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

Acorda Therapeutics Inc. v. Actavis Laboratories FL Inc.
1:14-cv-00882; filed July 7, 2014 in the District Court of Delaware

Infringement of U.S. Patent Nos. 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 Actavis' 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.

Sanofi-Aventis U.S. LLC et al. v. Eli Lilly and Company
1:14-cv-00884; filed July 7, 2014 in the District Court of Delaware

• Plaintiffs:  Sanofi-Aventis U.S. LLC; Sanofi-Aventis Deutschland GmbH
• Defendants:  Eli Lilly and Company

Infringement of U.S. Patent Nos. 7,476,652 ("Acidic Insulin Preparations Having Improved Stability," issued January 13, 2009), 7,713,930 (same title, issued May 11, 2010), 7,918,833 ("Pen-Type Injector," issued April 5, 2011), 8,512,297 (same title, issued August 20, 2013), 8,556,864 ("Drive Mechanisms Suitable for Use in Drug Delivery Devices," issued October 15, 2013), 8,603,044 ("Pen-Type Injector," issued December 10, 2013), and 8,679,069 (same title, issued March 25, 2014) following a Paragraph IV certification as part of Lilly's filing of an NDA (under § 505(b)(2) of the Food, Drug and Cosmetic Act) to manufacture an insulin glargine for injection in a prefilled insulin delivery device, comparable to Sanofi's Lantus® and Lantus® SoloSTAR® products (insulin glargine [rDNA origin] for injection, used to treat diabetes).  View the complaint here.

Eli Lilly and Company et al. v. HEC Pharm Co., Ltd. et al.
1:14-cv-01135; filed July 7, 2014 in the Southern District of Indiana

• Plaintiffs:  Eli Lilly and Company; Daiichi Sankyo Co., Ltd.; Daiichi Sankyo, Inc.; Ube Industries, Ltd.
• Defendants:  HEC Pharm Co., Ltd.; HEC Pharm USA Inc.

Infringement of U.S. Patent No. 8,404,703 ("Medicinal Compositions Containing Aspirin," issued March 26, 2013) following a Paragraph IV certification as part of HEC'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.  [NB: The case was voluntarily dismissed after defendants converted their Para IV Certification to a Para III Certification.]

Helsinn Healthcare S.A. et al. v. Dr. Reddy's Laboratories, Ltd. et al.
3:14-cv-04274; filed July 7, 2014 in the District Court of New Jersey

• Plaintiffs:  Helsinn Healthcare S.A.; Roche Palo Alto LLC
• Defendants:  Dr. Reddy's Laboratories, Ltd.; Dr. Reddy's Laboratories, Inc.

Infringement of U.S. Patent No. 8,729,094 ("Liquid Pharmaceutical Formulations of Palonosetron," issued May 20, 2014) following a Paragraph IV certification as part of Dr. Reddy's 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 complaint here.

Allos Therapeutics, Inc. et al. v. Dr. Reddy's Laboratories, Inc. et al.
1:14-cv-04273; filed July 7, 2014 in the District Court of New Jersey

• Plaintiffs:  Allos Therapeutics, Inc.; Sloan-Kettering Institute For Cancer Research; Southern Research Institute; SRI International, Inc.
• Defendants:  Dr. Reddy's Laboratories, Inc.; Dr. Reddy's Laboratories, Ltd.

Infringement of U.S. Patent Nos. 6,028,071 ("Purified Compositions of 10-propargyl-10-deazaaminopterin and Methods of Using Same in the Treatment of Tumors," issued February 22, 2000), 7,622,470 ("Treatment of T-cell Lymphoma Using 10-porpargyl-10-deazaaminopterin," issued November 24, 2009), and 8,200,078 (same title, issued October 30, 2012) following a Paragraph IV certification as part of Dr. Reddy's filing of an ANDA to manufacture a generic version of Allos' Folotyn® (pralatrexate, used to treat patients with relapsed or refractory peripheral T-cell lymphoma).  View the complaint here.

Otsuka Pharmaceutical Co., Ltd. v. Sun Pharmaceutical Industries Ltd. et al.
1:14-cv-04307; filed July 7, 2014 in the District Court of New Jersey

• Plaintiff:  Otsuka Pharmaceutical Co., Ltd.
• Defendants:  Sun Pharmaceutical Industries Ltd.; Sun Pharma Global Inc.; Sun Pharma Global PZE; Sun Pharma USA; Caraco Pharmaceutical Laboratories, Ltd.

