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Valentine) Tj 0 -11.04 TD (General Counsel) Tj 0 -11.28 TD (Â鶹´«Ã½ Trade Commission) Tj 0 -22.08 TD (Richard Parker, Director) Tj 0 -11.04 TD ( Bureau of Competition) Tj 0 -11.28 TD (David Pender, Deputy Assistant Director) Tj 0 -11.04 TD (Randall Marks, Attorney ) Tj T* (Suzanne Michel, Attorney ) Tj T* (Â鶹´«Ã½ Trade Commission) Tj 0 -22.32 TD (Melvin H. Orlans, ) Tj 0 -11.04 TD ( Special Litigation Counsel) Tj T* (Â鶹´«Ã½ Trade Commission) Tj 0 -11.28 TD (600 Pennsylvania Avenue, NW) Tj 0 -11.04 TD (Washington, DC 20580) Tj T* (Telephone: \(202\) 326 2475) Tj T* (Facsimile: \(202\) 326 2477) Tj 0 -22.32 TD /F1 12 Tf (LOCAL COUNSEL:) Tj 0 -11.04 TD /F0 12 Tf (John D. 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Tj 52.8 -23.28 TD /F0 10.08 Tf -0.048 Tc (Â鶹´«Ã½ Trade Commission Brief as Amicus Curiae) Tj 137.28 -12.24 TD /F0 12 Tf 0 Tc (1) Tj -194.4 636.48 TD (The United States Â鶹´«Ã½ Trade Commission \(\223FTC\224\) files) Tj -36 -22.32 TD (this brief as Amicus Curiae to alert the Court to the potential) Tj 0 -22.08 TD (anti-competitive ramifications of court approval of the proposed) Tj 0 -22.32 TD (settlement between American Bioscience, Inc. \(\223ABI\224\) and Bristol-) Tj 0 -22.08 TD (Myers Squibb Co. \(\223Bristol\224\). Because the Commission has just) Tj 0 -22.32 TD (recently initiated an investigation of the conduct of ABI and) Tj 0 -22.08 TD (Bristol, the Commission does not presently take a position with) Tj 0 -22.32 TD (regard to the fact that ABI and Bristol have agreed to settle) Tj 0 -22.08 TD (their dispute. However, the precise terms of the settlement that) Tj 0 -22.32 TD (the parties ask this Court to approve do raise potential) Tj 0 -22.08 TD (competitive issues. The parties seek court approval of a Final) Tj 0 -22.32 TD (Order and Judgment which asks this Court to find that U.S. Patent) Tj 0 -22.08 TD (No. 6,096,331 \(\223the \221331 patent\224\) must be listed in the Food and) Tj 0 -22.32 TD (Drug Administration\222s \(\223FDA\224\) \223Orange Book\224 and to order Bristol) Tj 0 -22.08 TD (to maintain that listing. The Commission is concerned that a) Tj 0 -22.32 TD (judicial finding that the patent meets the statutory requirements) Tj 0 -22.08 TD (for listing in the Orange Book will prejudice parties who may) Tj 0 -22.32 TD (later challenge the listing.) Tj 0 -22.08 TD /F1 12 Tf (I. INTEREST AND EXPERTISE OF THE FEDERAL TRADE COMMISSION) Tj 36 -22.32 TD /F0 12 Tf (The FTC\222s mission is to protect consumers. 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Tj -370.32 -12.72 TD (Balto & James Mongoven, Antitrust Â鶹´«Ã½ in Pharmaceutical) Tj 0 -13.44 TD (Industry Mergers, 54 ) Tj 151.2 0 TD /F2 12 Tf (Food & Drug Law Journal) Tj 165.6 0 TD /F0 12 Tf (, 255 \(1999\).) Tj -280.8 -20.64 TD /F0 7.2 Tf (3) Tj 4.32 -4.08 TD /F0 12 Tf ( Staff of the Â鶹´«Ã½ Trade Commission, \223The) Tj -40.32 -12.72 TD (Pharmaceutical Industry: A Discussion of Competitive and) Tj 0 -12.72 TD (Antitrust Issues in an Environment of Change\224 \(March 1999\)) Tj T* (. ) Tj 36 -20.64 TD /F0 7.2 Tf (4) Tj 4.32 -4.08 TD /F0 12 Tf ( FTC Staff Comments to the Food and Drug Administration,) Tj -40.32 -12.72 TD (Citizen Petitions \(March 2, 2000\); FTC Staff Comments to the Food) Tj 0 -12.72 TD (and Drug Administration, 180-Day Exclusivity Period for Generic) Tj T* (Drugs \(November 4, 1999\), .) 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Tj 172.8 4.08 TD /F0 7.2 Tf (3) Tj 4.32 -4.08 TD /F0 12 Tf ( In addition, the Commission commented) Tj -177.12 -22.08 TD (twice in the past year to the FDA) Tj 237.6 4.08 TD /F0 7.2 Tf (4) Tj 4.32 -4.08 TD /F0 12 Tf ( concerning its implementation) Tj -241.92 -22.32 TD (of the Hatch-Waxman Act, which encourages the introduction of) Tj ET endstream endobj 19 0 obj 4092 endobj 17 0 obj << /Type /Page /Parent 5 0 R /Resources << /Font << /F0 6 0 R /F2 15 0 R /F3 20 0 R >> /ProcSet 2 0 R >> /Contents 18 0 R >> endobj 23 0 obj << /Length 24 0 R >> stream BT 57.12 711.84 TD 0 0 0 rg /F0 12 Tf 0 Tc 0 Tw (1) Tj 0 -22.32 TD (2) Tj 0 -22.08 TD (3) Tj 0 -22.32 TD (4) Tj 0 -22.08 TD (5) Tj 0 -22.32 TD (6) Tj 0 -22.08 TD (7) Tj 0 -22.32 TD (8) Tj 0 -22.08 TD (9) Tj -7.2 -22.32 TD (10) Tj 0 -22.08 TD (11) Tj 0 -22.32 TD (12) Tj 0 -22.08 TD (13) Tj 0 -22.32 TD (14) Tj 0 -22.08 TD (15) Tj 0 -22.32 TD (16) Tj 0 -22.08 TD (17) Tj 0 -22.32 TD (18) Tj 0 -22.08 TD (19) Tj 0 -22.32 TD (20) Tj 0 -22.08 TD (21) Tj 0 -22.32 TD (22) Tj 0 -22.08 TD (23) Tj 0 -22.32 TD (24) Tj 0 -22.08 TD (25) Tj 0 -22.32 TD (26) Tj 0 -22.08 TD (27) Tj 0 -22.32 TD (28) Tj ET 69.6 18 0.96 756 re f 71.52 18 0.96 756 re f 546.72 18 0.96 756 re f 72 271.68 144 0.96 re f BT 108 254.16 TD /F0 7.2 Tf (5) Tj 4.32 -4.08 TD /F0 12 Tf ( ) Tj 14.4 0 TD /F2 12 Tf (See) Tj 21.6 0 TD /F0 12 Tf ( H.R.Rep. No.98-857\(I\), at 14-15 \(1984\), reprinted in) Tj -76.32 -12.72 TD (1984 U.S.C.C.A.N. 2647-48 \(stating that the purposes of the Drug) Tj 0 -12.72 TD (Price Competition and Patent Term Restoration Act of 1984,) Tj T* (commonly referred to as "the Hatch-Waxman Act," are \223to make) Tj T* (available more low cost generic drugs [and] to create a new) Tj T* (incentive for increased expenditures for research and development) Tj T* (of certain products which are subject to pre-market approval\224\).) Tj 36 -21.36 TD /F0 7.2 Tf (6) Tj 4.32 -4.08 TD /F0 12 Tf ( ) Tj 14.4 0 TD /F2 12 Tf (Hoechst Marion Roussel, Inc.) Tj 201.6 0 TD /F0 12 Tf (, Docket 9293 \(March 16,) Tj -256.32 -12.72 TD (2000\) \(complaint\), . ) Tj 36 -20.64 TD /F0 7.2 Tf (7) Tj 4.32 -4.08 TD /F0 12 Tf ( 21 U.S.C. \247 355\(j\)\(5\)\(B\)\(iv\).) Tj 52.8 -23.28 TD /F0 10.08 Tf -0.048 Tc (Â鶹´«Ã½ Trade Commission Brief as Amicus Curiae) Tj 137.28 -12.24 TD /F0 12 Tf 0 Tc (3) Tj -230.4 636.48 TD (generic drugs while protecting the incentives of brand drug) Tj 0 -22.32 TD (companies to invest in new drug development.) Tj 316.8 4.08 TD /F0 7.2 Tf (5) Tj -280.8 -26.16 TD /F0 12 Tf (In two recent cases, the Commission charged brand and) Tj -36 -22.32 TD (generic drug companies with entering into anticompetitive) Tj 0 -22.08 TD (settlement agreements that delayed or were intended to delay) Tj 0 -22.32 TD (generic drug competition. 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Tj 208.8 4.08 TD /F0 7.2 Tf (8) Tj 4.32 -4.08 TD /F0 12 Tf ( The complaint charged that Abbott) Tj -213.12 -22.32 TD (paid Geneva approximately $4.5 million per month to keep Geneva's) Tj 0 -22.08 TD (generic version of the drug off the U.S. market, potentially) Tj 0 -22.32 TD (costing consumers hundreds of millions of dollars a year. This) Tj 0 -22.08 TD (agreement also allegedly delayed the entry of other generic) Tj 0 -22.32 TD (versions of Hytrin because of Geneva's 180-day exclusivity rights) Tj 0 -22.08 TD (under the Hatch-Waxman Act. Both companies agreed to settle,) Tj 0 -22.32 TD (and the Commission issued final orders in May.) Tj 331.2 4.08 TD /F0 7.2 Tf (9) Tj -331.2 -26.16 TD /F1 12 Tf (II. BACKGROUND) Tj 36 -22.32 TD /F0 12 Tf (As with the Commission\222s recent cases involving Hoechst,) Tj -36 -22.08 TD (Andrx, Abbott and Geneva, the potential anticompetitive effects) Tj 0 -22.32 TD (of the proposed settlement between ABI and Bristol flow from the) Tj 0 -22.08 TD (role that generic drugs play in the pharmaceutical marketplace) Tj 0 -22.32 TD (and the statutory framework governing FDA approval of those) Tj 0 -22.08 TD (generics.) Tj 36 -22.32 TD /F1 12 Tf (A. Generic Drug Entry Into the Marketplace) Tj 0 -22.08 TD /F0 12 Tf (Generic drugs, which contain active ingredients that are) Tj -36 -22.32 TD (chemically identical to their branded counterparts, typically are) Tj 0 -22.08 TD (sold at substantial discounts from the branded price. The first) Tj ET endstream endobj 27 0 obj 3421 endobj 25 0 obj << /Type /Page /Parent 5 0 R /Resources << /Font << /F0 6 0 R /F1 10 0 R /F2 15 0 R >> /ProcSet 2 0 R >> /Contents 26 0 R >> endobj 29 0 obj << /Length 30 0 R >> stream BT 57.12 711.84 TD 0 0 0 rg /F0 12 Tf 0 Tc 0 Tw (1) Tj 0 -22.32 TD (2) Tj 0 -22.08 TD (3) Tj 0 -22.32 TD (4) Tj 0 -22.08 TD (5) Tj 0 -22.32 TD (6) Tj 0 -22.08 TD (7) Tj 0 -22.32 TD (8) Tj 0 -22.08 TD (9) Tj -7.2 -22.32 TD (10) Tj 0 -22.08 TD (11) Tj 0 -22.32 TD (12) Tj 0 -22.08 TD (13) Tj 0 -22.32 TD (14) Tj 0 -22.08 TD (15) Tj 0 -22.32 TD (16) Tj 0 -22.08 TD (17) Tj 0 -22.32 TD (18) Tj 0 -22.08 TD (19) Tj 0 -22.32 TD (20) Tj 0 -22.08 TD (21) Tj 0 -22.32 TD (22) Tj 0 -22.08 TD (23) Tj 0 -22.32 TD (24) Tj 0 -22.08 TD (25) Tj 0 -22.32 TD (26) Tj 0 -22.08 TD (27) Tj 0 -22.32 TD (28) Tj ET 69.6 18 0.96 756 re f 71.52 18 0.96 756 re f 546.72 18 0.96 756 re f 72 