RESTRICTEDWORLD TRADE
ORGANIZATIONIP/C/W/239
25 January 2001
(01-0407)
Council for Trade-Related Aspects
of Intellectual Property RightsOriginal:  English
REVIEW OF LEGISLATION
Questions posed by Switzerland
By means of a communication from the Permanent Mission of Switzerland, dated 23 January
2001, the Secretariat has received a copy of the foll owing questions that Switzerland has addressed to
Bolivia, Brazil, Cameroon, Congo, Grenada, Guyana, Jordan, Namibia, Papua New Guinea, SantaLucia, Suriname and Venezuela, respectively.
_______________
BOLIVIA
A.P ATENTS
1. Please explain whether, in the field of patents, the relevant Articles of Decision 486 of the
Commission of the Andean Community - the Common Industrial Property Regime – is directly
applicable in your legislation or whether you have adopted national implementing legislation.
If through national legislation, please specify the relevant legislation.
B.P ROTECTION OF UNDISCLOSED INFORMATION
2. 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 if and how your law prevents the responsible Authoritiesor a second applicant from relying on or referring to  the original data of the first applicant for the
market authorisation procedure of a second product  equivalent to the product of the first party.
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 a second applicant.
BRAZIL
A. P
ATENTS
1. In your law, are patents available for all categories of products? In particular, are all
pharmaceutical products patentable? Are there any exceptions? If so please explain in detail what
these exceptions are and how they comply with Article 27 of the TRIPS Agreement.
2. In Brazil, Provisional Measure 2014-1, dated 30 December 1999, requires acceptance of
pharmaceutical patent applications by the health agency ANVS. Please explain how this requirementIP/C/W/239
Page 2
complies with the obligation of Article 27.1 of the TRIPS Agreement that patents shall be available
and patent rights enjoyable without discrimination as to the field of technology?
3. Does your law, in accordance with Article 27.1 in combination with Article 31 of the TRIPS
Agreement, consider importation as “working a patent” (and therefore preclude compulsory licensing,
if a product is being imported)?
4. Does your law make compulsory licenses subject to all the conditions enumerated in
Article 31 of the TRIPS Agreement? Please cite the relevant provisions of law.
5. Please explain how Article 2 § 2 of the Presidential Decree 3.201, providing that compulsory
licences may be granted to support the socio-economic development, is compatible with Article 31 of
the TRIPS Agreement.
6. 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
7. Please explain in detail if your legislation ensures that undisclosed and confidential test data
or other data submitted by an applicant to the responsible State agency in the procedure for market
authorisation of a pharmaceutical or of an agricultur al chemical product is protected against disclosure
and against unfair commercial use by a competitor, for example by prohibiting 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 your legislation provide for
exceptions to this? If yes, under what conditions would such exceptions apply? Does your legislation
provide for a defined period of protection for undisclos ed information / for such test data of the first
applicant?
CAMEROON
A. PATENTS
1. In your law, are patents available for all categories of products? In particular, are all
pharmaceutical products patentable? Are there any exceptions? If so please explain in detail what
these exceptions are and how they comply with Article 27 of the TRIPS Agreement.
2. Does your law, in accordance with Article 27.1 in combination with Article 31 of the
TRIPS Agreement, consider importation as “working a patent” (and therefore preclude compulsory
licensing, if a product is being imported)?
3. Does your law make compulsory licenses subject to all the conditions enumerated in
Article 31 of the TRIPS Agreement? Please cite the relevant provisions of law.
4. 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
5. Please explain in detail if your legislation ensures that undisclosed and confidential test data
or other data submitted by an applicant to the responsible State agency in the procedure for market
authorisation of a pharmaceutical or of an agricultur al chemical product is protected against disclosure
and against unfair commercial use by a competitor, for example by prohibiting a second applicantIP/C/W/239
Page 3
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 your legislation provide for
exceptions to this? If yes, under what conditions would such exceptions apply? Does your legislation
provide for a defined period of protection for undisclo sed information / for such test data of the first
applicant?
CONGO
A. PATENTS
1. In your law, are patents available for all categories of products? In particular, are all
pharmaceutical products patentable? Are there any exceptions? If so please explain in detail what
these exceptions are and how they comply with Article 27 of the TRIPS Agreement.
2. Does your law, in accordance with Article 27.1 in combination with Article 31 of the
TRIPS Agreement, consider importation as “working a patent” (and therefore preclude compulsory
licensing, if a product is being imported)?
3. Does your law make compulsory licenses subject to all the conditions enumerated in
Article 31 of the TRIPS Agreement? Please cite the relevant provisions of law.
4. 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
5. Please explain in detail if your legislation ensures that undisclosed and confidential test data
or other data submitted by an applicant to the responsible State agency in the procedure for market
authorisation of a pharmaceutical or of an agricultur al chemical product is protected against disclosure
and against unfair commercial use by a competitor, for example by prohibiting 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 your legislation provide forexceptions to this? If yes, under what conditions would such exceptions apply? Does your legislation
provide for a defined period of protection for undisclo sed information / for such test data of the first
applicant?
GRENADA
A. 
PATENTS
1. In your law, are patents available for all categories of products? In particular, are all
pharmaceutical products patentable? Are there any exceptions? If so please explain in detail what
these exceptions are and how they comply with Article 27 of the TRIPS Agreement.
2. Does your law, in accordance with Article 27.1 in combination with Article 31 of the TRIPS
Agreement, consider importation as “working a patent” (and therefore preclude compulsory licensing,
if a product is being imported)?
