Pharma Litigations in USA

Abbot V/S Zydus ((divalproex sodium)
Abbott Laboratories has filed another patent suit to protect the billion-dollar U.S. market for the bipolar mania and epilepsy treatment Depakote, accusing Zydus Pharmaceuticals (USA) Inc. of infringing four patents related to controlled release formulations of Depakote's active ingredient. 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 Zydus' 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).

Sepracor v/s Anchen (Desloratadine)
Infringement of U.S. Patent Nos. 7,214,683 ("Compositions of Descarboethoxyloratadine," issued May 8, 2007) and 7,214,684 ("Methods for the Treatment of Allergic Rhinitis," issued May 8, 2007), licensed to Schering-Plough, following a paragraph IV certification as part of Anchen's filing of an ANDA to manufacture a generic version of Schering-Plough's Clarinex® (desloratidine, used to treat allergies)

Schering v/s Anchen (Desloratadine and pseudoephedrine)
Infringement of U.S. Patent Nos. 6,100,274 ("8-chloro-6,11-dihydro-11-] (4-piperidylidine)-5H-benzo[5,6]cyclohepta[1,2-bpyridine Oral Compositions," issued August 8, 2000) and 6,709,676 ("Extended Release Oral Dosage Composition," issued March 23, 2004) following a paragraph IV certification as part of Anchen's filing of an ANDA to manufacture a generic version of Schering-Plough's Clarinex-D® 12-hour (desloratidine and pseudoephedrine sulfate, used to treat allergies).

Senju v/s Apotex (Gatifloxacin)
Infringement of U.S. Patent No. 6,333,045 ("Aqueous Liquid Pharmaceutical Composition Comprised of Gatifloxacin," issued on December 25, 2001), following a paragraph IV certification as part of Apotex's filing of an ANDA to manufacture a generic version of plaintiff's Zymar® (gatifloxacin ophthalmic solution, used for the treatment of bacterial conjunctivitis).

Sun v/s Eli Lilly (Gemcitabine HCl)
filed November 29, 2007 in the Eastern District of Michigan
Declaratory judgment of invalidity and non-infringement of U.S. Patent No. 5,464,826 ("Method of Treating Tumors in Mammals with 2',2'-difluoronucleosides," issued November 7, 1995) in conjunction with Sun's filing of an ANDA to manufacture a generic version of Eli Lilly's Gemzar® (gemcitabine hydrochloride for injection, used to treat non-small cell lung cancer, pancreatic cancer, breast cancer, and ovarian cancer). Eli Lilly had filed suit against Sun in the Southern District of Indiana; the case was voluntarily dismissed without prejudice by Eli Lilly.