About Court Report: Each week we will report briefly on recently filed biotech and pharma cases.
Amarin Pharma, Inc. et al v. Teva Pharmaceuticals USA, Inc.
3:14-cv-03558; filed June 4, 2014 in the District Court of New Jersey
• 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.
Bristol-Myers Squibb Co. v. Aurobindo Pharma U.S.A., Inc. et al
3:14-cv-03585; filed June 4, 2014 in the District Court of New Jersey
• Plaintiff: Bristol-Myers Squibb Co.
• Defendants: Aurobindo Pharma U.S.A., Inc.; Aurobindo Pharma Ltd.
Infringement of U.S. Patent No. 6,087,383 ("Bisulfate Salt of HIV Protease Inhibitor," issued July 11, 2000), licensed to BMS, following a Paragraph IV certification as part of Aurobindo's filing of an ANDA to manufacture a generic version of BMS' Reyataz® (atazanavir bisulfate, used to treat HIV infection). View the complaint here.
Astrazeneca AB v. Apotex Corp. et al.
0:14-cv-61309; filed June 4, 2014 in the Southern District of Florida
• Plaintiff: Astrazeneca AB
• Defendants: Apotex Corp.; Apotex, Inc.
AstraZeneca AB v. Teva Pharmaceuticals USA Inc.
1:14-cv-00695; filed June 2, 2014 in the District Court of Delaware
AstraZeneca AB v. Apotex Corp et al.
1:14-cv-00698; filed June 2, 2014 in the District Court of Delaware
• Plaintiff: AstraZeneca AB
• Defendants: Apotex Corp.; Apotex Inc.
Astrazeneca AB v. Aurobindo Pharma Ltd. et al.
3:14-cv-03434; filed May 24, 2014 in the District Court of New Jersey
• Plaintiff: Astrazeneca AB
• Defendants: Aurobindo Pharma Ltd.; Aurobindo Pharma U.S.A., Inc.
Astrazeneca AB v. Watson Laboratories, Inc. et al.
3:14-cv-03428; filed May 24, 2014 in the District Court of New Jersey
• Plaintiff: Astrazeneca AB
• Defendants: Watson Laboratories, Inc.; Actavis, Inc.; Actavis LLC
The complaints in these cases are substantially identical. Infringement of U.S. Patent No. 7,951,400 ("Coated Tablet Formulation and Method," issued May 31, 2011) following a Paragraph IV certification as part of defendants' filing of an ANDA to manufacture a generic version of AstraZeneca's Onglyza® (saxagliptin hydrochloride, used as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus). View the Aurobindo complaint here.
Helsinn Healthcare SA et al v. Mylan Inc. et al.
1:14-cv-00709; filed June 4, 2014 in the District Court of Delaware
• Plaintiffs: Helsinn Healthcare SA; Roche Palo Alto LLC
• Defendants: Mylan Inc.; Mylan Institutional LLC
Infringement of U.S. Patent Nos. 7,947,724 ("Liquid Pharmaceutical Formulations of Palonosetron," issued May 24, 2011), 7,947,725 (same title, issued May 24, 2011), 7,960,424 (same title, issued June 14, 2011), 8,598,219 (same title, issued December 3, 2013), and 8,729,094 (same title, issued May 20, 2014) following a Paragraph IV certification as part of Mylan's filing of an ANDA to manufacture a generic version of Helsinn's Aloxi® (palonosetron hydrochloride intravenous solution, used to prevent chemotherapy induced nausea and vomiting). View the complaint here.
AstraZeneca Pharmaceuticals LP et al v. Sandoz Inc. et al.
3:14-cv-03547; filed June 3, 2014 in the District Court of New Jersey
• Plaintiffs: AstraZeneca Pharmaceuticals LP; AstraZeneca UK Ltd.; AstraZeneca AB
• Defendants: Sandoz Inc.; Sandoz International GmbH
Infringement of U.S. Patent Nos. 6,774,122 ("Formulation," issued August 10, 2004), 7,456,160 (same title, issued November 25, 2008), 8,329,680 (same title, issued December 11, 2012), and 8,466,139 (same title, issued June 18, 2013) following a Paragraph IV certification as part of Sandoz's filing of an ANDA to manufacture a generic version of AstraZeneca's Faslodex® (fulvestrant injection, used to treat hormone receptor positive metastatic breast cancer in postmenopausal women with disease progression following antiestrogen therapy). View the Sandoz complaint here.
Astrazeneca AB v. Sun Pharma Global FZE et al.
3:14-cv-03552; filed June 3, 2014 in the District Court of New Jersey
• Plaintiff: AstraZeneca AB
• Defendants: Sun Pharma Global FZE; Sun Pharmaceutical Industries Ltd.; Caraco Pharmaceutical Laboratories Ltd.
