LEADER 05412nam 2200673 450 001 9910297050903321 005 20220509065347.0 010 $a3-8452-5086-0 035 $a(CKB)3710000000222877 035 $a(EBL)1766726 035 $a(SSID)ssj0001438749 035 $a(PQKBManifestationID)12618808 035 $a(PQKBTitleCode)TC0001438749 035 $a(PQKBWorkID)11378277 035 $a(PQKB)10314082 035 $a(MiAaPQ)EBC1766726 035 $a(EXLCZ)993710000000222877 100 $a20160819h20142014 uy 0 101 0 $aeng 135 $aur|n|---||||| 181 $ctxt 182 $cc 183 $acr 200 10$aSecond generation patents in pharmaceutical innovation /$fHyewon Ahn 205 $a1. edition. 210 1$aBaden-Baden, [Germany] :$cNomos,$d2014. 210 4$d©2014 215 $a1 online resource (355 p.) 225 1 $aMIPLC Studies ;$vVolume 19 300 $aDescription based upon print version of record. 311 $a3-8487-0874-4 320 $aIncludes bibliographical references. 327 $aCover; I. INTRODUCTION; A. Overview; B. Outline of the dissertation; C. Scope of the dissertation; II. PHARMACEUTICAL INVENTIONS, INNOVATIONS & PRODUCTS; A. Cumulative nature of inventions; 1. Basic and second generation inventions; a) Improvement inventions; b) Selection inventions; B. Inventions and innovations in pharmaceutical field; 1. Inventions and patents in pharmaceutical field; a) Product invention and the absolute character of its protection; b) Hierarchy of pharmaceutical patents; 2. Innovations in pharmaceutical field; a) Invention v. innovation 327 $ab) NMEs as the core of pharmaceutical innovation C. Second generation inventions and patents in pharmaceuticals; 1. Product inventions and patents; a) Species selection inventions; Markush type claim; A species claim; b) Optical isomers; c) Crystalline forms; d) Metabolites and prodrugs; e) Esters and salts; f) Dosage forms; g) Combinations of active ingredients; 2. Use inventions; a) New Use/New method of treatment; b) Dosage regime; 3. Process inventions; a) Process; b) Intermediates; D. Pharmaceutical products in the market 327 $a1. New medical entities, new molecular entities 2. Similar or equivalent "me-too" products; 3. Second generation products; 4. Generic drugs; E. Summary; III. SPECIFICITIES IN PHARMACEUTICALS AND RECENT DEVELOPMENTS; A. Innovating and inventing in pharmaceutical industry; 1. Specificities in the drug development process; a) Highly regulated industry; b) R&D - a costly and lengthy road to a medicine; c) Uncertainties in post-invention development; (1) Scientific uncertainty: Unpredictability of substances; (2) Regulatory and market uncertainties; d) Information rich chemicals 327 $a2. Specificities in the market for pharmaceuticals a) Imitation with negligible cost and much reduced risk; b) Prescription based purchase: A disconnection between choosers and payers; c) Information asymmetry and high loyalty to a medicine; d) Pricing; 3. Specificities of the patent protection for pharmaceuticals; a) Patent protection for industrial technologies; b) Patent protection in the pharmaceutical industry; B. Challenges and overcoming efforts; 1. Decreased R&D productivity; 2. Dearth of new medical entities; a) Significance of NMEs; b) Decreased number of NMEs 327 $ac) Potential reasons for the decrease (1) Decrease in solvable scientific problems; (2) Stringent safety regulations; (3) Problem of over-disclosure; (4) Early and numerous abandonments of potential candidates; 3. Patent cliffs of blockbuster medications; 4. Frequent merger and acquisitions (M&As) and in-licensing; 5. Drastic increase of second generation inventions; a) Life cycle management or evergreening; b) Drastic increase of this activity supported by the number of second generation patents; C. Summary; IV. STANDARDS OF PATENTABILITY FOR PHARMACEUTICAL SELECTION INVENTIONS 327 $aA. Novelty and anticipation 330 $aDie Entwicklung neuer Medikamente und deren Verbesserungen sind entscheidend, um deutliche Fortschritte in der Gesundheitsversorgung zu gewa?hrleisten. Der Entwicklungsprozess ist lang und teuer, insbesondere der Aufwand,der betrieben werden muss,, um den hohen Regulierungsanforderungen gerecht zu werden. Im Gegensatz dazu verursacht die Nachahmung von Medikamenten vernachla?ssigbare Kosten und birgt deutlich weniger Risiken. Dies ist einer der Gru?nde, warum der Patentschutz fu?r die die pharmazeutische Industrie von so großer Bedeutung ist. Trotz des bestehenden Patentsystems i 410 0$aMIPLC studies ;$vVolume 19. 606 $aDrugs$vPatents 606 $aDrugs$xLaw and legislation 606 $aDrug development 606 $aPatent laws and legislation 608 $aPatents.$2fast 615 0$aDrugs 615 0$aDrugs$xLaw and legislation. 615 0$aDrug development. 615 0$aPatent laws and legislation. 676 $a338.4/76151 700 $aAhn$b Hyewon$0899875 712 02$aMunich Intellectual Property Law Center. 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910297050903321 996 $aSecond generation patents in pharmaceutical innovation$92010523 997 $aUNINA