Source: https://www.scribd.com/document/112766241/Ferring-v-Apotex-et-al
Timestamp: 2019-04-20 08:48:27+00:00

Document:
Ferring v. Apotex et. al.
Official Complaint for Patent Infringement in Civil Action No. 2:12-cv-01941: Ferring B.V. v. Apotex, Inc. et. al. Filed in U.S. District Court for the District of Nevada, no judge yet assigned. See http://news.priorsmart.com/-l74C for more info.
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Project MBA Ranbaxy Laboratories Ltd.
JAMES B. MONROE, ESQ. JUSTIN J. HASFORD, ESQ. FINNEGAN HENDERSON FARABOW GARRETT & DUNNER, LLP 901 New York Avenue, NW Washington, DC 20001-4413 Tel: (202) 408-4000 Fax: (202) 408-4400 Attorneys for Plaintiff Ferring B.V.
FERRING B.V., Plaintiff, v. APOTEX INC. and APOTEX CORP., Defendants.
Abbreviated New Drug Application (ANDA) under Section 505(j) of the Federal Food, Drug and Cosmetic Act (the Act), 21 U.S.C. 355(j), seeking U.S. Food and Drug Administration (FDA) approval to market generic tablets containing 650 mg tranexamic acid (Apotexs generic tranexamic acid tablets). JURISDICTION AND VENUE 5. This Court has subject matter jurisdiction under 28 U.S.C. 1331 and 1338(a).
information and belief, Apotex Corp. directly, or indirectly, manufactures, markets and sells generic drug products, including generic drug products manufactured by Apotex Inc., throughout the United States and in this judicial district. Upon information and belief, Apotex Corp.
owner of the 795 patent. A copy of the 795 patent is attached hereto as Exhibit A. 10. Ferring Pharmaceuticals AS is the holder of New Drug Application (NDA) No.
02-2430 for tranexamic acid tablets, which the FDA approved on November 13, 2009. The 795 patent is listed for NDA No. 02-2430 in the FDAs Approved Drug Products with Therapeutic Equivalence Evaluations (the Orange Book).
November 5, 2012, purporting to be a Notice of Certification for ANDA No. 202286 (Apotexs notice letter) under Section 505(j)(2)(B)(ii) of the Act, 21 U.S.C. 355(j)(2)(B)(ii), and 21 C.F.R. 314.95(c).
approved and marketed, infringe at least one claim of the 795 patent.
complained of herein were done with the cooperation, the participation, the assistance of, and at least in part for the benefit of, Apotex Corp. WHEREFORE, Plaintiff Ferring respectfully requests that the Court enter judgment in its favor and against Defendants Apotex Inc. and Apotex Corp. on the patent infringement claims set forth above and respectfully requests that this Court: 1) enter judgment that, under 35 U.S.C. 271(e)(2)(A), Apotex has infringed at least one claim of the 795 patent through Apotex Inc.s submission of ANDA No.
award Ferring such further and additional relief as this Court deems just and proper.
DATED this 9th day of November, 2012. GORDON SILVER By: /s/ Molly Malone Rezac GORDON SILVER MOLLY M. REZAC, ESQ. Nevada Bar No. 7435 Email: mrezac@gordonsilver.com JUSTIN J. BUSTOS, ESQ. Nevada Bar No. 10320 Email: jbustos@gordonsilver.com 100 W. Liberty Street Suite 690 Reno, NV 89501 Tel: (775) 343-7500 Fax: (775) 786-0131 Of Counsel: JAMES B. MONROE, ESQ. JUSTIN J. HASFORD, ESQ. FINNEGAN HENDERSON FARABOW GARRETT & DUNNER, LLP 901 New York Avenue, NW Washington, DC 20001-4413 Tel: (202) 408-4000 Fax: (202) 408-4400 Attorneys for Plaintiff Ferring B.V.
Exhibit page count is exclusive of exhibit slip sheets.
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