259.68 144 0.96 re f BT 108 242.16 TD /F0 7.2 Tf (10) Tj 8.64 -4.08 TD /F0 12 Tf ( Congressional Budget Office, ) Tj 223.2 0 TD /F2 12 Tf (How Increased Competition) Tj -267.84 -13.44 TD (from Generic Drugs Has Affected Prices and Returns in the) Tj 0 -13.44 TD (Pharmaceutical Industry) Tj 165.6 0 TD /F0 12 Tf ( \(July 1998\) .) Tj -129.6 -21.36 TD /F0 7.2 Tf (11) Tj 8.64 -4.08 TD /F0 12 Tf ( ) Tj 21.6 0 TD /F2 12 Tf (Id. ) Tj 28.8 0 TD /F0 12 Tf (at xiii, 13.) Tj -59.04 -20.64 TD /F0 7.2 Tf (12) Tj 8.64 -4.08 TD /F0 12 Tf ( Amy Barrett, "Crunch Time in Pill Land," Business Week) Tj -44.64 -12.72 TD (52 \(November 22, 1999\).) Tj 36 -20.64 TD /F0 7.2 Tf (13) Tj 8.64 -4.08 TD /F0 12 Tf ( Scott Hensley, \223Bristol-Myers Move May Slow Taxol) Tj -44.64 -12.72 TD (Challengers,\224 Wall Street Journal, B2 \(August 16, 2000\).) Tj 93.12 -23.28 TD /F0 10.08 Tf -0.048 Tc (Â鶹´«Ã½ Trade Commission Brief as Amicus Curiae) Tj 137.28 -12.24 TD /F0 12 Tf 0 Tc (5) Tj -230.4 636.48 TD (generic manufacturer to enter the market typically charges 70% to) Tj 0 -22.32 TD (80% of the brand manufacturer\222s price. As additional generic) Tj 0 -22.08 TD (versions of the same drug enter the market, the price continues) Tj 0 -22.32 TD (to drop, sometimes decreasing to a level of 50% or less of the) Tj 0 -22.08 TD (brand price.) Tj 86.4 4.08 TD /F0 7.2 Tf (10) Tj 8.64 -4.08 TD /F0 12 Tf ( The benefits to consumers are dramatic. A) Tj -95.04 -22.32 TD (Congressional Budget Office Report estimates that consumers saved) Tj 0 -22.08 TD ($8 to $10 billion on prescription drugs at retail pharmacies in) Tj 0 -22.32 TD (1994 by purchasing generic drugs instead of brand name) Tj 0 -22.08 TD (products.) Tj 64.8 4.08 TD /F0 7.2 Tf (11) Tj 8.64 -4.08 TD /F0 12 Tf ( Within the next 4 years, patents on 33 drugs,) Tj -73.44 -22.32 TD (representing over $14 billion in sales, will expire.) Tj 374.4 4.08 TD /F0 7.2 Tf (12) Tj 8.64 -4.08 TD /F0 12 Tf ( The) Tj -383.04 -22.08 TD (successful entry of generic versions of those drugs will affect) Tj 0 -22.32 TD (dramatically the amount that consumers pay for those drugs.) Tj 36 -22.08 TD (Taxol, an anti-cancer drug sold by Defendant Bristol, had) Tj -36 -22.32 TD (1999) Tj 28.8 0 TD /F1 12 Tf ( ) Tj 7.2 0 TD /F0 12 Tf (U.S. sales of one billion dollars.) Tj 244.8 4.08 TD /F0 7.2 Tf (13) Tj 8.64 -4.08 TD /F0 12 Tf ( The availability of a) Tj -289.44 -22.08 TD (generic version of Taxol would significantly reduce its cost to) Tj 0 -22.32 TD (consumers, potentially saving them hundreds of millions of) Tj 0 -22.08 TD (dollars in the aggregate. Ivax Corp. announced August 29, 2000,) Tj 0 -22.32 TD (that it received tentative approval from the FDA to market its) Tj ET endstream endobj 30 0 obj 3516 endobj 28 0 obj << /Type /Page /Parent 5 0 R /Resources << /Font << /F0 6 0 R /F1 10 0 R /F2 15 0 R >> /ProcSet 2 0 R >> /Contents 29 0 R >> endobj 33 0 obj << /Length 34 0 R >> stream BT 57.12 711.84 TD 0 0 0 rg /F0 12 Tf 0 Tc 0 Tw (1) Tj 0 -22.32 TD (2) Tj 0 -22.08 TD (3) Tj 0 -22.32 TD (4) Tj 0 -22.08 TD (5) Tj 0 -22.32 TD (6) Tj 0 -22.08 TD (7) Tj 0 -22.32 TD (8) Tj 0 -22.08 TD (9) Tj -7.2 -22.32 TD (10) Tj 0 -22.08 TD (11) Tj 0 -22.32 TD (12) Tj 0 -22.08 TD (13) Tj 0 -22.32 TD (14) Tj 0 -22.08 TD (15) Tj 0 -22.32 TD (16) Tj 0 -22.08 TD (17) Tj 0 -22.32 TD (18) Tj 0 -22.08 TD (19) Tj 0 -22.32 TD (20) Tj 0 -22.08 TD (21) Tj 0 -22.32 TD (22) Tj 0 -22.08 TD (23) Tj 0 -22.32 TD (24) Tj 0 -22.08 TD (25) Tj 0 -22.32 TD (26) Tj 0 -22.08 TD (27) Tj 0 -22.32 TD (28) Tj ET 69.6 18 0.96 756 re f 71.52 18 0.96 756 re f 546.72 18 0.96 756 re f 72 335.28 144 0.96 re f BT 108 318.48 TD /F0 7.2 Tf (14) Tj 8.64 -4.08 TD /F0 12 Tf ( Glenn Singer, \223Miami-Based Firm May Face Delay in) Tj -44.64 -12.72 TD (Marketing Cancer Drug,\224 Knight Ridder/Tribune, \(August 30, 2000\),) Tj 0 -12.72 TD (.) Tj 36 -21.36 TD /F0 7.2 Tf (15) Tj 8.64 -4.08 TD /F0 12 Tf ( ) Tj 14.4 0 TD /F2 12 Tf (Id.) Tj -23.04 -21.36 TD /F0 7.2 Tf (16) Tj 8.64 -4.08 TD /F0 12 Tf ( ) Tj 14.4 0 TD /F2 12 Tf (Bristol-Myers Squibb Co. v. Ben Venue Lab.) Tj 302.4 0 TD /F0 12 Tf (, 90 F.) Tj -361.44 -12.72 TD (Supp.2d 522 \(D.N.J. 2000\).) Tj 36 -20.64 TD /F0 7.2 Tf (17) Tj 8.64 -4.08 TD /F0 12 Tf ( ABI Application for Temporary Restraining Order at 3) Tj -44.64 -13.44 TD (\(August 10, 2000\); ABI First Amended