AstraZeneca AB v. Mylan Pharmaceuticals Inc.
1:14-cv-00094; filed June 3, 2014 in the Northern District of West Virginia
The complaints in these cases are substantially identical. Infringement of U.S. Patent Nos. RE44,186 ("Cyclopropyl-Fused Pyrrolidine-Based Inhibitors of Dipeptidyl Peptidase IV and Method," issued April 30, 2013). 7,951,400 ("Coated Tablet Formulation and Method," issued May 31, 2011), and 8,628,799 (same title, issued January 14, 2014) following a Paragraph IV certification as part of Sun's filing of ANDAs to manufacture generic versions of AstraZeneca's Onglyza® (saxagliptin hydrochloride, used as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus) and Kombiglyze XR (saxagliptin and metformin hydrochloride, extended-release, used as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus). View the Sun complaint here.
AstraZeneca AB v. Amneal Pharmaceuticals LLC
1:14-cv-00697; filed June 2, 2014 in the District Court of Delaware
AstraZeneca AB v. Sun Pharma Global FZE et al.
1:14-cv-00694; filed June 2, 2014 in the District Court of Delaware
• Plaintiff: AstraZeneca AB
• Defendants: Sun Pharma Global FZE; Sun Pharmaceutical Industries Ltd.; Caraco Pharmaceutical Laboratories Ltd.
AstraZeneca AB v. Mylan Pharmaceuticals Inc.
1:14-cv-00696; filed June 2, 2014 in the District Court of Delaware
The complaints in these cases are substantially identical. Infringement of U.S. Patent Nos. RE44,186 ("Cyclopropyl-Fused Pyrrolidine-Based Inhibitors of Dipeptidyl Peptidase IV and Method," issued April 30, 2013) and 7,951,400 ("Coated Tablet Formulation and Method," issued May 31, 2011) following a Paragraph IV certification as part of defendants' filing of an ANDA to manufacture a generic version of AstraZeneca's Onglyza® (saxagliptin hydrochloride, used as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus). View the Amneal complaint here.
Eaton Veterinary Pharmaceutical Inc. v. Diamondback Drugs of Delaware LLC et al.
2:14-cv-01208; filed June 2, 2014 in the District Court of Arizona
• Plaintiff: Eaton Veterinary Pharmaceutical Inc.
• Defendants: Diamondback Drugs of Delaware LLC; Diamondback Drugs LLC; Michael R Blaire; Rory J Albert
Infringement of U.S. Patent No. 6,930,127 ("Veterinary Treatment of Ophthalmic Disease in Animals Using Topical Tacrolimus" issued August 16, 2005) based on Daimondback's sale of a tacrolimus-containing non-aqueous substance for the treatment of ophthalmic disease in animals. View the complaint here.
Forest Laboratories Inc. et al v. Ranbaxy Inc. et al.
1:14-cv-00686; filed May 30, 2014 in the District Court of Delaware
• Plaintiffs: Forest Laboratories Inc.; Forest Laboratories Holdings Ltd.; Adamas Pharmaceuticals Inc.
• Defendants: Ranbaxy Inc.; Ranbaxy Laboratories Ltd.; Teva Pharmaceuticals USA Inc.
Infringement of U.S. Patent Nos. 8,168,209 ("Method and Composition for Administering an NMDA Receptor Antagonist to a Subject," issued May 1, 2012), 8,173,708 (same title, issued May 8, 2012), 8,283,379 ("Method and Compositions for the Treatment of CNS-Related Conditions," issued October 9, 2012), 8,329,752 ("Composition for Administering an NMDA Receptor Antagonist to a Subject," issued December 11, 2012), 8,362,085 ("Method for Administering an NMDA Receptor Antagonist to a Subject," issued January 29, 2013), and 8,598,233 (same title, issued December 3, 2013) following a Paragraph IV certification as part of Ranbaxy's filing of an ANDA to manufacture a generic version of Forest's Namenda XR® (memantine hydrochloride extended release, used for the treatment of moderate to severe dementia of the Alzheimer's type). View the complaint here.
Otsuka Pharmaceutical Co. v. Wockhardt Bio AG et al.
1:14-cv-03445; filed May 30, 2014 in the District Court of New Jersey
• Plaintiff: Otsuka Pharmaceutical Co.
• Defendants: Wockhardt Bio AG; Wockhardt USA LLC; Wockhardt Ltd.
Infringement of U.S. Patent No. 8,642,760 ("Low Hygroscopic Aripiprazole Drug Substance and Process for the Preparation Thereof," issued February 4, 2014) following a Paragraph IV certification as part of Wockhardt's filing of an ANDA to manufacture a generic version of Otsuka's Abilify® (aripiprazole, used to treat bipolar disorder and schizophrenia). View the complaint here.
