Protection of Data Submitted for the Registration of Pharmaceuticals: Implementing the Standards of the Trips Agreement
(2002; 77 pages) [Spanish] View the PDF document
Table of Contents
View the documentTHE SOUTH CENTRE
View the documentFOREWORD
View the documentEXECUTIVE SUMMARY
View the documentINTRODUCTION
View the documentI. DATA REQUIRED FOR THE REGISTRATION OF PHARMACEUTICALS
Open this folder and view contentsII. THE RATIONALE FOR DATA PROTECTION
Close this folderIII. CONDITIONS OF PROTECTION UNDER TRIPS
View the documentA. Protection of test data under the TRIPS Agreement
Close this folderB. The Article 39.3 conditions of protection
View the document1. Data necessary for marketing approval
View the document2. Protected data
View the document3. Undisclosed data
View the document4. New chemical entities
View the document5. Considerable effort (investment)
View the documentIV. NON-DISCLOSURE OBLIGATION
Open this folder and view contentsV. PROSCRIBED ACTS OF UNFAIR COMMERCIAL USE
View the documentVI. MEANS OF PROTECTION AGAINST UNFAIR COMMERCIAL USE
View the documentVII. THE EXCLUSIVITY APPROACH
View the documentVIII. THE HISTORY OF THE TRIPS NEGOTIATIONS
View the documentIX. CONCLUSIONS
View the documentANNEX I. EXCLUSIVE USE OF DATA AND COMPENSATION UNDER THE U.S. FEDERAL INSECTICIDE, FUNGICIDE AND RODENTICIDE ACT (FIFRA)
View the documentBIBLIOGRAPHY
View the documentBACK 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.

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