WORLD TRADE
ORGANIZATIONWT/DS171/3
WT/DS196/4IP/D/18/Add.1
IP/D/22/Add.1
20 June 2002
(02-3427)
Original:  English/
Spanish
ARGENTINA – PATENT PROTECTION FOR PHARMACEUTICALS
AND TEST DATA PROTECTION FOR AGRICULTURAL CHEMICALS
(WT/DS171)
ARGENTINA – CERTAIN MEASURES ON THE PROTECTION OF PATENTS
AND TEST DATA
(WT/DS196)
Notification of Mutually Agreed Solution
According to the Conditions Set Forth in the Agreement
The following communication, dated 31 May 2002, from the Permanent Mission of Argentina
and the Permanent Mission of the United States to the Chairman of the Dispute Settlement Body, is
circulated at the request of both parties.
_______________
The Governments of the United States of Am erica and the Republic of Argentina wish to
notify the Dispute Settlement Body (DSB) that they have reached an agreement on all of the matters
raised by the United States in document WT/DS171/1 ( Argentina – Patent Protection for
Pharmaceuticals and Test Data Protection for Agricultural Chemicals ) dated 6 May 1999 and in
document WT/DS196/1 ( Argentina – Certain Measures on the Protection of Patents and Test Data )
dated 30 May 2000.
Following the rounds of consultations held on 15 June 1999, 27 July 1999, 17 July 2000,
29 November 2000, 2 April 2001, 13 July 2001, 21 September 2001, 5 November 2001, and14 April 2002, the United States and Argentina have reached a mutually satisfactory solution on the
matters indicated in items 1 through 8(a).  The mutually satisfactory solution on the matters indicated
in items 4, 5 and 6 of the attached text is subject to the passage by the Argentine National Congress of
the bills referred to in those items within one year of the date of the submission of this notification.
The matters indicated in items 8(b) and 9 shall be subject to the conditions set forth in the respectiveparagraphs of this notification.  This agreement is without prejudice to the rights and obligations of
Argentina and the United States under the WTO agreements.
Please find attached the text of the agreement.  We would ask you to circulate this notification
and attachment to the relevant Councils and Committees, as well as to the DSB.
(s.) Mr. Alberto J. Dumont (s.) Mr. David P. Shark
Chargé d'Affaires, a.i. Chargé d'Affaires, a.i.
Permanent Mission of Argentina Permanent Mission of the United States
   of AmericaWT/DS171/3, WT/DS196/4,
IP/D/18/Add.1, IP/D/22/Add.1
Page 2
1. Compulsory Licenses
The Governments of the United States and Argentina have analyzed Argentinean law and
regulations, i.e., article 44 of the Law on Patents and Utility Models No. 24.481, as amended by LawNo. 24.572, (Law No. 24.481) and article 44 of the Regulatory Decree of such law, Annex II,
20/03/96, No. 260 (Decree 260/96), under the prov isions of Article 31(k) of the Agreement on
Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement).  Pursuant to this analysis,
Argentina has confirmed that if any of the situations defining "anti-competitive" practices in article 44
of Law No. 24.481 were found to exist, such a finding will not in and of itself warrant an automatic
determination that a patent owner is engaging in an "anti-competitive" practice.  Pursuant to article 44
of Decree 260/96, in order to justify the granting of a compulsory license by INPI under this authoritywhere one of these defined situations is established, a prior decision must have been handed down by
the National Commission on the Defense of Competition (or the body that might substitute it in the
future) analyzing the practice in question based on Law No. 25.156 (Law of Defense of Competition).
According to this law, the existence of an abus e of a dominant position in the market must be
established in order for a practice to be considered "anti-competitive."  On this basis, Argentina and
the United States agree that article 44 of Law No. 24.481, read in conjunction with article 44 of
Decree 260/96, is consistent with Argentina's obligations under TRIPS Article 31(k), and that
Argentina shall not grant compulsory licenses on the basis of a finding of anti-competitive practices
except in situations consistent with these provisions.
2. Exclusive Marketing Rights
The Governments of the United States and Argentina have analyzed article 101, first
paragraph of Law No. 24.481, article 101(III) of th e Decree 260/96, and the practice of Argentina
under the provisions of Articles 70.8 and 70.9 of the TRIPS Agreement.  Pursuant to this analysis,Argentina has confirmed that, according to article 101(III) of Decree 260/96, INPI shall grant an
exclusive right to a party to market a product for a period of five years after Argentina approves the
marketing of the product or until a product patent is granted or rejected by Argentina, if the product (i)
is the subject of a claim in a patent application filed in Argentina after January 1, 1995; (ii) is the
subject of the grant of a patent in another WTO Member; and (iii) has been granted marketing
approval in such other Member.  On this basis, Argentina and the United States agree that article 101
of Law No. 24.481, read in conjunction with articl e 101(III) of Decree 260/96, is consistent with
Argentina's obligations under Article 70.9 of the TRIPS Agreement.
