About Court Report: Each week we will report briefly on recently filed biotech and pharma cases.
Takeda Pharmaceutical Co. Ltd. v. Lee
1:16-cv-00852; filed July 1, 2016 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. 8,900,638 ("Solid Preparation Comprising Alogliptin and Metformin Hydrochloride," issued December 2, 2014). View the complaint here.
Alcon Pharmaceuticals Ltd. et al. v. Imprimis Pharmaceuticals, Inc.
1:16-cv-00563; filed June 30, 2016 in the District Court of Delaware
• Plaintiffs: Alcon Pharmaceuticals Ltd.; Alcon Research, Ltd.
• Defendants: Imprimis Pharmaceuticals, Inc.
Infringement of U.S. Patent Nos. 6,716,830 ("Ophthalmic Antibiotic Compositions Containing Moxifloxacin," issued April 6, 2004) and 7,671,070 ("Method of Treating Ophthalmic Infections with Moxifloxacin Compositions," issued March 2, 2010) based on Imprimis' manufacture and sale of moxifloxacin ophthalmic products, similar to Alcon's Vigamox® (moxifloxacin hydrochloride, used to treat bacterial conjunctivitis). View the complaint here.
Horizon Therapeutics, Inc. v. Par Pharmaceutical, Inc.
1:16-cv-03910; filed June 30, 2016 in the District Court of New Jersey
Infringement of U.S. Patent Nos. 9,095,559 ("Methods of Therapeutic Monitoring of Nitrogen Scavenging Drugs," issued August 4, 2015), 9,254,278 (same title, issued February 9, 2016), and 9,326,966 (same title, issued May 3, 2016) following Par's filing of an ANDA to manufacture a generic version of Horizon's Ravicti® (glycerol phenylbutyrate oral liquid, used as a nitrogen binding agent for chronic management of adult and pediatric patients ≥ 2 years of age with urea cycle disorders that cannot be managed by dietary protein restriction and/or amino acid supplementation alone). View the complaint here.
Genzyme Corp. et al. v. Zydus Pharmaceuticals (USA) Inc.
1:16-cv-03905; filed June 30, 2016 in the District Court of New Jersey
• Plaintiffs: Genzyme Corp.; Sanofi-Aventis U.S. LLC
• Defendant: Zydus Pharmaceuticals (USA) Inc.
Infringement of U.S. Patent Nos. 7,897,590 ("Methods to mobilize progenitor/stem cells" issued March 1, 2011) and 6,987,102 ("Methods to mobilize progenitor/stem cells" issued January 17, 2006) following a Paragraph IV certification as part of Zydus' filing of an ANDA to manufacture a generic version of Genzyme's Mozobil® (plerixafor solution for injection, used in combination with granulocyte-colony stimulating factor to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with non-Hodgkin's lymphoma and multiple myeloma). View the complaint here. [NB: The complaint was later voluntarily dismissed without prejudice.]
Genzyme Corp. et al. v. Amneal Pharmaceuticals LLC
2:16-cv-03892; filed June 29, 2016 in the District Court of New Jersey
• Plaintiffs: Genzyme Corp.; Southern Research Institute; Sanofi-Aventis U.S. LLC
• Defendant: Amneal Pharmaceuticals LLC
Infringement of U.S. Patent No. 5,661,136 ("2-Halo-2'-Fluoro ARA Adenosines as Antinoplastic Agents," issued August 26, 1997) following a Paragraph IV certification as part of Amneal's filing of an ANDA to manufacture a generic version of Genzyme's Clolar® (clofarabine injection, used to treat acute lymphoblastic leukemia). View the complaint here.