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
Open this folder and view contentsB. The Article 39.3 conditions of protection
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
 

A. Protection of test data under the TRIPS Agreement

The inclusion of test data as a category of intellectual property in TRIPS does not mean countries must provide exclusivity protections for such data.

According to Article 1.2 of the TRIPS Agreement, the protection of test data is a category of "intellectual property" like patents, copyrights and trademarks. The structure of Article 39 suggests that the regime for test data has been conceived by the negotiating parties as a particular case in the framework of the protection of "undisclosed" information. In this sense, the protection conferred cannot be properly deemed a sui generis system.

The categorization of test data as a subject matter of "intellectual property" does not mean that Article 39.3 puts their protection on the same footing as other intellectual property rights. In particular, it cannot be inferred that such protection requires exclusive rights. Though in most instances intellectual property rights confer a ius excluendi, this is far from being an absolute rule. It is well accepted, for example, that trade secrets protection in the framework of unfair competition does not give rise to a right to exclude. Nor does the protection of geographical indications under the TRIPS Agreement entail the granting of such faculty.8 Likewise, there are many situations in which copyright protection only allows the title-holder to claim remuneration, but not to prohibit unauthorized acts.

8 See article 22.2 of the TRIPS Agreement.

As Article 39.3 itself indicates (see below), test data protection is a reward for the investment in data production, rather than for the creativity or inventiveness involved in generating the data. Test data are developed in accordance with standard protocols and procedures, involving a systematic compilation of factual information. Though the testing may refer to a novel drug, the test results themselves are merely the outcome of routine scientific practices.

Thus, the inclusion of test data in the TRIPS Agreement as a category of "intellectual property" does not determine the nature of the protection conferred. In particular, it does not indicate that such data should be protected through grant of exclusive rights.

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