About Court Report: Each week we will report briefly on recently filed biotech and pharma cases.
Vanda Pharmaceuticals Inc. v. Roxane Laboratories Inc.
1:15-cv-00919; filed October 13, 2015 in the District Court of Delaware
Vanda Pharmaceuticals Inc. v. Inventia Healthcare Pvt. Ltd.
1:15-cv-00921; filed October 13, 2015 in the District Court of Delaware
The complaints in these cases are substantially identical. Infringement of U.S. Patent No. 9,138,432 ("Methods for the Administration of Iloperidone," issued September 22, 2015) in conjunction with defendants' filing of an ANDA to manufacture a generic version of Vanda's Fanapt® (iloperidone, used for the acute treatment of adults with schizophrenia). View the Roxane complaint here.
Vanda Pharmaceuticals Inc. v. Taro Pharmaceuticals USA, Inc. et al.
1:15-cv-00920; filed October 13, 2015 in the District Court of Delaware
• Plaintiff: Vanda Pharmaceuticals Inc.
• Defendants: Taro Pharmaceuticals USA, Inc.; Taro Pharmaceutical Industries, Ltd.
Vanda Pharmaceuticals Inc. v. Apotex Inc. et al.
1:15-cv-00922; filed October 13, 2015 in the District Court of Delaware
• Plaintiff: Vanda Pharmaceuticals Inc.
• Defendants: Apotex Inc.; Apotex Corp.
The complaints in these cases are substantially identical. Infringement of U.S. Patent Nos. 8,586,610 ("Methods for the Administration of Iloperidone," issued November 19, 2013) and 9,138,432 (same title issued September 22, 2015) following a Paragraph IV certification as part of Taro's filing of an ANDA to manufacture a generic version of Vanda's Fanapt® (iloperidone, used for the acute treatment of adults with schizophrenia). View the Taro complaint here.
Helsinn Healthcare S.A. et al. v. Fresenius Kabi USA, LLC
1:15-cv-00918; filed October 13, 2015 in the District Court of Delaware
• Plaintiffs: Helsinn Healthcare S.A.; Roche Palo Alto LLC
• Defendant: Fresenius Kabi USA, LLC
Infringement of U.S. Patent Nos. 7,947,724 ("Liquid Pharmaceutical Formulations of Palonosetron," issued May 24, 2011), 8,518,981 ("Liquid Pharmaceutical Formulations of Palonosetron," issued August 27, 2013), 8,598,218 (same title, issued December 3, 2013), 9,066,980 (same title, issued June 30, 2015), and 9,125,905 (same title, issued September 8, 2015) following a Paragraph IV certification as part of Fesenius' 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.
Boehringer Ingelheim Pharma GmbH & Co. KG et al. v. Sandoz Inc. et al.
1:15-cv-07461; filed October 13, 2015 in the District Court of New Jersey
• Plaintiffs: Boehringer Ingelheim Pharma GmbH & Co. KG; Boehringer Ingelheim International GmbH; Boehringer Ingelheim Pharmaceuticals, Inc.
• Defendants: Sandoz Inc.; Sun Pharma Global FZE; Sun Pharmaceutical Industries, Ltd.; Sun Pharmaceutical Industries, Inc.
Infringement of U.S. Patent No. 6,015,577 ("Pharmaceutical Compositions Containing Dipyridamole or Mopidamol and Acetylsalicylic Acid or the Physiologically Acceptable Salts Thereof, Processes for Preparing Them and Their Use in Treating Clot Formation," issued January 18, 2000) following a Paragraph IV certification as part of defendants' filing of an ANDA to manufacture a generic version of Boehringer's Aggrenox® (extended-release dipyridamole/acetylsalicylic acid, used to reduce the risk of stroke in patients who have had transient ischemia of the brain or completed ischemic stroke due to thrombosis). View the complaint here.
Novartis AG et al. v. Roxane Laboratories, Inc. et al.
2:15-cv-02905; filed October 13, 2015 in the Southern District of Ohio
• Plaintiffs: Novartis AG; Novartis Pharmaceuticals Corporation
• Defendants: Roxane Laboratories, Inc.; Boehringer Ingelheim Roxane Inc.
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 Roxane'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 complaint here. [NB: The complaint was later dismissed.]
