About Court Report: Each week we will report briefly on recently filed biotech and pharma cases.
Hoffmann-La Roche Inc. et al. v. Aurobindo Pharma Ltd. et al.
1:13-cv-00124; filed January 22, 2013 in the District Court of Delaware
• Plaintiffs: Hoffmann-La Roche Inc.; Genentech Inc.
• Defendants: Aurobindo Pharma Ltd.; Aurobindo Pharma USA Inc.
Infringement of U.S. Patent Nos. 7,718,634 ("Method of Treatment Using Bisphosphonic Acid," issued May 18, 2010), 7,410,957 (same title, issued August 12, 2008), and 6,294,196 ("Pharmaceutical Composition Containing Diphosphonic Acid or Salt Thereof," issued September 25, 2001) following a Paragraph IV certification as part of Aurobindo's filing of an ANDA to manufacture a generic version of Roche's Boniva® (150 mg once-monthly tablets) (ibandronate sodium, used to treat post-menopausal osteoporosis). View the complaint here.
Cadence Pharmaceuticals, Inc. et al. v. Fresenius Kabi USA, LLC
1:13-cv-00453; filed January 18, 2013 in the Northern District of Illinois
• Plaintiffs: Cadence Pharmaceuticals, Inc.; SCR Pharmatop
• Defendant: Fresenius Kabi USA, LLC
Infringement of U.S. Patent Nos. 6,028,222 ("Stable Liquid Paracetamol Compositions, and Method for Preparing the Same," issued February 22, 2000) and 6,992,218 ("Method for Obtaining Aqueous Formulations of Oxidation-Sensitive Active Principles," issued January 31, 2006), both licensed to Cadence, following a Paragraph IV certification as part of Fresenius' filing of an ANDA to manufacture a generic version of Cadence's Ofirmev® (acetaminophen injection, used for the management of mild to moderate pain, the management of moderate to severe pain with adjunctive opioid analgesics, and the reduction of fevers). View the complaint here.
Jazz Pharmaceuticals, Inc. v. Amneal Pharmaceuticals, LLC
2:13-cv-00391; filed January 18, 2013 in the District Court of New Jersey
Infringement of U.S. Patent Nos. 6,472,431 ("Microbiologically Sound and Stable Solutions of Gamma-Hydroxybutyrate Salt for the Treatment of Narcolepsy," issued October 29, 2002), 6,780,889 (same title, issued August 24, 2004), 7,262,219 (same title, issued August 28, 2007), 7,851,506 (same title, issued December 14, 2010), 7,895,059 ("Sensitive Drug Distribution System and Method" issued February 22, 2011), 8,263,650 ("Microbiologically Sound and Stable Solutions of Gamma-Hydroxybutyrate Salt for the Treatment of Narcolepsy," issued September 11, 2012), 8,324,275 (same title, issued December 4, 2012) following a Paragraph IV certification as part of Amneal's filing of an ANDA to manufacture a generic version of Jazz's Xyrem® (sodium oxybate, used to treat narcolepsy). View the complaint here.
Endo Pharmaceuticals Inc. et al. v. IMPAX Laboratories, Inc.
1:13-cv-00435; filed January 18, 2013 in the Southern District of New York
• Plaintiffs: Endo Pharmaceuticals Inc.; Grunenthal GmbH
• Defendant: IMPAX Laboratories, Inc.
Endo Pharmaceuticals Inc. et al. v. Actavis Inc. et al.
1:13-cv-00436; filed January 18, 2013 in the Southern District of New York
• Plaintiffs: Endo Pharmaceuticals Inc.; Grunenthal GmbH
• Defendant: Actavis Inc.; Actavis South Atlantic LLC; Watson Pharmaceuticals, Inc.
The complaints in these cases are substantially identical. Infringement of U.S. Patent Nos. 8,114,383 ("Abuse-Proofed Dosage Form," issued February 14, 2012), 8,192,722 (same title, issued June 5, 2012), 8,309,060 (same title, issued November 13, 2012), 7,851,482 ("Method for Making Analgesics," issued December 14, 2010), 8,309,122 ("Oxymorphone Controlled Release Formulations," issued November 13, 2012), and 8,329,216 (same title, issued December 11, 2012) following a Paragraph IV certification as part of Impax's filing of an ANDA to manufacture 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 Impax complaint here.
Horizon Pharma Inc. et al. v. Par Pharmaceutical Companies, Inc. et al.
1:13-cv-00102; filed January 17, 2013 in the District Court of Delaware
• Plaintiffs: Horizon Pharma Inc.; Horizon Pharma USA Inc.
• Defendants: Par Pharmaceutical Companies, Inc.; Par Pharmaceutical Inc.
Infringement of U.S. Patent Nos. 8,309,127 ("Stable Compositions of Famotidine and Ibuprofen," issued November 13, 2012) and 8,318,202 (same title, issued November 27, 2012) following a Paragraph IV certification as part of Par's filing of an ANDA to manufacture a generic version of Horizon's Duexis ® (famotidine and ibuprofen, used for the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis and to decrease the risk of developing upper gastrointestinal ulcers). View the complaint here.
Emotional Brain B.V. v. Kappos
1:13-cv-00076; filed January 17, 2013 in the Eastern District of Virginia
Review and correction of the patent term adjustment calculation made by the U.S. Patent and Trademark Office for U.S. Patent No. 8,227,453 ("Pharmaceutical Formulations and Uses Thereof in the Treatment of Female Sexual Dysfunction," issued July 24, 2012). View the complaint here.
