By Sherri Oslick --
About Court Report: Each week we will report briefly on recently filed biotech and pharma cases.
Warner Chilcott (US), LLC et al. v. Teva Pharmaceuticals USA, Inc. et al.
1:15-cv-00761; filed August 31, 2015 in the District Court of Delaware
• Plaintiffs: Warner Chilcott (US), LLC; Warner Chilcott Co., LLC; Qualicaps Co., Ltd.
• Defendants: Teva Pharmaceuticals USA, Inc.; Teva Pharmaceutical Industries Ltd.
Infringement of U.S. Patent No. 6,649,180 ("Hard Capsule Formed of Cellulose Ether Film with a Specific Content of Methoxyl and Hydroxypropoxyl Groups," issued November 18, 2003) following a Paragraph IV certification as part of Teva's filing of an ANDA to manufacture a generic version of Warner Chilcott's Delzicol® (mesalamine delayed release capsules, used for the treatment of mildly to moderately active ulcerative colitis in patients 12 years of age older and for the maintenance of remission of ulcerative colitis in adults). View the complaint here.
Johnson Matthey Pharmaceutical Materials, Inc. et al. v. InSite Vision Inc.
1:15-cv-00763; filed August 31, 2015 in the District Court of Delaware
• Plaintiffs: Johnson Matthey Pharmaceutical Materials, Inc.; Johnson Matthey Inc.; Johnson Matthey Public Limited Co.
• Defendant: InSite Vision Inc.
Infringement of U.S. Patent Nos. 8,299,295 ("Polymorphs of Bromfenac Sodium and Methods for Preparing Bromfenac Sodium Polymorphs," issued October 30, 2012), 8,481,780 (same title, issued July 9, 2013), 9,045,388 (same title, issued June 2, 2015), and 9,061,968 (same title, issued June 23, 2015) based on InSite's filing of an NDA seeking approval to manufacture and sell its BromSite™ product (bromfenac sodium (0.075%) ophthalmic product, used to reduce post-operative inflammation in the eye and to prevent pain following cataract surgery). View the complaint here.
Janssen Pharmaceutica, N.V. et al. v. Mylan Pharmaceuticals, Inc. et al.
1:15-cv-00760; filed August 31, 2015 in the District Court of Delaware
• Plaintiffs: Janssen Pharmaceutica, N.V.; Janssen Sciences Ireland UC; Gilead Sciences Ireland UC; Gilead Sciences, Inc.
• Defendants: Mylan Pharmaceuticals, Inc.; Mylan Inc.
Infringement of U.S. Patent Nos. 8,841,310 ("Combinations of a Pyrimidine Containing NNRTI with RT Inhibitors," issued September 23, 2014), 7,125,879 ("HIV Inhibiting Pyrimidines Derivatives" issued October 24, 2006), and 8,101,629 (""Salt of 4-[[4-[[4-(2-Cyanoethenyl)-2,6-Dimethylphenyl]amino]-2-Pyrimidinyl]Amino]Benzonitrile" issued January 24, 2012), all licensed to Gilead, following a Paragraph IV certification as part of Mylan's filing of an ANDA to manufacture a generic version of Gilead's Complera® (emtricitabine, rilpivirine, and tenofovir disoproxil fumarate, used to treat HIV-1 in adults who have never taken HIV-1 medicines before and who have no more than 100,000 copies/mL of virus in their blood). View the complaint here.
Merck Sharp & Dohme Corp. et al. v. Actavis Laboratories FL, Inc. et al.
2:15-cv-06541; filed August 31, 2015 in the District Court of New Jersey
• Plaintiffs: Merck Sharp & Dohme Corp.; Cubist Pharmaceutlcals LLC; Optimer Pharmaceuticals LLC; MSD Investment Holdings; MSD International GmbH
• Defendants: Actavis Laboratories FL, Inc.; Actavis Pharma, Inc.; Actavis, Inc.
Infringement of U.S. Patent Nos. 7,906,489 ("18-Membered Macrocycles and Analogs Thereof," issued March 15, 2011), 8,586,551 (same title, issued November 19, 2013), 7,378,508 ("Polymorphic Crystalline Forms of Tiacumicin B," issued May 27, 2008), 7,863,249 ("Macrolide Polymorphs, Compositions Comprising Such Polymorphs, and Methods of Use and Manufacture Thereof," issued January 4, 2011), and 8,859,510 (same title, issued October 14, 2014) following a Paragraph IV certification as part of Actavis' filing of an ANDA to manufacture a generic version of Merck's Dificid® (fidaxomicin, used for the treatment of Clostridium difficileassociated diarrhea in adults 18 years of age or older). View the complaint here.
Gilead Sciences, Inc. et al. v. Mylan Inc. et al.
1:15-cv-00149; filed August 31, 2015 in the Northern District of West Virginia
• Plaintiffs: Gilead Sciences, Inc.; Emory University
• Defendants: Mylan Inc.; Mylan Pharmaceuticals Inc.
Infringement of U.S. Patent Nos. 6,642,245 ("Antiviral Activity and Resolution of 2-Hydroxymethyl-5-(5-fluorocytosin-1-yl)-l,3-oxathiolane," issued November 4, 2003), 6,703,396 ("Method of Resolution and Antiviral Activity of 1,3-Oxathiolane Nucleoside Enantiomers," issued March 9, 2004), 8,592,397 ("Compositions and Methods for Combination Antiviral Therapy," issued November 26, 2013), and 8,716,264 (same title, issued May 6, 2014) following a Paragraph IV certification as part of Mylan's filing of an ANDA to manufacture a generic version of Gilead's Complera® (emtricitabine/rilpivirine/tenofovir disoproxil fumarate, used for the treatment of HIV-1 infection in adults). View the complaint here.
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