Protection of Data Submitted for the Registration of Pharmaceuticals: Implementing the Standards of the Trips Agreement: V. PROSCRIBED ACTS OF UNFAIR COMMERCIAL USE: A. The TRIPS Agreement text: 3. "Use"

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

3. "Use"

Finally, for Article 39.3 to apply, there must be "use" of the information submitted by the originator.¹⁸

¹⁸ In one of the texts under consideration by the negotiating parries in July 1990, the broader concept of "exploitation" was proposed (but not finally adopted). The text read:

"3Aa. Parties, when requiring the publication or submission of undisclosed information consisting of test [or other] data, the origination of which involves a considerable effort, shall protect such data against unfair exploitation by competitors. The protection shall last for a reasonable time commensurate with the efforts involved in the origination of the data, the nature of the data, and the expenditure involved in their preparation, and shall take no account of the availability of other forms of protection".