RESTRICTEDWORLD TRADE
ORGANIZATIONIP/C/W/263/Add.1
28 August 2001
(01-4139)
Council for Trade-Related Aspects
of Intellectual Property RightsOriginal:  English
REVIEW OF LEGISLATION
Follow-up questions posed by Switzerland
Addendum
By means of a communication from the Permanent Delegation of Switzerland, dated
15 August 2001, the Secretariat has received a copy  of the following follow-up questions that
Switzerland has communicated to Albania, Botswana, Costa Rica, Croatia, Dominican Republic,
Egypt, Georgia, Honduras, Jamaica, Kenya, Morocco, Nicaragua, Oman, the Philippines and the
United Arab Emirates, respectively.
_______________
ALBANIA1
A. P ATENTS
Ad response to question 3:
Please confirm whether your law, in accordance with Article 27.1 of the TRIPS Agreement
in combination with Article 31 of the TRIPS Agreement, considers importation as "working/utilising"
a patent (and therefore precludes compulsory licensing, if a product is imported).
Ad response to question 4:
Does your legislation provide for the granting of compulsory license to allow the exploitation
of a patent ("second patent") which cannot be exploited without infringing another patent ("the first
patent") as mentioned in Article 31 (l) of the TRIPS Agreement?  If so, which conditions shall applyfor the granting of such licences in your legislation?
                                                     
1 Albania's responses to initial questions posed by Switzerland have been circulated in document
IP/C/W/267/Add.1.IP/C/W/263/Add.1
Page 2
BOTSWANA2
A. G EOGRAPHICAL INDICATIONS
Ad response to question 1:
You mention that you are currently developing the legislation on geographical indications.
Please explain what the draft Act provides and when the new regulation is supposed to be adopted.
B. P ATENTS
Ad response to question 2:
Please confirm that your legislation grants patent protection to all categories of products. If
there are exceptions, please specify.
Ad response to question 4:
You mention that Section 30 of the Industrial Property Act, 1996 sets out most of the
conditions enumerated in Article 31 of the TRI PS Agreement.  Please confirm that, with the
mentioned amendment of your law relating to Article 31 (l) of the TRIPS Agreement, the granting of
compulsory licences will be subject to all the conditions enumerated in Article 31 of the TRIPS
Agreement.  Please explain what the draft Act provides in this regard. When will the new regulation
enter into force?
C. P ROTECTION OF UNDISCLOSED INFORMATION
Ad response to question 6:
A. You mention that, currently, you do not have laws for protection of undisclosed information
in Botswana, but that you will provide for such protection in the amendment of your IndustrialProperty Act, 1996. Please explain what the draft amendment provides in relation to protection of
undisclosed information.  When will the new regulation enter into force?
B. Referring to the issue of unfair commercial use of data submitted by an applicant to the
responsible State Agency in the procedure for market authorisation of a pharmaceutical or of anagricultural chemical product, please explain in detail if the draft amendment will prohibit a second
applicant from relying on, or from referring to, the original data of the first applicant, when applying
subsequently for market authorisation for his own product.  Will the responsible State Agency require
the same amount of data from the second applicant as from the first applicant? Will the draft
amendment set a specific term of protection for undisclosed test or other data of the first applicant?
D. E
NFORCEMENT
Ad response to question 7:
Please explain how your legislation implements Article 50 of the TRIPS Agreement and how
the special requirements related to border measures of Articles 51 to 60 of the TRIPS Agreement are
implemented in your legislation.
                                                     
