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Litigation Details for TEVA PHARMACEUTICALS USA v. FOOD AND DRUG ADMINISTRATION (D.C. 2005)

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TEVA PHARMACEUTICALS USA v. FOOD AND DRUG ADMINISTRATION (D.C. 2005)

Docket ➤ Sign Up Date Filed 2005-07-26
Court District Court, District of Columbia Date Terminated 2005-10-21
Cause 05:0706 Judicial Review of Agency Actions Assigned To John D. Bates
Jury Demand None Referred To
Parties APOTEX, INC.; FOOD AND DRUG ADMINISTRATION; LESTER M. CRAWFORD; MICHAEL O. LEAVITT; RANBAXY INC.; RANBAXY LABORATORIES LIMITED; RANBAXY PHARMACEUTICALS INC; TEVA PHARMACEUTICALS USA
Patents 4,105,776; 4,128,658; 4,231,938; 4,337,201; 4,344,949; 4,346,227; 4,374,829; 4,521,431; 4,591,592; 5,030,447; 5,180,589; 5,248,699; 5,622,985; 6,194,415; 6,248,741; 6,465,464
Attorneys Andrew E. Clark; Arthur Y. Tsien; Christine J. Siwik; Jay P. Lefkowitz; Jeffrey Stuart Bucholtz; Kate Cumming Beardsley; Patricia Eggleston Pahl; Steven Andrew Engel; William A. Rakoczy
Firms Buc & Beardsley, LLP; King & Spalding, LLP; Kirkland & Ellis LLP; Olsson Frank Weeda Terman Bode Matz Pc; Olsson, Frank & Weeda, P.C.; Rakoczy Molino Mazzochi Siwik; U.S. DEPARTMENT OF JUSTICE, Office of Legal Counsel
Link to Docket External link to docket
Small Molecule Drugs cited in TEVA PHARMACEUTICALS USA v. FOOD AND DRUG ADMINISTRATION

Details for TEVA PHARMACEUTICALS USA v. FOOD AND DRUG ADMINISTRATION (D.C. 2005)

Date Filed Document No. Description Snippet Link To Document
2005-07-26 1 Complaint lists four patents in connection with Pravachol®, U.S. Patent Nos. 4,346,227 (“the ‘227 patent”), 5,030,…5,030,447 (“the ‘447 patent”), 5,180,589 (“the ‘589 patent”, and 5,622,985 (“the ‘985 patent”). 21. The ‘227… vulnerable patents, as well as the litigation costs that can come from protracted patent infiingement…227 patent is a compound patent for pravastatin sodium and expires on April 20, 2006. The ‘447 and ‘589…application would not infringe those patents and/or that the patents were invalid. Case 1:05-cv-01469-JDB External link to document
2005-08-09 11 Answer to Complaint purports to summarize the contents of U.S. Patent l\los. 4,346,227; 50,030,447; 5,180,589; and 5,622,985, …invaiidity and/or unenforceability as to three patents, as set forth in Apotex’s Complaint in that case External link to document
2005-08-25 17 Exhibit 1- Letter to FDA Nos. 5,030,447 (the ’447 patent), 5,180,589 (the '589 patent) and 5,622,985 (the ’985 patent) began…? (the ’227 patent}, the '44'? patent, the '589 patent and the '985 patent Ranbaxy’s ANDA… arising from the '447 patent, the '589 patent and the ‘985 patent began to run on August 22, …listed four patents in the Orange Boolc as claiming each strength cfPravachof: U.S. Patent No. 4,346,22… as to two ot` these patents, a section viii statement as to the '985 patent and a paragraph IiI certification External link to document
2005-08-25 18 Exhibit Exhibit 6 - Teva Teva I D.C. Cir. Br. will expire on June 4, 2002, and Patent No. 4,128, 658 (the 658 patent) covers Form 1, and expired on July…35. PATENTS PART III--PATENTS AND PROTECTION OF PATENT RIGHTS CHAPTER 28--INFRINGEMENT OF PATENTS Copr…The only listed patent for ticlopidine is.. U.S. Patent No. 4,591_,592 (the “ ’592 patent”), a formulation…such a patent holder could effectively extend its patent by expresslv acknowledging that the patent would…quot; Patent" defined For purposes of this section, the term "patent" means a patent issued External link to document
2005-08-25 19 Memorandum in Opposition relevant patents in the Orange Book with respect to its drug: U.S. Patent Nos. 4,346,227 (“the ‘227…227 patent”); 5,030,447 (“the ‘447 patent”); 5,180,589 (“the ‘589 patent”); and 5,622,985 (“the ‘985 patent… any patent that claims the drug, or a method of using the drug, and for which a claim of patent infringement…depends, in part, on patent protections for the pioneer drug. A. Patent Certifications … that the required patent information relating to such patent has not been filed External link to document
2005-09-20 27 Errata lists four patents in connection with Pravacho l®: U.S. Patent Nos. 4,346,227 (“the ‘227 patent”), 5,030,447… 40 ‘447 patent and the ‘589 patent claim formulations of the drug, and the ‘985 patent claims a method…to challenge a patent bears research and legal costs in either designing around a patent or challenging…5,030,447 (“the ‘447 patent”) (expires January 2009), 5,180,589 (“the ‘589 patent”) (expires January 2009… and 5,622,985 (“the ‘985 patent”) (expires October 2014). The ‘227 patent claims the compound itself External link to document
2005-07-26 3 Exhibit D - Apotex Complaint atherosclerosis. U.S. Pat. Nos. 4,046,889 and 4,105,776 to Ondetti et al disclose proline derivatives,…submitted any patent information to FDA; (II) that the listed patent has expired; (III) that the patent will expire…NDA-holder/patent owner to obtain a judicial declaration with respect to the patent or patents at issue …he ‘589 patent is prior art 10 the ‘985 patent 151. On information and belief, the ‘589 patent is owned…_ United States Patent mr mr Patent Number= 5,030,447 Joshi et al. [45] Date of Patent: Jnl. 9, 1991 \ External link to document
Date Filed Document No. Description Snippet Link To Document

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