DS: Argentina — Patent Protection for Pharmaceuticals and Test Data Protection for Agricultural Chemicals
This summary has been prepared by the Secretariat under its own responsibility. The summary is for general information only and is not intended to affect the rights and obligations of Members.
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(as cited in request for consultations)
|Request for Consultations received:||
|Mutually Agreed Solution notified:||20 June 2002|
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Summary of the dispute to date
The summary below was up-to-date at
Complaint by the United States.
On 6 May 1999, the US requested consultations with Argentina in respect of
- the alleged absence in Argentina of either patent
protection for pharmaceutical products or an effective system for
providing exclusive marketing rights in such products, and
- Argentina’s alleged 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.
Under item (i), the US contended that 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. According to the United States, Argentina’s law 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. The US therefore contended that Argentina’s legal regime appears to be inconsistent with Articles 27, 65 and 70 of the TRIPS Agreement.
Under item (ii), the US contended that prior to August 1998, 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. The US further alleged that 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. The United States therefore alleges that Argentina’s legal regime is inconsistent with Article 65.5 of the TRIPS Agreement.
Mutually agreed solution
On 31 May 2002, the US and Argentina notified the DSB that they have reached an agreement on all of the matters raised by the US in its requests for consultations regarding this dispute and that concerning Argentina — Certain Measures on the Protection of Patents and Test Data (WT/DS196).
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