3. Import Restrictions
The Governments of the United States and Argentina have analyzed article 36(c) of Law
No. 24.481 and article 36 of Decree 260/96 in light of the provisions of Articles 6 and 28.1 of the
TRIPS Agreement.  Pursuant to this analysis, Argentina has confirmed that, according to its law and
regulations, the owner of a patent granted in the Argentinean Republic shall have the right to prevent
third parties not having the owner's consent from the acts of making, using, offering for sale, selling
or importing the patented product in the territory of Argentina.  However, a voluntary licensee inArgentina authorized by the Argentinean patent owner to import the patented product may import the
product if he proves the product has been put on the market in a foreign country by the owner of the
Argentinean patent or by a third party authorized for its commercialization.  On this basis, Argentina
and the United States agree that article 36(c) of Law No. 24.481, read in conjunction with article 36 of
Decree 260/96, is consistent with Argentina's obligations under the TRIPS Agreement.WT/DS171/3, WT/DS196/4,
IP/D/18/Add.1, IP/D/22/Add.1
Page 3
4. Product by Process Patent Protection
The Governments of the United States and Argentina have analyzed article 8(b) of Law
No. 24.481 in the light of Article 28.1(b) of the TRIPS Agreement.  Pursuant to this analysis, theGovernment of Argentina will submit a bill to the National Congress containing a proposal to amend
the present text of article 8(b) of Law No. 24.481 in the following terms:
"(b) where the subject matter of a patent is a process, to prevent third parties
without his consent from the act of using the process, and from engaging in acts of
use, offering for sale, sale or importation for these purposes of the product obtained
directly by that process".
5. Shifting of the Burden of Proof in Process Patent Infringement Cases
The Governments of the United States and Argentina have analyzed the Argentinean
provisions in the light of Article 34 of the TRIPS Agreement.  Pursuant to this analysis, the
Government of Argentina will submit to the National Congress a bill to amend article 88 of LawNo. 24.481 as follows:
"Article 88 is replaced by the following text:
1. For the purposes of civil procedures, where the subject
matter of the patent is a process for obtaining a product, the courtsshall order the defendant to prove that the process that he is using
for obtaining a product is different from the patented process.
2. The courts, however, shall be empowered to order the
plaintiff to prove that the process that the defendant is using for
obtaining a product infringes the process patent if the productobtained by the patented process is not new.  It shall be presumed
that, in the absence of proof to the contrary, the product obtained by
the patented process is not new if the defendant or if an expert
appointed by the court at the request of the defendant is able to show
that, at the time of the alleged infringement, there exists in the market
a non-infringing product identical to the one produced by the
patented process that originated from a source different from theright owner or the defendant.
3. In the adduction of proof under this Article, the legitimate
interests of defendants in protecting their manufacturing and
business secrets shall be taken into account."
6. Preliminary Injunctions
The Governments of the United States and Argentina have analyzed the Argentinean
legislation in the light of the provisions of Article 50 of the TRIPS Agreement.  Pursuant to this
analysis, the Government of Argentina will submit a bill to the National Congress containing the
following text to be incorporated into  the current article 83 of Law No. 24.481:
"The judicial authorities shall have the authority to order provisional measures in
relation to a patent granted in conformity with articles 30, 31 and 32 of the Law, in
order to:WT/DS171/3, WT/DS196/4,
IP/D/18/Add.1, IP/D/22/Add.1
Page 4
(1) prevent an infringement of the patent and, in particular, to
prevent the entry into channels of commerce of goods,
including imported goods, immediately after customsclearance;
(2) preserve relevant evidence in regard to the alleged
infringement,
whenever the following conditions are met:
(a) there is a reasonable likelihood that the patent, if challenged
by the defendant as being invalid, shall be declared valid;
(b) it is summarily proven that any delay in granting such
measures will cause an irreparable harm to the patent
holder;
(c) the harm that may be caused to the title holder exceeds the
harm that the alleged infringer will suffer in case the
measure was wrongly granted;
(d) there is a reasonable likelihood that the patent is infringed.
Provided that the above conditions are met, in exceptional cases such as when there
is a demonstrable risk of evidence being destroyed, the judicial authorities can grant
such measures inaudita altera parte.
In all cases, before granting a provisional measure, the judicial authority shall
request that an expert appointed ex officio examine items (a) and( d) above within a
maximum period of 15 days.
