RESTRICTEDWORLD TRADE
ORGANIZATIONIP/C/W/315/Add.1
7 February 2002
(02-0615)
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
5 February 2002, the Secretariat has received a copy of the following follow-up questions that
Switzerland has communicated to Barbados, Brunei Darussalam, India, Lithuania, Malaysia, Pakistan,
Sri Lanka, Tunisia and Uruguay, respectively.   These questions supplement those posed by
Switzerland in document IP/C/W/315.
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BARBADOS1
A. PATENTS
Ad response to question 2:
Please explain whether your legislation provides  for other exceptions to patent protection
besides the ones mentioned in your answer.
Ad response to question 3:
In your answer you mention that importation is not considered as "working" a patent.  Please
indicate whether, in Barbados, a compulsory licence on the grounds of non-working can be issued
even if the product is being imported.  If this should be the case, please explain how this complieswith the obligation of Article 27.1, providing that patent rights shall be enjoyable without
discrimination as to whether products are being imported or locally produced.
Ad response to question 5:
In your answer you mention that your legislat ion does not provide for the possibility of the
judicial authority to order the reversal of the burden of proof in a process patent litigation.  Please
explain how this complies with the obligation of Article 34 of the TRIPS Agreement.
                                                     
1 Barbados' responses to initial questions posed by Switzerland were circulated in document
IP/C/W/325/Add.1.IP/C/W/315/Add.1
Page 2
B. PROTECTION 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 authorization of a pharmaceutical or of anagricultural chemical product, please specify whether the responsible State Agency will require the
same amount of data from a second applicant requesting market authorization for a similar or identical
product as from the first applicant.
BRUNEI DARUSSALAM
2
A. PATENTS
Ad response to question 1:
With regard to the issue of exceptions from patent protection, you refer in your answer to
Section 13(2) & (3) of the Patents Order, 1999.  The Patents Order seems not to have been notified tothe WTO yet.  Please explain in detail what the relevant Section of the Order provide for in this regard
.
Ad response to question 3:
Referring to the issue of conditions set out in your legislation for the granting of compulsory
licences, you mention Section 55 of the Patents Order, 1999.  The Patents Order seems not to have
been notified to the WTO yet.  Please explain in detail what the relevant provisions of this section
provide in this regard.
B. PROTECTION OF UNDISCLOSED INFORMATION
Ad response to question 5:
In your answer you mention that, for the time being, your legislation does not provide for
provisions for the protection of undisclosed information or test data regarding pharmaceutical and
agricultural chemical products which is submitted to the Government in Brunei Darussalam.  You
mention also that a new Medicines Act is in the process of being drafted  and that the new Act willincorporate such provisions.  Please explain in de tail what the draft law provides in this respect.
When is the new Act expected to enter into force?
INDIA
3
A. PATENTS
Ad response to question 5:
In your answer you indicate that according to your present patent legislation (Patents Act
1970), importation of a patented product is not considered as working a patent.  Please confirm
                                                     
2 Brunei Darussalam's responses to initial questions posed by Switzerland were circulated in document
IP/C/W/318.
3 India's responses to initial questions posed by Sw itzerland were circulated in document IP/C/W/326.IP/C/W/315/Add.1
Page 3
whether, under the new law (Patents Bill, 1999, second Amendment) importation will be considered
as working a patent in accordance with Article 27.1 of the TRIPS Agreement.
B. PROTECTION OF UNDISCLOSED INFORMATION
Ad response to question 9:
Referring to the issue of unfair commercial use of test data submitted by an applicant to the
responsible State Agency in the procedure for market authorization of a pharmaceutical or of an
agricultural chemical product, please specify whether the responsible State Agency will require the
same amount of data from a second applicant requesting market authorization for a similar or identical
product as from the first applicant.
If yes, does your law provide for a time period after the expiration of which a second
applicant can refer to the data of the first applicant and will therefore not have to submit these data in
his own application for market authorization?
LITHUANIA4
A. PATENTS
Ad response to question 2:
In your answer you indicate that your Patent  Law does not provide explicitly that importation
is considered as "working" a patent.  Please confirm, whether, according to your law and practice, a
compulsory licence on the grounds of non-working may not be granted for a product in case that
product is being imported into Lithuania.
MALAYSIA5
A. PATENTS
Ad response to question 4:
In your answer you indicate that importation is not being considered as "working" a patent.
Please explain how this complies with Article 27.1 of the TRIPS Agreement, requiring that patent
rights shall be enjoyable without discrimination as to whether products are imported or locally
produced.
B. PROTECTION OF UNDISCLOSED INFORMATION
Ad response to question 7:
Referring to the issue of unfair commercial use of data submitted by an applicant to the
responsible State Agency in the procedure for market authorization of a pharmaceutical or of an
agricultural chemical product, please specify whether the responsible State Agency will require the
                                                     
