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
Open this folder and view contentsIII. CONDITIONS OF PROTECTION UNDER TRIPS
View the documentIV. NON-DISCLOSURE OBLIGATION
Close this folderV. PROSCRIBED ACTS OF UNFAIR COMMERCIAL USE
Close this folderA. The TRIPS Agreement text
View the document1. "Unfair"
View the document2. "Commercial"
View the document3. "Use"
View the document4. Analysing "Unfair Commercial Use"
View the documentB. National case law
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
 

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.

to previous section
to next section
 
 
The WHO Essential Medicines and Health Products Information Portal was designed and is maintained by Human Info NGO. Last updated: June 25, 2014