By Sherri Oslick --
About Court Report: Each week we will report briefly on recently filed biotech and pharma cases.
Unimed Pharmaceuticals, LLC et al. v. Amneal Pharmaceuticals, LLC
1:15-cv-00964; filed October 22, 2016 in the District Court of Delaware
• Plaintiffs: Unimed Pharmaceuticals, LLC; Besins Healthcare Inc.; Besins Healthcare Luxembourg SARL
• Defendant: Amneal Pharmaceuticals, LLC
Infringement of U.S. Patent Nos. 6,503,894 ("Pharmaceutical Composition and Method for Treating Hypogonadism," issued January 7, 2003), 8,729,057 ("Testosterone Gel and Method of Use," issued May 20, 2014), 8,741,881 (same title, issued June 3, 2014), 8,754,070 (same title, issued June 17, 2014), and 8,759,329 (same title, issued June 24, 2014), 9,125,816 ("Pharmaceutical Composition and Method for Treating Hypogonadism," issued September 8, 2015), 9,132,089 (same title, issued September 15, 2015) following a Paragraph IV certification as part of Amneal's filing of an ANDA to manufacture a generic version of AbbVie's AndroGel® (testosterone gel, used to treat conditions associated with a deficiency or absence of endogenous testosterone). View the complaint here.
Pfizer Inc. et al. v. Mylan Inc. et al.
1:15-cv-00960; filed October 22, 2016 in the District Court of Delaware
• Plaintiffs: Pfizer Inc.; Wyeth LLC; Pfizer Pharmaceuticals LLC; PF Prism C.V.; Pfizer Manufacturing Holdings LLC
• Defendants: Mylan Inc.; Mylan N.V.; Mylan Laboratories Ltd.; Mylan Pharmaceuticals Inc.
Infringement of U.S. Patent Nos. 7,879,828 ("Tigecycline Compositions and Methods of Preparation," issued February 1, 2011), 8,372,995 ("Crystalline Solid Forms of Trigecycline and Methods of Preparing Same," issued February 12, 2013), and 8,975,242 ("Tigecycline Compositions and Methods of Preparation," issued March 10, 2015), licensed to Pfizer, following a Paragraph IV certification as part of Mylan's filing of an ANDA to manufacture a generic version of Pfizer's Tygacil® (tigecycline injectible, used for the treatment of complicated skin and skin structure infections, complicated intra-abdominal infections, and community-acquired bacterial pneumonia). View the complaint here.
Alcon Pharmaceuticals Ltd. et al. v. Akorn, Inc.
1:15-cv-00948; filed October 21, 2016 in the District Court of Delaware
• Plaintiffs: Alcon Pharmaceuticals Ltd.; Alcon Research, Ltd.
• Defendant: Akorn, Inc.
Infringement of U.S. Patent Nos. 6,716,830 ("Ophthalmic Antibiotic Compositions Containing Moxifloxacin," issued April 6, 2004) and 7,671,070 ("Method of Treating Ophthalmic Infections with Moxifloxacin Compositions," issued March 2, 2010) following a Paragraph IV certification as part of Akorn's filing of an ANDA to manufacture a generic version of Alcon's Vigamox® (moxifloxacin hydrochloride, used to treat bacterial conjunctivitis). View the complaint here.
Takeda Pharmaceutical Co. Ltd. et al. v. Aurobindo Pharma Ltd. et al.
3:15-cv-07635; filed October 21, 2016 in the District Court of New Jersey
• Plaintiffs: Takeda Pharmaceutical Co. Ltd.; Takeda Pharmaceuticals U.S.A., Inc.; Takeda Pharmaceuticals America, Inc.
• Defendants: Aurobindo Pharma Ltd.; Aurobindo Pharma U.S.A., Inc.; Aurolife Pharma LLC
Infringement of U.S. Patent Nos. 6,328,994 ("Orally Disintegrable Tablets," issued December 11, 2001), 7,431,942 ("Orally Disintegrable Tablets," issued October 7, 2008), 7,875,292 ("Orally Disintegrable Tablets," issued January 25, 2011), and 7,399,485 ("Rapidly Disintegrable Solid Preparation," issued July 15, 2008) following a Paragraph IV certification as part of Aurobindo's filing of an ANDA to manufacture a generic version of plaintiffs' Prevacid® SoluTab (lansoprazole delayed release orally disintegrating tablets, used to treat ulcers, gastroesophageal reflux disease, erosive esophagitis, and pathological hypersecretory conditions, including Zollinger-Ellison syndrome). View the complaint here.
I am probably missing something.
The ANDA suppose to help generic drugs to be introduced into the market as soon as the patent expires, isn't it? Are they sue just because there is an option of a future infringement or the ANDA filing act suppose to be an infrigement act?
Please write a short post that explains these terms and the problems they create (I saw several complaints that look quite the same).. Thank you.
Posted by: Gad | April 12, 2016 at 06:56 AM