About Court Report: Each week we will report briefly on recently filed biotech and pharma cases.
Glenmark Generics Ltd. et al. v. Ferring, B.V.
3:14-cv-00422; filed June 9, 2014 in the Eastern District of Virginia
• Plaintiffs: Glenmark Generics Ltd.; Glenmark Generics Inc., USA
• Defendant: Ferring, B.V.
Declaratory judgment of unenforceability of U.S. Patent No. 7,022,340 ("Pharmaceutical Composition as Solid Dosage Form and Method for Manufacturing Thereof," issued April 4, 2006) in conjunction with Glenmark's Paragraph IV certification as part of its filing of an ANDA to manufacture a generic version of Sanofi-Aventis' DDAVP® Tablets (desmopressin acetate, used as antidiuretic replacement therapy in the management of central diabetes insipidus and for the management of the temporary polyuria and polydipsia following head trauma or surgery in the pituitary region). View the complaint here.
Gilead Sciences, Inc. et al. v. Mylan Inc. et al.
1:14-cv-00099; filed June 9, 2014 in the Northern District of West Virginia
• Plaintiffs: Gilead Sciences, Inc.; Emory University
• Defendants: Mylan Inc.; Mylan Pharmaceuticals Inc.
Gilead Sciences, Inc. et al. v. Mylan Inc. et al.
1:14-cv-03928; filed June 2, 2014 in the Southern District of New York
• Plaintiffs: Gilead Sciences, Inc.; Emory University
• Defendants: Mylan Inc.; Mylan Pharmaceuticals Inc.
The complaints in these cases are substantially identical. Infringement of U.S. Patent Nos. 6,642,245 ("Antiviral Activity and Resolution of 2-Hydroxymethyl-5-(5-fluorocytosin-1-yl)-l,3-oxathiolane," issued November 4, 2003), 6,703,396 ("Method of Resolution and Antiviral Activity of 1,3-Oxathiolane Nucleoside Enantiomers," issued March 9, 2004), and 8,592,397 ("Compositions and Methods for Combination Antiviral Therapy," issued November 26, 2013) following a Paragraph IV certification as part of Mylan's filing of an ANDA to manufacture a generic version of Gilead's Truvada® (emtricitabine and tenofovir disoproxil fumarate, used for the treatment of HIV-1 infection in adults). View the SDNY complaint here.
Warner Chilcott Co. et al. v. Amneal Pharmaceuticals LLC et al.
1:14-cv-00718; filed June 6, 2014 in the District Court of Delaware
• Plaintiffs: Warner Chilcott Co. LLC; Warner Chilcott (US) LLC
• Defendants: Amneal Pharmaceuticals LLC; Amneal Pharmaceuticals of New York LLC
Infringement of U.S. Patent No. 6,106,864 ("Pharmaceutical Formulations Containing Darifenacin," issued August 22, 2000) following a Paragraph IV certification as part of Amneal's filing of an ANDA to manufacture a generic version of Warner Chilcott's Enablex® (darifenacin, used to treat symptoms of overactive bladder). View the California Anchen Pharmaceuticals complaint here.
Warner Chilcott Co. v. Lupin Atlantis Holdings SA et al.
1:14-cv-01827; filed June 6, 2014 in the District Court of Maryland
• Plaintiff: Warner Chilcott Co., LLC
• Defendants: Lupin Atlantis Holdings SA; Lupin Ltd.; Lupin Pharmaceuticals, Inc.
Infringement of U.S. Patent No. 6,667,050 ("Chewable Oral Contraceptive," issued December 23, 2003) following a Paragraph IV certification as part of Lupin's filing of an ANDA to manufacture a generic version of Warner Chilcott's Minastrin® 24 Fe (ethinyl estradiol and norethindrone acetate, used for oral contraception). View the complaint here.
Cipher Pharmaceuticals Inc. et al. v. Actavis Laboratories FL, Inc. et al.
1:14-cv-03653; filed June 6, 2014 in the District Court of New Jersey
• Plaintiffs: Cipher Pharmaceuticals Inc.; Galephar Pharmaceutical Research, Inc.; Ranbaxy, Inc.; Ranbaxy Pharmaceuticals, Inc.
• Defendants: Actavis Laboratories FL, Inc.; Andrx Corp.; Actavis, Inc.; Actavis Pharma, Inc.
Infringement of U.S. Patent No. 7,435,427 ("Pharmaceutical Semi-Solid Composition of Isotretinoin," issued October 14, 2008) following a Paragraph IV certification as part of Actavis' filing of an ANDA to manufacture a generic version of Ranbaxy's Absorica® (isotretinoin, used for the treatment of severe recalcitrant nodular acne). View the complaint here.
Amarin Pharma, Inc. et al. v. Teva Pharmaceuticals USA, Inc.
2:14-cv-03251; filed June 6, 2014 in the Eastern District of Pennsylvania
• Plaintiffs: Amarin Pharma, Inc.; Amarin Pharmaceuticals Ireland Ltd.
• Defendant: Teva Pharmaceuticals USA, Inc.
Infringement of U.S. Patent Nos. 8,293,728 ("Methods of Treating Hypertriglyceridemia," issued October 23, 2012), 8,318,715 (same title, issued November 27, 2012), 8,357,677 (same title, issued January 22, 2013), 8,367,652 (same title, issued February 5, 2013), 8,377,920 (same title, issued February 19, 2013), 8,399,446 (same title, issued March 19, 2013), 8,415,335 (same title, issued April 9, 2013), 8,426,399 (same title, issued April 23, 2013), 8,431,560 (same title, issued April 30, 2013), 8,440,650 (same title, issued May 14, 2013), 8,501,225 ("Stable Pharmaceutical Composition and Methods of Using Same," issued August 6, 2013), 8,518,929 ("Methods of Treating Hypertriglyceridemia," issued August 27, 2013), 8,524,698 (same title, issued September 3, 2013), 8,546,372 (same title, issued October 1, 2013), 8,551,521 ("Stable Pharmaceutical Composition and Methods of Using Same," issued October 8, 2013), and 8,617,594 (same title, issued December 31, 2013) following a Paragraph IV certification as part of Teva's filing of an ANDA to manufacture a generic version of Amarin's Vascepa® (icosapent ethyl, used as an adjunct to diet to reduce triglyceride levels in adult patients with severe hypertriglyceridemia). View the complaint here.
Teva Women's Health et al. v. Lupin Ltd.
1:14-cv-04055; filed June 4, 2014 in the Southern District of New York
• Plaintiffs: Teva Women's Health; Teva Branded Pharmaceutical Products R & D, Inc.
• Defendant: Lupin Ltd.; Lupin Pharmaceuticals, Inc.
Infringement of U.S. Patent Nos. 8,415,332 ("Methods of Hormonal Treatment Utilizing Ascending-Dose Extended Cycle Regimens," issued April 9, 2013) and 8,450,299 (same title, issued May 28, 2013) following a Paragraph IV certification as part of Lupin's filing of an ANDA to manufacture a generic version of Teva's Quartette® (levonorgestrel/ethinyl estradiol and ethinyl estradiol, used for oral contraception). View the complaint here. [NB: The complaint was voluntarily dismissed 6 days after it was filed.]