4 Lithuania's responses to initial questions posed by Switzerland were circulated in document
IP/C/W/335.
5 Malaysia's responses to initial questions posed by Switzerland were circulated in document
IP/C/W/327.IP/C/W/315/Add.1
Page 4
same amount of data from a second applicant requesting market authorization for a similar or identical
product as from the first applicant.
If yes, does your law provide for a time period after the expiration of which a second
applicant can refer to the data of the first applicant and will therefore not have to submit these data inhis own application for market authorization?
PAKISTAN
6
A. TRADEMARKS
Ad response to question 1:
In your answer you indicate that "the registration of a trademark is completed within a
reasonable period of time".  Please indicate how long it takes on average to register a trademark.
B. PATENTS
Ad response to question 4:
In your answer you mention that patents for the protection of pharmaceutical and agricultural
chemical products will only be granted with eff ect from 1 January 2005.  Article 70.8 of the TRIPS
Agreement requires the provision of a mail-box system in this case.  Please explain how you haveimplemented this obligation.
Ad response to question 5:
In your answer you mention that the grant of  a compulsory licence "shall exclude both: the
conclusion of license contracts by the owner of the patent; the continued exercise, by the owner of the
patent of his rights; or the issuance of a non-voluntary licence".  Please explain how this complies
with Article 31(d) of the TRIPS Agreement, requiring such use as made from a compulsory licence to
be  non-exclusive.
Ad response to question 8:
In your answer you indicate that under Section 48 of the Patents Ordinance, 2000, the Federal
Government may revoke a patent if the patent is being exercised in a manner that is "mischievous to
the state or generally prejudicial to the public".  Please give examples of exercises of a patent as
envisaged by this provision.
                                                     
6 Pakistan's responses to some of the initial questions posed by Switzerland were circulated in
document IP/C/W/329.IP/C/W/315/Add.1
Page 5
SRI LANKA7
A. PROTECTION OF UNDISCLOSED INFORMATION
Ad response to question 5:
Referring to the issue of unfair commercial use of data submitted by an applicant to the
responsible State Agency in the procedure for market authorization of a pharmaceutical or of an
agricultural chemical product, please specify whether the responsible State Agency will require the
same amount of data from a second applicant requesting market authorization for a similar or identical
product as from the first applicant.
TUNISIA8
A. PATENTS
Ad response to question 1:
You mention that according to your Law, plant varieties shall be excluded from patent
protection.  Please explain how your legislation provides for protection of plant varieties.  Is it by a
sui generis  protection as referred to in Article 27.3(b) of the TRIPS Agreement?
B. PROTECTION OF UNDISCLOSED INFORMATION
Ad response to question 5:
Referring to the issue of unfair commercial use of data submitted by an applicant to the
responsible State Agency in the procedure for market authorization of a pharmaceutical or of an
agricultural chemical product, please specify whether your legislation set a specific term of protectionfor undisclosed test or other data of the first applicant.
URUGUAY
9
A. PROTECTION OF UNDISCLOSED INFORMATION
Ad response to question 7:
Referring to the issue of unfair commercial use of data submitted by an applicant to the
responsible State Agency in the procedure for market authorization of a pharmaceutical or of an
agricultural chemical product, please specify whether the responsible State Agency will require the
same amount of data from a second applicant requesting market authorization for a similar or identicalproduct as from the first applicant.
                                                     
7 Sri Lanka's responses to initial questions posed by Switzerland were circulated in document
IP/C/W/324.
8 Tunisia's responses to initial questions posed by Switzerland were circulated in document
IP/C/W/331.
9 Uruguay's responses to initial questions posed by Switzerland were circulated in document
IP/C/W/330.IP/C/W/315/Add.1
Page 6
If yes, does your law provide for a time period after the expiration of which a second
applicant can refer to the data of the first applicant and will therefore not have to submit these data in
his own application for market authorization?
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