ARGENTINA  - PATENT PROTECTION FOR PHARMACEUTICALS AND TEST DATA PROTECTION FOR AGRICULTURAL CHEMICALS
Document: Request for Consultations by the United States
Date: 10 May 1999
Document codes: WT/DS171/1; IP/D/18
Complainant: U.S.
Respondent: Argentina
Dispute stage: Consultation
Agreements cited: Art. 27, 39.2, 65, 70  Intellectual Property (TRIPS)

ARGENTINA - PATENT PROTECTION FOR PHARMACEUTICALS
AND TEST DATA PROTECTION FOR AGRICULTURAL CHEMICALS
Request for Consultations by the United States
The following communication, dated 6 May 1999, from the Permanent Mission of the
United States to the Permanent Mission of Argentina and to the Chairman of the Dispute Settlement
Body, is circulated in accordance with Article 4.4 of the DSU.
My authorities have instructed me to request consultations with the Government of Argentina
pursuant to Article 4 of the Understanding on Rules and Procedures Governing the Settlement of
Disputes (DSU) and Article 64 of the Agreement on Trade-Related Aspects of Intellectual Property
Rights (TRIPS Agreement) (to the extent that it incorporates by reference Article XXII of the General
Agreement on Tariffs and Trade 1994) regarding (1) the absence in Argentina of either patent
protection for pharmaceutical products or an effective system for providing exclusive marketing rights
in such products; and (2) Argentina's failure to ensure that changes in its laws, regulations and
practice during the transition period provided under Article 65.2 of the TRIPS Agreement do not
result in a lesser degree of consistency with the provisions of the TRIPS Agreement.
The first issue on which my authorities seek to consult with the Government of Argentina
concerns the obligation in the TRIPS Agreement on all Members of the
(WTO) that do not provide product patent protection for pharmaceuticals on the date of entry into
force of the WTO Agreement (1 January 1995) to establish a system whereby exclusive marketing
rights will be granted for products that are the subject of applications for patents for such inventions,
subject to certain stated requirements. The TRIPS Agreement does not permit WTO Members to
allow third parties to market products subject to exclusive marketing rights without the consent of the
right holder.
Argentina's law currently does not provide product patent protection for pharmaceutical
inventions, or a system that conforms to Article 70.9 of the TRIPS Agreement with regard to the grant
of exclusive marketing rights. As a result, Argentina's legal regime appears to be inconsistent with
Argentina's obligations under the TRIPS Agreement, including but not necessarily limited to
Articles 27, 65 and 70 of the Agreement.
The second issue on which my authorities seek to consult with the Government of Argentina
concerns the obligation in Article 65.5 of the TRIPS Agreement on all Members availing themselves
of a transitional period under paragraphs 1, 2, 3 or 4 of Article 65 of the TRIPS Agreement to ensure
that any changes in its laws, regulations and practice made during the transitional period do not result
in a lesser degree of consistency with the provisions of the TRIPS Agreement.

IP/D/18

Prior to August 1998, the Government of Argentina provided a ten-year term of protection
against unfair commercial use for undisclosed test data or other data submitted to Argentine
regulatory authorities in support of applications for marketing approval for agricultural chemical
products. Since the issuance in 1998 of Regulation 440/98, which inter alia revoked earlier
regulations, Argentina has provided no effective protection for such data against unfair commercial
use. As a result, Argentina's legal regime appears to be inconsistent with the obligation in
Article 65.5 of the TRIPS Agreement in that changes to its laws, regulations or practice during the
transitional period have resulted in a lesser degree of consistency with the provisions of Article 39.3
of the TRIPS Agreement.
We look forward to receiving your reply to the present request and to fixing a mutually
convenient date for consultations.