2 Botswana's responses to initial questions posed by Switzerland have been circulated in document
IP/C/W/295.IP/C/W/263/Add.1
Page 3
COSTA RICA3
A. P ROTECTION OF UNDISCLOSED INFORMATION
Ad response to question 6:
Referring to the issue of unfair commercial use of data submitted by an applicant to the
responsible State Agency in the procedure for market authorisation of a pharmaceutical or of an
agricultural chemical product, please explain in detail if your law prohibits a second applicant from
relying on, or from referring to, the original data of the first applicant, when applying subsequently for
market authorisation for his own product. Does the responsible State Agency require the same amount
of data from the second applicant as from the fi rst applicant?  What will the new draft regulation
provide in this regard?  Will the draft amendment set a specific term of protection for undisclosed test
or other data of the first applicant?  Please explain in more detail what your legislation considers as"practices that unreasonably restrain trade" (as mentioned in your answer).
CROATIA
4
A. P ATENTS
Ad response to question 2:
You mention that according to Article 4, paragr aph 1 of the Patent Law (NN No. 78/99), the
patent protection shall exclude plant varieties. Please explain how your legislation provides forprotection of plant varieties.  Is it a protection by a sui generis  system as indicated in Article 27.3 (b)
of the TRIPS Agreement?
Ad response to question 3:
Please confirm whether your law, in accordance with Article 27.1 of the TRIPS Agreement
in combination with Article 31 of the TRIPS Agreement, considers importation as "working/utilising“
a patent (and therefore precludes compulsory licensing, if a product is imported).
Ad response to question 4:
A. Please explain whether your legislation provid es for judicial review or other independent
review of the legal validity of any decision by administrative Authorities relating to the authorisation
of use as mentioned in Article 31 of the TRIPS Agreement.
B. Does your legislation provide for the granting of compulsory license to allow the exploitation
of a patent (“second patent”) which cannot be exploited without infringing another patent ("the first
patent") as mentioned in Article 31 (l) TRIPS Agreem ent?  If so, which conditions shall apply for the
granting of such licences in your legislation?
                                                     
3 Costa Rica's responses to initial questions posed by Switzerland have been circulated in document
IP/C/W/269.
4 Croatia's responses to initial questions posed by Switzerland have been circulated in document
IP/C/W/262/Add.1.IP/C/W/263/Add.1
Page 4
B. P ROTECTION OF UNDISCLOSED INFORMATION
Ad response to question 6:
Referring to the issue of unfair commercial use of data submitted by an applicant to the
responsible State Agency in the procedure for market authorisation of a pharmaceutical or of an
agricultural chemical product, please explain in detail if your legislation explicitly prohibits a secondapplicant from relying on, or from referring to, the original data of the first applicant, when applying
subsequently for market authorisation for his own product.  Does the responsible State Agency require
the same amount of data from the second applicant as from the first applicant?  Does your legislation
set a specific term of protection for undisclosed test or other data of the first applicant?
C. E
NFORCEMENT
Ad response to question 7:
Please explain how your legislation implements Article 50 of the TRIPS Agreement and how
the special requirements related to border measures of Articles 51 to 60 of the TRIPS Agreement are
implemented in your legislation.
DOMINICAN REPUBLIC5
A. P ROTECTION OF UNDISCLOSED INFORMATION
Ad response to question 6:
Referring to the issue of unfair commercial use of data submitted by an applicant to the
responsible State Agency in the procedure for market authorisation of a pharmaceutical or of an
agricultural chemical product, please explain what the expressions "[...] a terceros hacer referencia a
autorizaciones anteriores [...]" implies. Does this mean that a second applicant can actually rely on, orrefer to the original data of the first applicant, when applying subsequently for market authorisation
for his own product? If so, please explain how this complies with Article 39.3 of the TRIPS
Agreement.  Please explain in this context the passage in your answer "[...] autorided podrá
internamente tomar en cuenta cualquier informacíon a su disposición, cualquiera sea su origen [...]"
and whether a second applicant will have to submit the same amount of test data for marketauthorisation to the responsible State Agency as the first one.
EGYPT
6
A. P ATENTS
Ad response to question 2:
In your answer, you mention that under Article 2 of your new IPR law (currently in draft
form) living organs, tissues, cells, DNA and genome are excluded from patentability. Does this mean
that inventions relating to such subject matter, ev en if fulfilling the conditions of patentability,
i.e. novelty, inventive step and industrial applicability are nevertheless excluded from patentability
                                                     
