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
 

5. Considerable effort (investment)

The subject matter of the protection under Article 39.3 is test data which cover matters such as toxicology, clinical trials for the pharmaceuticals and field trials for agrochemicals. Because this information is not "invented" or "created", the TRIPS Agreement does not define any substantive standard for granting protection (like inventive step or novelty). It simply mandates protection when the process of obtaining the data involved "a considerable effort".

The text is vague about the type of effort involved (technical, economic?) and also with respect to its magnitude (when would it be deemed "considerable"?). As mentioned, the proponents of this formulation intended to protect the investment made in producing test data.

The extension of intellectual property beyond its boundaries so as to protect investment, and not intellectual contributions12 disrupts the essence of a system conceived to reward the creators of original ideas and new inventions.13 Even if it may be argued that "free riding" or "unfair use" of such data by third parties may create unfair advantages or unjust enrichment, it is not the role of the intellectual property system to solve competition problems that do not relate to the creation or use of ideas. Nonetheless, Article 39.3 exists. And it includes the considerable effort standard. Inclusion of this standard suggests national regulatory authorities may request the applicant prove that the information for which protection is sought is the result of considerable effort.

12 An investment-based system was adopted by the European Community in the form of a sui generis regime for the protection of data bases. Despite the efforts of WIPO, however, no agreement has been reached so far to adopt an international convention modeled on the European approach. A bill on the matter proposed in the United States has also found strong opposition, particularly from the scientific and librarian communities (Reichman and Uhlir, 1999).

13 According to the Trans Atlantic Consumer Dialogue (TACD), "data exclusivity provisions are part of a growing class of sui generis forms of protection that are designed to protect investment, rather than innovation. Because data exclusivity is not a reward for invention (which is already rewarded by patents) but rather a protection of investment, there should be greater transparency of the basis for the protection and a reasonable relationship between the investment and the protection" (available at www.tacd.org).

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