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
 

2. "Commercial"

Article 39.3 only covers "commercial" uses. This requirement clearly excludes use by the government, notably by the national health authority to assess the efficacy and toxicity of a pharmaceutical or agrochemical product.

In the view of the European Union, however, there is a substantial difference between the underlying principle in Article 39.1, which refers to relationships between competitors and Article 39.3, which includes governmental acts:

"The main question of interpretation is what is meant by "unfair commercial use". Clearly, this concept is different from the concept of "unfair competition", as used in Article 39.1 with a reference to Article 10bis of the Paris Convention on the protection of Industrial Property, and which relates to behaviour among competitors. Protection of registration data is a government function. Article 39.3 does not indicate whether the notion of "unfair commercial use" refers to unfair commercial use by generic manufacturers to those who have submitted the data (usually research-based pharmaceutical industry) or to use by regulatory authorities of these data to the benefit of competitors. Protecting data against "unfair commercial use" is also different from protecting them from disclosure, since the latter is a separate and distinct obligation under Article 39.3" (EU, 2001, p.3).

The EU argument, however, disregards that Article 39 develops and does not add to Article 10bis of the Paris Convention. It only incorporates examples of the general principle contained in paragraph (2) of Article 10bis.

In addition, though the use by the governments will indirectly have commercial consequences (the entry of a competitor in the market), it does not represent a commercial activity as such, but a legitimate State practice. In order to be "commercial", the use of the information should be made by an entity which is actually in commerce. As also noted by Ladas,

"The general clause of Article 10bis, in establishing as its foundation "honest usages," looks to the relations between competitors and to the interests of customers, and these provide an objective test which reflects an evolving pattern of competition in most of the present world... By definition, competition in commerce refers to the efforts of two or more persons, acting independently, to secure the custom of third parties, with the results that one may increase the sale of his goods and reduce the sale of the goods of the other" (Ladas. 1975, p. 1688).

The same concept underlies the WIPO "Model Provisions on Protection Against Unfair Competition" which, in relation to data protection, suggests the adoption by national laws of the following provision:

"Use or Disclosure of Secret Information Submitted for Procedure of Approval of Marketing: Any act or practice, in the course of industrial or commercial activities, shall be considered an act of unfair competition if it consists or results in an unfair commercial use of secret test or other data, the origination of which have been submitted to a competent authority for the purposes of obtaining approval of the marketing of pharmaceutical or agricultural chemical products which utilize new chemical entities" (emphasis added) (WIPO, 1996).

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