Protection of Data Submitted for the Registration of Pharmaceuticals: Implementing the Standards of the Trips Agreement: III. CONDITIONS OF PROTECTION UNDER TRIPS: B. The Article 39.3 conditions of protection: 1. Data necessary for marketing approval

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

1. Data necessary for marketing approval

A basic premise for the application of Article 39.3 is that test data must only be protected if national authorities require their submission for obtaining marketing approval of pharmaceuticals or agrochemical products. The first sentence of this article states:

"Members, when requiring, as a condition of approving the marketing of..."

Given the territoriality of the intellectual property system - a feature that the TRIPS Agreement has not altered - the obligation to protect test data only arises in the Member countries where national regulations require the submission of such data. If a Member country opts not to require those data, Article 39.3 will be not apply.

In addition, the submission of data must be necessary to obtain approval. Data voluntarily submitted by an applicant, or in excess of what is required for approval, are not subject to protection under Article 39.3.