By Sherri Oslick --
About
Court Report: Each week we will report briefly on recently filed
biotech and pharma cases, and a few interesting cases will be selected
for periodic monitoring.
SB Pharmco Puerto Rico, Inc. d/b/a GlaxoSmithKline et al. v. Mutual Pharmaceutical Company, Inc. et al.
2:08-cv-00549; filed February 4, 2008 in the Eastern District of Pennsylvania
Declaratory judgment that Mutual’s Paragraph IV notice was improper, null, void, and without legal effect, that the Court therefore has no subject matter jurisdiction over the claims surrounding the patents at issue, that Mutual’s notice did not trigger the 45-day period for filing an infringement action under the Hatch-Waxman Act, and that Mutual must serve new Paragraph IV notice upon GSK if and when the FDA accepts Mutual’s ANDA. Also, infringement of U.S. Patent No. 7,268,156 ("Carvedilol Phosphate Salts and/or Solvates Thereof, Corresponding Compositions and/or Methods of Treatment," issued September 11, 2007) following a paragraph IV certification as part of Mutual’s filing of an ANDA to manufacture a generic version of GSK’s Coreg® CR (carvedilol, used to treat congestive heart failure). View the complaint here.
Boehringer Ingelheim Pharmaceuticals, Inc. v. Apotex Inc. et al.
2:08-cv-00098; filed February 4, 2008 in the Middle District of Florida
Boehringer Ingelheim Pharmaceuticals Inc. v. Apotex Inc. et al.
1:08-cv-00065; filed January 31, 2008 in the District Court of Delaware
Infringement of U.S. Patent No. 5,098,715 ("Flavored Film-Coated Tablet," issued March 24, 1992) following a paragraph IV certification as part of Apotex’s filing of an ANDA to manufacture a generic version of Boehringer’s Zantac® 150 products (ranitidine hydrochloride, used to treat gastroesophageal reflux disease). The complaints in these cases are substantially identical. View the Delaware complaint here.
Forest Laboratories, Inc. et al. v. Kendle International Inc.
1:08-cv-00078; filed February 4, 2008 in the Southern District of Ohio
Forest Laboratories, Inc. et al. v. Sun India Pharmaceutical Industries Ltd.
1:08-cv-00749; filed February 4, 2008 in the Northern District of Illinois
Forest Laboratories, Inc. et al. v. Genpharm, L.P. et al.
1:08-cv-00444; filed January 31, 2008 in the Eastern District of New York
Forest Laboratories, Inc. et al. v. Lupin Pharmaceuticals, Inc. et al.
1:08-cv-00167; filed January 28, 2008 in the District Court of the District of Columbia
Infringement of U.S. Patent No. 5,061,703 ("Adamantane Derivatives in the Prevention and Treatment of Cerebral Ischemia," issued on October 29, 1991), following a paragraph IV certification as part of defendants’ filing of an ANDA to manufacture a generic version of Forest's Namenda® (memantine hydrochloride, used for the treatment of moderate to severe dementia of the Alzheimer's type). The complaints in these cases are substantially identical. View the Lupin complaint here.
Abbott Laboratories v. Sun Pharmaceutical Industries, Ltd.
2:08-cv-10498; filed February 4, 2008 in the Eastern District of Michigan
Infringement of U.S. Patent Nos. 6,511,678 ("Controlled Release Formulation of Divalproex Sodium," issued January 28, 2003), 6,528,090 (same title, issued March 4, 2003), 6,713,086 (same title, issued March 30, 2004), and 6,720,004 (same title, issued April 13, 2004) following a paragraph IV certification as part of Sun’s filing of an ANDA to manufacture a generic version of Abbott's Depakote® ER (divalproex sodium, used to treat manic episodes associated with bipolar disorder, epilepsy, and migraine headaches). View the complaint here.
SB2, Inc. v. Alexion Pharmaceuticals, Inc.
4:08-cv-00730; filed February 1, 2008 in the Northern District of Illinois
Infringement of U.S. Patent No. 5,624,821 ("Antibodies with Altered Effector Functions," issued April 29, 1997) based on Alexion’s manufacture and sale of allegedly infringing antibodies, including Alexion’s Soliris® monoclonal antibody (eculizumab, used to treat paroxysmal nocturnal hemoglobinuria (PNH)). View the complaint here.
Procter & Gamble Company v. Teva Pharmaceuticals USA Inc.
1:08-cv-00066; filed February 1, 2008 in the District Court of Delaware
Infringement of U.S. Patent No. 5,583,122 ("Pharmaceutical Compositions Containing Geminal Diphosphonates," issued December 10, 1996) following a paragraph IV certification as part of Teva’s filing of an ANDA to manufacture a generic version of P&G’s Actonel® (risedronate sodium, used to treat and prevent postmenopausal osteoporosis). View the complaint here.
Comments