Infringement of U.S. Patent Nos. 8,017,615 ("Low Hygroscopic Aripiprazole Drug Substance and Process for the Preparation Thereof," issued September 13, 2011), 8,580,796 (same title, issued November 12, 2013), and 8,642,760 (same title, issued February 4, 2014) following a Paragraph IV certification as part of Sun's filing of an ANDA to manufacture a generic version of Otsuka's Abilify® (aripiprazole, used to treat bipolar disorder and schizophrenia).  View the complaint here.

Sanofi et al. v. Amneal Pharmaceuticals LLC et al.
1:14-cv-00875; filed July 3, 2014 in the District Court of Delaware

• Plaintiffs:  Sanofi; Sanofi-Aventis US LLC
• Defendants:  Amneal Pharmaceuticals LLC; Amneal Pharmaceuticals of New York LLC; Amneal Pharmaceuticals Co. India Private Ltd.

Infringement of U.S. Patent Nos. 8,318,800 ("Solid Pharmaceutical Compositions Containing Benzofuran Derivatives," issued November 27, 2012), 8,410,167 ("Use of Dronedarone for the Preparation of a Medicament for Use in the Prevention of Cardiovascular Hospitalization or of Mortality," issued April 2, 2013), and 8,602,215 ("Methods for Reducing the Risk of an Adverse Dronedarone/Beta-Blockers Interaction in a Patient Suffering from Atrial Fibrillation," issued December 10, 2013) following a Paragraph IV certification as part of Amneal's filing of an ANDA to manufacture a generic version of Sanofi's Multaq® (dronedarone, used to reduce the risk of hospitalization for atrial fibrillation in patients in sinus rhythm with a history of paroxysmal or persistent atrial fibrillation).  View the complaint here.

Sanofi et al. v. Unimark Remedies Ltd.
1:14-cv-00876; filed July 3, 2014 in the District Court of Delaware

• Plaintiffs:  Sanofi; Sanofi-Aventis US LLC
• Defendant:  Unimark Remedies Ltd.

Infringement of U.S. Patent Nos. 7,323,493 ("Solid Pharmaceutical Composition Containing Benzofuran Derivatives," issued January 29, 2008), 8,318,800 ("Solid Pharmaceutical Compositions Containing Benzofuran Derivatives," issued November 27, 2012), 8,410,167 ("Use of Dronedarone for the Preparation of a Medicament for Use in the Prevention of Cardiovascular Hospitalization or of Mortality," issued April 2, 2013), and 8,602,215 ("Methods for Reducing the Risk of an Adverse Dronedarone/Beta-Blockers Interaction in a Patient Suffering from Atrial Fibrillation," issued December 10, 2013) following a Paragraph IV certification as part of Unimark's filing of an ANDA to manufacture a generic version of Sanofi's Multaq® (dronedarone, used to reduce the risk of hospitalization for atrial fibrillation in patients in sinus rhythm with a history of paroxysmal or persistent atrial fibrillation).  View the complaint here.

Novo Nordisk Inc. et al. v. Teva Pharmaceuticals USA, Inc.
3:14-cv-04248; filed July 3, 2014 in the District Court of New Jersey

• Plaintiffs:  Novo Nordisk Inc.; Novo Nordisk Femcare AG
• Defendant:  Teva Pharmaceuticals USA, Inc.

Infringement of U.S. Patent Nos. 7,018,992 ("Hormone Composition," issued March 28, 2006) and  5,860,946 ("Instrument for Inserting a Suppository," issued January 19, 1999) following a Paragraph IV certification as part of Teva's filing of an ANDA to manufacture a generic version of Novo Nordisk's Vagifem® (estradiol vaginal tablets, used to treat atrophic vaginitis due to menopause).  View the complaint here.

Teva Women's Health, Inc. et al. v. Famy Care Ltd. et al.
1:14-cv-04981; filed July 2, 2014 in the Southern District of New York

• Plaintiffs:  Teva Women's Health, Inc.; Teva Branded Pharmaceutical Products R&D, Inc.
• Defendants:  Famy Care Ltd.; Mylan Pharmaceuticals, Inc.; Mylan Inc.

Infringement of U.S. Patent Nos. 8,415,332 ("Methods of Hormonal Treatment Utilizing Ascending-Dose Extended Cycle Regimens," issued April 9, 2013) and 8,450,299 (same title, issued May 28, 2013) following a Paragraph IV certification as part of defendants' filing of an ANDA to manufacture a generic version of Teva's Quartette® (levonorgestrel/ethinyl estradiol and ethinyl estradiol, used for oral contraception).  View the complaint here.

Topics:  Actavis Inc., Biotechnology, Patent Infringement, Patent Litigation, Patents, Pharmaceutical, Pharmaceutical Patents, Prescription Drugs

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.

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