In the case of granting of any of the measures provided for under this article, the
judicial authorities shall order the applicant to provide a security or equivalent
assurance sufficient to protect the defendant and to prevent abuses."
Pursuant to the above analysis, the Government of Argentina will submit a bill to the National
Congress amending article 87 of the Patent Law, which will read as follows:
"In cases where provisional measures were not granted pursuant to article 83 of the
Law, the plaintiff may demand security from the defendant not to interrupt the
defendant's exploitation of the invention where he wishes to continue with such
exploitation."
7. Patentability of Micro-organisms and other Subject Matter:
Regarding the matter of the consultations referring to the patentability of:
(a) micro-organisms, per se (e.g. yeasts, bacteria, unicellular organisms);(b) a composition that includes as one element a micro-organism (e.g., a culture containing a
yeast, bacterium, etc.);WT/DS171/3, WT/DS196/4,
IP/D/18/Add.1, IP/D/22/Add.1
Page 5
(c) a chemical compound, per se (i.e., the chemical compound not in combination with other
materials);
(d) a composition containing a chemical compound that had an industrial application other than
use as a pharmaceutical composition;
(e) a chemical compound or a purified composition containing a chemical compound (in the form
of a nucleic acid comprising a specified sequence of nucleoside (i.e., a nucleotide sequence);
a peptide, polypeptide or protein (i.e., an amino acid sequence); a lipid; or a polysaccharide);
(f) a chemical compound having a structure identical to a chemical compound isolated from a
plant, animal, micro-organism or other naturally occurring sources;
(g) a purified composition containing a chemical compound having a structure identical to a
chemical compound isolated from a plant, animal, micro-organism or other naturallyoccurring source, such that the composition is not identical to a composition containing the
chemical compound as it would be found in its natural state; and
(h) a chemical compound or a composition containing that compound where the composition
does not have a predominantly pharmaceutical application,
the Governments of Argentina and the United States have analyzed the legislation and practice of
Argentina in the light of Article 27.3(b) of the TRIPS Agreement.  Pursuant to this analysis, the
Government of Argentina has elaborated and published guidelines about its practices relating to
patentability of micro-organisms in INPI Resolution 633/2001 (Official Gazette, dated22 October 2001).
8. Transitional Patents
(a) Article 70.4 of the TRIPS Agreement
The Governments of the United States and Argentina have expressed their respective
points of view regarding the obligations under Article 70.4 of the TRIPS Agreement, and
have examined the Argentinean legislation in the light of this provision, in particular
paragraph 3 of article 101 of Law No. 24.481 and article 101(II) of Decree 260/96.  Pursuant
to this analysis, Argentina has confirmed that article 101, paragraph 3 of Law No. 24.481,
which can only be read in conjunction with article 101(II) of Decree 260/96, establishes thatonly third parties who completed investments in  preparation for using a patented invention
prior to January 1, 1995, can continue to use the invention upon payment of fair and
reasonable remuneration to the patent holder.  On this basis, Argentina and the United States
agree that article 101, paragraph 3 of Law No. 24.481, which can only be read in conjunction
with article 101(II) of Decree 260/96, is consistent with Argentina's obligations under TRIPSArticle 70.4.
(b) Article 70.7 of the TRIPS Agreement
The Governments of the United States and Argentina agree that Argentina will fulfill
its WTO obligations on this matter through its legal system and practices, including decisions
of the Supreme Court of Justice.WT/DS171/3, WT/DS196/4,
IP/D/18/Add.1, IP/D/22/Add.1
Page 6
9. Protection of Test Data Against Unfair Commercial Use
The Governments of the United States and Argentina have expressed their respective points
of view on the provisions of Article 39.3 of the TRIPS Agreement, and have agreed that differences ininterpretations shall be solved under the DSU rules.  The Parties will continue consultations to assess
the progress of the legislative process of approval of items 4, 5 and 6 of this notification, and in the
light of this assessment, the United States may decide to continue consultations or request the
establishment of a panel related to Article 39.3 of the TRIPS Agreement.
In addition, the Parties agree that should the Dispute Settlement Body adopt recommendations
and rulings clarifying the content of the rights related to undisclosed test data submitted for marketingapproval according to Article 39.3 of the TRIPS Agreement, and should Argentinean law be
inconsistent with Article 39.3 as clarified by the above-mentioned recommendations and rulings,
Argentina agrees to submit to the National Congress within one year an amendment to Argentinean
law, as necessary, to put its legislation in conformity with its obligations under Article 39.3 as
clarified in such recommendations and rulings.
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