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

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

A. The TRIPS Agreement text

One of the crucial interpretative issues in Article 39.3 is whether the reliance by a national authority on data submitted by one company (the "originator") to evaluate a subsequent application by another company (a "follower"), constitutes an "unfair commercial use" of the information.

The expression "unfair commercial use" is not defined in Article 39. Pursuant to Article 31 (1) of the Vienna Convention, its interpretation should be based on the ordinary meaning of the terms of the treaty in their context and in the light of the agreement's object and purpose.