About Court Report: Each week we will report briefly on recently filed biotech and pharma cases.
AbbVie Inc. et al. v. Aurobindo Pharma Ltd. et al.
1:14-cv-00215; filed February 19, 2014 in the District Court of Delaware
• Plaintiffs: AbbVie Inc.; Wisconsin Alumni Research Foundation
• Defendants: Aurobindo Pharma Ltd.; Aurobindo Pharma USA Inc.
Infringement of U.S. Patent Nos. 5,597,815 ("Prevention of Hyperphosphatemia in Kidney Disorder Patients," issued January 28, 1997) 6,136,799 ("Cosolvent Formulations," issued October 24, 2000), and 6,361,758 (same title, issued March 26, 2002), following a Paragraph IV certification as part of Aurobindo's filing of an ANDA to manufacture a generic version of AbbVie's Zemplar® (paricalcitol, used to treat secondary hyperparathyroidism in patients with kidney failure). View the complaint here.
AbbVie Inc. v. Gilead Sciences Inc. et al.
1:14-cv-00209; filed February 18, 2014 in the District Court of Delaware
• Plaintiff: AbbVie Inc.
• Defendants: Gilead Sciences Inc.; Gilead Pharmasset LLC; Gilead Sciences Ltd.
Infringement of U.S. Patent Nos. 8,466,159 ("Methods for Treating HCV," issued June 18, 2013) and 8,492,386 (same title, issued July 23, 2013) based on Gilead's anticipated manufacture and sale of its combination therapy for the treatment of HCV using sofosbuvir and ledipasvir. View the (redacted) complaint here (original filed under seal).
Salix Pharmaceuticals Inc. et al. v. Novel Laboratories Inc.
1:14-cv-00213; filed February 18, 2014 in the District Court of Delaware
• Plaintiffs: Salix Pharmaceuticals Inc.; Dr. Falk Pharma GmbH
• Defendant: Novel Laboratories Inc.
Infringement of U.S. Patent Nos. 6,551,620 ("Pellet Formulation for the Treatment of the Intestinal Tract," issued April 22, 2003), 8,337,886 (same title, issued December 25, 2012), and 8,496,965 (same title, issued July 30, 2013) following a paragraph IV certification as part of Novel's filing of an ANDA to manufacture a generic version of Salix's Apriso® (mesalamine, used for the maintenance of remission of ulcerative colitis in adults). View the Delaware complaint here.
Otsuka Pharmaceutical Co., Ltd. v. Torrent Pharmaceuticals Ltd. et al.
1:14-cv-01078; filed February 18, 2014 in the District Court of New Jersey
• Plaintiff: Otsuka Pharmaceutical Co., Ltd.
• Defendants: Torrent Pharmaceuticals Ltd.; Torrent Pharma Inc.
Infringement of U.S. Patent Nos. 8,017,615 ("Low Hygroscopic Aripiprazole Drug Substance and Process for the Preparation Thereof," issued September 13, 2011) and 8,580,796 (same title, issued November 12, 2013) following a Paragraph IV certification as part of Torrent'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.
Merck Sharp & Dohme Corp. v. Xellia Pharmaceuticals ApS
3:14-cv-00124; filed February 18, 2014 in the Western District of Wisconsin
Merck Sharp & Dohme Corp. v. Xellia Pharmaceuticals ApS
1:14-cv-00199; filed February 14, 2014 in the District Court of Delaware
The complaints in these cases are substantially identical. Infringement of U.S. Patent No. 5,952,300 ("Antifungal Compositions," issued September 14, 1999) following a Paragraph IV certification as part of Xellia's filing of an ANDA to manufacture a generic version of Merck's Cancidas® (caspofungin acetate, used to treat presumed fungal infections in febrile, neutropenic patients, candidemia and certain Candida infections, esophageal candidiasis, and invasive aspergillosis in patients who are refractory to or intolerant of other therapies). View the Delaware complaint here.
Forest Laboratories Inc. et al. v. Apotex Corp. et al.
1:14-cv-00200; filed February 14, 2014 in the District Court of Delaware
• Plaintiffs: Forest Laboratories Inc.; Forest Laboratories Holdings Ltd.; Adamas Pharmaceuticals Inc.
• Defendants: Apotex Corp.; Apotex Inc.; Zydus Pharmaceuticals (USA) Inc.; Cadila Healthcare Ltd. d/b/a/ Zydus Cadila; Par Pharmaceutical Inc.; Anchen Pharmaceuticals Inc.; Watson Laboratories Inc. - Florida
Infringement of U.S. Patent Nos. 8,039,009 ("Modified Release Formulations of Memantine Oral dosage Forms," issued October 18, 2011), 8,168,209 ("Method and Composition for Administering an NMDA Receptor Antagonist to a Subject," issued May 1, 2012), 8,173,708 (same title, issued May 8, 2012), 8,283,379 ("Method and Compositions for the Treatment of CNS-Related Conditions," issued October 9, 2012), 8,329,752 ("Composition for Administering an NMDA Receptor Antagonist to a Subject," issued December 11, 2012), 8,362,085 ("Method for Administering an NMDA Receptor Antagonist to a Subject," issued January 29, 2013), and 8,598,233 (same title, issued December 3, 2013) following a Paragraph IV certification as part of defendants' filing of an ANDA to manufacture a generic version of Forest's Namenda XR® (memantine hydrochloride extended release, used for the treatment of moderate to severe dementia of the Alzheimer's type). View the complaint here.
Teijin Ltd. et al. v. Roxane Laboratories Inc.
1:14-cv-00189; filed February 12, 2014 in the District Court of Delaware
• Plaintiffs: Teijin Ltd.; Teijin Pharma Ltd.; Takeda Pharmaceuticals USA Inc.
• Defendant: Roxane Laboratories Inc.
Infringement of U.S. Patent No. 6,225,474 ("Polymorphs of 2-(3-cyano-4-isobutyloxyphenyl)-4-methyl-5-thiazolecarboxylic acid and Method of Producing the Same," issued May 1, 2001) following a Paragraph IV certification as part of Roxane's 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.
