Second Generation Patents in Pharmaceutical Innovation

Hyewon Ahn

doi:10.5771/9783845250861

Second Generation Patents in Pharmaceutical Innovation

Reihe: Munich Intellectual Property Law Center - MIPLC Studies

Band 19 1. Auflage 2014

CC-BY Vollzugriff

doi.org/10.5771/9783845250861
ISBN print: 978-3-8487-0874-1
ISBN online: 978-3-8452-5086-1
Nomos, Baden-Baden Nomos, Baden-Baden

Abstract

The development of new medications and improvements thereof are crucial to ensure continued gains in health. The development process is long and costly, and mainly to produce the information to meet high regulatory requirements. In contrast, imitation involves negligible costs and much reduced risks. This is one of the reasons the pharmaceutical industry depends greatly on patent protection. Despite the existing patent system, however, the number of new medications per year has decreased, especially during the last decade. In comparison, the number of second generation patents and products has been drastically increased. This industry is accused both of neglecting its real mission of providing new medications while generating second generation products, and of preventing the entry of generics. The dissertation reviewed whether the concerns are justified, and, if so, whether or how the patent system can improve the situation that confronts pharmaceutical companies and society.

Zusammenfassung

Die Entwicklung neuer Medikamente und deren Verbesserungen sind entscheidend, um deutliche Fortschritte in der Gesundheitsversorgung zu gewährleisten. 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 vernachlässigbare Kosten und birgt deutlich weniger Risiken. Dies ist einer der Gründe, warum der Patenschutz für die die pharmazeutische Industrie von so großer Bedeutung ist.

Trotz des bestehenden Patentsystems ist gerade während des letzten Jahrzehnts die Zahl der neuen Medikamente pro Jahr zurückgegangen. Im Vergleich dazu hat sich die Zahl der Patente und Produkte der zweiten Generation drastisch erhöht.

Der Pharmaindustrie wird vorgeworfen, ihre ursprüngliche Aufgabe, die Entwicklung neuer Medikamente, zu vernachlässigen, indem sie Produkte der zweiten Generation erzeugt und die Einführung von Generika verhindert. Die Dissertation überprüft, ob diese Bedenken gerechtfertigt sind, und wenn ja, ob oder wie das Patentsystem den Konflikt zwischen Pharma-Unternehmen und der Gesellschaft im Hinblick auf eine bedarfsgerechte Arzneimittelversorgung lösen kann.

Kapitel Ausklappen | EinklappenSeiten
1–21 Titelei/Inhaltsverzeichnis 1–21
22–28 I. INTRODUCTION 22–28
29–59 II. PHARMACEUTICAL INVENTIONS, INNOVATIONS & PRODUCTS 29–59
60–95 III. SPECIFICITIES IN PHARMACEUTICALS AND RECENT DEVELOPMENTS 60–95
96–184 IV. STANDARDS OF PATENTABILITY FOR PHARMACEUTICAL SELECTION INVENTIONS 96–184
185–245 V. IMPLICATIONS OF THE PATENTABILITY REQUIREMENTS ON INNOVATION AND COMPETITION IN THE PHARMACEUTICAL INDUSTRY 185–245
246–312 VI. PROPOSALS 246–312
313–321 VII. FINAL CONCLUSIONS 313–321
322–323 List of Statutory Instruments 322–323
324–333 List of Case Laws 324–333
334–355 Bibliography 334–355

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