About Court Report: Each week we will report briefly on recently filed biotech and pharma cases.
Forest Laboratories LLC et al. v. Sigmapharm Laboratories LLC
1:14-cv-01119; filed September 3, 2014 in the District Court of Delaware
• Plaintiffs: Forest Laboratories LLC; Forest Laboratories Holdings Ltd.
• Defendant: Sigmapharm Laboratories LLC
Infringement of U.S. Patent Nos. 5,763,476 ("Sublingual or Buccal Pharmaceutical Composition," issued June 9, 1998) and 7,741,358 ("Crystal Form of Asenapine Maleate," issued June 22, 2010) following a Paragraph IV certification as part of Sigmapharm's filing of an ANDA to manufacture a generic version of Forest's Saphris® (asenapine maleate, sublingual, used to treat schizophrenia and manic or mixed episodes associated with bipolar I disorder). View the complaint here.
Cephalon, Inc. v. Nang Kuang Pharmaceutical Co., LTD et al.
1:14-cv-05180; filed September 3, 2014 in the Eastern District of New York
• Plaintiff: Cephalon, Inc.
• Defendants: Nang Kuang Pharmaceutical Co., LTD; Canada NK-1, LLC
Cephalon, Inc. v. Nang Kuang Pharmaceutical Co LTD et al.
1:14-cv-01117; filed September 2, 2014 in the District Court of Delaware
• Plaintiff: Cephalon, Inc.
• Defendants: Nang Kuang Pharmaceutical Co LTD; Canada NK-1 LLC
Cephalon, Inc. v. Sagent Pharmaceuticals Inc. et al.
1:14-cv-01116; filed September 2, 2014 in the District Court of Delaware
• Plaintiff: Cephalon, Inc.
• Defendants: Sagent Pharmaceuticals Inc.; Sagent Agila LLC
The complaints in these cases are substantially identical. Infringement of U.S. Patent Nos. 8,445,524 ("Solid Forms of Bendamustine Hydrochloride," issued May 21, 2013), 8,436,190 ("Bendamustine Pharmaceutical Compositions," issued May 7, 2013), 8,609,863 (same title, issued December 17, 2013), and 8,791,270 (same title, issued July 29, 2014) following a Paragraph IV certification as part of defendants' 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 Sagent complaint here.
United Therapeutics Corp. v. Teva Pharmaceuticals USA, Inc.
3:14-cv-05498; filed September 2, 2014 in the District Court of New Jersey
Infringement of U.S. Patent Nos. 6,765,117 ("Process for Stereoselective Synthesis of Prostacyclin Derivatives," issued July 20, 2004), 8,497,393 ("Process to Prepare Treprostinil, the Active Ingredient in Remodulin®," issued July 30, 2014), 7,999,007 ("Buffer Solutions Having Selective Bactericidal Activity Against Gram Negative Bacteria," issued August 16, 2011), 8,653,137 (same title, issued February 18, 2014), and 8,658,694 (same title, issued February 25, 2014) following a Paragraph IV certification as part of Teva's filing of an ANDA to manufacture a generic version of United's Remodulin® (treprostinil sodium injection, used to treat pulmonary arterial hypertension). View the complaint here.
United Therapeutics Corp. v. Sandoz, Inc.
3:14-cv-05499; filed September 2, 2014 in the District Court of New Jersey
Infringement of U.S. Patent No. 8,497,393 ("Process to Prepare Treprostinil, the Active Ingredient in Remodulin®," issued July 30, 2014) following a Paragraph IV certification as part of Sandoz's filing of an ANDA to manufacture a generic version of United's Remodulin® (treprostinil sodium injection, used to treat pulmonary arterial hypertension). View the complaint here.
Mission Pharmacal Co. v. Acella Pharmaceuticals, L.L.C.
5:14-cv-00771; filed September 2, 2014 in the Western District of Texas
Infringement of U.S. Patent No. 6,521,247 ("Dual Iron Containing Nutritional Supplement," issued February 18, 2003) based on Acella's manufacture and sale of its Prenaissance Promise, Prenaissance DHA, and Prenaissance 90 DHA prenatal supplements. View the complaint here.
Hospira, Inc. v. Janssen Biotech, Inc. et al.
1:14-cv-07049; filed August 29, 2014 in the Southern District of New York
• Plaintiff: Hospira, Inc.
• Defendants: Janssen Biotech, Inc.; New York University; NYU Langone Medical Center; Kennedy Trust for Rheumatology Research
Declaratory judgment of non-infringement and invalidity U.S. Patent Nos. 6,284,471 ("Anti-TNFa Antibodies And Assays Employing Anti-TNFa Antibodies," issued September 4, 2001), 7,223,396 ("Methods of Treatment of Fistulas in Crohn's Disease with Anti-TNF Antibodies," issued May 29, 2007), 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 ("Concomitant Treatment of Rheumatoid Arthritis with Anti-TNF-alpha Antibodies and Methotrexate," issued February 26, 2013) based on Hospira's anticipated manufacture and sale of its Inflectra® 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.
Boehringer Ingelheim Pharma Gmbh & Co. KG et al. v. Mylan Pharmaceuticals Inc.
1:14-cv-00146; filed August 29, 2014 in the Northern District of West Virginia
• Plaintiffs: Boehringer Ingelheim Pharma GmbH & Co. KG; Boehringer Ingelheim International GmbH; Boehringer Ingelheim Pharmaceuticals, Inc.
• Defendant: Mylan Pharmaceuticals Inc.
Infringement of U.S. Patent No. 6,015,577 ("Pharmaceutical Compositions Containing Dipyridamole or Mopidamol and Acetylsalicylic Acid or the Physiologically Acceptable Salts Thereof, Processes for Preparing Them and Their Use in Treating Clot Formation," issued January 18, 2000) following a Paragraph IV certification as part of Mylan's filing of an ANDA to manufacture a generic version of Boehringer's Aggrenox® (extended-release dipyridamole/acetylsalicylic acid, used to reduce the risk of stroke in patients who have had transient ischemia of the brain or completed ischemic stroke due to thrombosis). View the complaint here.
