About Court Report: Each week we will report briefly on recently filed biotech and pharma cases.
Novartis Pharmaceuticals Corp. et al. v. Noven
Pharmaceuticals Inc. et al.
1:13-cv-00527; filed April 3, 2013 in the District Court of Delaware
• Plaintiffs: Novartis Pharmaceuticals Corp.; Novartis AG; Novartis Pharma AG; Novartis International Pharmaceutical Ltd.; LTS Lohmann Therapie-Systeme AG
• Defendants: Noven Pharmaceuticals Inc.; Noven Therapeutics LLC; Hisamitsu Pharmaceutical Co. Inc.
Infringement of U.S. Patent Nos. 6,316,023 ("TTS Containing an Antioxidant," issued November 13, 2001) and 6,335,031 (same title, issued January 1, 2002) following a Paragraph IV certification as part of Noven's filing of an ANDA to manufacture a generic version of Novartis' Exelon® Patch (rivastigmine tartrate, used to treat mild to moderate dementia of the Alzheimer's type, and mild to moderate dementia associated with Parkinson's disease). View the complaint here.
Purdue Pharmaceutical Products L.P. et al. v. Dr. Reddy's Laboratories, Inc. et al.
2:13-cv-02067; filed April 2, 2013 in the District Court of New Jersey
• Plaintiffs: Purdue Pharmaceutical Products L.P.; Purdue Pharma L.P.; Transcept Pharmaceuticals, Inc.
• Defendants: Dr. Reddy's Laboratories, Inc.; Dr. Reddys Laboratories, Ltd.
Infringement of U.S. Patent Nos. 7,682,628 ("Compositions for Delivering Hypnotic Agents Across the Oral Mucosa and Methods of Use Thereof," issued March 23, 2010), 8,242,131 ("Methods of Treating Middle-of-the-Night Insomnia," issued August 14, 2012), and 8,252,809 ("Compositions for Treating Insomnia," issued August 28, 2012) following a Paragraph IV certification as part of Dr. Reddy's filing of an ANDA to manufacture a generic version of Purdue's Intermezzo® (sublingual zolpidem tartrate, used to treat insomnia when middle-of-the-night awakening is followed by difficulty returning to sleep). View the complaint here.
Taro Pharmaceuticals North America, Inc. v. Rea
1:13-cv-00410; filed April 1, 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. 8,277,780 ("Stable Liquid Desoximethasone Compositions with Reduced Oxidized Impurity," issued October 2, 2012). View the complaint here.
Incyte Corp. v. Rea
1:13-cv-00409; filed March 29, 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. 8,278,318 ("Spriocycles and Inhibitors of 11-Beta Hydroxyl Steroid Dehydrogenase Type 1," issued October 2, 2012). View the complaint here.
Unimed Pharmaceuticals LLC et al. v. Watson Laboratories Inc. et al.
1:13-cv-00496; filed March 29, 2013 in the District Court of Delaware
• Plaintiffs: Unimed Pharmaceuticals LLC; Besins Healthcare Inc.
• Defendants: Watson Laboratories Inc.; Actavis Inc.
Infringement of U.S. Patent No. 6,503,894 ("Pharmaceutical Composition and Method for Treating Hypogonadism," issued January 7, 2003) following a Paragraph IV certification as part of Watson's filing of an ANDA to manufacture a generic version of AbbVie's AndroGel® (testosterone gel, used to treat conditions associated with a deficiency or absence of endogenous testosterone). View the complaint here.
Takeda Pharmaceuticals USA Inc. v. Amneal Pharmaceuticals LLC
1:13-cv-00493; filed March 28, 2013 in the District Court of Delaware
Infringement of U.S Patent Nos. 7,619,004 ("Methods for Concomitant Administration of Colchicine and Macrolide Antibiotics," issued November 17, 2009), 7,601,758 ("Methods for Concomitant Administration of Colchicine and Macrolide Antibiotics in the Treatment of Gout Flares," issued October 13, 2009), 7,820,681 ("Methods for Concomitant Administration of Colchicine and a Second Active Agent," issued October 26, 2010), 7,915,269 (same title, issued March 29, 2011), 7,964,647 ("Colchicine Compositions and Methods," issued June 21, 2011), 7,964,648 ("Methods for Concomitant Administration of Colchicine and a Second Active Agent," issued June 21, 2011), 7,981,938 ("Colchicine Compositions and Methods," issued July 19, 2011), 8,093,296 ("Methods for Concomitant Administration of Colchicine and Macrolide Antibiotics," issued January 10, 2012), 8,093,297 ("Methods for Concomitant Administration of Colchicine and a Second Active Agent," issued January 10, 2012), and 8,097,655 ("Methods for Concomitant Administration of Colchicine and Macrolide Antibiotics," issued January 17, 2012) following Amneal's filing of an ANDA to manufacture a generic version of Takeda's Colcrys® (single-ingredient colchicine product, used to prevent and treat gout flares). View the complaint here.
Mallinckrodt LLC et al. v. Taro Pharmaceutical Industries Ltd. et al.
1:13-cv-00494; filed March 28, 2013 in the District Court of Delaware
• Plaintiffs: Mallinckrodt LLC; Mallinckrodt Inc.; Nuvo Research Inc.
• Defendants: Taro Pharmaceutical Industries Ltd.; Taro Pharmaceutical USA Inc.
Infringement of U.S. Patent No. 8,217,078 ("Treatment of Pain with Topical Diclofenac," issued July 10, 2012) following a Paragraph IV certification as part of Taro's filing of an ANDA to manufacture a generic version of Mallinckrodt's Pennsaid® (diclofenac sodium topical solution, used for the treatment of signs and symptoms of osteoarthritis of the knee(s)). View the complaint here.