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Novartis et. al. v. Glenmark Pharmaceuticals et. al.

Novartis et. al. v. Glenmark Pharmaceuticals et. al.

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Published by PriorSmart
Official Complaint for Patent Infringement in Civil Action No. None: Novartis AG et. al. v. Glenmark Pharmaceuticals Ltd. et. al. Filed in U.S. District Court for the District of Delaware, no judge yet assigned. See http://news.priorsmart.com/-laAE for more info.
Official Complaint for Patent Infringement in Civil Action No. None: Novartis AG et. al. v. Glenmark Pharmaceuticals Ltd. et. al. Filed in U.S. District Court for the District of Delaware, no judge yet assigned. See http://news.priorsmart.com/-laAE for more info.

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Published by: PriorSmart on Jun 19, 2014
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06/19/2014

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ME1 18295435v.1
 
IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE
NOVARTIS AG and NOVARTIS PHARMACEUTICALS CORPORATION, Plaintiffs, v. GLENMARK PHARMACEUTICALS, LTD., GLENMARK GENERICS LTD., and GLENMARK GENERICS INC., USA, Defendants. X : : : : : : : : : : : : : X C.A. No. ____________
COMPLAINT FOR PATENT INFRINGEMENT
 Plaintiffs Novartis AG and Novartis Pharmaceuticals Corporation, for their Complaint herein against Defendants Glenmark Pharmaceuticals, Ltd. Glenmark Generics Ltd. and Glenmark Generics Inc., USA allege as follows:
NATURE OF ACTION
1.
 
This is an action for patent infringement.
PARTIES
2.
 
Plaintiff Novartis AG (“Novartis AG”) is a corporation organized and existing under the laws of Switzerland, having an office and place of business at Lichtstrasse 35, CH-4056, Basel, Switzerland. 3.
 
Plaintiff Novartis Pharmaceuticals Corporation (“NPC”) is a corporation organized and existing under the laws of the State of Delaware, having a principal place of business at 59 Route 10, East Hanover, New Jersey 07936.
 
 
ME1 18295435v.1
 24.
 
On information and belief, Defendant Glenmark Pharmaceuticals, Ltd. (“Glenmark Pharma”) is a corporation organized and existing under the laws of India, having a principal place of business at Glenmark House, HDO - Corporate Bldg., Wing A, B. D. Sawant Marg, Chakala, Off Western Express Highway, Andheri [East], Mumbai, 400099, India. On information and belief, Glenmark Pharma, itself and through its subsidiaries and agents, sells various drug products in the United States, including in this judicial district. 5.
 
On information and belief, Defendant Glenmark Generics Ltd. (“Glenmark Ltd.”) is a corporation organized and existing under the laws of India, having a principal place of business at Glenmark House, HDO-Corporate Bldg., Wing A, B. D. Sawant Marg, Chakala, Off Western Express Highway, Andheri [East], Mumbai 400099, India. On information and belief, Glenmark Ltd. is owned by Glenmark Pharma. On information and belief, Glenmark Ltd., itself and through its subsidiaries and agents, sells various drug products in the United States, including in this judicial district. 6.
 
On information and belief, Defendant Glenmark Generics Inc., USA (“Glenmark USA”) is a corporation organized and existing under the laws of the State of Delaware, having a principal place of business at 750 Corporate Drive, Mahwah, New Jersey 07430. On information and belief, Glenmark USA is a wholly owned subsidiary of Glenmark Ltd. On information and belief, Glenmark USA sells various drug products in the United States, including in this judicial district. 7.
 
Glenmark Pharma, Glenmark Ltd. and Glenmark USA are referred to collectively herein as “Glenmark.”
 
 
ME1 18295435v.1
 3 
JURISDICTION AND VENUE
 8.
 
This action arises under the patent laws of the United States of America. This Court has jurisdiction over the subject matter of this action under 28 U.S.C. §§ 1331 and 1338(a). 9.
 
This Court has personal jurisdiction over Glenmark USA, Glenmark Ltd. and Glenmark Pharma, by virtue of,
inter alia,
the incorporation of Glenmark USA in the state of Delaware and the fact that they have availed themselves of the rights and benefits of the laws of Delaware by engaging in systematic and continuous contacts with Delaware. 10.
 
Venue is proper in this Court pursuant to 28 U.S.C. §§ 1391(b) and (c) and 28 U.S.C. § 1400(b).
CLAIM FOR RELIEF – PATENT INFRINGEMENT
11.
 
Plaintiff NPC holds an approved new drug application (“NDA”) NDA No. 50-791 for Myfortic
®
 delayed-release tablets (180 mg and 360 mg), which tablets contain the active ingredient mycophenolic acid in its sodium salt form, mycophenolate sodium. Myfortic
®
 tablets were approved by the United States Food And Drug Administration (“FDA”) in 2004 for the prophylaxis (or prevention) of organ rejection in patients receiving allogeneic renal transplants, administered in combination with cyclosporine and corticosteroids. NPC markets Myfortic
®
 delayed-release tablets (180 mg and 360 mg) in the United States. 12.
 
Myfortic
®
 delayed-release tablets are an enteric formulation of mycophenolate sodium that delivers the active moiety mycophenolic acid. Mycophenolic acid is an immunosuppressant agent. As the sodium salt, mycophenolic acid can be chemically

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