About Court Report: Each week we will report briefly on recently filed biotech and pharma cases.
Astrazeneca
AB et al. v. Dr. Reddy's Laboratories Inc. et al.
3:13-cv-06157;
filed October 23, 2013 in the District Court of New Jersey
• Plaintiffs:
Astrazeneca AB; KBI-E Inc.; Pozen, Inc.; Astrazeneca LP
• Defendants:
Dr. Reddy's Laboratories Inc.; Dr. Reddy's Laboratories Ltd.
Astrazeneca
AB et al. v. Lupin Ltd. et al.
3:13-cv-06315;
filed October 23, 2013 in the District Court of New Jersey
• Plaintiffs:
Astrazeneca AB; Astrazeneca LP; KBI-E Inc.; Pozen, Inc.
• Defendants:
Lupin Ltd.; Lupin Pharmaceuticals Inc.
Astrazeneca
AB et al. v. Mylan Pharmaceuticals et al.
3:13-cv-06316;
filed October 23, 2013 in the District Court of New Jersey
• Plaintiffs:
Astrazeneca AB; Astrazeneca LP; KBI-E Inc.; Pozen, Inc.
• Defendants:
Mylan Pharmaceuticals; Mylan Laboratories Ltd.; Mylan, Inc.
Astrazeneca
AB et al. v. Watson Laboratories, Inc. - Florida et al.
3:13-cv-06318;
filed October 23, 2013 in the District Court of New Jersey
• Plaintiffs:
Astrazeneca AB; Astrazeneca LP; KBI-E Inc.; Pozen, Inc.
• Defendants:
Watson Laboratories, Inc. – Florida; Actavis Pharma, Inc.
The complaints in these cases are substantially identical. Infringement of U.S. Patent No. 8,557,285 ("Pharmaceutical Compositions for the Coordinated Delivery of NSAIDs," issued October 15, 2013) in conjunction with defendants' filing of an ANDA to manufacture a generic version of AstraZeneca's Vimovo® (naproxen and esomeprazole magnesium, used to relieve the signs and symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis, and to decrease the risk of stomach (gastric) ulcers in patients at risk of developing stomach ulcers from treatment with non-steroidal anti-inflammatory drugs (NSAIDs)). View the Dr. Reddy's complaint here.
Horizon Pharma
AG et al. v. Par Pharmaceutical Companies, Inc. et al.
1:13-cv-06298;
filed October 22, 2013 in the District Court of New Jersey
• Plaintiffs:
Horizon Pharma AG; Jagotec AG
• Defendants:
Par Pharmaceutical Companies, Inc.; Par Pharmaceutical, Inc.
Infringement of U.S. Patent Nos. 6,488,960 ("Corticosteroid Formulation" issued December 3, 2002), 6,677,326 ("Corticosteroid Formulation Comprising Less Than 2.5 mg Prednisolone for Once Daily Administration," issued January 13, 2004), 8,309,124 ("Delayed Release Tablet with Defined Core Geometry," issued November 13, 2012), 8,168,218 (same title, issued May 1, 2012), and 8,394,407 (same title, issued March 12, 2013) following a Paragraph IV certification as part of Par's filing of an ANDA to manufacture a generic version of Horizon's Rayos® (prednisone delayed-release tablets, used as an anti-inflammatory or immunosuppressive agent for certain allergic, dermatologic, gastrointestinal, hematologic, ophthalmologic, nervous system, renal respiratory, rheumatologic, specific infectious diseases or conditions and organ transplantation; for the treatment of certain endocrine conditions; and for palliation of certain neoplastic conditions). View the complaint here.
University of
Utah Research Foundation et al. v. Quest Diagnostics et al.
