About Court Report: Each week we will report briefly on recently filed biotech and pharma cases.
AstraZeneca AB v. Watson Laboratories Inc. et al.
1:14-cv-01051; filed August 15, 2014 in the District Court of Delaware
• Plaintiff: AstraZeneca AB
• Defendants: Watson Laboratories Inc.; Actavis Inc.; Actavis LLC
Infringement of U.S. Patent No. RE44,186 ("Cyclopropyl-Fused Pyrrolidine-Based Inhibitors of Dipeptidyl Peptidase IV and Method," issued April 30, 2013) following a Paragraph IV certification as part of Watson's filing of an ANDA to manufacture a generic version of AstraZeneca's Onglyza® (saxagliptin hydrochloride, used as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus). View the complaint here.
Novartis Pharmaceuticals Corp. et al. v. Breckenridge Pharmaceutical, Inc.
9:14-cv-81067; filed August 15, 2014 in the Southern District of Florida
• Plaintiffs: Novartis Pharmaceuticals Corp.; Novartis AG
• Defendant: Breckenridge Pharmaceutical, Inc.
Novartis Pharmaceuticals Corporation et al. v. Breckenridge Pharmaceutical Inc.
1:14-cv-01043; filed August 13, 2014 in the District Court of Delaware
• Plaintiffs: Novartis Pharmaceuticals Corp.; Novartis AG
• Defendant: Breckenridge Pharmaceutical Inc.
The complaints in these cases are substantially identical. Infringement of U.S. Patent Nos. 5,665,772 ("O-alkylated Rapamycin Derivatives and Their Use, Particularly as Immunosuppressants," issued September 9, 1997), 6,004,973 ("Pharmaceutical Compositions Comprising Rafamycin Coprecipitates," issued December 21, 1999), 6,239,124 ("Pharmaceutical Compositions for the Treatment of Transplant Rejection or Autoimmune or Inflammatory Conditions Comprising Cyclosporin A and 40-0-(2-hydroxyethyl)-rapamycin," issued May 29, 2001), and 6,455,518 ("Pharmaceutical Compositions for the Treatment of Transplant Rejection, Autoimmune or Inflammatory Conditions Comprising Cyclosporin A and 40-O-(2-hydroxyethyl)-rapamycin," issued September 24, 2002) following a Paragraph IV certification as part of Ben Venue's filing of an ANDA to manufacture a generic version of Novartis' Zortress® (everolimus, used for the prophylaxis of organ rejection in adult patients at low-moderate immunologic risk receiving a kidney transplant, and for the prophylaxis of allograft rejection in adult patients receiving a liver transplant). View the Delaware complaint here.
Cephalon Inc. v. Ben Venue Laboratories Inc. et al.
1:14-cv-01045; filed August 13, 2014 in the District Court of Delaware
• Plaintiff: Cephalon Inc.
• Defendants: Ben Venue Laboratories Inc.; Hikma Pharmaceuticals PLC; West-Ward Pharmaceutical Corp.
Infringement of U.S. Patent Nos. 8,791,270 ("Bendamustine Pharmaceutical _Compositions," issued July 29, 2014), 8,445,524 ("Solid Forms of Bendamustine Hydrochloride," issued May 21, 2013), 8,436,190 ("Bendamustine Pharmaceutical Compositions," issued May 7, 2013), and 8,609,863 ("Bendamustine Pharmaceutical Compositions," issued December 17, 2013) following a Paragraph IV certification as part of Ben Venue's filing of an ANDA to manufacture a generic version of Cephalon's Treanda® (bendamustine hydrochloride, used to treat chronic lymphocytic leukemia and non-Hodgkin's lymphoma). View the complaint here.
Dow Pharmaceutical Sciences, Inc. et al. v. Taro Pharmaceuticals U.S.A., Inc. et al.
2:14-cv-05079; filed August 13, 2014 in the District Court of New Jersey
• Plaintiffs: Dow Pharmaceutical Sciences, Inc.; Valeant Pharmaceuticals North America LLC
• Defendants: Taro Pharmaceuticals U.S.A., Inc.; Taro Pharmaceutical Industries Ltd.
Infringement of U.S. Patent No. 8,288,434 ("Topical Pharmaceutical Formulations Containing a Low Concentration of Benzoyl Peroxide in Suspension in Water and a Water-Miscible Organic Solvent," issued October 16, 2012) and 8,663,699 ("Topical Pharmaceutical Formulations Containing a Low Concentration of Benzoyl Peroxide in Suspension in Water and a Water-Miscible Organic Solvent," issued March 4, 2014) following a Paragraph IV certification as part of Taro's filing of an ANDA to manufacture a generic version of Dow's Acanya® (clindamycin phosphate and benzoyl peroxide gel, 1.2%/2.5%, used to treat acne). View the complaint here.
Janssen Products, L.P. et al. v. Cipla Ltd. et al.
2:14-cv-05093; filed August 13, 2014 in the District Court of New Jersey
• Plaintiffs: Janssen Products, L.P.; Janssen R&D Ireland
• Defendants: Cipla Ltd.; Cipla USA, Inc.
Infringement of U.S. Patent Nos. 7,700,645 ("Pseudopolymorphic Forms of a HIV Protease Inhibitor," issued April 20, 2010), 7,126,015 ("Method for the Preparation of Hexahydro-furo-[2,3-b]furan-3-ol," issued October 24, 2006), 7,595,408 ("Methods for the Preparation of (3R,3aS,6aR)hexahydro-furo[2,3-b]furan-3-ol," issued September 29, 2009), and 8,518,987 ("Pseudopolymorphic Forms of a HIV Protease Inhibitor," issued August 27, 2013) following a Paragraph IV certification as part of Cipla's filing of an ANDA to manufacture a generic version of Janssen's Prezista® (darunavir, used to treat human immunodeficiency virus (HIV-1) infection). View the complaint here.
UCB, Inc. v. Yeda Research and Development Co. Ltd.
1:14-cv-01038; filed August 13, 2014 in the Eastern District of Virginia
Declaratory judgment invalidity, unenforceability, and non-infringement of U.S. Patent No. 6,090,923 ("Murine Monoclonal Antibody Binding TNFα," issued July 18, 2000) based on UCB's manufacture and sale of its Cimzia® product (certolizumab pegol, used to treat Crohn's disease, rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis). View the complaint here.
Cephalon Inc. v. Eagle Pharmaceuticals Inc.
1:14-cv-01042; filed August 12, 2014 in the District Court of Delaware
Infringement of U.S. Patent No. 8,791,270 ("Bendamustine Pharmaceutical Compositions," issued July 29, 2014) in conjunction with Eagle's filing of an NDA (under § 505(b)(2) of the Food, Drug and Cosmetic Act) to manufacture a generic version of Cephalon's Treanda® (bendamustine hydrochloride, used to treat chronic lymphocytic leukemia and non-Hodgkin's lymphoma). View the complaint here.
