RESTRICTEDWORLD TRADE
ORGANIZATIONIP/C/W/207/Add.3
19 February 2001
(01-0815)
Council for Trade-Related Aspects
of Intellectual Property RightsOriginal:  English
REVIEW OF LEGISLATION
Follow-up Questions Posed by Switzerland to Chile, Estonia and Kuwait
Addendum
By means of communications from the Permanent Mission of Switzerland, dated
5 February 2001, the Secretariat has received the following follow-up questions addressed to Chile,
Estonia and Kuwait.
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CHILE1
A. PATENTS
Ad response to question 4:
Please confirm whether in your law, in acco rdance with Article 27.1 of the TRIPS Agreement
in combination with Article 31 of the TR IPS Agreement, importation is considered as
"working/utilising a patent" (and therefore precluding compulsory licensing, if a product is being
imported).
B. PROTECTION OF UNDISCLOSED INFORMATION
Ad response to question 8:
In your response, you mention the more general provisions of your legislation on the
protection of confidential information.
(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
his application for market authorization of his own product to the original data submitted by
the first applicant.  In particular, has a second applicant 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?
                                                     
1 These questions follow up Chile's responses contained in document IP/C/W/222/Add.1.IP/C/W/207/Add.3
Page 2
ESTONIA2
A. PROTECTION OF UNDISCLOSED INFORMATION
Ad response to question 5:
(a) Referring to the issue of unfair commercial use of data submitted by an applicant to the
responsible authorities in the procedure for market authorization of a pharmaceutical or of an
agricultural chemical product, please explain more in detail whether and how your law
prevents the responsible authorities or a second applicant from relying on or from referring to
the original data of the first applicant for the market authorization procedure of the product of
the second applicant.  In particular, has a second applicant to provide to the responsibleauthorities the same amount of data on safety and efficacy for such a 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 the authorities or by a second applicant for the marketauthorization of such a second product whic h is equivalent to the original product?
(c) You mention that amendments have been drafted for the Medicinal Products Act and are
currently being drafted for the Plant Protection Act in order to comply with the requirements
of Article 39.3 of the TRIPS Agreement.  Please explain in detail what the contents of theseamendments will be.
KUWAIT
3
A. PATENTS
Ad response to question 1:
(a) In your answer, you mention that according to your legislation patents shall not be granted in
for chemical inventions relating to foodstuf fs, medicines and pharmaceutical formula unless
such products are made by special chemical methods or processes.  How does this comply
with Article 27.1 of the TRIPS Agreement requiring patents to be available for inventions,whether products or processes, in all fields of technology?
(b) You mention that in your legislation amendm ents are currently undertaken with regards the
issue of patentability.  Please indicate what the contents of these amendments will be.
Ad response to question 2:
Please confirm whether in your law, in acco rdance with Article 27.1 of the TRIPS Agreement
in combination with Article 31 of the TR IPS Agreement, importation is considered as
"working/utilising a patent" (and therefore precluding compulsory licensing, if a product is beingimported).
                                                     
2 These questions follow up Estonia's responses in document IP/C/W/235.
3 These questions follow up Kuwait's responses in document IP/C/W/232.IP/C/W/207/Add.3
Page 3
Ad response to question 3:
Does your legislation provide for the principle of the reversal of burden of proof in a process
patent litigation?  Please cite the relevant provisions of law.
B. PROTECTION OF UNDISCLOSED INFORMATION
Ad response to question 4:
(a) Referring to the issue of unfair commercial use of data submitted by an applicant to the
responsible authorities in the procedure for market authorization of a pharmaceutical or of an
agricultural chemical product, please explain whether and how your law prevents the
responsible authorities or a second applicant from relying on or from referring to the originaldata of the first applicant for the market authorization procedure of the product of the second
applicant.  In particular, has a second applicant to provide to the responsible authorities the
same amount of data on safety and efficacy for such a 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 the authorities or by a second applicant for the market
authorization of such a second product whic h is equivalent to the original product?
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