2:13-cv-00967;
filed October 22, 2013 in the District Court of Utah
• Plaintiffs:
University of Utah Research Foundation; Trustees of the University of
Pennsylvania; HSC Research and Development Limited Partnership; Endorecherche;
Myriad Genetics
• Defendants:
Quest Diagnostics; Quest Diagnostics Nichols Institute
Infringement of U.S. Patent Nos. 5,709,999 ("Linked Breast and Ovarian Cancer Susceptibility Gene," issued January 20, 1998), 5,747,282 ("17Q-Linked Breast and Ovarian Cancer Susceptibility Gene," issued May 5, 1998), 5,753,441 (same title, issued May 19, 1998), 5,837,492 ("Chromosome 13-Linked Breast Cancer Susceptibility Gene," issued November 17, 1998), 6,033,857 (same title, issued March 7, 2000), 6,051,379 ("Cancer Susceptibility Mutations of BRCA2," issued April 18, 2000), 6,951,721 ("Method for Determining the Haplotype of a Human BRCA1 Gene," issued October 4, 2005), and 7,250,497 ("Large Deletions in Human BRCA1 Gene and Use Thereof," issued July 31, 2007) based on Quest'smanufacture, use, and sale of its BRCA Assay. View the complaint here.
Cephalon Inc.
v. Eagle Pharmaceuticals Inc.
1:13-cv-01738;
filed October 21, 2013 in the District Court of Delaware
Infringement of U.S. Patent No. 8,445,524 ("Solid Forms of Bendamustine Hydrochloride," issued May 21, 2013) following a Paragraph IV certification as part of Eagle's filing of an NDA (under § 505(b)(2) of the Food, Drug and Cosmetic Act) to manufacture a generic version of Cephalon's Treanda® (bendamustine hydrochloride, used to treat chronic lymphocytic leukemia and non-Hodgkin's lymphoma). View the complaint here.
Takeda
Pharmaceuticals USA Inc. v. Amneal Pharmaceuticals LLC
1:13-cv-01729;
filed October 21, 2013 in the District Court of Delaware
Infringement of U.S Patent Nos. 7,906,519 ("Methods for Concomitant Administration of Colchicine and a Second Active Agent," issued March 15, 2011), 7,935,731 ("Methods for Concomitant Administration of Colchicine and Macrolide Antibiotics," issued May 11, 2011), 8,093,298 (same title, issued January 10, 2012), 7,964,648 ("Methods for Concomitant Administration of Colchicine and a Second Active Agent," issued June 21, 2011), and 8,093,297 (same title, issued January 10, 2012) following Amneal's filing of an ANDA to manufacture a generic version of Takeda's Colcrys® (single-ingredient colchicine product, used to treat Familial Mediterranean Fever). View the complaint here.
Forest
Laboratories Inc. et al. v. Amneal Pharmaceuticals LLC et al.
1:13-cv-01737;
filed October 21, 2013 in the District Court of Delaware
• Plaintiffs:
Forest Laboratories Inc.; Forest Laboratories Holdings Ltd.; Royalty Pharma
Collection Trust
• Defendants:
Amneal Pharmaceuticals LLC; Amneal Pharmaceuticals of New York LLC; Amneal
Pharmaceuticals Co. India Pvt. Ltd.
Infringement of U.S. Patent Nos. 6,602,911 ("Methods of Treating Fibromyalgia," issued August 5, 2003), 7,888,342 ("Methods of Treating Fibromyalgia Syndrome, Chronic Fatigue Syndrome and Pain," issued February 15, 2011), and 7,994,220 ("Milnacipran for the Long-Term Treatment of Fibromyalgia Syndrome," issued August 9, 2011), all licensed to Forest, following a Paragraph IV certification as part of Amneal's filing of an ANDA to manufacture a generic version of Forest's Savella® (milnacipran hydrochloride, used in the management of fibromyalgia). View the complaint here.
Baxter
Healthcare Corp. et al. v. HQ Specialty Pharma Corp.
2:13-cv-06228;
filed October 18, 2013 in the District Court of New Jersey
• Plaintiffs:
Baxter Healthcare Corp.; Baxter International Inc.; Baxter Healthcare
S.A.
• Defendant:
HQ Specialty Pharma Corp.
Infringement of U.S. Patent Nos. 6,310,094 ("Ready-to-Use Esmolol Solution," issued October 30, 2001) and 6,528,540 ("Esmolol Formulation," issued March 4, 2003) following a Paragraph IV certification as part of HQ's filing of an NDA (under § 505(b)(2) of the Food, Drug and Cosmetic Act) to manufacture a generic version of Baxter's Brevibloc® (esmolol hydrochloride, used for the rapid control of the heart rate in patients with atrial fibrillation or atrial flutter in perioperative, postoperative, or other emergent circumstances where short term control of the heart rate with a short-acting agent is desirable). View the complaint here.
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