About Court Report: Each week we will report briefly on recently filed biotech and pharma cases.
Celltrion Healthcare Co. et al. v. Janssen Biotech, Inc.
1:14-cv-11613; filed March 31, 2014 in the District Court of Massachusetts
• Plaintiffs: Celltrion Healthcare Co., Ltd.; Celltrion, Inc.
• Defendant: Janssen Biotech, Inc.
Declaratory judgment of invalidity and unenforceability of U.S. Patent Nos. 5,919,452 ("Methods of Treating TNFa-Mediated Disease Using Chimeric Anti-TNF Antibodies," issued July 6, 1999), 6,284,471 ("Anti-TNFa Antibodies And Assays Employing Anti-TNFa Antibodies," issued September 4, 2001) and 7,223,396 ("Methods of Treatment of Fistulas in Crohn's Disease with Anti-TNF Antibodies," issued May 29, 2007) based on Celltrion's anticipated manufacture and sale of its Remsima® product, 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.
Celltrion Healthcare Co. et al. v. Kennedy Trust for Rheumatology Research
1:14-cv-02256; filed March 31, 2014 in the Southern District of New York
• Plaintiffs: Celltrion Healthcare Co., Ltd.; Celltrion, Inc.
• Defendant: Kennedy Trust for Rheumatology Research
Declaratory judgment of invalidity of U.S. Patent Nos. 7,846,442 ("Methods of Treating Rheumatoid Arthritis with an Anti-TNF-alpha Antibodies and Methotrexate," issued December 7, 2010), 8,298,537 ("Concomitant Treatment of Rheumatoid Arthritis with Anti-TNF-a Antibodies and Methotrexate," issued October 30, 2012) and 8,383,120 (same title, issued February 26, 2013) based on Celltrion's anticipated manufacture and sale of its Remsima® product, 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.
Supernus Pharmaceuticals, Inc. v. Actavis Inc. et al.
1:14-cv-01981; filed March 28, 2014 in the District Court of New Jersey
• Plaintiffs: Supernus Pharmaceuticals, Inc.
• Defendants: Actavis Inc.; Watson Laboratories, Inc. – Florida; Actavis Pharma, Inc.; Watson Laboratories, Inc.; Anda, Inc.
Infringement of U.S. Patent No. 8,617,600 ("Modified Release Preparations Containing Oxcarbazepine and Derivatives Thereof," issued December 31, 2013) following a Paragraph IV certification as part of Actavis' filing of an ANDA to manufacture a generic version of Supernus' Oxtellar XR (oxcarbazepine extended-release tablets, used for adjunctive therapy in the treatment of partial seizures in adults and in children 6 to 17 years of age). View the complaint here.
Bausch & Lomb Incorporated et al. v. Micro Labs Limited et al.
1:14-cv-01974; filed March 28, 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: Micro Labs Ltd.; Micro Labs USA, Inc.
Bausch & Lomb Inc. et al. v. Apotex Inc. et al.
1:14-cv-01975; filed March 28, 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: Apotex Inc.; Apotex Corp.
The complaints in these cases are substantially identical. 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 defendants' 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 Micro Labs complaint here.
Otsuka Pharmaceutical Co. v. Wockhardt Bio AG et al.
1:14-cv-01979; filed March 28, 2014 in the District Court of New Jersey
• Plaintiff: Otsuka Pharmaceutical Co., Ltd.
• Defendants: Wockhardt Bio AG; Wockhardt USA LLC; Wockhardt Ltd.
Infringement of U.S. Patent Nos. 8,017,615 ("Low Hygroscopic Aripiprazole Drug Substance and Process for the Preparation Thereof," issued September 13, 2011) and 8,580,796 (same title, issued November 12, 2013) following a Paragraph IV certification as part of Wockhardt's filing of an ANDA to manufacture a generic version of Otsuka's Abilify® (aripiprazole, used to treat bipolar disorder and schizophrenia). View the complaint here.
Mallinckrodt LLC et al. v. Amneal Pharmaceuticals LLC
1:14-cv-00389; filed March 27, 2014 in the District Court of Delaware
• Plaintiffs: Mallinckrodt LLC; Mallinckrodt Inc.; Nuvo Research Inc.
• Defendant: Amneal Pharmaceuticals LLC
Infringement of U.S. Patent Nos. 8,217,078 ("Treatment of Pain with Topical Diclofenac," issued July 10, 2012), 8,546,450 (same title, issued October 1, 2013), and 8,618,164 (same title, issued December 31, 2013) following a Paragraph IV certification as part of Amneal's filing of an ANDA to manufacture a generic version of Mallinckrodt's Pennsaid® (diclofenac sodium topical solution, used for the treatment of signs and symptoms of osteoarthritis of the knee(s)). View the complaint here.
