. /.RESTRICTEDWORLD TRADE
ORGANIZATIONIP/C/W/330/Add.1
5 March 2002
(02-1095)
Council for Trade-Related Aspects
of Intellectual Property RightsOriginal:  Spanish
REVIEW OF LEGISLATION
Response from Uruguay to the Follow-up Questions
Posed by Switzerland
Addendum
By means of a communication from the Permanent Mission of Uruguay, dated 1 March 2002,
the Secretariat has received the following respons e to the follow-up question posed by Switzerland,
circulated in document IP/C/W/315/Add.1.
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A. PROTECTION OF UNDISCLOSED INFORMATION
Ad response to question 7:
With regard to the unfair commercial use of data submitted by an applicant to the
relevant state agency as part of the proce dure to obtain market authorization for a
pharmaceutical or agricultural chemical product, please specify whether the relevant state
agency will require the same amount of data from a second applicant requesting market
authorization for a similar or identical produc t, as it required from the first applicant.
If the answer is affirmative, does your legislation provide for a time period, after which
the second applicant can refer to the data of the first applicant and therefore not have to submit
this data in his own application for market authorization?
As regards the protection of undisclosed information, Uruguay does not have any specific
legislative provisions.
The provisions of the TRIPS Agreement and the  Paris Convention – in particular those of
Article 10 bis on unfair competition – have been incorporated into Uruguay's domestic law.
Consequently, and via the application of these provisions and the general rules and principles of law,
any act performed with regard to undisclosed test or other data which implies unfair competition isunlawful and will give rise to civil and criminal proceedings.
Consequently, the protection of such data against all unfair competition laid down in
Article 9.2 and 39.3 of the TRIPS Agreement is adequately provided for in Uruguay's legislation.IP/C/W/330/Add.1
Page 2
Section A.6 of the regulations on marketing approval for pharmaceutical products, Executive
Decree No. 324/1999 of 12 October 1999, stipulates that the applicant must declare the undisclosed
nature of information in the data which is submitted in order to obtain authorization.
Uruguay has no provisions which stipulate that the authority responsible for giving sanitary
approval cannot use the test data which it has previously had access to when issuing authorization, for
the same product of another owner, apart from the aforementioned protection against unfair use under
Article 39.3 of the TRIPS Agreement.
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