About Court Report: Each week we will report briefly on recently filed biotech and pharma cases.
Par Pharmaceutical, Inc. v. Glaxosmithkline LLC et al.
2:14-cv-06627; filed November 19, 2014 in the Eastern District of Pennsylvania
• Plaintiff: Par Pharmaceutical, Inc.
• Defendants: Glaxosmithkline LLC; Aptalis Pharma US, Inc.; Aptalis Pharmatech, Inc.; Aptalis Pharma Canada Inc.
Declaratory judgment of non-infringement of U.S. Patent No. 7,919,115 ("Orally Disintegrating Tablet Compositions of Lamotrigine," issued April 5, 2011) based on Par's filing of an ANDA (and Paragraph IV certification) to manufacture a generic version of GSK's Lamictal ODT® (orally disintegrating lamotrigine tablets). View the complaint here.
Teva Pharmaceuticals USA Inc. et al. v. Synthon Pharmaceuticals, Inc. et al.
1:14-cv-01419; filed November 18, 2014 in the District Court of Delaware
• Plaintiffs: Teva Pharmaceuticals USA Inc.; Teva Pharmaceutical Industries Ltd; Teva Neuroscience Inc; Yeda Research and Development Co Ltd.
• Defendants: Synthon Pharmaceuticals, Inc.; Synthon B.V.; Synthon s.r.o. Blansko
Teva Pharmaceuticals USA, Inc. et al. v. Synthon Pharmaceuticals, Inc. et al.
1:14-cv-00975; filed November 19, 2014 in the Middle District of North Carolina
• Plaintiffs: Teva Pharmaceuticals USA, Inc.; Teva Pharmaceutical Industries Ltd.; Teva Neuroscience, Inc.; Yeda Research and Development Co., Ltd.
• Defendants: Synthon Pharmaceuticals, Inc.; Synthon B.V.; Synthon s.r.o. Blansko
The complaints in these cases are substantially identical. Infringement of U.S. Patent Nos. 8,232,250 ("Low Frequency Glatiramer AcetateTherapy," issued July 31, 2012) and 8,399,413 (same title, issued March 19, 2013) following a Paragraph IV certification as part of Synthon's filing of an ANDA to manufacture a generic version of Teva's Copaxone® (glatiramer acetate injection, used for the reduction or frequency of relapses in patients with relapsing-remitting multiple sclerosis). View the Delaware complaint here.
Amgen Inc. v. Sanofi et al.
1:14-cv-01414; filed November 17, 2014 in the District Court of Delaware
• Plaintiff: Amgen Inc.
• Defendants: Sanofi ; Sanofi-Aventis U.S. LLC; Aventisub LLC; Regeneron Pharmaceuticals Inc.
Infringement of U.S. Patent No. 8,889,834 ("Antigen Binding Proteins to Proprotein Convertase Subtilisin Kexin Type 9 (PCSK9)," issued November 18, 2014) based on defendants' current and/or imminent manufacture, use, sale, offer to sell, and/or importation into the U.S. of alirocumab, an anti-PCSK9 antibody (used to treat dyslipidemia and other cholesterol disorders). View the complaint here.
BioMarin Pharmaceutical Inc. et al. v. Dr. Reddy's Laboratories, Inc. et al.
3:14-cv-07203; filed November 17, 2014 in the District Court of New Jersey
• Plaintiffs: BioMarin Pharmaceutical Inc.; Merck & Cie
• Defendants: Dr. Reddy's Laboratories, Inc.; Dr. Reddy's Laboratories, Ltd.
Infringement of U.S. Patent Nos. 7,566,462 ("Stable Tablet Formulation," issued July 28, 2009), 7,566,714 ("Methods and Compositions for the Treatment of Metabolic Disorders," issued July 28, 2009), 7,612,073 ("Methods of Administering Tetrahydrobiopterin, Associated Compositions, and Methods of Measuring," issued November 3, 2009), 8,003,126 ("Stable Table Formulation," issued August 23, 2011), 8,067,416 ("Methods and Compositions for the Treatment of Metabolic Disorders," issued November 29, 2011), RE43,797 ("Methods of Administering Tetrahydrobiopterin," issued November 6, 2012), and 8,318,745 ("Crystalline Forms of (6R)-L-Erythro-Tetrahydrobiopterin Dihydrochloride," issued November 27, 2012) following a Paragraph IV certification as part of Dr. Reddy's filing of an ANDA to manufacture a generic version of BioMarin's Kuvan® (sapropterin dihydrochloride, used to reduce blood phenylalanine levels in patients with hyperphenylalaninemia due to tetrahydrobiopterin- (BH4-) responsive phenylketonuria). View the complaint here.
Purdue Pharma L.P. v. Watson Laboratories Inc.
1:14-cv-01410; filed November 14, 2014 in the District Court of Delaware
Infringement of U.S. Patent Nos. RE41,408 ("Method of Providing Sustained Analgesia with Buprenorphine," issued June 29, 2010), RE41,489 (same title, issued August 10, 2010), and RE41,571 (same title, issued August 24, 2010) following a Paragraph IV certification as part of Watson's amendment of its ANDA (adding another dosage) to manufacture a generic version of Purdue Pharma's Butrans® (buprenorphine transdermal, used for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate). View the complaint here.
