Court Report - November 2015

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

Janssen Biotech Inc. et al. v. Par Pharmaceutical Inc. et al.
1:15-cv-00679; filed August 3, 2015 in the District Court of Delaware

• Plaintiffs:  Janssen Biotech Inc.; Janssen Oncology Inc.; Janssen Research & Development LLC
• Defendants:  Amneal Pharmaceuticals LLC; Amneal Pharmaceuticals of New York LLC; Par Pharmaceutical Inc.; Par Pharmaceutical Companies Inc.

Infringement of U.S. Patent No. 8,822,438 ("Methods and Compositions for Treating Cancer," issued September 2, 2014) following a Paragraph IV certification as part of defendants' filing of an ANDA to manufacture a generic version of Janssen's Zytiga® (abiraterone acetate, used in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer).  View the complaint here.  [NB: The complaint was voluntarily dismissed.]

BTG International Ltd. et al. v. Actavis Laboratories FL, Inc. et al.
9:15-cv-81076; filed August 3, 2015 in the Southern District of Florida

• Plaintiffs:  BTG International Ltd.; Janssen Biotech Inc.; Janssen Oncology Inc.; Janssen Research & Development LLC
• Defendants:  Actavis Laboratories FL, Inc.; Actavis Pharma, Inc.; Actavis, Inc.

Infringement of U.S. Patent Nos. 5,604,213 ("17-Substituted Steroids Useful in Cancer Treatment," issued February 18, 1997) and 8,822,438 ("Methods and Compositions for Treating Cancer," issued September 2, 2014) following a Paragraph IV certification as part of Actavis' filing of an ANDA to manufacture a generic version of Janssen's Zytiga® (abiraterone acetate, used in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer).  View the complaint here.  [NB: The complaint was voluntarily dismissed.]

Sanofi-Aventis US LLC et al. v. AstraZeneca Pharmaceuticals LP et al.
1:15-cv-00662; filed July 31, 2015 in the District Court of Delaware

• Plaintiffs:  Sanofi-Aventis US LLC; Sanofi-Aventis Deutschland GmbH
• Defendants:  AstraZeneca Pharmaceuticals LP; Amylin Pharmaceuticals LLC

Declaratory judgment of non-infringement and invalidity of U.S. Patent Nos. 6,902,744 ("Exendin Agonist Formulations and Methods of Administration Thereof," issued June 7, 2005), 7,399,489 ("Exendin Analog Formulations," issued July 15, 2008), and 7,521,423 ("Exendin Pharmaceutical Compositions," issued April 21, 2009) based on Sanofi's filing of an NDA seeking approval to market in the U.S. its Lyxumia® product (lixisenatide, a GLP-1 agonist used for the treatment of adults with type 2 diabetes mellitus to achieve glycaemic control in combination with oral glucose-lowering medicinal products and/or basal insulin when these, together with diet and exercise, do not provide adequate glycaemic control).  View the complaint here.

IDEXX Laboratories Inc. et al. v. Charles River Laboratories Inc. et al.
1:15-cv-00668; filed July 31, 2015 in the District Court of Delaware

• Plaintiffs:  IDEXX Laboratories Inc.; IDEXX Distribution Inc.
• Defendants:  Charles River Laboratories Inc.; Charles River Laboratories International Inc.

Infringement of U.S. Patent Nos. 8,927,298 ("Sample Collection and Analysis," issued January 6, 2015), 8,945,945 (same title, issued February 3, 2015), and 9,040,308 (same title, issued May 26, 2015) based on Charles' River's marketing of its EZ-Spot® product, a dry whole blood spot sample collection method, using Multiplexed Fluorometric Immunoassay technology to detect virus, bacterial, and other contaminants, similar to IDEXX's Opti-Spot® product.  View the complaint here.

Galderma Laboratories L.P. et al. v. Dr. Reddy's Laboratories Ltd. et al.
1:15-cv-00670; filed July 31, 2015 in the District Court of Delaware

• Plaintiffs:  Galderma Laboratories L.P.; Nestle Skin Health S.A.; TCD Royalty Sub LLC
• Defendants:  Dr. Reddy's Laboratories Ltd.; Dr. Reddy's Laboratories Inc.; Promius Pharma LLC

Infringement of U.S. Patent Nos. 7,211,267 ("Methods of Treating Acne" issued May 1, 2007), 7,232,572 ("Methods of Treating Rosacea," issued June 19, 2007), 8,603,506 ("Once Daily Formulations of Tetracyclines" issued July 6, 2010), 7,749,532 ("Once Daily Formulation of Tetracyclines," issued July 6, 2010), 8,206,740 ("Once Daily Formulations of Tetracyclines," issued June 26, 2012); 8,394,405 (same title, issued March 12, 2013); 8,394,406 (same title, issued March 12, 2013); 8,470,364 (same title, issued same title, issued March 12, 2013); and 8,709,478 (same title, issued April 29, 2014) following a Paragraph IV certification as part of Dr. Reddy's filing of an NDA (under § 505(b)(2) of the Food, Drug and Cosmetic Act) to manufacture a generic version of Galderma's Oracea® (doxycyline delayed release capsules, used to treat inflammatory lesions of rosacea).  View the complaint here.

Validus Pharmaceuticals LLC v. Aurobindo Pharma Ltd. et al.
3:15-cv-05912; filed July 31, 2015 in the District Court of New Jersey

• Plaintiff:  Validus Pharmaceuticals LLC
• Defendants:  Aurobindo Pharma Ltd.; Aurobindo Pharma USA, Inc.; Aurolife Pharma LLC

Infringement of U.S. Patent No. 6,977,253 ("Methods for the Treatment of Bipolar Disorder Using Carbamazepine," issued December 20, 2005) following a paragraph IV certification as part of Aurobindo's filing of an ANDA to manufacture a generic version of Validus' Equetro® (carbamazepine extended-release capsules, used for the treatment of acute manic to mixed episodes associated with Bipolar I disorder).  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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