Court Report - November 2014 #4

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

Fresenius Kabi USA LLC v. Agila Specialties Private Ltd. et al.
1:14-cv-01438; filed November 26, 2014 in the District Court of Delaware

• Plaintiff:  Fresenius Kabi USA LLC
• Defendants: Agila Specialties Private Ltd.; Mylan Inc.

Fresenius Kabi USA, LLC v. Agila Specialties Private Ltd. et al.
1:14-cv-00205; filed November 26, 2014 in the Northern District of West Virginia

• Plaintiff:  Fresenius Kabi USA, LLC
• Defendants:  Agila Specialties Private Ltd.; Mylan Inc.

The complaints in these cases are substantially identical.  Infringement of U.S. Patent No. 8,476,010 ("Propofol Formulations with Non-Reactive Container Closures," issued July 2, 2013) following a Paragraph IV certification as part of Agila's filing of an ANDA to manufacture a generic version of Fresenius' Diprivan® (propofol injectable emulsion, used for the induction and maintenance of general anesthesia and sedation in certain patient populations).  View the Delaware complaint here.

Sanofi et al. v. Sandoz Inc.
1:14-cv-01434; filed November 24, 2014 in the District Court of Delaware

• Plaintiffs:  Sanofi; Sanofi-Aventis U.S. LLC
• Defendant:  Sanofi-Aventis U.S. LLC

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 Sandoz'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.

Endo Pharmaceuticals Solutions Inc. et al. v. Paddock Laboratories LLC et al.
1:14-cv-01422; filed November 21, 2014 in the District Court of Delaware

• Plaintiffs:  Endo Pharmaceuticals Solutions Inc.; Bayer Intellectual Property GmbH; Bayer Pharma AG
• Defendants:  Paddock Laboratories LLC; Perrigo Co.

Infringement of U.S. Patent Nos. 7,718,640 ("Methods and Pharmaceutical Compositions for Reliable Achievement of Acceptable Serum Testosterone Levels," issued May 18, 2010) and 8,338,395 (same title, issued December 25, 2012), licensed to Endo, following a Paragraph IV certification as part of Paddock's filing of an ANDA to manufacture a generic version of Endo's Aveed® (testosterone undecanoate, used to restore andmaintain physiologically acceptable testosterone concentrations in patients suffering from hypogonadism).  View the complaint here.

Otsuka Pharmaceutical Co., Ltd. v. Zydus Pharmaceuticals USA Inc. et al.
1:14-cv-07252; filed November 20, 2014 in the District Court of New Jersey

• Plaintiff:  Otsuka Pharmaceutical Co., Ltd.
• Defendants:  Zydus Pharmaceuticals USA Inc.; Cadila Healthcare 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 Zydus' 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.

Astrazeneca AB et al. v. Actavis Laboratories FL, Inc. et al.
3:14-cv-07263; filed November 20, 2014 in the District Court of New Jersey

• Plaintiffs:  Astrazeneca AB; Aktiebolaget Hassle; Astrazeneca LP; Zeneca Inc.
• Defendants:  Actavis Laboratories FL, Inc.; Actavis Pharma, Inc.

Infringement of U.S. Patent Nos. 6,369,085 ("Form of S-omeprazole," issued April 9, 2002) and 7,411,070 (same title, issued August 12, 2008) following a Paragraph IV certification as part of Actavis' filing of an ANDA to manufacture a generic version of AstraZeneca's Nexium 24HR® (esomeprazole magnesium, used for the treatment of gastroesophageal reflux disease).  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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