WORLD TRADE  
ORGANIZATION  IP/Q/ARG/1/Add.2 
IP/Q2/ARG/1/Add.2 
IP/Q3/ARG/1/Add.2 IP/Q4/ARG/1/Add.2 
7 April 2005 
 
 
(05-1417) 
Council for Trade-Related Aspects of Intellectual Property Rights Original:   Spanish 
 
  
REVIEW OF LEGISLATION 
 
ARGENTINA 
 
Addendum
 
  
 By a communication from the Permanent Mission of Argentina, dated 7 March 2005, the 
Secretariat has received the following replies to questions addressed to Argentina by Switzerland in connection with the review of its legislation at the Council's meeting of 18 to 22 June 2001. 
 
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A. 
GENERAL  
Ad response to question 1 : 
 
 In your answer, you mention that:  "The requirements relating to international 
agreements are set forth in Article 31 and Articl e 75, paragraphs 22 and 24 of the Constitution 
of the Argentine Republic.  Of particular rele vance to the TRIPS Agreement are Articles 27 and 
31 read together with Article 75, paragraph 22". 
 
 Please confirm whether these provisions can be interpreted to the effect that Argentina 
has a monistic system as regards the application of provisions of international law and that such 
provisions might be applicable with direct effect, i. e. without national implementing legislation?  
If so, please specify whether all provisions of the TRIPS Agreement are directly applicable and 
have direct effect in the Argentine legislative system.  If no, please cite those provisions which do have direct effect.  Have there already been national court rulings confirming the direct effect of provisions of international law, and more specifi cally, of the TRIPS Agreement?  Please cite the 
relevant decisions.  
 Article 31 of the National Constitution explicitly st ates that "the Constitution, the laws of the 
Nation enacted by Congress in pursu ance thereof, and treaties with foreign powers, are the supreme 
law of the Nation".  This means that in the Argen tine legal system, treaties are an autonomous source 
of law, and their application is therefore not de pendent on a law incorporating them into Argentine 
legislation.   Article 75, paragraph 22, explicitly ranks trea ties higher than laws, which means that in the 
event of conflict between a national law and a treaty,  the provisions of the treaty take precedence.  IP/Q/ARG/1/Add.2, IP/Q2/ARG/1/Add.2,  
IP/Q3/ARG/1/Add.2, IP/Q4/ARG/1/Add.2 Page 2 
 
 
 This must be read together with Article 27, whic h requires treaties signed by the Government to be 
consistent with the principles of public law set forth in the National Constitution.   The system is therefore a monistic one, in wh ich international treaties are accorded a higher 
status than laws, while both are subordinate to the National Constitution.  However, this does not 
mean that Argentina may not legislate domestically on subject-matter covered by a treaty, since many 
treaties require national implementi ng legislation, for example when: 
  (i) They contain clauses which are not directly applicable; 
 
 (ii) they establish minimum standards of protection, in which case the parties are free to 
enlarge on them; 
  (iii) they contain clauses allowing the par ties to choose the means by which the treaty's 
objectives are to be fulfilled. 
  The TRIPS Agreement is an agreement whic h sets forth minimum standards of protection 
and, in some cases, grants a choice between various methods of protection.  Article 1.1 provides that 
"Members shall be free to determine the appropriate  method of implementing the provisions of this 
Agreement within their own legal system and practice". 
 
 Argentina adopts its domestic intellectual pr operty legislation, notified to the Council on 
TRIPS and listed in document IP/N/1/ARG/2 , within the framework of these provisions. 
  With regard to the question of whether there are national court rulings confirming the direct 
effect of provisions of international law, and specifically, of the TRIPS Agreement, the following 
judgments of the National Supreme Court of  Justice are listed by way of example: 
 
• "Ekmedjian, Miguel Angel v Sofo vich, Gerardo and others"; 
 
• "Unilever NV v"; 
 
• Federal Civil and Commercial Court of Appeal, Chamber No. 3.  "Pirelli SPA v 
National Industrial Property Institute, concer ning the refusal of a patent".  Case 
No. 22,932/96, 11 August 1998. 
 
PROTECTION OF GEOGRAPHICAL INDICATIONS 
  Please give examples of case scenarios where your authorities (whether administrative or judicial) would consider the use of a geographical indication on a product which is not originating in the geographical area designated by  the geographical indication as misleading the 
public on the geographical origin of the product. 
 
 Have there been instances where the use of a geographical indication was prohibited by 
your authorities (whether administrative or judicial) by applying Article 22.2(a) and/or (b)?  If yes, please cite the relevant decisions. 
 
