Court Report - October 2014

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

Shire LLC v. Amerigen Pharmaceuticals Ltd.
1:14-cv-06095; filed October , 2014 in the District Court of New Jersey

Infringement of U.S. Patent Nos. RE42,096 ("Oral Pulsed Dose Drug Delivery System," issued February 1, 2011) and RE41,148 (same title, issued February 23, 2010) following a Paragraph IV certification as part of Amerigen's filing of an ANDA to manufacture a generic version of Shire's Adderall XR® (a combination of dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate, used to treat attention deficit hyperactivity disorder).  View the complaint here.

Astellas US LLC et al. v. Actavis Elizabeth LLC
1:14-cv-01246; filed September 29, 2014 in the District Court of Delaware

• Plaintiffs:  Astellas US LLC; Astellas Pharma US Inc.; Astellas Pharma Inc.
• Defendant:  Actavis Elizabeth LLC

Infringement of U.S. Patent Nos. 6,440,458 ("Sustained Release Preparations," issued August 27, 2002), 6,576,259 ("Sustained Release Formulations Containing Tacrolimus," issued June 10, 2003), 6,884,433 (same title, issued April 26, 2005), and 8,551,522 ("Sustained-Release Formulation," issued October 8, 2013) following a Paragraph IV certification as part of Actavis' filing of an ANDA to manufacture a generic version of Astellas' Astagraf XL (tacrolimus extended release, used for the prophylaxis of organ rejection in patients receiveing a kidney transplant).  View the complaint here.

Cephalon Inc. v. Dr. Reddy's Laboratories Ltd., et al.
1:14-cv-01241; filed September 26, 2014 in the District Court of Delaware

• Plaintiff:  Cephalon Inc.
• Defendants:  Dr. Reddy's Laboratories Ltd.; Dr. Reddy's Laboratories Inc.

Cephalon Inc. v. Hospira Inc.
1:14-cv-01242; filed September 26, 2014 in the District Court of Delaware

Cephalon Inc. v. Sun Pharma Global FZE, et al.
1:14-cv-01243; filed September 26, 2014 in the District Court of Delaware

• Plaintiff:  Cephalon Inc.
• Defendants:  Sun Pharma Global FZE; Sun Pharmaceutical Industries Ltd.

Cephalon Inc. v. Agila Specialties Inc. et al.
1:14-cv-01237; filed September 25, 2014 in the District Court of Delaware

• Plaintiff:  Cephalon Inc.
• Defendants:  Agila Specialties Inc.; Onco Therapies Ltd.

Cephalon Inc. v. InnoPharma Inc.
1:14-cv-01238; filed September 25, 2014 in the District Court of Delaware

Cephalon Inc. v. InnoPharma Inc.
1:14-cv-01239; filed September 25, 2014 in the District Court of Delaware

The complaints in these cases are substantially identical.  Infringement of U.S. Patent No. 8,791,270 ("Bendamustine Pharmaceutical Compositions," issued July 29, 2014) following a Paragraph IV certification as part of defendants' 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 Agila complaint here.

AbbVie Inc. v. Mylan Pharmaceuticals Inc. et al.
1:14-cv-01236; filed September 25, 2014 in the District Court of Delaware

• Plaintiff:  AbbVie Inc.
• Defendants:  Mylan Pharmaceuticals Inc.; Mylan Laboratories Ltd.

Infringement of U.S. Patent No. 8,691,878 ("Solid Pharmaceutical Dosage Form," issued April 8, 2014) following a Paragraph IV certification as part of Mylan's filing of an ANDA to manufacture a generic version of AbbVie's Norvir® (ritonavir, used to treat human immunodeficiency virus (HIV) infection).  View the complaint here.

Cadence Pharmaceuticals, Inc. et al. v. Innopharma Licensing LLC et al.
1:14-cv-06051; filed September 25, 2014 in the District Court of New Jersey

• Plaintiffs:  Cadence Pharmaceuticals, Inc.; Cadence Pharmaceuticals, Inc.; Mallinckrodt IP
• Defendants:  Innopharma Licensing LLC; Innopharma, Inc.

Infringement of U.S. Patent Nos. 6,028,222 ("Stable Liquid Paracetamol Compositions, and Method for Preparing the Same," issued February 22, 2000) and 6,992,218 ("Method for Obtaining Aqueous Formulations of Oxidation-Sensitive Active Principles," issued January 31, 2006), both licensed to Cadence, following a Paragraph IV certification as part of InnoPharma's filing of an NDA (under § 505(b)(2) of the Food, Drug and Cosmetic Act) to manufacture a generic version of Cadence's Ofirmev® (acetaminophen injection, used for the management of mild to moderate pain, the management of moderate to severe pain with adjunctive opioid analgesics, and the reduction of fevers).  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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