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Kowa Company et. al. v. Orient Pharma

Kowa Company et. al. v. Orient Pharma

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Published by PriorSmart
Official Complaint for Patent Infringement in Civil Action No. 1:14-cv-03336: Kowa Company, LTD. et. al. v. Orient Pharma Co., LTD. Filed in U.S. District Court for the Northern District of Illinois, no judge yet assigned. See http://news.priorsmart.com/-laqF for more info.
Official Complaint for Patent Infringement in Civil Action No. 1:14-cv-03336: Kowa Company, LTD. et. al. v. Orient Pharma Co., LTD. Filed in U.S. District Court for the Northern District of Illinois, no judge yet assigned. See http://news.priorsmart.com/-laqF for more info.

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Published by: PriorSmart on May 07, 2014
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IN THE UNITED STATES DISTRICT COURTFOR THE NORTHERN DISTRICT OF ILLINOISEASTERN DIVISION
KOWA COMPANY, LTD.,KOWA PHARMACEUTICALS AMERICA,INC. and NISSAN CHEMICAL INDUSTRIES, LTD.,Plaintiffs,v.ORIENT PHARMA CO., LTD.,Defendant.)))))))))))Civil Action No. ___________ 
COMPLAINT
Plaintiffs, Kowa Company, Ltd. (“KCL”), Kowa Pharmaceuticals America, Inc.(“KPA”)(collectively, “Kowa”), and Nissan Chemical Industries, Ltd. (“NCI”) by theiundersigned counsel, for their Complaint against defendant Orient Pharma Co., Ltd. (“Orient”),allege as follows:
Jurisdiction and Venue
1. This is an action for patent infringement arising under the patent laws of theUnited States, Title 35, United States Code and arising under 35 U.S.C. §§ 271(e)(2), 271(b),271(c), and 281-283. Subject matter jurisdiction is proper under 28 U.S.C. §§ 1331 and 1338(a).Venue is proper under 28 U.S.C. §§ 1391 (c)(3) and 1400(b). Personal jurisdiction over thedefendant in Chicago and this district is proper based on defendant’s designation of an agent for service of process in this jurisdiction, 735 ILCS 5/2-209, and/or Fed. R. Civ. P. 4(k)(2).
Parties
2. KCL is a Japanese corporation having its corporate headquarters and principal place of business in Aichi, Japan. KPA is a wholly owned U.S. subsidiary of KCL. KPA has its
 
2corporate headquarters and principal place of business in Montgomery, Alabama and isorganized under the laws of Delaware.3. NCI is a Japanese corporation having its corporate headquarters and principal place of business in Tokyo, Japan.4. KCL and NCI are engaged in the business of research, developing,manufacturing, and marketing of a broad spectrum of innovative pharmaceutical products,including Livalo
®
.5. Upon information and belief, Orient is a corporation organized and existing under the laws of Taiwan having a place of business in Taipei, Taiwan. Upon information and belief,Orient filed Abbreviated New Drug Application (“ANDA”) No. 20-5932.6. Upon information and belief, Orient intends to transact business in the NorthernDistrict of Illinois, at least by making and shipping into this Judicial District, or by using,offering to sell or selling or by causing others to use, offer to sell or sell, pharmaceutical productsinto this Judicial District.7. Upon information and belief, Orient will derive substantial revenue frominterstate and/or international commerce, including substantial revenue from goods used or consumed or services rendered in the State of Illinois and the Northern District of Illinois.Orient has also designated “an agent authorized to accept service of process” pursuant to 21C.F.R. § 314.95(c)(7) in Chicago, Illinois. By filing its ANDA, Orient has committed, andunless enjoined, will continue to commit a tortious act without the state of Illinois, that Orientexpects or should reasonably expect to have consequences in the State of Illinois including inthis Judicial District.
 
3
The New Drug Application
8. KPA sells drug products containing pitavastatin calcium (the “pitavastatin drug product”) under the trade name Livalo
®
in the United States pursuant to the United States Foodand Drug Administration’s approval of a New Drug Application (“NDA”) held by KCL (NDA No. 22-363).9. Livalo
®
is approved for use as an adjunctive therapy to diet to reduce elevatedtotal cholesterol, low-density lipoprotein cholesterol, apolipoprotein B, triglycerides, and toincrease HDL-C in adult patients with primary hyperlipidemia or mixed dyslipidemia.10. The approval letter for Livalo
®
, with approved labeling, was issued by the FDAon August 3, 2009.11. Certain amendments to the approved labeling for Livalo
®
have subsequently beenapproved.
The Patents in Suit
12. United States Patent No. 5,856,336 (“the ‘336 patent”), entitled “Quinoline TypeMevalonolactones,” a true and correct copy of which is appended hereto as
 Exhibit A
, was dulyissued on January 5, 1999 to inventors Yoshihiro Fujikawa, Mikio Suzuki, Hiroshi Iwasaki,Mitsuaki Sakashita, and Masaki Kitahara, and assigned to plaintiff NCI. The ‘336 patent claims,
inter alia
, the pitavastatin drug product, and a method for reducing hyperlipidemia,hyperlipoproteinemia or atherosclerosis, which comprises administering an effective amount of the pitavastatin drug product.13. Plaintiff NCI has been and still is the owner through assignment of the ‘336 patent, which expires on December 25, 2020 pursuant to a patent-term extension. KCL is NCI’slicensee for the ‘336 patent and KPA holds a license from KCL for the ‘336 patent.

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