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AbbVie v. Roxane Laboratories

AbbVie v. Roxane Laboratories

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Published by PriorSmart
Official Complaint for Patent Infringement in Civil Action No. 2:13-cv-00708-EAS-EPD: AbbVie Inc v. Roxane Laboratories, Inc. Filed in U.S. District Court for the Southern District of Ohio, the Hon. Edmund A Sargus presiding. See http://news.priorsmart.com/-l8Lu for more info.
Official Complaint for Patent Infringement in Civil Action No. 2:13-cv-00708-EAS-EPD: AbbVie Inc v. Roxane Laboratories, Inc. Filed in U.S. District Court for the Southern District of Ohio, the Hon. Edmund A Sargus presiding. See http://news.priorsmart.com/-l8Lu for more info.

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Published by: PriorSmart on Jul 18, 2013
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07/19/2013

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IN THE UNITED STATES DISTRICT COURTFOR THE SOUTHERN DISTRICT OFOHIOEASTERN DIVISION
ABBVIE INC.1 North Waukegan Road North Chicago, IL 60064,Plaintiff,v.ROXANE LABORATORIES, INC.1809 Wilson RoadColumbus, OH 43228c/o CT Corporation System1300 East 9
th
StreetCleveland, OH 44114,Defendant.)))))))))))))))))Civil Action No. 13-708
COMPLAINT
Plaintiff AbbVie Inc., by way of Complaint against Roxane Laboratories, Inc., states asfollows:
THE PARTIES
1. Plaintiff AbbVie Inc. (“AbbVie”) is a corporation organized and existing undethe laws of Delaware with its corporate headquarters at 1 North Waukegan Road, North Chicago,Illinois 60064. AbbVie is a global biopharmaceutical company engaged in the business of research, development, manufacture, and sale of pharmaceutical products throughout the world.2. On information and belief, Defendant Roxane Laboratories, Inc. (“Roxane”) is acorporation organized and existing under the laws of Nevada, having its principal place of  business located at 1809 Wilson Road, Columbus, Ohio 43228.
 
2
NATURE OFTHE ACTION
3. This is a civil action for patent infringement of United States Patent Number 8,268,349 B2 (“the ’349 patent”) and United States Patent Number 8,399,015 B2 (“the ’015 patent”), arising under the United States Patent Laws, Title 35, United States Code, §100,
et seq.
,and in particular under 35 U.S.C. § 271. This action relates to Abbreviated New DrugApplication (“ANDA”) No. 202573, which Roxane filed or caused to be filed under 21 U.S.C.§ 355(j) with the United States Food and Drug Administration (“FDA”), for approval to market ageneric copy of AbbVie’s successful Norvir 
®
tablets that are sold in the United States, and whichRoxane subsequently amended.
JURISDICTION AND VENUE
4. This is a civil action for patent infringement and declaratory judgment arisingunder the patent laws of the United States, 35 U.S.C. §§ 1
et seq.
, and the Declaratory JudgmentAct, 28 U.S.C. §§ 2201 and 2202. This Court has subject matter jurisdiction under 28 U.S.C.§§ 1331 and 1338(a).5. This Court has personal jurisdiction over Roxane as evidenced by,
inter alia
,having conducted business in Ohio including but not limited to the substantial, continuous andsystematic distribution, marketing, and/or sales of pharmaceutical products to residents of this judicial district, having availed itself of the rights and benefits of Ohio law, previously admittingto personal jurisdiction in this Court, availing itself of the jurisdiction of this Court, and havingengaged in systematic and continuous contacts with the State of Ohio.6. Venue is proper in this judicial district under 28 U.S.C. §§ 1391(b) and (c), and§ 1400(b).
 
3
BACKGROUND
7. AbbVie is the holder of approved New Drug Application (“NDA”) No. 22-417for ritonavir tablets, marketed and sold under the trademark Norvir 
®
. AbbVie manufactures andsells Norvir 
®
100 mg tablets in the United States under NDA No. 22-417.8. Roxane filed with the FDA ANDA No. 202573 under 21 U.S.C. § 355(j)(2)(B),seeking FDA approval to market ritonavir tablets 100 mg (“Roxane’s generic ritonavir tablets”),which are generic copies of AbbVie’s Norvir 
®
tablets.9. ANDA No. 202573 seeks FDA approval of a pharmaceutical compositioncomprising ritonavir in a 100 mg dosage strength.10. ANDA No. 202573 seeks FDA approval to market Roxane’s generic ritonavitablets in the United States.11. On March 24, 2011, Abbott Laboratories (“Abbott”) received a letter on behalf of Roxane, dated March 21, 2011, purporting to be a “Patent Notice Pursuant to § 505(b)(3)(B) [21USC § 355(b)(4)(B)]” for ANDA No. 202573 pursuant to section 505(j)(2)(B)(ii) of the FederalFood, Drug and Cosmetic Act and 21 C.F.R. § 314.95. Roxane’s March 24, 2011, notice letter notified Abbott that Roxane had filed ANDA No. 202573, seeking approval to market Roxane’sgeneric ritonavir tablets prior to the expiration of United States Patent Number 7,148,359 B2(“the ’359 patent”) and United States Patent Number 7,364,752 B1 (“the ’752 patent”). The ’359 patent and the ’752 patent are the subject of 
Roxane Laboratories, Inc. v. Abbott Laboratoriesand AbbVie Inc.
, C.A. No. 2:12-cv-312-MHW-NMK, which is currently pending in this District.12. On April 6, 2012, Abbott received a letter on behalf of Roxane, dated March 29,2012, purporting to be a “Patent Notice Pursuant to § 505(j)(2)(B)(ii) [21 USC §

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