5 The Dominican Republic's responses to initial questions posed by Switzerland have been circulated in
document IP/C/W/285.
6 Egypt's responses to some initial questions posed by Switzerland have been circulated in document
IP/C/W/278.IP/C/W/263/Add.1
Page 5
according to your law? If so, please explain how this complies with the obligation of Article 27.1
TRIPS Agreement prohibiting discrimination as regards patentability between different fields of
technology.
Ad response to question 7:
It does not resort clearly from your answer whether a patented product needs to be produced
in your country in order to satisfy the requirement of the use of the invention.  Please confirm
whether, according to your new legislation, importation is considered as working the patent and
satisfies therefore the requirement of use/exploitation of the patent.  If this should not be the case,
please explain how this complies with the obligations contained in Article 27.1 of the TRIPS
Agreement, requiring patent rights to be enjoyable without discrimination as to whether products are
imported or locally produced.
B. P ROTECTION OF UNDISCLOSED INFORMATION
Ad response to question 9:
In your answer, there is no mention of legal provisions providing protection against unfair
commercial use for confidential test data submitte d to the Egyptian authority responsible for market
authorisation. Please explain how your new le gislation will provide protection against unfair
commercial use of test data as required by Articl e 39.3 of the TRIPS Agreement.  Will the responsible
state authority require the same amount of data for market authorisation from the second applicant as
from the first applicant?
GEORGIA7
A. P ATENTS
Ad response to question 3:
Please confirm that, in accordance with Article 27.1 of the TRIPS Agreement, your
legislation provides that patent rights shall be enjoyable without discrimination as to whether products
are imported or locally produced and that importation of patented products shall be taken into accountwhen determining if the needs of the national market are sufficiently covered.
HONDURAS
8
A. P ATENTS
Ad response to question 2:
Please explain in detail how the following exception to patentability, foreseen in Art. 7 of
your Law on Industrial Property, complies with Article 27 TRIPS Agreement prohibiting
discrimination as regards patentability between different fields of technology: "[...] incluyendo los
procesos genéticos o relativos a material capaz de conducir su propria aplicación, por sí mismo o porcualquier otra manera indirecta, cuando consistan en seleccionar o aislar material biológico disponible
                                                     
7 Georgia's responses to initial questions posed by Switzerland have been circulated in document
IP/C/W/290.
8 Honduras's responses to initial questions posed by Switzerland have been circulated in document
IP/C/W/277.IP/C/W/263/Add.1
Page 6
y dejarlo que actúe en condiciones naturales". Does this exception mean that inventions relating to
such subject matter, even if fulfilling the conditions  of patentability, i.e. novelty, inventive step and
industrial applicability are nevertheless excluded from patentability according to your law?
B. P ROTECTION OF UNDISCLOSED INFORMATION
Ad response to question 6:
Referring to the issue of unfair commercial use of data submitted by an applicant to the
responsible Authorities in the procedure for market authorisation of a pharmaceutical or of an
agricultural chemical product, please explain in detail if your legislation explicitly prohibits a second
applicant from relying on, or from referring to, the original data of the first applicant (in the absence
of any disclosure by the State agency), when applying subsequently for market authorisation for his
own product. Does your legislation set a specific term of protection for undisclosed test or other dataof the first applicant?
JAMAICA
9
A. P ATENTS
Ad response to question 3:
You mention that Article 51 excepts from non-voluntary licensing the importation of the
patented product from specified countries. Please specify these countries and explain how suchregulation complies with Article 4 of the TRIPS Agreement.
B. P
ROTECTION OF UNDISCLOSED INFORMATION
Ad response to question 6:
You mention that there is no legislation governing undisclosed information in your country.
Does this mean that the obligations contained in Article 39 of the TRIPS Agreement are directly
applicable in your legislation?
KENYA10
A. P ROTECTION OF UNDISCLOSED INFORMATION
Ad response to question 6:
You mention that you are currently developing the legislation on protection of undisclosed
information.  Please explain what the draft Bill provides in this regard and when the new regulation issupposed to enter into force.
                                                     
9 Jamaica's responses to initial questions posed by Switzerland have been circulated in document
IP/C/W/266/Add.1.
10 Kenya's responses to initial questions posed by Switzerland have been circulated in document
IP/C/W/294.IP/C/W/263/Add.1
Page 7
B. E NFORCEMENT OF INTELLECTUAL PROPERTY RIGHTS
Ad response to question 7:
Please explain how the special requirements related to border measures of Articles 51 to 60 of
the TRIPS Agreement are implemented in your legislation.
MOROCCO11
A. P ATENTS
Ad response to question 3:
Please confirm whether your law, in accordance with Article 27.1 of the TRIPS Agreement
in combination with Article 31 TRIPS Agreement, considers importation as "working/utilising" a
patent (and therefore precludes compulsory licensing, if a product is imported).
B. P ROTECTION OF UNDISCLOSED INFORMATION
Ad response to question 6:
Referring to the issue of unfair commercial use of data submitted by an applicant to the
responsible State Agency in the procedure for market authorisation of a pharmaceutical or of an
agricultural chemical product, please explain in detail if your legislation explicitly prohibits a second
applicant from relying on, or from referring to the or iginal data of the first applicant, when applying
subsequently for market authorisation for his own product.  Does the responsible State Agency requirethe same amount of data from the second applicant as from the first applicant?
NICARAGUA
12
A. P ROTECTION OF UNDISCLOSED INFORMATION
Ad response to question 6:
Referring to the issue of unfair commercial use of data submitted by an applicant to the
responsible State Agency in the procedure for market authorisation of a pharmaceutical or of anagricultural chemical product, please explain in detail if your legislation explicitly prohibits a second
applicant from relying on, or from referring to the or iginal data of the first applicant, when applying
subsequently for market authorisation for his own product.  Does the responsible State Agency require
the same amount of data from the second applicant as from the first applicant?
                                                     
