RESTRICTEDWORLD TRADE
ORGANIZATIONIP/C/W/135
12 March 1999
(99-0996)
Council for Trade-Related Aspects
of Intellectual Property RightsOriginal:  Spanish
IMPLEMENTATION OF ARTICLES 70.8 AND 70.9
The present document reproduces the responses provided by Argentina, at the meeting of the
Council for TRIPS of 17 February 1999, as posed by the United States and distributed in document
IP/C/W/113.
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1. In addition to the information provided in your notification concerning the filing of patent
applications directed to pharmaceutical or agricultural chemical product inventions, please:
(a) identify the basis in your law that governs the handling of patent applications by the
responsible Government agency in situations where the application is directed to subject-
matter that is not eligible to be patented;  and
Argentine law lays down the same patentability requirements as the TRIPS Agreement.
These criteria are applied to patent applications filed as of the entry into force of the new
legislation, and if they are not met, patent protection is not granted.
In the case of pharmaceutical products for which applications were filed on or after 1 January
1995, the patentability requirements laid down in the TRIPS Agreement, approved byArgentina under Law 24.425, are applied.
(b) confirm that the measures specified in your notification will ensure that any patent
application directed to pharmaceutical or agricultural chemical product inventions that was
filed on or after 1 January 1995, can serve as the basis for a grant of a patent with a termthat expires no earlier than 20 years from the date of its filing, once your Government extends
patent protection to inventions consistent with the scope of Article 27 of the TRIPS
Agreement.
We confirm that any patent application directed to pharmaceutical product inventions (which
are in a transitional period) serve as a basis for a grant of a patent with a term that expires no
earlier than 20 years from the date of its filing.
2. Please identify the provisions of your law that govern the granting of exclusive marketing
rights for products covered by Articles 70.8 and 70.9 of the TRIPS Agreement.
During the transitional period, applications for exclusive marketing rights are to be filed with
the National Industrial Property Institute (INPI) together with the necessary documentation certifying:
(a) that the product is the subject of a patent application before the said body;IP/C/W/135
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(b) that a patent application was filed after 1 January 1995 to protect the same product in
another WTO/TRIPS Member with evidence that the two applications are the same;
(c) that a patent has been granted after 1 January 1995 for that product in such other
Member;
(d) that marketing approval has been obtained for that product in such other Member
after 1 January 1995.
Once it has verified these elements, the INPI decides on whether to grant exclusive marketing
rights in Argentina for a period of five years after obtaining marketing approval in Argentina, under
the proviso that the permission expires prior to that date if the patent application filed with the INPI isaccepted or rejected or the marketing approval withdrawn.
The granting of exclusive marketing rights is conditional upon approval for the manufacturing
and marketing of pharmaceuticals products, which has to be obtained from the Ministry of Public
Health and Social Action.
3. Please provide the identity and address of the government authority that is responsible for the
granting of exclusive marketing rights.
The National Industrial Property Institute, located at Av. Paseo Colón 717 in Buenos Aires,
decides on the granting of exclusive marketing rights, which is conditional upon manufacturing and
marketing approval for pharmaceuticals by the National Food, Drug and Medical Technology
Administration (ANMAT), located at Avenida de Mayo 869, 3
rd floor, Buenos Aires, and which is
under the authority of the Ministry of Public Health and Social Action.
4. Please explain the procedures to be followed  by a private company or individual wishing to
obtain exclusive marketing rights for a pharmaceutica l or agricultural chemical product that fulfils
the requirements of Articles 70.8 and 70.9.
In the case of pharmaceuticals, the applicant must provide the INPI with documentation
certifying that he has fulfilled the requirements laid down by Argentine law, which correspond to
those contained in Article 70.9 of the TRIPS Agreement, and must obtain manufacturing andmarketing approval from the ANMAT.
5. Please identify the fee, if any, for obtaining exclusive marketing rights for a product or family
of products.
No fee is currently collected.  Regulations set ting the rates for such fees are currently being
prepared.
6. Please explain how an entity that has obtain ed exclusive marketing rights pursuant to TRIPS
Article 70.9 can enjoy the benefit of such rights?  In particular:
(a) Can marketing approval be granted under any circumstances to another party prior to the
expiration of the exclusive marketing rights period defined in Article 70.9?
Marketing approval for a pharmaceutical product is governed in Argentina by Laws 16.463
and 24.766 and by Decree 150/92 (regulatory enactment by Decree 177/93).  This regime
does not provide for marketing approval for a particular drug exclusively, nor does it provide
the possibility of cancelling an approval already granted for reasons that are not strictly
related to health.IP/C/W/135
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(b) What remedies or procedures are available to  the holder of an exclusive marketing right to
prevent the issuance of marketing privileges to another party in respect of a product that is
the subject of the exclusive marketing rights?
The holder of an exclusive marketing right for a given drug may appeal to the national courts
and ask the competent judge to take the necessary measures to guarantee the effective
protection of those rights.
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