Horizon Pharma et. al. v. Par Pharmaceutical Companies et. al. | Generic Drug | Food And Drug Administration

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  Official Complaint for Patent Infringement in Civil Action No. None: Horizon Pharma Inc. et. al. v. Par Pharmaceutical Companies, Inc. et. al. Filed in U.S. District Court for the District of Delaware, no judge yet assigned. See http://news.priorsmart.com/-l7uZ for more info.
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  IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE HORIZON PHARMA, mc. and HORIZON PHARMA USA, mc., Plaintiffs, v. PAR PHARMACEUTICAL COMPANIES, mc. and PAR PHARMACEUTICAL, mc., Defendants. COMPLAINT C.A. No. _____ Plaintiffs Horizon Pharma, Inc. and Horizon Pharma USA, Inc. (collectively, Horizon ) by their undersigned attorneys, bring this action against Defendants ParPharmaceutical Companies, Inc. and Par Pharmaceutical, Inc. (collectively, Par ), andhereby allege as follows: THE PARTIES 1. Plaintiff Horizon Pharma, Inc. is a corporation organized and existingunder the laws of the State of Delaware, with a principal place of business at 520 Lake Cook Road, Suite 520, Deerfield, Illinois.  2. Plaintiff Horizon Pharma USA, Inc. is a corporation organized andexisting under the laws of the State of Delaware, with a principal place of business at1033 Skokie Boulevard, Suite 355, Northbrook, Illinois 60062.3. Upon information and belief, Defendant Par Pharmaceutical Companies,Inc. is a company organized and existing under the laws of the State of Delaware, with aprincipal place of business at 300 Tice Boulevard, Woodcliff Lake, New Jersey 07677.4. Upon information and belief, Defendant Par Pharmaceutical, Inc. is acorporation organized and existing under the laws of the State of Delaware, with aprincipal place of business at One Ram Ridge Road, Spring Valley, New York 10977,and is a wholly-owned subsidiary of Par Pharmaceutical Companies, Inc.5. Upon information and belief, Par Pharmaceutical, Inc. is in the businessof, among other activities, offering for sale, selling and/or importing copies of brandedpharmaceutical products throughout the United States, including in the State of Delaware.6. Upon information and belief, Par Pharmaceutical, Inc. makes regulatorysubmissions to the United States Food and Drug Administration ( FDA ), includingsubmissions on behalf of Par Pharmaceutical Companies, Inc. 7. Upon information and belief, Par Pharmaceutical Companies, Inc. marketsand sells generic drugs throughout the United States, and in particular within this judicialdistrict, and therefore Par Pharmaceutical Companies, Inc. has engaged in systematic andcontinuous business within this judicial district. In addition, and upon information andbelief, Par Pharmaceutical Companies, Inc. controls and dominates Par Pharmaceutical,Inc., and thus the activities of Par Pharmaceutical, Inc. in this judicial district areattributable to Par Pharmaceutical Companies, Inc. 2  8. On information and belief, Par Pharmaceutical, Inc. alone and through itsparent Par Pharmaceutical Companies, Inc., markets and sells generic drugs throughoutthe United States, and in particular within this judicial district, and therefore ParPharmaceutical, Inc. has engaged in systematic and continuous business within thisjudicial district.9. Upon information and belief, Par Pharmaceutical Companies, Inc. and ParPharmaceutical, Inc. collaborated in the research and development of Par's Abbreviated New Drug Application ( ANDA ) No. 203658 for tablets that contain 800 mg of ibuprofen and 26.6 mg offamotidine as active ingredients ( the Par ANDA Product ),continue to collaborate in seeking approval of that application by the FDA, and intend tocollaborate in the commercial manufacture, marketing, offer for sale and sale of the ParANDA Product throughout the United States, including in the State of Delaware, in theevent the FDA approves Par's ANDA. JURISDICTION AND VENUE 10. This is a civil action arising under the patent laws of the United States,Title 35, United States Code, for infringement of U.S. Patent No. 8,309,127 ( the '127patent ) and U.S. Patent No. 8,318,202 C'the '202 patent ). This Court has jurisdictionover the subject matter of this action under 28 U.S.C. §§ 1331 and 1338(a).11. Upon information and belief, Par Pharmaceutical Companies, Inc. issubject to personal jurisdiction in this judicial district because it is incorporated in thisState and it has purposely availed itself of the benefits and protections of this State's lawssuch that it should reasonably anticipate being haled into court in this judicial district.3  12. Upon information and belief, Par Pharmaceutical, Inc. is subject to personal jurisdiction in this judicial district because, inter alia, Par Pharmaceutical, Inc. isincorporated in this state, and Par Pharmaceutical, Inc., alone and through its parent ParPharmaceutical Companies, Inc., has purposely availed itself of the benefits andprotections of this State's laws such that it should reasonably anticipate being haled intocourt in this judicial district. 13. Upon information and belief, Par Pharmaceutical Companies, Inc. and/orPar Pharmaceutical, Inc. did not object to personal jurisdiction or venue in this judicialdistrict in Civil Action Nos. 09-305-JJF, 09-481-LDD, 11-107-SLR, 11-705-LPS, and12-393-LPS. 14. Venue is proper in this judicial district under 28 U.S.C. §§ 1391(b) and (c)and § 1400(b). BACKGROUND 15. Horizon Pharma, Inc. is the holder of the approved New Drug Application( NDA ) No. 022519 for Duexis® tablets, which contains 26.6 mg offamotidine and 800mg of ibuprofen as active ingredients. Duexis® was approved by the FDA on April 23, 2011, for the relief of signs and symptoms of rheumatoid arthritis and osteroarthritis andto decrease the risk of developing upper gastrointestinal ulcers. 16. On information and belief, Par Pharmaceutical, Inc. submitted ANDA No.203658 to the FDA under the provisions of21 U.S.C. § 355G) seeking approval toengage in the commercial manufacture, use, offer for sale, sale and/or importation of generic copies of Duexis® tablets. 4
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