About Court Report: Each week we will report briefly on recently filed biotech and pharma cases.
Medicis Pharmaceutical Corp. v. Taro Pharmaceuticals U.S.A., Inc. et el.
3:15-cv-02841; filed April 22, 2015 in the District Court of New Jersey
• Plaintiff: Medicis Pharmaceutical Corp.
• Defendants: Taro Pharmaceuticals U.S.A., Inc.; Taro Pharmaceutical Industries, Ltd.
Infringement of U.S. Patent Nos. 8,236,816 ("2x2x2 Week Dosing Regimen for Treating Actinic Keratosis with Pharmaceutical Compositions Formulated with 3.75% Imiquimod," issued August 7, 2012), 8,299,109 ("Method of Treating Actinic Keratosis with 3.75% Imiquimod Cream," issued October 30, 2012), and 8,598,196 ("Methods of Treating Dermatological Disorders and Inducing Interferon Biosynthesis with Shorter Durations of Imiquimod Therapy," issued December 3, 2013) following a Paragraph IV certification as part of Taro's filing of an ANDA to manufacture a generic version of Medicis' Zyclara® Cream (3.75% imiquimod cream, used for the topical treatment of clinically typical, visible, or palpable actinic keratoses ("AK") of the full face or balding scalp in immunocompetent adults). View the complaint here.
Shire Pharmaceutical Development Inc. et el. v. Amneal Pharmaceuticals LLC et el.
3:15-cv-02865; filed April 22, 2015 in the District Court of New Jersey
• Plaintiffs: Shire Pharmaceutical Development Inc.; Shire Development LLC; Cosmo Technologies Limited; Nogra Pharma Ltd.
• Defendants: Amneal Pharmaceuticals LLC; Amneal Pharmaceuticals of New York, LLC; Amneal Pharmaceuticals Co. (I) PVT. Ltd.; Amneal Life Sciences PVT. Ltd.
Infringement of U.S. Patent No. 6,773,720 ("Mesalazine Controlled Release Oral Pharmaceutical Compositions," issued August 10, 2004) following a Paragraph IV certification as part of Amneal's filing of an ANDA to manufacture a generic version of Shire's Lialda® (mesalamine, used to induce remission in patients with active, mild to moderate ulcerative colitis). View the complaint here.
Glycobiosciences, Inc. v. Fidia Farmaceutici S.P.A.
1:15-cv-00592; filed April 20, 2015 in the District Court of the District of Columbus
Infringement of U.S. Patent No. 6,387,407 ("Topical Drug Preparations," issued May 14, 2002) based on Fidia's manufacture and sale of its Bionect Gel (hyaluronic acid gel, used for various skin diseases and disorders). View the complaint here.
Vivus, Inc. v. Teva Pharmaceuticals USA, Inc. et el.
2:15-cv-02693; filed April 15, 2015 in the District Court of New Jersey
• Plaintiff: Vivus, Inc.
• Defendants: Teva Pharmaceuticals USA, Inc.; Teva Pharmaceutical Industries Ltd.
Infringement of U.S. Patent Nos. 7,056,890 ("Combination Therapy for Effecting Weight Loss and Treating Obesity, issued June 6, 2006), 7,553,818 (same title, issued June 30, 2009), 7,659,256 (same title, issued February 9, 2010), 7,674,776 (same title, issued March 9, 2010), 8,580,298 ("Low Dose Topiramate/Phentermine Composition and Methods of Use Thereof," issued November 12, 2013), 8,580,299 ("Escalating Dosing Regimen for Effecting Weight Loss and Treating Obesity," issued November 12, 2013), 8,895,057 (same title, 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 Teva's 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.
