About Court Report: Each week we will report briefly on recently filed biotech and pharma cases.
Janssen Biotech, Inc. v. Celltrion Healthcare Co., Ltd. et al.
1:16-cv-11117; filed June 14, 2016 in the District Court of Massachusetts
• Plaintiff: Janssen Biotech, Inc.
• Defendants: Celltrion Healthcare Co., Ltd.; Celltrion, Inc.; Hospira, Inc.
Infringement of U.S. Patent No. 7,598,083 ("Chemically Defined Media Compositions," issued October 6, 2009) based on defendants' alleged control of the development of cell culture media, used to manufacture of defendants' infliximab biosimilar, a biosimilar to Janssen's Remicade® (infliximab, used to treat rheumatoid arthritis, ulcerative colitis, Crohn's disease, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis). View the complaint here.
Janssen Biotech v. Hyclone Laboratories
1:16-cv-00071; filed June 14, 2016 in the District Court of Utah
Infringement of U.S. Patent No. 7,598,083 ("Chemically Defined Media Compositions," issued October 6, 2009) based on HyClone's development of cell culture media, supplied to Celltrion and Hospira to manufacture an infliximab biosimilar, a biosimilar to Janssen's Remicade® (infliximab, used to treat rheumatoid arthritis, ulcerative colitis, Crohn's disease, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis). View the complaint here.
Novartis Pharmaceuticals Corp. et al. v. Breckenridge Pharmaceutical Inc.
1:16-cv-00431; filed June 13, 2016 in the District Court of Delaware
• Plaintiffs: Novartis Pharmaceuticals Corp.; Novartis AG
• Defendant: Breckenridge Pharmaceutical Inc.
Infringement of U.S. Patent Nos. 5,665,772 ("O-alkylated Rapamycin Derivatives and Their Use, Particularly as Immunosuppressants," issued September 9, 1997), 8,410,131 ("Cancer Treatment," issued April 2, 2013), and 8,778,962 ("Treatment of Solid Tumors with Rapamycin Derivatives," issued July 15, 2014) following a Paragraph IV certification as part of Breckenridge's filing of an ANDA to manufacture a generic version of Novartis' Afinitor® (everolimus, used for the treatment of: postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer in combination with exemestane after failure of treatment with letrozole or anastrozole; adults with progressive neuroendocrine tumors of pancreatic origin that are unresectable, locally advanced or metastatic; adults with advanced renal cell carcinoma after failure of treatment with sunitinib or sorafenib; adults with renal angiomyolipoma and tuberous sclerosis complex, not requiring immediate surgery; and pediatric and adult patients with tuberous sclerosis complex who have subependymal giant cell astrocytoma that requires therapeutic intervention but cannot be curatively resected). View the complaint here.
LEO Pharma A/S et al. v. Perrigo UK FINCO Limited Partnership et al.
1:16-cv-00430; filed June 10, 2016 in the District Court of Delaware
• Plaintiffs: LEO Pharma A/S; LEO Laboratories Ltd.; LEO Pharma, Inc.
• Defendants: Perrigo UK FINCO Limited Partnership; Perrigo Co.
Infringement of U.S. Patent Nos. 6,432,452 ("Anti-Cancer Compounds," issued August 13, 2002), 6,787,161 (same title, issued September 7, 2004), 6,844,013 ("Methods of Stimulating the Immune System," issued January 18, 2005), 7,410,656 ("Anti-Cancer Compounds," issued August 12, 2008), 8,278,292 ("Therapeutic Compositions," issued October 2, 2012), 8,372,827 (same title, issued February 12, 2013), 8,372,828 (same title, issued February 12, 2013), 8,377,919 (same title, issued February 19, 2013), 8,536,163 (same title, issued September 17, 2013), 8,716,271 (same title, issued May 6, 2014), and 8,735,375 (same title, issued May 27, 2014) following a Paragraph IV certification as part of Perrigo's filing of an ANDA to manufacture a generic version of LEO Pharma's Picato® ( ingenol mebutate gel, used for the topical treatment of actinic keratosis). View the complaint here.
Purdue Pharma, L.P. v. Collegium Pharmaceutical, Inc.
1:16-cv-11091; filed June 10, 2016 in the District Court of Massachusetts
• Plaintiff: Purdue Pharma, L.P.
• Defendant: Collegium Pharmaceutical, Inc.; Collegium Pharmaceutical, Inc.
Infringement of U.S. Patent No. 9,155,717 ("Pharmaceutical Formulation Containing Irritant," issued October 13, 2015) based on Collegium's filing of an NDA (under § 505(b)(2) of the Food, Drug and Cosmetic Act) to manufacture its Xtampza ER product (oxycodone myristate), comparable to Purdue Pharma's OxyContin® (controlled release oxycodone hydrochloride, used to treat pain). View the complaint here.
Aurobindo Pharma USA Inc. et al. v. Apicore US LLC et al.
1:16-cv-03358; filed June 9, 2016 in the District Court of New Jersey
• Plaintiffs: Aurobindo Pharma Usa Inc.; Aurobindo Pharma Ltd.; Auromedics Pharma LLC
• Defendants: Apicore US LLC; Mylan Institutional LLC
Declaratory judgment of non-infringement and invalidity of U.S. Patent Nos. 7,662,992 ("Process for Preparation of Isosulfan Blue," issued February 16, 2010), 8,969,616 (same title, issued March 3, 2015), and 9,353,050 (same title, issued May 31, 2016) based on Aurobindo's filing of an ANDA to manufacture a 1% strength isosulfan blue for injection. View the complaint here.
