About Court Report: Each week we will report briefly on recently filed biotech and pharma cases.
Allergan, Inc. v. Actavis plc et al.
2:14-cv-00188; filed March 6, 2014 in the Eastern District of Texas
• Plaintiff: Allergan, Inc.
• Defendants: Actavis plc; Actavis, Inc.; Watson Laboratories, Inc.; Actavis Pharma, Inc.
Infringement of U.S. Patent No. 8,629,111 ("Methods of Providing Therapeutic Effects Using Cyclosporine Components," issued January 14, 2014) following a Paragraph IV certification as part of Actavis' filing of an ANDA to manufacture a generic version of Allergan's Retasis (cyclosporine ophthalmic emulsion, used to increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca). View the complaint here.
Novartis Pharmaceuticals Corp. v. Pharmaceutics International, Inc.
2:14-cv-01347; filed March 4, 2014 in the District Court of New Jersey
Infringement of U.S. Patent No. 8,324,189 ("Use of Zolendronate for the Manufacture of a Medicament for the Treatment of Bone Metabolism Diseases," issued December 4, 2012) following a Paragraph IV certification as part of Pharmaceutics International's filing of an NDA (under § 505(b)(2) of the Food, Drug and Cosmetic Act) to manufacture a generic version of Novartis' Zometa® (zoledronic acid, used for the prevention of skeletal-related complications associated with cancer). View the complaint here.
Amarin Pharmaceuticals Ireland Ltd. v. Omthera Pharmaceuticals Inc. et al.
1:14-cv-00279; filed March 4, 2014 in the District Court of Delaware
• Plaintiff: Amarin Pharmaceuticals Ireland Ltd.
• Defendants: Omthera Pharmaceuticals Inc.; AstraZeneca Pharmaceuticals LP
Infringement of U.S. Patent No. 8,663,662 ("Stable Pharmaceutical Compositions and Methods of Using Same" issued March 4, 2014) based on AstraZeneca's anticipated marketing and sale of their Epanova™ (mixture of polyunsaturated free fatty acids derived from fish oils for use as an adjunct to diet to reduce triglyceride levels in adult patients with severe (= 500 mg/dL) hypertriglyceridemia). View the complaint here.
Roxane Laboratories, Inc. v. Camber Pharmaceuticals, Inc. et al.
2:14-cv-00232; filed March 4, 2014 in the Southern District of Ohio
• Plaintiff: Roxane Laboratories, Inc.
• Defendants: Camber Pharmaceuticals, Inc.; Invagen Pharmaceuticals, Inc.
Infringement of U.S. Patent No. 8,563,032 ("Formulation and Manufacturing Process for Calcium Acetate Capsules," issued October 22, 2013) based on defendants' anticipated manufacture and sale of a generic calcium acetate capsule, having filed an ANDA to manufacture a generic version of Fresenius' PhosLo® Gelcaps (calcium acetate, used for the reduction of serum phosphorous in patients with end stage renal disease). View the complaint here.
Bausch & Lomb Inc. et al. v. Sandoz Inc. et al.
1:14-cv-01325; filed March 2, 2014 in the District Court of New Jersey
• Plaintiffs: Bausch & Lomb Inc.; Bausch & Lomb Pharma Holdings Corp.; Mitsubishi Tanabe Pharma Corp.; Ube Industries, Ltd.
• Defendants: Sandoz Inc.; Sandoz International GmbH
Infringement of U.S. Patent No. 6,780,877 ("Acid Addition Salt of Optically Active Piperidine Compound and Process for Preparing the Same," issued August 24, 2004) following a Paragraph IV certification as part of Sandoz's filing of an ANDA to manufacture a generic version of Bausch & Lomb's Bepreve® (bepotastine besilate ophthalmic solution, used for the treatment of itching associated with allergic conjunctivitis). View the complaint here.