About Court Report: Each week we will report briefly on recently filed biotech and pharma cases.
Endo Pharmaceuticals Inc. v. Impax Laboratories, Inc.
2:16-cv-02526; filed May 6, 2016 in the District Court of New Jersey
Infringement of U.S. Patent Nos. 8,309,122 ("Oxymorphone Controlled Release Formulations," issued November 13, 2012), 8,329,216 (same title, issued December 11, 2012), and 8,808,737 ("Method of Treating Pain Utilizing Controlled Release Oxymorphone Pharmaceutical Compositions and Instruction on Dosing for Renal Impairment," issued August 19, 2014) in conjunction with Impax's manufacture and sale of a generic version of Endo's Opana® ER (oxymorphone hydrochloride, used to treat moderate to severe pain in patients requiring continuous, around-the-clock opioid treatment for an extended period of time). View the complaint here.
Imprimis Pharmaceuticals, Inc. v. Regents of the University of California et al.
3:16-cv-01063; filed May 3, 2016 in the Southern District of California
• Plaintiff: Imprimis Pharmaceuticals, Inc.
• Defendants: Regents of the University of California; Urigen Pharmaceuticals, Inc.
Declaratory judgment of invalidity of U.S. Patent No. 7,414,039 ("Interstitial Therapy for Immediate Symptom Relief and Chronic Therapy in Interstitial Cystitis," issued August 19, 2008) relating to certain of Imprimis' commercialization of its Hep-Lido-A product (used to treat interstitial cystitis). View the complaint here.
Aurobindo Pharmaceuticals Ltd. et al. v. Daiici Sankyo, Inc. et al.
1:16-cv-04876; filed May 2, 2016 in the Northern District of Illinois
• Plaintiffs: Aurobindo Pharmaceuticals Ltd.; Aurobindo Pharma, Inc.
• Defendants: Daiici Sankyo, Inc.; Daiichi Sankyo Co., Ltd.; Mylan Pharmaceuticals Inc.
Declaratory judgment of non-infringement of U.S. Patent No. 6,878,703 ("Pharmaceutical Composition," issued April 12, 2005) in conjunction with Aurobindo's filing of ANDAs to manufacture a generic version of Daiichi's Benicar® (olmesartan medoxomil, used to treat hypertension) and Benicar® HCT (olmesartan medoxomil/ hydrochlorothiazide, used to treat hypertension). View the complaint here.
Otsuka Pharmaceutical Co., Ltd. v. Zhejiang Huahai Pharmaceutical Co., Ltd. et al.
1:16-cv-02476; filed May 2, 2016 in the District Court of New Jersey
• Plaintiff: Otsuka Pharmaceutical Co., Ltd.
• Defendants: Zhejiang Huahai Pharmaceutical Co., Ltd.; Huahai US Inc.; Prinston Pharmaceutical Inc.; Solco Healthcare U.S., LLC
Infringement of U.S. Patent No. 9,089,567 ("Method of Treating Cognitive Impairments and Schizophrenias," issued July 28, 2015) following Zhejiang'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.
Otsuka Pharmaceutical Co., Ltd. v. Zhejiang Huahai Pharmaceutical Co., Ltd. et al.
1:16-cv-02475; filed May 2, 2016 in the District Court of New Jersey
• Plaintiff: Otsuka Pharmaceutical Co., Ltd.
• Defendants: Zhejiang Huahai Pharmaceutical Co., Ltd.; Huahai US Inc.; Prinston Pharmaceutical Inc.; Solco Healthcare U.S., LLC
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 Zhejiang'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.
BTG International Ltd. et al. v. Amerigen Pharmaceuticals, Inc. et al.
2:16-cv-02449; filed May 2, 2016 in the District Court of New Jersey
• Plaintiffs: BTG International Ltd.; Janssen Biotech, Inc.; Janssen Oncology, Inc.; Janssen Research & Development, LLC
• Defendants: Amerigen Pharmaceuticals, Inc.; Amerigen Pharmaceuticals Ltd.
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 Amerigen's 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.
AstraZeneca AB et al. v. Hetero USA Inc. et al.
3:16-cv-02442; filed April 29, 2016 in the District Court of New Jersey
• Plaintiffs: AstraZeneca AB; Aktiebolaget Hassle; AstraZeneca LP; Zeneca Inc.
• Defendants: Hetero USA Inc.; Hetero Labs Ltd. Unit-III; Hetero Labs Ltd.
Infringement of U.S. Patent Nos. 6,369,085 ("Form of S-omeprazole," issued April 9, 2002) and 7,411,070 (same title, issued August 12, 2008) following a Paragraph IV certification as part of Hetero's filing of an ANDA to manufacture a generic version of AstraZeneca's Nexium 24HR® (esomeprazole magnesium, used for the treatment of gastroesophageal reflux disease). View the complaint here.
Boehringer Ingelheim Pharmaceuticals Inc. et al. v. Dr. Reddy's Laboratories, Ltd. et al.
3:16-cv-02394; filed April 28, 2016 in the District Court of New Jersey
• Plaintiffs: Boehringer Ingelheim Pharmaceuticals Inc.; Boehringer Ingelheim International GmbH; Boehringer Ingelheim Corp.; Boehringer Ingelheim Pharma GmbH & Co. KG
• Defendants: Dr. Reddy's Laboratories, Ltd.; Reddy's Laboratories, Inc.; Prinston Pharmaceutical Inc.; Solco Healthcare U.S., LLC; Huahai US Inc.; Zhejiang Huahai Pharmaceutical Co., Ltd.; Invagen Pharmaceuticals Inc.
Infringement of U.S. Patent No. 9,173,859 ("Uses of DPP-IV Inhibitors," issued November 3, 2015) following a Paragraph IV certification as part of defendants' filing of an ANDA to manufacture a generic version of Boehringer's Tradjenta® (linagliptin, used as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus) and Jentadueto® (linagliptin and metformin hydrochloride, used an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both linagliptin and metformin is appropriate) products. View the complaint here.
