WORLD TRADE
ORGANIZATIONIP/C/W/397
14 February 2003
(03-0971)
Council for Trade-Related Aspects
of Intellectual Property RightsOriginal:  English
REVIEW OF LEGISLATION
Questions by Switzerland
By means of a communication from the Permanent Mission of Switzerland, dated
11 February 2003, the Secretariat has received copies  of the following follow-up and other questions
that Switzerland has communicated to Argentina and Guyana, respectively.
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ARGENTINA1
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 Article 75, paragraphs 22 and 24 of the Constitution of the Argentine
Republic.  Of particular relevance 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 ofinternational law, and more specifically, of the TRIPS Agreement?  Please cite the relevant decisions.
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 inthe 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, pleasecite the relevant decisions.
                                                     
1 Argentina's responses to initial questions posed by Switzerland have been circulated in document
IP/Q/ARG/1/Add.1.IP/C/W/397
Page 2
B. PATENTS
Ad response to question 2:
Please describe how inventions relating to micr o-organisms are protected in your legislation.
Please explain in this respect the relevant sections of your legislation.
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 sole ground that a patented invention is only imported but not locally produced.Please indicate how and where this is reflected in your legislation.
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 Argentina’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 agricult ural chemical product, the same amount of data
from a second applicant requesting 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?
GUYANA2
A. PATENTS
Ad response to question 1:
In your answer, you mention that "[p]rima facie patents are available for all categories of
products providing they satisfy the definition in Section 2  and fulfill the requirements of Sections 3
and 4 of the Patent and Designs' Act Cap 90:03 ".  Section 2 defines patents as "letters patent for an
invention" and Sections 3 and 4 deal with proc edural aspects of applications for a patent.
Please clarify in more detail how it can be inferred from these or other provisions as well as,
if necessary, from practice, that, according to your legislation, patents are available for all fields oftechnology as required by Article 27.1 of the TRIPS Agreement.
                                                     
2 Guyana's responses to initial questions posed by Switzerland have been circulated in document IP/C/W/381.IP/C/W/397
Page 3
Ad response to question 2:
In your answer, you mention Section 28(c) of your Patent and Design Act, which allows to
preclude the licensee from importing infringing goods into Guyana.  Article 27.1 of the TRIPS
Agreement deals with the so-called problem of "local working" and specifies that patents must beavailable and patent rights enjoyable without discrimination as to whether products are imported or
locally produced.  That means a Member cannot force the patent holder to produce on its territory, be
it by a compulsory licence or by any other means.  How and where is this reflected in your
legislation?
Ad response to question 3:
In your answer, you mention that the patent law of Guyana has not been amended to reflect
the provisions of Article 31 of the TRIPS Agreement.  Does this mean that the obligations contained
in Article 31 of the TRIPS Agreement are directly applicable in your legislation?
Ad response to question 4:
You mention that your legislation does not provide for the principal of reversal of burden of
proof in process patent litigation.  Does this mean that the obligations contained in Article 34 of the
TRIPS Agreement are directly applicable in your legislation?
B. PROTECTION OF UNDISCLOSED INFORMATION
Ad response to question 5:
In your response, you mention the general provisions of your legislation on the provisional
protection of inventions between the patent application and the date of sealing of a patent.
(a) As far as the more specific issue of unfair commercial use by a competitor of data submitted
by an earlier applicant to the responsible author ities in the procedure for market authorization
of a pharmaceutical or of an agricultural chemical product is concerned, please explain
whether, and how, your law prevents a second applicant from relying on or from referring in
the application for market authorization of his own product to the original data submitted by
the first applicant.  In particular, does a second applicant have to provide to the responsibleauthorities the same amount of data on safety and efficacy for his own product as the first
applicant?
(b) Does your legislation provide for time-limits before the expiration of which such data cannot
be relied upon or referred to by a second applicant?
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