Court Report - October 2014 #3

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

Tris Pharma Inc. v. Actavis Laboratories FL Inc. et al.
1:14-cv-01309; filed October 15, 2014 in the District Court of Delaware

• 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.

Helsinn Healthcare, S.A. et al. v. Teva Pharmaceuticals USA, Inc. et al.
3:14-cv-06341; filed October 13, 2014 in the District Court of New Jersey

• Plaintiffs:  Helsinn Healthcare, S.A.; Roche Palo Alto LLC
• Defendants:  Teva Pharmaceuticals USA, Inc.; Teva Pharmaceutical Industries, Ltd.

Infringement of U.S. Patent No. 8,729,094 ("Liquid Pharmaceutical Formulations of Palonosetron," issued May 20, 2014) following a Paragraph IV certification as part of Teva's filing of an ANDA to manufacture a generic version of Helsinn's Aloxi® (palonosetron hydrochloride intravenous solution, used to prevent chemotherapy induced nausea and vomiting).  View the complaint here.

Novartis Pharmaceuticals Corp. et al. v. Par Pharmaceutical Inc.
1:14-cv-01289; filed October 10, 2014 in the District Court of Delaware

• Plaintiffs:  Novartis Pharmaceuticals Corp.; Novartis AG
• Defendant:  Par Pharmaceutical Inc.

Infringement of U.S. Patent Nos. 5,665,772 ("O-alkylated Rapamycin Derivatives and Their Use, Particularly as Immunosuppressants," issued September 9, 1997), 6,004,973 ("Pharmaceutical Compositions Comprising Rafamycin Coprecipitates," issued December 21, 1999), and 6,455,518 ("Pharmaceutical Compositions for the Treatment of Transplant Rejection, Autoimmune or Inflammatory Conditions Comprising Cyclosporin A and 40-O-(2-hydroxyethyl)-rapamycin," issued September 24, 2002) following a Paragraph IV certification as part of Par's filing of an ANDA to manufacture a generic version of Novartis' Zortress® (everolimus, used for the prophylaxis of organ rejection in adult patients at low-moderate immunologic risk receiving a kidney transplant, and for the prophylaxis of allograft rejection in adult patients receiving a liver transplant).  View the complaint here.

Otsuka Pharmaceutical Co., Ltd. v. Amneal Pharmaceuticals, LLC et al.
3:14-cv-06340; filed October 10, 2014 in the District Court of New Jersey

• Plaintiff:  Otsuka Pharmaceutical Co., Ltd.
• Defendants:  Amneal Pharmaceuticals, LLC; Amneal Pharmaceuticals of New York, LLC; Amneal Pharmaceuticals Co. India Private Ltd.

Otsuka Pharmaceutical Co., Ltd. v. Sun Pharmaceutical Industries Ltd. et al.
1:14-cv-06397; filed October 6, 2014 in the District Court of New Jersey

• Plaintiff: Otsuka Pharmaceutical Co., Ltd.
• Defendants: Sun Pharmaceutical Industries Ltd.; Sun Pharma Global Inc.; Sun Pharma Global FZE; Sun Pharma USA; Sun Pharmaceuticals Industries, Inc.; Caraco Pharmaceutical Laboratories, Ltd.

The complaints in these cases are substantially identical.  Infringement of U.S. Patent No. 8,759,350 ("Carbostyril Derivatives and Serotonin Reuptake Inhibitors for Treatment of Mood Disorders," issued June 24, 2014) following a Paragraph IV certification as part of defendants' filing of an ANDA to manufacture a generic version of Otsuka's Abilify® (aripiprazole, used to treat bipolar disorder and schizophrenia).  View the Sun complaint here.

AbbVie Inc. v. Mylan Pharmaceuticals Inc.
1:14-cv-01288; filed October 9, 2014 in the District Court of Delaware

• Plaintiffs:  AbbVie Inc.; Abbvie Deutschland GmbH & Co. KG
• Defendant:  Mylan Pharmaceuticals Inc.

Infringement of U.S. Patent Nos. 7,148,359 ("Polymorph of a Pharmaceutical," issued December 12, 2006) and 7,364,752 ("Solid Dispersion Pharmaceutical Formulations," issued April 29, 2008) 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.

Novartis Pharmaceuticals Corp. et al. v. Dr. Reddy's Laboratories, Ltd. et al.
2:14-cv-06280; filed October 9, 2014 in the District Court of New Jersey

• Plaintiffs:  Novartis Pharmaceuticals Corp.; Novartis AG
• Defendants:  Dr. Reddy's Laboratories, Ltd.; Dr. Reddy's Laboratories, Inc.

Novartis Pharmaceuticals Corp. et al. v. Dr. Reddy's Laboratories Ltd. et al.
1:14-cv-01283; filed October 8, 2014 in the District Court of Delaware

• Plaintiffs: Novartis Pharmaceuticals Corp.; Novartis AG
• 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. 6,894,051 ("Crystal Modification of a N-phenyl-2-pyrimidineamine Derivative, Processes for Its Manufacture and Its Use," issued May 17, 2005) and RE43,932 ("Crystal Modification of a N-phenyl-2-pyrimidineamine Derivative, Processes for Its Manufacture and Its Use," issued January 15, 2013) following a Paragraph IV certification as part of Dr. Reddy's filing of an ANDA to manufacture a generic version of Novartis' Gleevec® (imatinib mesylate, used for various indications, including treatment of myeloid leukemia).  View the Delaware complaint here.

Eli Lilly and Company et al. v. Nang Kuang Pharmaceutical Co., Ltd. et al.
1:14-cv-01647; filed October 8, 2014 in the Southern District of Indiana

• Plaintiffs:  Eli Lilly and Company; The Trustees of Princeton University
• Defendants:  Nang Kuang Pharmaceutical Co., Ltd.; Canda NX-2, LLC

Infringement of U.S. Patent Nos. 5,344,932 ("N-(pyrrolo(2,3-d)pyrimidin-3-ylacyl)-Glutamic Acid Derivatives," issued September 6, 1994) and 7,772,209 ("Novel Antifolate Combination Therapies," issued August 10, 2010) following a Paragraph IV certification as part of Nang Kuang's filing of an ANDA to manufacture a generic version of Lilly's Alimta® (pemetrexed for injection, used to treat malignant pleural mesothelioma and locally advanced or metastatic non-small cell lung cancer).  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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