Complaint, \266\266 22-23; ) Tj 424.8 0 TD /F2 12 Tf (see) Tj -424.8 -13.44 TD (also) Tj 28.8 0 TD /F0 12 Tf ( Scott Hensley, \223Bristol-Myers Move May Slow Taxol) Tj -28.8 -12.72 TD (Challengers,\224 Wall Street Journal, B2 \(August 16, 2000\) \(stating) Tj 0 -12.72 TD (that FDA approval of a generic version of Taxol was expected this) Tj T* (summer\).) Tj 36 -20.64 TD /F0 7.2 Tf (18) Tj 8.64 -4.08 TD /F0 12 Tf ( 21 U.S.C. \247 355\(a\). ) Tj 48.48 -23.28 TD /F0 10.08 Tf -0.048 Tc (Â鶹´«Ã½ Trade Commission Brief as Amicus Curiae) Tj 137.28 -12.24 TD /F0 12 Tf 0 Tc (6) Tj -230.4 636.48 TD (generic version of Taxol.) Tj 180 4.08 TD /F0 7.2 Tf (14) Tj 8.64 -4.08 TD /F0 12 Tf ( Only Brisol\222s listing of the \221331) Tj -188.64 -22.32 TD (patent in the Orange Book prevents full FDA approval and Ivax\222s) Tj 0 -22.08 TD (marketing of generic Taxol.) Tj 194.4 4.08 TD /F0 7.2 Tf (15) Tj 8.64 -4.08 TD /F0 12 Tf ( Several other applications to) Tj -203.04 -22.32 TD (market generic Taxol are currently pending before the FDA) Tj 410.4 4.08 TD /F0 7.2 Tf (16) Tj 8.64 -4.08 TD /F0 12 Tf (. ABI) Tj -419.04 -22.08 TD (acknowledges that one or more of these \223could be granted approval) Tj 0 -22.32 TD (by that agency, literally any day.\224) Tj 252 4.08 TD /F0 7.2 Tf (17) Tj -216 -26.16 TD /F1 12 Tf (B. Hatch-Waxman Act) Tj 0 -22.32 TD /F0 12 Tf ( The Hatch-Waxman Act establishes the statutory framework) Tj -36 -22.08 TD (for the FDA\222s approval of generic drugs, as well as procedures) Tj 0 -22.32 TD (for considering patent claims that may cover those drugs. This) Tj 0 -22.08 TD (Act complements and builds on the procedures for approving new) Tj 0 -22.32 TD (branded drugs. The FDA approves a new branded drug through the) Tj 0 -22.08 TD (filing of a New Drug Application \(NDA\).) Tj 280.8 4.08 TD /F0 7.2 Tf (18) Tj 8.64 -4.08 TD /F0 12 Tf ( In accordance with 21) Tj -289.44 -22.32 TD (U.S.C. \247 355\(b\)\(1\), an NDA must list each patent which \223claims) Tj 0 -22.08 TD (the drug or a method of using the drug\224 and \223with respect to) Tj 0 -22.32 TD (which a claim of patent infringement could reasonably be asserted) Tj 0 -22.08 TD (if a person not licensed by the owner of the patent engaged in) Tj ET endstream endobj 34 0 obj 3800 endobj 31 0 obj << /Type /Page /Parent 32 0 R /Resources << /Font << /F0 6 0 R /F1 10 0 R /F2 15 0 R >> /ProcSet 2 0 R >> /Contents 33 0 R >> endobj 36 0 obj << /Length 37 0 R >> stream BT 57.12 711.84 TD 0 0 0 rg /F0 12 Tf 0 Tc 0 Tw (1) Tj 0 -22.32 TD (2) Tj 0 -22.08 TD (3) Tj 0 -22.32 TD (4) Tj 0 -22.08 TD (5) Tj 0 -22.32 TD (6) Tj 0 -22.08 TD (7) Tj 0 -22.32 TD (8) Tj 0 -22.08 TD (9) Tj -7.2 -22.32 TD (10) Tj 0 -22.08 TD (11) Tj 0 -22.32 TD (12) Tj 0 -22.08 TD (13) Tj 0 -22.32 TD (14) Tj 0 -22.08 TD (15) Tj 0 -22.32 TD (16) Tj 0 -22.08 TD (17) Tj 0 -22.32 TD (18) Tj 0 -22.08 TD (19) Tj 0 -22.32 TD (20) Tj 0 -22.08 TD (21) Tj 0 -22.32 TD (22) Tj 0 -22.08 TD (23) Tj 0 -22.32 TD (24) Tj 0 -22.08 TD (25) Tj 0 -22.32 TD (26) Tj 0 -22.08 TD (27) Tj 0 -22.32 TD (28) Tj ET 69.6 18 0.96 756 re f 71.52 18 0.96 756 re f 546.72 18 0.96 756 re f 72 282.24 144 0.96 re f BT 108 265.44 TD /F0 7.2 Tf (19) Tj 8.64 -4.08 TD /F0 12 Tf ( 21 U.S.C. \247 355\(b\)\(1\). The pertinent FDA regulation, 21) Tj -44.64 -12.72 TD (C.F.R. \247 314.53\(b\), essentially parrots the statute and) Tj 0 -12.72 TD (elaborates upon it by giving examples of the type of patents) Tj T* (which may be listed in the Orange Book.) Tj 36 -20.64 TD /F0 7.2 Tf (20) Tj 8.64 -4.08 TD /F0 12 Tf ( 21 U.S.C. \247 355\(j\)\(7\)\(A\)\(iii\). ) Tj -8.64 -20.64 TD /F0 7.2 Tf (21) Tj 8.64 -4.08 TD /F0 12 Tf ( 21 U.S.C. \247 355\(b\)-\(c\).) Tj -8.64 -21.36 TD /F0 7.2 Tf (22) Tj 8.64 -4.08 TD /F0 12 Tf ( ) Tj 14.4 0 TD /F2 12 Tf (Ben Venue Lab., Inc. v. Novartis Pharmaceutical Corp.) Tj 381.6 0 TD /F0 12 Tf (,) Tj -440.64 -12.72 TD (10 F. Supp. 2d 446, 456 \(D.N.J. 1998\)) Tj 273.6 0 TD (.) Tj -237.6 -20.64 TD /F0 7.2 Tf (23) Tj 8.64 -4.08 TD /F0 12 Tf ( 59 Fed. Reg. 50338, 50343 \(October 3, 1994\).) Tj 48.48 -23.28 TD /F0 10.08 Tf -0.048 Tc (Â鶹´«Ã½ Trade Commission Brief as Amicus Curiae) Tj 137.28 -12.24 TD /F0 12 Tf 0 Tc (7) Tj -230.4 636.48 TD (the manufacture, use or sale of the drug.