Protection of Data Submitted for the Registration of Pharmaceuticals: Implementing the Standards of the Trips Agreement: III. CONDITIONS OF PROTECTION UNDER TRIPS

Protection of Data Submitted for the Registration of Pharmaceuticals: Implementing the Standards of the Trips Agreement
(2002; 77 pages) [Spanish]

Table of Contents

THE SOUTH CENTRE
FOREWORD
EXECUTIVE SUMMARY
INTRODUCTION
I. DATA REQUIRED FOR THE REGISTRATION OF PHARMACEUTICALS
II. THE RATIONALE FOR DATA PROTECTION
	A. Approaches to Data Protection
	B. National Practices before TRIPS
III. CONDITIONS OF PROTECTION UNDER TRIPS
	A. Protection of test data under the TRIPS Agreement
	B. The Article 39.3 conditions of protection
		1. Data necessary for marketing approval
		2. Protected data
		3. Undisclosed data
		4. New chemical entities
		5. Considerable effort (investment)
IV. NON-DISCLOSURE OBLIGATION
V. PROSCRIBED ACTS OF UNFAIR COMMERCIAL USE
	A. The TRIPS Agreement text
		1. "Unfair"
		2. "Commercial"
		3. "Use"
		4. Analysing "Unfair Commercial Use"
	B. National case law
VI. MEANS OF PROTECTION AGAINST UNFAIR COMMERCIAL USE
VII. THE EXCLUSIVITY APPROACH
VIII. THE HISTORY OF THE TRIPS NEGOTIATIONS
IX. CONCLUSIONS
ANNEX I. EXCLUSIVE USE OF DATA AND COMPENSATION UNDER THE U.S. FEDERAL INSECTICIDE, FUNGICIDE AND RODENTICIDE ACT (FIFRA)
BIBLIOGRAPHY
BACK COVER

III. CONDITIONS OF PROTECTION UNDER TRIPS

The TRIPS Agreement establishes a minimum international standard for the protection of marketing approval data. WTO Member countries need to determine what is actually needed to fulfil their obligations under the Agreement. Understanding the obligations imposed by Article 39.3 requires a close reading of the text, an assessment of each of its components, as well as a review of the negotiating history and national practice. The remainder of this paper turns to these tasks.