Court Report - December 29, 2013

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

Janssen Pharmaceuticals Inc. et al. v. Alkem Laboratories Limited
1:13-cv-09227; filed December 26, 2013 in the Northern District of Illinois

• Plaintiffs:  Janssen Pharmaceuticals Inc.; Grünenthal GmbH
• Defendant:  Alkem Laboratories Ltd.

Janssen Pharmaceuticals, Inc. et al. v. Alkem Laboratories Ltd.
2:13-cv-07803; filed December 23, 2013 in the District Court of New Jersey

• Plaintiffs:  Janssen Pharmaceuticals, Inc.; Grunenthal GmbH
• Defendant:  Alkem Laboratories Ltd.

The complaints in these cases are substantially identical.  Infringement of U.S. Patent No. 8,536,130 (""Use of 1 Phenyl-3-Dimethylamino-Propane Compounds for Treating Neuropathic Pain," issued September 17, 2013), licensed to Janssen, following a Paragraph IV certification as part of Alkem's filing of an ANDA to manufacture a generic version of Janssen's Nucynta® ER (tapentadol hydrochloride, used for the management of moderate to severe acute pain in adults).  View the New Jersey complaint here.

Merck Sharp & Dohme B.V. v. Warner Chilcott Co. LLC et al.
1:13-cv-02088; filed December 24, 2013 in the District Court of Delaware

• Plaintiff:  Merck Sharp & Dohme B.V.
• Defendants:  Warner Chilcott Co. LLC; Warner Chilcott (US) LLC

Infringement of U.S. Patent No. 5,989,581 ("Drug Delivery System for Two or More Active Substances," issued November 23, 1999) following a Paragraph IV certification as part of Warner Chilcott's filing of an ANDA to manufacture a generic version of MSD's NuvaRing® drug product (ethinyl estradiol and etonogestrel vaginal ring, used for contraception).  View the complaint here.

Teijin Ltd. et al. v. Zydus Pharmaceuticals USA Inc. et al.
1:13-cv-02086; filed December 23, 2013 in the District Court of Delaware

• Plaintiffs:  Teijin Ltd.; Teijin Pharma Ltd.; Takeda Pharmaceuticals U.S.A., Inc.
• Defendants:  Zydus Pharmaceuticals USA Inc.; Cadila Healthcare Ltd.

Infringement of U.S. Patent No. 7,361,676 ("Solid Preparation Containing Single Crystal Form," issued April 22, 2008) following a Paragraph IV certification as part of Zydus' filing of an ANDA to manufacture a generic version of Takeda's Uloric® (febuxostat, used for the chronic management of hyperuricemia in patients with gout).  View the complaint here.

Genetic Veterinary Sciences Inc. v. Canine EIC Genetics LLC
2:13-cv-00422; filed December 20, 2013 in the Eastern District of Washington

Declaratory judgment of non-infringement of U.S Patent No. 8,178,297 ("Method of Detecting Canine Exercise-Induced Collapse," issued May 15, 2012) based on PPG's genetic screening service for Exercise-Induced Collapse ("EIC") in dogs.  Also, various claims sounding in state law, including unfair competition, etc.  View the complaint here.

Cephalon Inc. v. Agila Specialties Inc. et al.
1:13-cv-02080; filed December 20, 2013 in the District Court of Delaware

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

Cephalon Inc. v. InnoPharma Inc.
1:13-cv-02081; filed December 20, 2013 in the District Court of Delaware

Cephalon Inc. v. Dr. Reddy's Laboratories Ltd. et al.
1:13-cv-02082; filed December 20, 2013 in the District Court of Delaware

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

The complaints in these cases are substantially identical.  Infringement of U.S. Patent Nos. 8,445,524 ("Solid Forms of Bendamustine Hydrochloride," issued May 21, 2013) and 8,436,190 ("Bendamustine Pharmaceutical Compositions," issued May 7, 2013) 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.

Cephalon Inc. v. Hetero Labs Ltd. et al.
1:13-cv-02046; filed December 19, 2013 in the District Court of Delaware

• Plaintiff:  Cephalon Inc.
• Defendants:  Hetero Labs Ltd.; Hetero USA Inc.

Infringement of U.S. Patent No. 8,445,524 ("Solid Forms of Bendamustine Hydrochloride," issued May 21, 2013) following a Paragraph IV certification as part of Hetero'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.

IGI Laboratories Inc. v. Mallinckrodt LLC et al.
1:13-cv-02044; filed December 19, 2013 in the District Court of Delaware

• Plaintiff:  IGI Laboratories Inc.
• Defendants:  Mallinckrodt LLC; Mallinckrodt Inc.; Nuvo Research Inc.

Declaratory judgment of non-infringement of U.S. Patent Nos. 8,217,078 ("Treatment of Pain with Topical Diclofenac," issued July 10, 2012) and 8,546,450 ("Treatment of Pain with Topical Diclofenac Compounds," issued October 1, 2013) based on IGI's Paragraph IV certification as part of its filing of an ANDA to manufacture a generic version of Mallinckrodt's Pennsaid® (diclofenac sodium topical solution, used for the treatment of signs and symptoms of osteoarthritis of the knee(s)).  View the complaint here.

Topics:  ANDA, Infringement, Patents, Pharmaceutical, 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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