 With regard to the request for an example of  a case scenario on the use of a geographical 
indication which misleads the public as to the geographical origin of a product, it should be pointed 
out that such an exercise ex ceeds the requirements of Article 63 of the TRIPS Agreement. 
  IP/Q/ARG/1/Add.2, IP/Q2/ARG/1/Add.2,  
 IP/Q3/ARG/1/Add.2, IP/Q4/ARG/1/Add.2  Page 3 
 
 
  Article 63, paragraph 1, lays down an obliga tion to publish "laws and regulations, and final 
judicial decisions and administrative rulings of general application, made effective by a Member 
pertaining to the subject-matter of this Agreemen t (the availability, scope, acquisition, enforcement 
and prevention of the abuse of inte llectual property rights)".  Paragr aph 3 provides that "each Member 
shall be prepared to supply, in response to a wr itten request from another Member, information of the 
sort referred to in paragraph 1", incl uding information regarding "a specific
 judicial decision or 
administrative ruling or bilateral agreement in the area of intellectual property rights" which affects 
the requesting Member's rights under the TRIPS Agreement.  
 If a case having the characteristics set out in the question were brought before the Argentine 
administrative or judicial authorities, those authoriti es would have to reach a decision consistent with 
the existing legislation on geographical indications, which has been duly notified.   In relation to the second part of the ques tion, there are no known cases of the Argentine 
administrative or judicial authorities applying Article 22.2(a) and/or (b) in order to prohibit the use of 
a geographical indication.  
 B. 
PATENTS  
Ad response to question 2 : 
  Please describe how inventions relating to micro-organisms are protected in your 
legislation. Please explain in this respect the relevant sections of your legislation. 
 
 Micro-organisms which have been modified from their natural state are patentable under 
Article 27.3 (b) of the TRIPS Agreement. 
 
 Patents relating to this type of micro-organism  are protected in the same way as other patents, 
subject only to the provision in Article 20 of the Law on Patents that "in the case of applications 
relating to micro-organisms, the product to be obt ained through a claimed process shall be described 
together with that in the application, and the stra in shall be deposited at an institution authorised for 
that purpose, in accordance with the rules laid down in the regulations.  The public shall have access 
to the depository institution from the date when the patent application is published, under the 
conditions established by regulations".  Ad response to question 3
: 
  Article 27.1 of the TRIPS Agreement provides that patents shall be available and patent 
rights enjoyable without discrimination as to whether products are imported or locally produced.  Patent protection must therefore not be made dependent on local production and 
compulsory licences may not be granted on the so le ground that a patented invention is only 
imported but not locally produced.  Please indi cate how and where this is reflected in your 
legislation. 
 
 The provisions of Article 27.1 of the TRIPS Agreement are reflected in Article 43 of the 
Regulatory Decree of the Law on Patents which provi des that "a product shall be deemed to be 
worked when distributed and marketed in a manne r sufficient to satisfy domestic market demand, 
under reasonable commercial conditions". 
 IP/Q/ARG/1/Add.2, IP/Q2/ARG/1/Add.2,  
IP/Q3/ARG/1/Add.2, IP/Q4/ARG/1/Add.2 Page 4 
 
 
 C. 
PROTECTION OF UNDISCLOSED INFORMATION  
Ad response to question 8 : 
 
 In your response, you mention that your legislation is compatible with Article 39 of the 
TRIPS Agreement.  Please explain in detail Arge ntina’s interpretation of the obligations under 
Article 39.3 of the TRIPS Agreement.  How and where are these obligations reflected in the Argentine legislation? 
 
 Please specify whether the responsible State Agency will require, in the procedure for 
market authorization of a pharmaceutical or of  an agricultural chemical product, the same 
amount of data from a second applicant request ing market authorisation for a similar or 
identical product as from the first applicant. 
 
 Does your legislation provide for time-limits before the expiration of which test data 
cannot be relied upon or referred to by a second applicant for market authorization? 
 
 Article 39 of the TRIPS Agreement is reflected in the Law on Confidentiality – 
Law No. 24.766 - and the Resolutions of the Ministry of Agriculture, Livestock, Fisheries and Food – Resolutions No. 440/1988 and No. 350/1999 – wh ich were notified to the TRIPS Council in 
documents IP/N/1/ARG/U/1 and IP/N/1/ARG/U/3. 
 
 It should be pointed out that under the provisi ons of Article 63 of the TRIPS Agreement there 
is no obligation to "explain in detail Argentina's in terpretation of the obligations under Article 39.3". 
 
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