11 Morocco's responses to initial questions posed by  Switzerland have been circulated in document
IP/C/W/265/Add.2.
12 Nicaragua's responses to initial questions posed by Switzerland have been circulated in document
IP/C/W/288.IP/C/W/263/Add.1
Page 8
OMAN13
A. P ATENTS
Ad response to question 3:
You mention that according to Article (15)/c [of the Patent Law No 82/2000], "import of the
produce shall not be deemed a legitimate reason to prevent the issue of the obligatory authorisation".
Please explain how this complies with Article 27.1 of the TRIPS Agreement, which provides that
patent rights shall be enjoyable without discrimination as to whether products are imported or locally
produced.
Ad response to question 4:
Please explain how your legislation implements the conditions set out in Article 31 (a) to (l)
of the TRIPS Agreement.  Please cite the relevant provisions of your law.
B. P ROTECTION OF UNDISCLOSED INFORMATION
Ad response to question 6:
Referring to the issue of unfair commercial use of data submitted by an applicant to the
responsible State Agency in the procedure for market authorisation of a pharmaceutical or of an
agricultural chemical product, please explain in detail if your legislation explicitly prohibits a second
applicant from relying on, or from referring to, the original data of the first applicant, when applyingsubsequently for market authorisation for his own product.  Does the responsible State Agency require
the same amount of data from the second applicant as from the first applicant?  Does your legislation
set a specific term of protection for undisclosed test or other data of the first applicant?
THE PHILIPPINES
14
A. P ATENTS
Ad response to question 3:
You mention that "the proposed sui generis system for protecting plant varieties is pending
with the Philippines legislation".  Please explain what the draft legislation provides in the regard and
when it will enter into force.
B. P ROTECTION OF UNDISCLOSED INFORMATION
Ad response to question 6:
Referring to the issue of unfair commercial use of data submitted by an applicant to the
responsible State Agency in the procedure for market authorisation of a pharmaceutical or of an
agricultural chemical product, please explain in detail if your legislation explicitly prohibits a second
applicant from relying on, or from referring to, the original data of the first applicant, when applying
                                                     
13 Oman's responses to initial questions posed by  Switzerland have been circulated in document
IP/C/W/282/Add.1
14 The Philippines' responses to initial questions posed by Switzerland have been circulated in
document IP/C/W/272.IP/C/W/263/Add.1
Page 9
subsequently for market authorisation for his own product.  Does the responsible State Agency require
the same amount of data from the second applicant as from the first applicant?  Does your legislation
set a specific term of protection for undisclosed test or other data of the first applicant?
UNITED ARAB EMIRATES15
A. P ATENTS
Ad response to question 4:
Please explain how your legislation implements the conditions set out in Article 31 (a) to (l)
of the TRIPS Agreement.  Please cite the relevant provisions of your law.
Ad response to question 7:
In your answer, you mention that "[i]n defend ing its position, the owner of the patent cannot
introduce imported product as a valid ground. It does not present a legitimate reason for avoiding
compulsory licensing [...]". Please confirm whether, according to your legislation, importation isconsidered as working the patent and satisfies therefore the requirement of use/exploitation of the
patent.  If this should not be the case, please explain how this complies with the obligations contained
in Article 27.1 of the TRIPS Agreement, requiring patent rights to be enjoyable without
discrimination as to whether products are imported or locally produced.
B. P
ROTECTION OF UNDISCLOSED INFORMATION
Ad response to question 10:
Referring to the issue of unfair commercial use of data submitted by an applicant to the
responsible Authorities in the procedure for market authorisation of a pharmaceutical or of anagricultural chemical product, please explain in detail if your legislation explicitly prohibits a second
applicant from relying on, or from referring to the or iginal data of the first applicant, when applying
subsequently for market authorisation for his own product. Does the responsible State Agency require
the same amount of data from the second applicant as from the first applicant?
__________
                                                     
15 The United Arab Emirates' responses to initial questions posed by Switzerland have been circulated
in document IP/C/W/291.