The obligation to protect undisclosed test or other data necessary for the marketing approval of pharmaceutical or agricultural chemical products established by Article 39.3 of TRIPs is a matter of intense debate. It can be argued that scientific data protection constitutes a new and autonomous IP category, and that acknowledging data protection as a new IP category is the only suitable way to protect the data originator's right. GATT- TRIPs provides this acknowledgment.
Part I of TRIPs, "General Provisions and Basic Principles", under "Nature and scope of obligations", paragraph 2, establishes that: "For the purposes of this Agreement, the term 'intellectual property' refers to all categories of intellectual property that are the subject of Sections 1 through 7 of Part II." Therefore, copyright and related rights, trade marks, geographic indications, industrial designs, patents, layout designs (topographies) of integrated circuits, and protection of undisclosed information (which includes data protection of article 39.3) are all IP categories.
Argentine Law Nº 24,766 is meant to implement TRIPS Article 39.2 related to trade secrets and Article 39.3 related to scientific data. However, Argentina's Confidentiality Law No. 24,766, Decree No. 150/92 allows third parties reliance on scientific data of a product that was previously approved. Such reliance is permitted without any consideration for the investment and efforts made by the originator of the data.
The Argentine Constitution gives precedence to international treaties over domestic law and, consequently, the Confidentiality Law No. 24,766 could be considered unconstitutional since it is in conflict with Article 39.3 of the TRIPS Agreement. The reliance on third parties' scientific data permitted by Confidentiality Law No. 24,766 for the purpose of approving new pharmaceutical products could be understood as unfair commercial use of scientific data under Article 39.3. Therefore, in cases of conflict between the TRIPS Agreement and the Confidentiality Law or Decree No. 150/92, the TRIPS Agreement should prevail.
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