\224) Tj 302.4 4.08 TD /F0 7.2 Tf (19) Tj 8.64 -4.08 TD /F0 12 Tf ( Once the FDA) Tj -311.04 -22.32 TD (approves the NDA, the patents submitted with the application are) Tj 0 -22.08 TD (listed in the FDA\222s \223Approved Drug Products with Therapeutic) Tj 0 -22.32 TD (Equivalence Evaluations,\224 known as the \223Orange Book.\224) Tj 381.6 4.08 TD /F0 7.2 Tf (20) Tj 8.64 -4.08 TD /F0 12 Tf ( The) Tj -390.24 -22.08 TD (listing of patents in the Orange Book which issue after approval) Tj 0 -22.32 TD (of the NDA is governed by 21 U.S.C. \247 355\(c\)\(2\), which) Tj 0 -22.08 TD (establishes the same criteria for patent listing as does section) Tj 0 -22.32 TD (355\(b\)\(1\), quoted above. Only the NDA holder may request that) Tj 0 -22.08 TD (the FDA list patents in the Orange Book.) Tj 288 4.08 TD /F0 7.2 Tf (21) Tj -252 -26.4 TD /F0 12 Tf (As described below, the listing of a patent in the Orange) Tj -36 -22.08 TD (Book has significant legal effects. However, ) Tj 331.2 0 TD (\223the FDA\222s listing) Tj -331.2 -22.32 TD (should not create any presumption that [a] patent was correctly) Tj 0 -22.08 TD (listed.\224) Tj 57.6 4.08 TD /F0 7.2 Tf (22) Tj 8.64 -4.08 TD /F0 12 Tf ( ) Tj 7.2 0 TD ( The FDA has stated that it lacks the resources and) Tj -73.44 -22.32 TD (the expertise to review patents submitted with NDAs. The agency) Tj 0 -22.08 TD (does not ensure that patent information is complete and relevant) Tj 0 -22.32 TD (to an approved drug before publishing it in the Orange Book.) Tj 432 4.08 TD /F0 7.2 Tf (23) Tj 8.64 -4.08 TD /F0 12 Tf ( ) Tj -404.64 -22.08 TD (The Hatch-Waxman Act promotes generic drug entry by) Tj -36 -22.32 TD (streamlining the FDA\222s approval process for generic drugs. A) Tj 0 -22.08 TD (generic drug manufacturer may seek expedited approval to market a) Tj ET endstream endobj 37 0 obj 3719 endobj 35 0 obj << /Type /Page /Parent 32 0 R /Resources << /Font << /F0 6 0 R /F2 15 0 R >> /ProcSet 2 0 R >> /Contents 36 0 R >> endobj 39 0 obj << /Length 40 0 R >> stream BT 57.12 711.84 TD 0 0 0 rg /F0 12 Tf 0 Tc 0 Tw (1) Tj 0 -22.32 TD (2) Tj 0 -22.08 TD (3) Tj 0 -22.32 TD (4) Tj 0 -22.08 TD (5) Tj 0 -22.32 TD (6) Tj 0 -22.08 TD (7) Tj 0 -22.32 TD (8) Tj 0 -22.08 TD (9) Tj -7.2 -22.32 TD (10) Tj 0 -22.08 TD (11) Tj 0 -22.32 TD (12) Tj 0 -22.08 TD (13) Tj 0 -22.32 TD (14) Tj 0 -22.08 TD (15) Tj 0 -22.32 TD (16) Tj 0 -22.08 TD (17) Tj 0 -22.32 TD (18) Tj 0 -22.08 TD (19) Tj 0 -22.32 TD (20) Tj 0 -22.08 TD (21) Tj 0 -22.32 TD (22) Tj 0 -22.08 TD (23) Tj 0 -22.32 TD (24) Tj 0 -22.08 TD (25) Tj 0 -22.32 TD (26) Tj 0 -22.08 TD (27) Tj 0 -22.32 TD (28) Tj ET 69.6 18 0.96 756 re f 71.52 18 0.96 756 re f 546.72 18 0.96 756 re f 72 244.08 144 0.96 re f BT 108 227.28 TD /F0 7.2 Tf (24) Tj 8.64 -4.08 TD /F0 12 Tf ( 21 U.S.C. \247 355\(j\); 21 C.F.R. \247 314.94. ) Tj -8.64 -20.64 TD /F0 7.2 Tf (25) Tj 8.64 -4.08 TD /F0 12 Tf ( 35 U.S.C. \247 271\(e\)\(1\). ) Tj -8.64 -20.64 TD /F0 7.2 Tf (26) Tj 8.64 -4.08 TD /F0 12 Tf ( 21 U.S.C. \247 355\(j\)\(2\)\(A\)\(vii\)\(III-IV\).) Tj -8.64 -20.64 TD /F0 7.2 Tf (27) Tj 8.64 -4.08 TD /F0 12 Tf ( 21 U.S.C. \247 355\(j\)\(4\)\(B\)\(iii\). ) Tj -8.64 -21.36 TD /F0 7.2 Tf (28) Tj 8.64 -4.08 TD /F0 12 Tf ( ) Tj 14.4 0 TD /F2 12 Tf (Rite-Hite Corp. v. Kelley Co.) Tj 208.8 0 TD /F0 12 Tf (, 56 F.3d 1538 \(Fed. Cir.) Tj -267.84 -12.72 TD (1995\).) Tj 93.12 -23.28 TD /F0 10.08 Tf -0.048 Tc (Â鶹´«Ã½ Trade Commission Brief as Amicus Curiae) Tj 137.28 -12.24 TD /F0 12 Tf 0 Tc (8) Tj -230.4 636.48 TD (generic version of an already-approved drug by submitting an) Tj 0 -22.32 TD (Abbreviated New Drug Application \(ANDA\).) Tj 288 4.08 TD /F0 7.2 Tf (24) Tj 8.64 -4.08 TD /F0 12 Tf ( While performing) Tj -296.64 -22.08 TD (development work necessary to seek such approval, a generic drug) Tj 0 -22.32 TD (manufacturer is free from liability for patent infringement.) Tj 432 4.08 TD /F0 7.2 Tf (25) Tj 8.64 -4.08 TD /F0 12 Tf ( ) Tj -440.64 -22.08 TD (If a patent listed in the Orange Book has not expired, however,) Tj 0 -22.32 TD (the generic drug manufacturer seeking approval of an ANDA must) Tj 0 -22.08 TD (certify either that the generic drug will not enter the market) Tj 0 -22.32 TD (before the patent\222s expiration date \(a paragraph III) Tj 0 -22.08 TD (certification\), or that the patent is \223invalid or will not be) Tj 0 -22.32 TD (infringed by the manufacture, use, or sale of the drug for which) Tj 0 -22.08 TD (the [ANDA] is submitted\224 \(a paragraph IV certification\).) Tj 403.2 4.08 TD /F0 7.2 Tf (26) Tj 8.64 -4.08 TD /F0 12 Tf ( ) Tj -375.84 -22.32 TD (If the ANDA contains the paragraph IV certification of) Tj -36 -22.08 TD (invalidity or non-infringement, the generic drug manufacturer) Tj 0 -22.32 TD (must notify the patent owner and the NDA holder. If the patent) Tj 0 -22.08 TD (owner disagrees with the certification and sues the ANDA) Tj 0 -22.32 TD (applicant for patent infringement within forty-five days of) Tj 0 -22.08 TD (notification, the Hatch-Waxman Act prohibits the FDA from) Tj 0 -22.32 TD (approving the ANDA for 30 months.) Tj 237.6 4.08 TD /F0 7.2 Tf (27) Tj 8.64 -4.08 TD /F0 12 Tf ( \(An NDA holder who is not) Tj -246.24 -22.08 TD (also the patent owner may sue as co-plaintiff with the patent) Tj 0 -22.32 TD (owner if it is the exclusive patent licensee.) Tj 324 4.08 TD /F0 7.2 Tf (28) Tj 8.64 -4.08 TD /F0 12 Tf (\) This automatic) Tj -332.64 -22.08 TD (stay forestalls the sale of the generic drug for 30 months,) Tj ET endstream endobj 40 0 obj 3571 endobj 38 0 obj << /Type /Page /Parent 32 0 R /Resources << /Font << /F0 6 0 R /F2 15 0 R >> /ProcSet 2 0 R >> /Contents 39 0 R >> endobj 42 0 obj << /Length 43 0 R >> stream BT 57.12 711.84 TD 0 0 0 rg /F0 12 Tf 0 Tc 0 Tw (1) Tj 0 -22.32 TD (2) Tj 0 -22.08 TD (3) Tj 0 -22.32 TD (4) Tj 0 -22.08 TD (5) Tj 0 -22.32 TD (6) Tj 0 -22.08 TD (7) Tj 0 -22.32 TD (8) Tj 0 -22.08 TD (9) Tj -7.2 -22.32 TD (10) Tj 0 -22.08 TD (11) Tj 0 -22.32 TD (12) Tj 0 -22.08 TD (13) Tj 0 -22.32 TD (14) Tj 0 -22.08 TD (15) Tj 0 -22.32 TD (16) Tj 0 -22.08 TD (17) Tj 0 -22.32 TD (18) Tj 0 -22.08 TD (19) Tj 0 -22.32 TD (20) Tj 0 -22.08 TD (21) Tj 0 -22.32 TD (22) Tj 0 -22.08 TD (23) Tj 0 -22.32 TD (24) Tj 0 -22.08 TD (25) Tj 0 -22.32 TD (26) Tj 0 -22.08 TD (27) Tj 0 -22.32 TD (28) Tj ET 69.6 18 0.96 756 re f 71.52 18 0.96 756 re f 546.72 18 0.96 756 re f 72 234.24 144 0.96 re f BT 108 216.72 TD /F0 7.2 Tf (29) Tj 8.64 -4.08 TD /F0 12 Tf ( ) Tj 14.4 0 TD /F2 12 Tf (Id.) Tj 21.6 0 TD /F0 12 Tf ( ) Tj -44.64 -21.36 TD /F0 7.2 Tf (30) Tj 8.64 -4.08 TD /F0 12 Tf ( ) Tj 14.4 0 TD /F2 12 Tf (See Purdue Pharma. L.P. v. Boehringer Ingelheim, GmbH) Tj 381.6 0 TD /F0 12 Tf (,) Tj -440.64 -12.72 TD (2000 Lexis 6563 \(S.D.N.Y. 2000\).) Tj 36 -21.36 TD /F0 7.2 Tf (31) Tj 8.64 -4.08 TD /F0 12 Tf ( ) Tj 14.4 0 TD /F2 12 Tf ( See Ben Venu Lab., Inc.) Tj 172.8 0 TD /F0 12 Tf (, 10 F. Supp. 2d at 450. ) Tj -195.84 -21.36 TD /F0 7.2 Tf (32) Tj 8.64 -4.08 TD /F0 12 Tf ( ) Tj 21.6 0 TD /F2 12 Tf (See Abbott Lab. v. Novopharm Ltd) Tj 230.4 0 TD /F0 12 Tf (., 104 F.3d 1305 \(Fed.) Tj -296.64 -12.72 TD (Cir. 1997\). ) Tj 93.12 -23.28 TD /F0 10.08 Tf -0.048 Tc (Â鶹´«Ã½ Trade Commission Brief as Amicus Curiae) Tj 137.28 -12.24 TD /F0 12 Tf 0 Tc (9) Tj -230.4 636.48 TD (regardless of the merits of the suit, unless the suit is resolved) Tj 0 -22.32 TD (earlier in the generic company\222s favor or the patent expires.) Tj 439.2 4.08 TD /F0 7.2 Tf (29) Tj 8.64 -4.08 TD /F0 12 Tf ( ) Tj -447.84 -22.08 TD (In contrast, for patents not listed in the Orange Book, the) Tj 0 -22.32 TD (patent owner\222s recourse is to sue a generic company for patent) Tj 0 -22.08 TD (infringement only after the company obtains FDA approval of its) Tj 0 -22.32 TD (ANDA. To prevent sale of the generic product prior to conclusion) Tj 0 -22.08 TD (of the suit, the patent owner must obtain a preliminary) Tj 0 -22.32 TD (injunction, which requires that it demonstrate, ) Tj 345.6 0 TD /F2 12 Tf (inter alia) Tj 72 0 TD /F0 12 Tf (, a) Tj -417.6 -22.08 TD (likelihood of success on the merits.) Tj 259.2 4.08 TD /F0 7.2 Tf (30) Tj -223.2 -26.4 TD /F0 12 Tf (A generic company may cut short the automatic 30-month stay) Tj -36 -22.08 TD (by successfully challenging the listing of a patent in the Orange) Tj 0 -22.32 TD (Book on the grounds that it does not claim the drug or a method) Tj 0 -22.08 TD (of using the drug. For instance, the generic company may bring a) Tj 0 -22.32 TD (declaratory judgment action and seek a preliminary injunction) Tj 0 -22.08 TD (requiring the NDA holder to delist the patent.) Tj 331.2 4.08 TD /F0 7.2 Tf (31) Tj 8.64 -4.08 TD /F0 12 Tf ( \(A generic) Tj -339.84 -22.32 TD (company may also challenge the appropriateness of an Orange Book) Tj 0 -22.08 TD (listing as a counterclaim in a patent infringement suit.) Tj 403.2 4.08 TD /F0 7.2 Tf (32) Tj 8.64 -4.08 TD /F0 12 Tf (\) ) Tj -375.84 -22.32 TD (There is no effective way for a party to challenge an Orange) Tj -36 -22.08 TD (Book listing through the FDA, however. The FDA has declined to) Tj 0 -22.32 TD (enact any administrative procedures for resolving listing) Tj 0 -22.08 TD (disputes. 