By Sherri Oslick --
About Court Report: Each week we will report briefly on recently filed biotech and pharma cases.
Par Pharmaceutical, Inc. et al. v. TWi Pharmaceuticals, Inc.
1:11-cv-02466; filed September 1, 2011 in the District Court of Maryland
• Plaintiffs: Par Pharmaceutical, Inc.; EDT Pharma Holdings Ltd.
• Defendant: TWi Pharmaceuticals, Inc.
Par Pharmaceutical, Inc. et al. v. TWI Pharmaceuticals, Inc.
1:11-cv-06134; filed September 2, 2011 in the Northern District of Illinois
• Plaintiffs: PAR Pharmaceutical, Inc.; EDT Pharma Holdings Ltd.
• Defendant: TWI Pharmaceuticals, Inc.
The complaints in these cases are substantially identical. Infringement of U.S. Patent No. 7,101,576 ("Nanoparticulate Megestrol Formulations," issued September 5, 2006) following a Paragraph IV certification as part of TWi's filing of an ANDA to manufacture a generic version of Par's Megace ES® (megestrol acetate, used for the treatment of appetite loss, severe malnutrition, or unexplained, significant weight loss in AIDS patients). View the Maryland complaint here.
Warner Chilcott Co., LLC v. Lupin Ltd. et al.
3:11-cv-05048; filed September 1, 2011 in the District Court of New Jersey
• Plaintiff: Warner Chilcott Co., LLC
• Defendants: Lupin Ltd.; Lupin Pharmaceuticals, Inc.
Infringement of U.S. Patent Nos. 5,552,394 ("Low Dose Oral Contraceptives with Less Breakthrough Bleeding and Sustained Efficacy," issued September 3, 1996) and 7,704,984 ("Extended Estrogen Dosing Contraceptive Regimen" issued April 27, 2010) following a Paragraph IV certification as part of Lupin's filing of an ANDA to manufacture a generic version of Warner Chilcott's Lo Loestrin® Fe (norethindrone acetate and ethinyl estradiol tablets, and ethinyl estradiol and ferrous fumarate tablets, used for oral contraception). View the complaint here.
Avanir Pharmaceuticals Inc. et al. v. Impax Laboratories Inc.
1:11-cv-00757; filed August 29, 2011 in the District Court of Delaware
• Plaintiffs: Avanir Pharmaceuticals Inc.; Avanir Holding Co.; Center for Neurologic Study
• Defendant: Impax Laboratories Inc.
Avanir Pharmaceuticals Inc. et al. v. Wockhardt Ltd. et al.
1:11-cv-00758; filed August 29, 2011 in the District Court of Delaware
• Plaintiffs: Avanir Pharmaceuticals Inc.; Avanir Holding Co.; Center for Neurologic Study
• Defendants: Wockhardt Ltd.; Wockhardt USA LLC
The complaints in these cases are substantially identical. Infringement of U.S. Patent Nos. 7,659,282 ("Pharmaceutical Compositions Comprising Dextromethorphan and Quinidine for the Treatment of Neurological Disorder," issued February 9, 2010) and RE38,115 ("Dextromethorphan and an Oxidase Inhibitor for Treating Intractable Conditions," issued May 6, 2003) following a Paragraph IV certification as part of defendants' filing of an ANDA to manufacture a generic version of Avanir's Nuedexta® (dextromethorphan hydrobromide/quinidine sulfate, used to treat pseudobulbar affect). View the Impax complaint here.
Gilead Sciences, Inc. et al. v. Natco Pharma Ltd. et al.
2:11-cv-04969; filed August 29, 2011 in the District Court of New Jersey
• Plaintiffs: Gilead Sciences, Inc.; Hoffmann-La Roche Inc.; F. Hoffmann-La Roche Ltd.; Genentech, Inc.
• Defendants: Natco Pharma Ltd.; Natco Pharma Inc.
Infringement of U.S. Patent No. 5,763,483 ("Carbocyclic Compounds," issued June 9, 1998) following a Paragraph IV certification as part of Natco's filing of an ANDA to manufacture a generic version of Genentech's Tamiflu® (oseltamivir phosphate, used to treat uncomplicated acute illness due to influenza infection in patients one year or older who have been symptomatic for no more than two days and for the prophylaxis of influenza in patients one year or older). View the complaint here.
Abbott Laboratories et al. v. Mylan Pharmaceuticals Inc. et al.
2:11-cv-04966; filed August 26, 2011 in the District Court of New Jersey
• Plaintiffs: Abbott Laboratories; Laboratories Fournier S.A.
• Defendants: Mylan Pharmaceuticals Inc.; Mylan Inc.
Infringement of U.S. Patent Nos. 6,277,405 ("Fenofibrate Pharmaceutical Composition Having High Bioavailability and Method for Preparing It," issued August 21, 2001), 7,037,529 (same title, issued May 2, 2006), and 7,041,319 ("Fenofibrate Pharmaceutical Composition Having High Bioavailabilty," issued May 9, 2006) following a Paragraph IV certification as part of Mylan's filing of an ANDA to manufacture a generic version of Abbott's Tricor® (fenofibrate, used in the treatment of increased triglyceride levels). View the complaint here.
EDT Pharma Holdings Ltd. et al. v. Mylan Pharmaceuticals Inc. et al.
2:11-cv-04967; filed August 26, 2011 in the District Court of New Jersey
• Plaintiffs: EDT Pharma Holdings Ltd.; Fournier Laboratories Ireland Ltd.
• Defendants: Mylan Pharmaceuticals Inc.; Mylan Inc.
Infringement of U.S. Patent Nos. 7,276,249 ("Nanoparticulate Fibrate Formulations," issued October 2, 2007) and 7,320,802 ("Methods of Treatment Using Nanoparticulate Fenofibrate Compositions," issued January 22, 2008), all licensed to Abbott, following a Paragraph IV certification as part of Mylan's filing of an ANDA to manufacture a generic version of Abbott's Tricor® (fenofibrate, used in the treatment of increased triglyceride levels). View the complaint here.
Allergan, Inc. v. Sandoz Inc.
6:11-cv-00441; filed August 26, 2011 in the Eastern District of Texas
Infringement of U.S. Patent Nos. 7,851,504 ("Enhanced Bimatoprost Ophthalmic Solution," issued December 14, 2010) and 5,688,819 ("Cyclopentane Heptanoic Acid, 2-Cycloalkyl or Arylalkyl Derivatives as Therapeutic Agents," issued November 18, 1997) following a Paragraph IV certification as part of Sandoz's filing of an ANDA to manufacture a generic version of Allergan's Lumigan® (0.03% bimatoprost ophthalmic solution, used to treat lower intraocular eye pressure in people with open-angle glaucoma or ocular hypertension). View the complaint here.
Kindly be advised that the litigation case Allergan, Inc. v. Sandoz Inc.
6:11-cv-00441; filed August 26, 2011 in the Eastern District of Texas w.r.t Infringement of U.S. Patent No. 7,851,504 ("Enhanced Bimatoprost Ophthalmic Solution," issued December 14, 2010) following a Paragraph IV certification as part of Lupin's filing of an ANDA to manufacture a generic version of Allergan's Lumigan® (0.03% bimatoprost ophthalmic solution)is not against the 0.03% strength but LUMIGAN (BIMATOPROST SOLUTION/DROPS; OPHTHALMIC 0.01%). Refer the PDF attachment.
Posted by: Kuldeep Sharma | December 12, 2011 at 06:15 AM
Yes, indeed that is correct. Thank you for catching that inadvertent error on our part.
Posted by: Sherri O. | December 19, 2011 at 07:18 PM