About Court Report: Each week we will report briefly on recently filed biotech and pharma cases.
Amarin Pharma, Inc. et al. v. Apotex, Inc. et al.
1:14-cv-02958; filed April 24, 2014 in the Northern District of Illinois
• Plaintiffs: Amarin Pharma, Inc.; Amarin Pharmaceuticals Ireland Ltd.
• Defendants: Apotex, Inc.; Apotex Corp.
Amarin Pharma, Inc. et al. v. Apotex, Inc. et al.
3:14-cv-02550; filed April 21, 2014 in the District Court of New Jersey
• Plaintiffs: Amarin Pharma, Inc.; Amarin Pharmaceuticals Ireland Ltd.
• Defendants: Apotex, Inc.; Apotex Corp.
Amarin Pharma, Inc. et al. v. Roxane Laboratories, Inc.
3:14-cv-02551; filed April 21, 2014 in the District Court of New Jersey
• Plaintiffs: Amarin Pharma, Inc.; Amarin Pharmaceuticals Ireland Ltd.
• Defendant: Roxane Laboratories, Inc.
The complaints in these cases are substantially identical. 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 defendants' 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 New Jersey Apotex complaint here.
Kowa Co. et al. v. Zydus Pharmaceuticals (USA) Inc. et al.
3:14-cv-02552; filed April 22, 2014 in the District Court of New Jersey
• Plaintiffs: Kowa Co.; Kowa Pharmaceuticals America, Inc.; Nissan Chemical Industries, Ltd.
• Defendants: Zydus Pharmaceuticals (USA) Inc.; Cadila Healthcare Ltd.
Kowa Co. et al. v. Orient Pharma Co., Ltd.
1:14-cv-02759; filed April 17, 2014 in the Southern District of New York
• Plaintiffs: Kowa Co.; Kowa Pharmaceuticals America, Inc.; Nissan Chemical Industries, Ltd.
• Defendant: Orient Pharma Co., Ltd.
Kowa Co. et al. v. Zydus Pharmaceuticals (USA) Inc. et al.
1:14-cv-02760; filed April 17, 2014 in the Southern District of New York
• Plaintiffs: Kowa Co.; Kowa Pharmaceuticals America, Inc.; Nissan Chemical Industries, Ltd.
• Defendants: Zydus Pharmaceuticals (USA) Inc.; Cadila Healthcare Ltd.
Kowa Co. et al. v. Mylan, Inc. et al.
2:14-cv-00504; filed April 17, 2014 in the Western District of Pennsylvania
• Plaintiffs: Kowa Co.; Kowa Pharmaceuticals America, Inc.; Nissan Chemical Industries, Ltd.
• Defendants: Mylan, Inc.; Mylan Pharmaceuticals, Inc.
The complaints in these cases are substantially identical. Infringement of U.S. Patent Nos. 5,856,336 ("Quinoline Type Mevalonolactones," issued January 5, 1999), 6,465,477 ("Stable Pharmaceutical Composition," issued October 15, 2002), and 8,557,993 ("Crystalline Forms of Pitavastatin Calcium," issued October 15, 2013) following a Paragraph IV certification as part of defendants' filing of an ANDA to manufacture a generic version of Kowa's Livalo® (pitavastatin, used as an adjunctive therapy to diet to reduce elevated total cholesterol, lowdensity lipoprotein cholesterol, apolipoprotein B, triglycerides, and to increase high-density lipoprotein cholesterol). View the Mylan complaint here.
Forest Laboratories Inc. et al. v. Amneal Pharmaceuticals LLC et al.
1:14-cv-00508; filed April 21, 2014 in the District Court of Delaware
• Plaintiffs: Forest Laboratories Inc.; Forest Laboratories Holdings Ltd.; Merz Pharma GmbH & Co. KGaA; Merz Pharmaceuticals GmbH; Adamas Pharmaceuticals Inc.
• Defendants: Amneal Pharmaceuticals LLC; Amneal Pharmaceuticals of New York LLC; Amerigen Pharmaceuticals Inc.; Amerigen Pharmaceuticals Ltd.; Mylan Pharmaceuticals Inc.
Infringement of U.S. Patent Nos. 5,061,703 ("Adamantane Derivatives in the Prevention and Treatment of Cerebral Ischemia," issued on October 29, 1991), 8,039,009 ("Modified Release Formulations of Memantine Oral dosage Forms," issued October 18, 2011), 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 Amneal'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.
Hospira Inc. et al. v. Aurobindo Pharma Ltd. et al.
1:14-cv-00486; filed April 18, 2014 in the District Court of Delaware
• Plaintiffs: Hospira Inc.; Orion Corp.
