About Court Report: Each week we will report briefly on recently filed biotech and pharma cases.
Janssen Biotech, Inc. et al. v. Celltrion Healthcare Co., Ltd. et al.
1:15-cv-10698; filed March 6, 2015 in the District Court of Massachusetts
• Plaintiffs: Janssen Biotech, Inc.; New York University
• Defendants: Celltrion Healthcare Co., Ltd.; Celltrion, Inc.; Hospira Inc.
Infringement of 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), 5,807,715 ("Methods And Transformed Mammalian Lymphocyte Cells For Producing Functional Antigen-Binding Protein Including Chimeric Immunoglobulin," issued September 15, 1998), 7,598,083 ("Chemically Defined Media Compositions," issued October 6, 2009), 6,900,056 ("Chemically Defined Medium for Cultured Mammalian Cells," issued May 31, 2005), and 6,773,600 ("Use of Clathrate Modifier, To Promote Passage of Proteins During Nanofiltration," issued August 10, 2004) based on defendants' filing of an aBLA to manufacture and sell 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 AG et al. v. HEC Pharm Co., Ltd. et al.
2:15-cv-01647; filed March 5, 2015 in the District Court of New Jersey
• Plaintiffs: Novartis AG; Novartis Pharmaceuticals Corp.; Mitsubishi Tanabe Pharma Corp.; Mitsui Sugar Co., Ltd.
• Defendants: HEC Pharm Co., Ltd.; HEC Pharm Group; HEC Pharm USA Inc.
Infringement of U.S. Patent No. 5,604,229 ("2-Amino-1,3-Propanediol Compound and Immunosuppressant," issued February 18, 1997) following a Paragraph IV certification as part of HEC's filing of an ANDA to manufacture a generic version of Novartis' Gilenya® (fingolimod hydrochloride, used to reduce the frequency of clinical exacerbations and to delay the accumulation of physical disability in patients with relapsing forms of multiple sclerosis). View the complaint here.
Boehringer Ingelheim Pharma GmbH & Co. KG et al. v. Breckenridge Pharmaceutical, Inc.
2:15-cv-01647; filed March 5, 2015 in the District Court of New Jersey
• Plaintiffs: Boehringer Ingelheim Pharma GmbH & Co. KG; Boehringer Ingelheim International GmbH; Boehringer Ingelheim Pharmaceuticals, Inc.
• Defendant: Breckenridge Pharmaceutical, Inc.
Infringement of U.S. Patent No. 6,087,380 ("Disubstituted Bicyclic Heterocycles, the Preparations and the Use Thereof as Pharmaceutical Compositions," issued July 11, 2000) following a Paragraph IV certification as part of Breckenridge's filing of an ANDA to manufacture a generic version of Boehringer's Pradaxa® (dabigatran etexilate mesylate, used to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation). View the complaint here.
Vivus, Inc. v. Actavis Laboratories FL, Inc. et al.
2:15-cv-01636; filed March 4, 2015 in the District Court of New Jersey
• Plaintiff: Vivus, Inc.
• Defendants: Actavis Laboratories FL, Inc.; Actavis, Inc.; Actavis PLC
Infringement of U.S. Patent Nos. 8,895,057 ("Escalating Dosing Regimen for Effecting Weight Loss and Treating Obesity," issued November 25, 2014) and 8,895,058 ("Low Dose Topiramate/Phentermine Composition and Methods of Use Thereof," issued November 25, 2014) following a Paragraph IV certification as part of Actavis' filing of an ANDA to manufacture a generic version of Vivus' Qsymia® (phentermine and topiramate extended-release capsules, used as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management). View the complaint here.
Otsuka Pharmaceutical Co., Ltd. v. Amneal Pharmaceuticals LLC et al.
1:15-cv-01585; filed March 2, 2015 in the District Court of New Jersey
• Plaintiff: Otsuka Pharmaceutical Co., Ltd.
• Defendants: Amneal Pharmaceuticals LLC; Amneal Pharmaceuticals India PVT. Ltd.; MSN Pharmachem PVT. Ltd.; MSN Laboratories PVT. 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), 8,580,796 (same title, issued November 12, 2013), 8,642,760 (same title, issued February 4, 2014), and 8,759,350 ("Carbostyril Derivatives and Serotonin Reuptake Inhibitors for Treatment of Mood Disorders," issued June 24, 2014) following a Paragraph IV certification as part of Amneal'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.
Purdue Pharma L.P. v. Actavis Laboratories UT Inc.
1:15-cv-00192; filed February 27, 2015 in the District Court of Delaware
Infringement of U.S. Patent Nos. RE41,408 ("Method of Providing Sustained Analgesia with Buprenorphine," issued June 29, 2010), RE41,489 (same title, issued August 10, 2010), and RE41,571 (same title, issued August 24, 2010) following a Paragraph IV certification as part of Actavis' filing of an ANDA to manufacture a generic version of Purdue Pharma's Butrans® (buprenorphine transdermal, used for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate). View the complaint here.
AstraZeneca Pharmaceuticals LP et al. v. Macleods Pharmaceuticals, Ltd. et al.
2:15-cv-01513; filed February 27, 2015 in the District Court of New Jersey
• Plaintiffs: AstraZeneca Pharmaceuticals LP; AstraZeneca UK Ltd.
• Defendants: Macleods Pharmaceuticals, Ltd.; Macleods Pharma USA, Inc.; AB Pharmaceuticals, LLC
Infringement of U.S. Patent No. 5,948,437 ("Pharmaceutical Compositions Using Thiazepine," issued September 7, 1999) following a Paragraph IV certification as part of Macleod's filing of an ANDA to manufacture a generic version of AstraZeneca's Seroquel® XR (quetiapine fumarate, used to treat schizophrenia and bipolar disorder). View the complaint here.
