About Court Report: Each week we will report briefly on recently filed biotech and pharma cases.
United Therapeutics Corp. v. Watson Laboratories, Inc.
3:15-cv-05723; filed July 22, 2015 in the District Court of New Jersey
Infringement of U.S. Patent Nos. 6,521,212 ("Method for Treating Peripheral Vascular Disease By Administering Benzindene Prostaglandins By Inhalation," issued February 18, 2003), 6,756,033 ("Method for Delivering Benzindene Prostaglandins by Inhalation," issued June 29, 2004), and 8,497,393 ("Process to Prepare Treprostinil, the Active Ingredient in Remodulin®," issued July 30, 2014) following a Paragraph IV certification as part of Watson's filing of an ANDA to manufacture a generic version of UTC's Tyvaso® (treprostinil inhalation solution, used to treat pulmonary arterial hypertension). View the complaint here.
Alcon Research Ltd. v. Lupin Ltd. et al.
1:15-cv-00621; filed July 20, 2015 in the District Court of Delaware
• Plaintiff: Alcon Research Ltd.
• Defendants: Lupin Ltd.; Lupin Pharmaceuticals Inc.
Infringement of U.S. Patent Nos. 8,268,299 ("Self Preserved Aqueous Pharmaceutical Compositions," issued September 18, 2012), 8,323,630 (same title, issued December 4, 2012), and 8,388,941 (same title, issued March 5, 2013) following a Paragraph IV certification as part of Lupin's filing of an ANDA to manufacture a generic version of Alcon's Travatan Z® (travoprost ophthalmic solution, used to reduce elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertention). View the complaint here.
Meda Pharmaceuticals Inc. v. Amneal Pharmaceuticals LLC et al.
1:15-cv-00617; filed July 17, 2015 in the District Court of Delaware
• Plaintiff: Meda Pharmaceuticals Inc.
• Defendants: Amneal Pharmaceuticals LLC; Amneal Pharmaceuticals of New York LLC; Amneal Pharmaceuticals Co. India Private Ltd.
Infringement of U.S. Patent Nos. 8,017,073 ("Compositions Comprising Azelastine and Methods of Use Thereof," issued December 6, 2011) and 8,518,919 (same title, issued August 27, 2013) following a Paragraph IV certification as part of Amneal's filing of an ANDA to manufacture a generic version of Meda's Astepro® (azelastine hydrochloride nasal spray, used to treat hay fever and allergy symptoms). View the complaint here.
Roxane Laboratories, Inc. v. Novel Laboratories, Inc. et al.
2:15-cv-05618; filed July 17, 2015 in the District Court of New Jersey
• Plaintiff: Roxane Laboratories, Inc.
• Defendants: Novel Laboratories, Inc.; Gavis Pharmaceuticals, LLC
Infringement of U.S. Patent No. 8,563,032 ("Formulation and Manufacturing Process for Calcium Acetate Capsules," issued October 22, 2013) based on Novel's anticipated manufacture and sale of a generic calcium acetate capsule, having filed an ANDA to manufacture a generic version of Roxane's PhosLo® Gelcaps (calcium acetate, used for the reduction of serum phosphorous in patients with end stage renal disease). View the complaint here.
Jazz Pharmaceuticals, Inc. et al. v. Wockhardt Bio AG et al.
2:15-cv-05619; filed July 17, 2015 in the District Court of New Jersey
• Plaintiffs: Jazz Pharmaceuticals, Inc.; Jazz Pharmaceuticals Ireland Ltd.
• Defendants: Wockhardt Bio AG; Wockhardt Limited; Wockhardt USA LLC
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 ("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), 8,461,203 ("Microbiologically Sound and Stable Solutions of Gamma-Hydroxybutyrate Salt for the Treatment of Narcolepsy," issued June 11, 2013), 7,668,730 ("Sensitive Drug Distribution System and Method," issued February 23, 2010), 7,765,106 (same title, issued July 27, 2010), 7,765,107 (same title, issued July 27, 2010), 7,895,059 (same title, issued February 22, 2011), 8,457,988 (same title, issued June 4, 0213), 8,589,182 (same title, issued November 19, 2013), 8,731,963 (same title, issued May 20, 2014), 8,772,306 ("Method of Administration of Gamma Hydroxybutyrate with Monocarboxylate Transporters," issued July 8, 2014), 8,859,619 ("Microbiologically Sound and Stable Solutions of Gamma-Hydroxybutyrate Salt for the Treatment of Narcolepsy," issued October 14, 2014), and 8,952,062 (same title, issued February 10, 2015) following a Paragraph IV certification as part of Wockhardt's filing of an ANDA to manufacture a generic version of Jazz's Xyrem® (sodium oxybate, used to treat narcolepsy). View the complaint here.
Spectrum Pharmaceuticals, Inc. et al. v. Actavis LLC
2:15-cv-01360; filed July 17, 2015 in the District Court of Nevada
• Plaintiffs: Spectrum Pharmaceuticals, Inc.; University of Strathclyde
• Defendant: Actavis LLC
Infringement of U.S. Patent No. 6,500,829 ("Substantially Pure Diastereoisomers of Tetrahydrofolate Derivatives," issued December 31, 2002) following a Paragraph IV certification as part of Actavis' filing of an ANDA to manufacture a generic version of Spectrum's Fusilev® (levoleucovorin, used to treat advanced metastatic colorectal cancer). View the complaint here.