• Defendants: Aurobindo Pharma Ltd.; Aurobindo Pharma USA Inc.
Hospira Inc. et al. v. Ben Venue Laboratories Inc.
1:14-cv-00487; filed April 18, 2014 in the District Court of Delaware
• Plaintiffs: Hospira Inc.; Orion Corp.
• Defendant: Ben Venue Laboratories Inc.
Hospira Inc. et al. v. Actavis LLC et al.
1:14-cv-00488; filed April 18, 2014 in the District Court of Delaware
• Plaintiffs: Hospira Inc.; Orion Corp.
• Defendants: Actavis US Holding LLC; Actavis LLC
Hospira Inc. et al. v. Akorn, Inc.
1:14-cv-02811; filed April 18, 2014 in the Northern District of Illinois
• Plaintiffs: Hospira Inc.; Orion Corp.
• Defendant: Akorn, Inc.
Hospira, Inc. et al. v. Intas Pharmaceuticals Ltd. et al.
1:14-cv-00336; filed April 18, 2014 in the Middle District of North Carolina
• Plaintiffs: Hospira Inc.; Orion Corp.
• Defendants: Intas Pharmaceuticals Ltd.; Accord Healthcare, Inc. USA
The complaints in these cases are substantially identical. Infringement of U.S. Patent No. 6,716,867 ("Use of Dexmedetomidine for ICU Sedation," issued April 6, 2004) following a Paragraph IV certification as part of defendats' filing of an ANDA to manufacture a generic version of Hospira's Precedex® (dexmedetomidine hydrochloride injection, used for the sedation of initially intubated and mechanically ventilated patients during treatment in an intensive care setting). View the Aurobindo complaint here.
Westport Pharmaceuticals, LLC et al. v Acura Pharmaceuticals, Inc.
4:14-cv-00770; filed April 18, 2014 in the Eastern District of Missouri
• Plaintiffs: Westport Pharmaceuticals, LLC; Highland Pharmaceuticals, LLC
• Defendant: Acura Pharmaceuticals, Inc.
Declaratory judgment of non-infringement of U. S. Patent No. 8,409,616 ("Extended Release Opioid Abuse Deterrent Compositions and Methods of Making Same," issued April 2, 2013) based on Westport's manufacture and sale of its Zephrex-D® product (tamper-resistant pseudoephedrine, used to provide congestion relief for allergy, cold and sinus sufferers). View the complaint here.
Kowa Co. et al. v. Amneal Pharmaceuticals, LLC
3:14-cv-02488; filed April 18, 2014 in the District Court of New Jersey
• Plaintiffs: Kowa Co.; Kowa Pharmaceuticals America, Inc.; Nissan Chemical Industries, Ltd.
• Defendant: Amneal Pharmaceuticals, LLC
Kowa Co. et al. v. Amneal Pharamceuticals, L.L.C.
1:14-cv-02758; filed April 17, 2014 in the Southern District of New York
• Plaintiffs: Kowa Co.; Kowa Pharmaceuticals America, Inc.; Nissan Chemical Industries, Ltd.
• Defendant: Amneal Pharmaceuticals, L.L.C.
The complaints in these cases are substantially identical. Infringement of U.S. Patent Nos. 5,856,336 ("Quinoline Type Mevalonolactones," issued January 5, 1999) and 8,557,993 ("Crystalline Forms of Pitavastatin Calcium," issued October 15, 2013) following a Paragraph IV certification as part of Amneal's filing of an ANDA to manufacture a generic version of Kowa's Livalo® (pitavastatin, used as an adjunctive therapy to diet to reduce elevated total cholesterol, lowdensity lipoprotein cholesterol, apolipoprotein B, triglycerides, and to increase high-density lipoprotein cholesterol). View the SDNY complaint here.
Mallinckrodt LLC et al. v. Metrics, Inc.
2:14-cv-02219; filed April 7, 2014 in the District Court of New Jersey
• Plaintiffs: Mallinckrodt LLC; Mallinckrodt Inc.; Nuvo Research Inc.
• Defendant: Metrics, Inc. d/b/a/ Coastal Pharmaceuticals
Infringement of U.S. Patent Nos. 8,217,078 ("Treatment of Pain with Topical Diclofenac," issued July 10, 2012), 8,546,450 (same title, issued October 1, 2013), and 8,618,164 (same title, issued December 31, 2013) following a Paragraph IV certification as part of Coastal's filing of an ANDA to manufacture a generic version of Mallinckrodt's Pennsaid® (diclofenac sodium topical solution, used for the treatment of signs and symptoms of osteoarthritis of the knee(s)). View the complaint here.