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Supp. 2d) Tj -354.24 -13.44 TD (at 456; ) Tj 64.8 0 TD /F2 12 Tf (see also) Tj 57.6 0 TD /F0 12 Tf ( ) Tj 7.2 0 TD (Elizabeth Dickinson, "FDA's Role in Making) Tj -129.6 -13.44 TD (Exclusivity Determinations," 54 ) Tj 230.4 0 TD /F2 12 Tf (Food & Drug L.J.) Tj 115.2 0 TD /F0 12 Tf (, 195, 196) Tj -345.6 -12.72 TD (\(1999\).) Tj 93.12 -23.28 TD /F0 10.08 Tf -0.048 Tc (Â鶹´«Ã½ Trade Commission Brief as Amicus Curiae) Tj 115.68 -12.24 TD /F0 12 Tf 0 Tc (10) Tj -208.8 636.48 TD (the FDA will request that the NDA holder confirm that the listed) Tj 0 -22.32 TD (patent information is correct. But unless the NDA holder) Tj 0 -22.08 TD (voluntarily withdraws or amends its listed information, the FDA) Tj 0 -22.32 TD (will not change the patent information in the Orange Book. As) Tj 0 -22.08 TD (long as the patent remains listed, ANDA applicants must still) Tj 0 -22.32 TD (make a paragraph IV certification, potentially triggering the 30-) Tj 0 -22.08 TD (month stay of FDA approval of generic drug applications.) Tj 403.2 4.08 TD /F0 7.2 Tf (33) Tj -403.2 -26.4 TD /F1 12 Tf (III. POTENTIAL COMPETITIVE IMPACT OF THE PROPOSED SETTLEMENT) Tj 36 -22.08 TD /F0 12 Tf (The parties to this action ask this Court to enter a) Tj -36 -22.32 TD (proposed settlement which requires the Court to make a specific) Tj 0 -22.08 TD (factual finding and issue an order without any examination and) Tj 0 -22.32 TD (testing of the evidence through discovery and the adversarial) Tj 0 -22.08 TD (process. The Proposed Final Order and Judgment submitted by the) Tj 0 -22.32 TD (parties states:) Tj 36 -22.08 TD ( WHEREFORE, this Court, BASED ON GOOD CAUSE SHOWN,) Tj 0 -11.04 TD (including the representations made and evidence offered) Tj 0 -11.28 TD (by plaintiff \(\223ABI\224\) in its papers herein, hereby) Tj 0 -11.04 TD (finds, determines, and concludes that:) Tj 0 -22.08 TD (1. ABI has established that, within the meaning and) Tj 0 -11.28 TD (for the purposes of 21 U.S.C. \247 355\(c\)\(2\) and 21 C.F.R.) Tj 0 -11.04 TD (\247 314.53\(b\), \(d\) \(the \223Listing Statute and) Tj T* (Regulations\224\) United States Patent Number 6,096,331) Tj T* (\(the \221331 Patent\) claims the drug or a method of using) Tj 0 -11.28 TD (the drug that is the subject of the Taxol New Drug) Tj 0 -11.04 TD (Application filed by defendant \(\223Bristol\224\) and with) Tj T* (respect to that product a claim of patent infringement) Tj T* (could reasonably be asserted against Bristol;) Tj 0 -22.32 TD (2. 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As explained) Tj 0 -22.08 TD (above, the \223Listing Statute and Regulations\224 cited in paragraph) Tj 0 -22.32 TD (one require Orange Book listing of a patent which \223claims the) Tj 0 -22.08 TD (drug or a method of using a drug\224 which is the subject of an) Tj 0 -22.32 TD (approved new drug application, and \223with respect to which a claim) Tj 0 -22.08 TD (of patent infringement could reasonably be asserted if a person) Tj 0 -22.32 TD (not licensed by the owner of the patent engaged in the) Tj 0 -22.08 TD (manufacture, use or sale of the drug.\224 A finding by this Court) Tj 0 -22.32 TD (that the \221331 patent satisfies these statutory and regulatory) Tj 0 -22.08 TD (criteria is a judicial finding that the \221331 patent must be) Tj 0 -22.32 TD (listed by Bristol in the Orange Book. Paragraph two would result) Tj 0 -22.08 TD (in a judicial order requiring Bristol to maintain the listing of) Tj 0 -22.32 TD (the \221331 patent in the Orange Book.) Tj 36 -22.08 TD (The Commission takes no position on whether the \221331 patent) Tj -36 -22.32 TD (meets the statutory criteria for listing in the Orange Book. ) Tj 0 -22.08 TD (However, this Court\222s imprimatur on the listing of the \221331) Tj 0 -22.32 TD (patent in the Orange Book has several consequences for potential) Tj 0 -22.08 TD (generic competitors that wish to introduce a generic Taxol) Tj 0 -22.32 TD (product before expiration of the \221331 patent in 2017. ) Tj 36 -22.08 TD (Although no other valid patents currently prevent entry of) Tj -36 -22.32 TD (generic Taxol, due to the listing of the \221331 patent in the) Tj 0 -22.08 TD (Orange Book, each potential generic competitor must certify to) Tj 0 -22.32 TD (Bristol \(the NDA holder\) and ABI \(the patent owner\) that its) Tj 0 -22.08 TD (generic product either does not infringe the \221331 patent or that) Tj 0 -22.32 TD (the patent is invalid. 