila Healthcare Ltd.

The complaints in these cases are substantially identical.  Infringement of U.S. Patent Nos. 6,316,023 ("TTS Containing an Antioxidant," issued November 13, 2001) and 6,335,031 (same title, issued January 1, 2002) following a Paragraph IV certification as part of Zydus' filing of an ANDA to manufacture a generic version of Novartis' Exelon® Patch (rivastigmine tartrate, used to treat mild to moderate dementia of the Alzheimer's type, and mild to moderate dementia associated with Parkinson's disease).  View the Delaware complaint here.

Senju Pharmaceutical Co. Ltd. et al. v. Micro Labs Ltd. et al.
1:14-cv-01105; filed August 27, 2014 in the District Court of Delaware

• Plaintiffs:  Senju Pharmaceutical Co. Ltd.; Kyorin Pharmaceutical Co. Ltd.; Allergan Inc.
• Defendants:  Micro Labs Ltd.; Micro Labs 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 certification as part of Micro Labs' filing of an ANDA to manufacture a generic version of Allergan's Zymaxid® (0.5 w/v % gatifloxacin ophthalmic solution, used to treat bacterial conjunctivitis).  View the complaint here.

Bristol-Myers Squibb Co. v. Amneal Pharmaceuticals LLC
1:14-cv-01086; filed August 22, 2014 in the District Court of Delaware

Infringement of U.S. Patent No. 5,206,244 ("Hydroxymethyl (Methylenecyclopentyl) Purines and Pyrimidines," issued April 27, 1993) following a Paragraph IV certification as part of Amneal's filing of an ANDA to manufacture a generic version of BMS's Baraclude® (entecavir, used to treat chronic hepatitis B virus infectrion).  View the complaint here.

Janssen Pharmaceuticals Inc. v. VIVUS Inc.
1:14-cv-01088; filed August 22, 2014 in the District Court of Delaware

Infringement of U.S. Patent No. 6,071,537 ("Anticonvulsant Derivatives Useful in Treating Obesity," issued June 6, 2000) based on Vivus' manufacture and sale of its Qsymia product (phentermine and topiramate, used to for chronic weight management in adults with a high initial body mass index (BMI)).  View the complaint here.  [NB: The case was voluntarily dismissed two days after filing.]

Acorda Therapeutics, Inc. et al. v. Mylan Pharmaceuticals Inc. et al.
1:14-cv-00139; filed August 22, 2014 in the Northern District of West Virginia

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

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 Mylan's 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 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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