Court Report - October 2014 #4

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

AstraZeneca Pharmaceuticals LP et al. v. Pharmadax USA, Inc. et al.
8:14-cv-01710; filed October 23, 2014 in the Central District of California

• Plaintiffs:  AstraZeneca Pharmaceuticals LP; AstraZeneca UK Ltd.
• Defendants:  Pharmadax USA, Inc.; Pharmadax Inc.; Pharmadax Guangzhou Inc.

Infringement of U.S. Patent No. 5,948,437 ("Pharmaceutical Compositions Using Thiazepine," issued September 7, 1999) following a Paragraph IV certification as part of Pharmadax's filing of an ANDA to manufacture a generic version of AstraZeneca's Seroquel® XR (quetiapine fumarate, used to treat schizophrenia and bipolar disorder).  View the complaint here.

Cephalon Inc. v. Wockhardt Bio Ltd. et al.
1:14-cv-01332; filed October 17, 2014 in the District Court of Delaware

• Plaintiff:  Cephalon Inc.
• Defendants:  Wockhardt Bio Ltd.; Wockhardt Ltd.; Wockhardt USA LLC

Infringement of U.S. Patent Nos. 8,445,524 ("Solid Forms of Bendamustine Hydrochloride," issued May 21, 2013), 8,436,190 ("Bendamustine Pharmaceutical Compositions," issued May 7, 2013), 8,609,863 (same title, issued December 17, 2013), and 8,791,270 (same title, issued July 29, 2014) following a Paragraph IV certification as part of Wockhardt's filing of an ANDA to manufacture a generic version of Cephalon's Treanda® (bendamustine hydrochloride, used to treat chronic lymphocytic leukemia and non-Hodgkin's lymphoma).  View the complaint here.

Amgen Inc. v. Sanofi et al.
1:14-cv-01317; filed October 17, 2014 in the District Court of Delaware

• Plaintiff:  Amgen Inc.
• Defendants:  Sanofi; Aventisub LLC; Regeneron Pharmaceuticals Inc.

Infringement of U.S. Patent Nos. 8,563,698 ("Antigen Binding Proteins to Proprotein Convertase Subtilisin Kexin Type 9," issued October 22, 2013), 8,829,165 (same title, issued September 9, 2014), and 8,859,741 (same title, issued October 14, 2014) based on defendants' current and/or imminent manufacture, use, sale, offer to sell, and/or importation into the U.S. of alirocumab, an anti-PCSK9 antibody (used to treat dyslipidemia and other cholesterol disorders).  View the complaint here.

Noven Therapeutics, LLC v. Actavis Laboratories FL, Inc. et al.
2:14-cv-06414; filed October 16, 2014 in the District Court of New Jersey

• Plaintiff:  Noven Therapeutics, LLC
• Defendants:  Actavis Laboratories FL, Inc.; Actavis Pharma Inc.; Andrx Corp.; Actavis, Inc.

Infringement of U.S. Patent Nos. 5,874,447 ("4-Phenylpiperidine Compounds for Treating Depression," issued February 23, 1999), 7,598,271 ("Crystalline Paroxetine Methane Sulfonate," issued October 6, 2009), and 8,658,663 ("Method of Treating Thermoregulatory Dysfunction with Paroxetine," issued February 25, 2014) following a Paragraph IV certification as part of Actavis' filing of an ANDA to manufacture a generic version of Noven's Brisdelle® (paroxetine mesylate, used for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause).  View the complaint here.

Tris Pharma, Inc. v. Actavis Laboratories FL, Inc. et al.
2:14-cv-06425; filed October 16, 2014 in the District Court of New Jersey

• Plaintiff:  Tris Pharma, Inc.
• Defendants:  Actavis Laboratories FL, Inc.; Andrx Corp.; Actavis, Inc.; Actavis Pharma, Inc.

Infringement of U.S. Patent Nos. 8,465,765 ("Orally Effective Methylphenidate Extended Release Powder and Aqueous Suspension Product," issued June 18, 2013), 8,653,033 (same title, issued October 22, 2013), and 8,778,390 (same title, issued July 15, 2014) following a Paragraph IV certification as part of Actavis' filing of an ANDA to manufacture a generic version of Tris' Quillivant XR® (methylphenidate hydrochloride oral solution, used to treat attention deficit hyperactivity disorder, distributed by Pfizer).  View the complaint here.

Otsuka Pharmaceutical Co. Ltd. v. Teva Pharmaceuticals USA, Inc. et al.
1:14-cv-06398; filed October 10, 2014 in the District Court of New Jersey

• Plaintiff:  Otsuka Pharmaceutical Co. Ltd.
• Defendants:  Teva Pharmaceuticals USA, Inc.; Teva Pharmaceutical Industries Ltd.

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

 

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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