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Tj 36 -22.08 TD (Because the listing of the \221331 patent may have serious) Tj -36 -22.32 TD (ramifications for generic entry, the Commission urges the Court) Tj 0 -22.08 TD (to consider whether it is necessary for settlement of this matter) Tj 0 -22.32 TD (for the Court to make the factual finding that Orange Book) Tj 0 -22.08 TD (listing is required; whether ABI and Bristol will be prejudiced) Tj 0 -22.32 TD (by the court\222s failure to enter paragraphs 1 and 2 of the) Tj 0 -22.08 TD (Proposed Final Order and Judgment; and whether such court) Tj 0 -22.32 TD (approval may prejudice any party who later may seek to challenge) Tj ET endstream endobj 53 0 obj 3087 endobj 50 0 obj << /Type /Page /Parent 51 0 R /Resources << /Font << /F0 6 0 R >> /ProcSet 2 0 R >> /Contents 52 0 R >> endobj 55 0 obj << /Length 56 0 R >> stream BT 57.12 711.84 TD 0 0 0 rg /F0 12 Tf 0 Tc 0 Tw (1) Tj 0 -22.32 TD (2) Tj 0 -22.08 TD (3) Tj 0 -22.32 TD (4) Tj 0 -22.08 TD (5) Tj 0 -22.32 TD (6) Tj 0 -22.08 TD (7) Tj 0 -22.32 TD (8) Tj 0 -22.08 TD (9) Tj -7.2 -22.32 TD (10) Tj 0 -22.08 TD (11) Tj 0 -22.32 TD (12) Tj 0 -22.08 TD (13) Tj 0 -22.32 TD (14) Tj 0 -22.08 TD (15) Tj 0 -22.32 TD (16) Tj 0 -22.08 TD (17) Tj 0 -22.32 TD (18) Tj 0 -22.08 TD (19) Tj 0 -22.32 TD (20) Tj 0 -22.08 TD (21) Tj 0 -22.32 TD (22) Tj 0 -22.08 TD (23) Tj 0 -22.32 TD (24) Tj 0 -22.08 TD (25) Tj 0 -22.32 TD (26) Tj 0 -22.08 TD (27) Tj 0 -22.32 TD (28) Tj ET 69.6 18 0.96 756 re f 71.52 18 0.96 756 re f 546.72 18 0.96 756 re f BT 165.12 87.6 TD /F0 10.08 Tf -0.048 Tc (Â鶹´«Ã½ Trade Commission Brief as Amicus Curiae) Tj 144.48 -12.24 TD /F0 12 Tf 0 Tc (13) Tj -237.6 636.48 TD (that listing. The Commission also urges the Court to consider) Tj 0 -22.32 TD (the pendency of the Commission\222s investigation before entering) Tj 0 -22.08 TD (the Order proposed by the parties. ) Tj 0 -22.32 TD /F1 12 Tf (IV. CONCLUSION) Tj 36 -22.08 TD /F0 12 Tf (For these reasons, the Commission urges the Court to) Tj -36 -22.32 TD (consider the ramifications for generic entry and the pendency of) Tj 0 -22.08 TD (the Commission\222s investigation before entering the order proposed) Tj 0 -22.32 TD (by the parties.) Tj 144 -66.48 TD (Respectfully submitted,) Tj -144 -66.72 TD (John D. Jacobs,) Tj 252 0 TD (Debra A. Valentine, ) Tj -252 -11.04 TD (Attorney,) Tj 288 0 TD (General Counsel ) Tj -288 -11.04 TD (Western Regional Office) Tj 252 0 TD (Melvin H. Orlans, ) Tj 36 -11.04 TD (Special Litigation Counsel ) Tj 0 -11.28 TD (Office of General Counsel) Tj -36 -22.08 TD (Richard G. Parker, Director) Tj -144 -11.04 TD ( ) Tj 144 0 TD (David R. Pender, ) Tj 36 -11.28 TD (Deputy Asst. 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Michel, Attorney) Tj T* (Bureau of Competition) Tj -252 -44.4 TD (Â鶹´«Ã½ Trade Commission) Tj 252 0 TD (Â鶹´«Ã½ Trade Commission) Tj -252 -11.28 TD (10877 Wilshire Blvd., Suite 700) Tj 252 0 TD (600 Pennsylvania Avenue, NW) Tj -252 -11.04 TD (Los Angeles, CA 90024 ) Tj 252 0 TD (Washington, DC 20580) Tj -252 -11.04 TD (Telephone: \(310\) 824 4360) Tj 252 0 TD (Telephone: \(202\) 326 2475) Tj -252 -11.04 TD (Facsimile: \(310\) 824 4380) Tj 252 0 TD (Facsimile: \(202\) 326 2477) Tj ET endstream endobj 56 0 obj 2465 endobj 54 0 obj << /Type /Page /Parent 51 0 R /Resources << /Font << /F0 6 0 R /F1 10 0 R >> /ProcSet 2 0 R >> /Contents 55 0 R >> endobj 6 0 obj << /Type /Font /Subtype /TrueType /Name /F0 /BaseFont /CourierNew /FirstChar 32 /LastChar 255 /Widths [ 600 600 600 600 600 600 600 600 600 600 600 600 600 600 600 600 600 600 600 600 600 600 600 600 600 600 600 600 600 600 600 600 600 600 600 600 600 600 600 600 600 600 600 600 600 600 600 600 600 600 600 600 600 600 600 600 600 600 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