3. Does your law make compulsory licenses subject to all the conditions enumerated in
Article 31 of the TRIPS Agreement? Please cite the relevant provisions of law.
4. 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.IP/C/W/239
Page 4
B. PROTECTION OF DISCLOSED INFORMATION
5. Please explain in detail if your legislation ensures that undisclosed and confidential test data
or other data submitted by an applicant to the responsible State agency in the procedure for market
authorisation of a pharmaceutical or of an agricultur al chemical product is protected against disclosure
and against unfair commercial use by a competitor, for example by prohibiting a second applicantfrom relying on, or from referring to the original data of the first applicant, when applying
subsequently for market authorisation for his own product.  Does your legislation provide for
exceptions to this? If yes, under what conditions would such exceptions apply? Does your legislation
provide for a defined period of protection for undisclo sed information / for such test data of the first
applicant?
GUYANA
A. 
PATENTS
1. In your law, are patents available for all categories of products? In particular, are all
pharmaceutical products patentable? Are there any exceptions? If so please explain in detail what
these exceptions are and how they comply with Article 27 of the TRIPS Agreement.
2. Does your law, in accordance with Article 27.1 in combination with Article 31 of the
TRIPS Agreement, consider importation as “working a patent” (and therefore preclude compulsory
licensing, if a product is being imported)?
3. Does your law make compulsory licenses subject to all the conditions enumerated in
Article 31 of the TRIPS Agreement? Please cite the relevant provisions of law.
4. 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
5. Please explain in detail if your legislation ensures that undisclosed and confidential test data
or other data submitted by an applicant to the responsible State agency in the procedure for market
authorisation of a pharmaceutical or of an agricultur al chemical product is protected against disclosure
and against unfair commercial use by a competitor, for example by prohibiting a second applicantfrom relying on, or from referring to the original data of the first applicant, when applying
subsequently for market authorisation for his own product.  Does your legislation provide for
exceptions to this? If yes, under what conditions would such exceptions apply? Does your legislationprovide for a defined period of protection for undisclo sed information / for such test data of the first
applicant?
JORDAN
A. 
PATENTS
1. In your law, are patents available for all categories of products? In particular, are all
pharmaceutical products patentable? Are there any exceptions? If so please explain in detail what
these exceptions are and how they comply with Article 27 of the TRIPS Agreement.IP/C/W/239
Page 5
2. Does your law, in accordance with Article 27.1 in combination with Article 31 of the
TRIPS Agreement, consider importation as “working a patent” (and therefore preclude compulsory
licensing, if a product is being imported)?
3. Does your law make compulsory licenses subject to all the conditions enumerated in
Article 31 of the TRIPS Agreement? Please cite the relevant provisions of law.
4. 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 UNDISLOSED INFORMATION
5. Please explain in detail if your legislation ensures that undisclosed and confidential test data
or other data submitted by an applicant to the responsible State agency in the procedure for marketauthorisation of a pharmaceutical or of an agricultur al chemical product is protected against disclosure
and against unfair commercial use by a competitor, for example by prohibiting 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 your legislation provide for
exceptions to this? If yes, under what conditions would such exceptions apply? Does your legislationprovide for a defined period of protection for undisclosed information / for such test data of the first
applicant?
NAMIBIA
A. 
PATENTS
1. In your law, are patents available for all categories of products? In particular, are all
pharmaceutical products patentable? Are there any exceptions? If so please explain in detail whatthese exceptions are and how they comply with Article 27 of the TRIPS Agreement.
2. Does your law, in accordance with Article 27.1 in combination with Article 31 of the
TRIPS Agreement, consider importation as “working a patent” (and therefore preclude compulsory
licensing, if a product is being imported)?
3. Does your law make compulsory licenses subject to all the conditions enumerated in
Article 31 of the TRIPS Agreement? Please cite the relevant provisions of law.
4. 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
5. Please explain in detail if your legislation ensures that undisclosed and confidential test data
or other data submitted by an applicant to the responsible State agency in the procedure for market
authorisation of a pharmaceutical or of an agricultur al chemical product is protected against disclosure
and against unfair commercial use by a competitor, for example by prohibiting a second applicantfrom relying on, or from referring to the original data of the first applicant, when applying
subsequently for market authorisation for his own product.  Does your legislation provide for
exceptions to this? If yes, under what conditions would such exceptions apply? Does your legislation
provide for a defined period of protection for undisclo sed information / for such test data of the first
applicant?IP/C/W/239
Page 6
PAPUA NEW GUINEA
A. PATENTS
1. In your law, are patents available for all categories of products? In particular, are all
pharmaceutical products patentable? Are there any exceptions? If so please explain in detail what
these exceptions are and how they comply with Article 27 of the TRIPS Agreement.
2. Does your law, in accordance with Article 27.1 in combination with Article 31 of the TRIPS
Agreement, consider importation as “working a patent” (and therefore preclude compulsory licensing,
if a product is being imported)?
3. Does your law make compulsory licenses subject to all the conditions enumerated in
Article 31 of the TRIPS Agreement? Please cite the relevant provisions of law.
4. 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
5. Please explain in detail if your legislation ensures that undisclosed and confidential test data
or other data submitted by an applicant to the responsible State agency in the procedure for market
authorisation of a pharmaceutical or of an agricultur al chemical product is protected against disclosure
and against unfair commercial use by a competitor, for example by prohibiting 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 your legislation provide forexceptions to this? If yes, under what conditions would such exceptions apply? Does your legislation
provide for a defined period of protection for undisclos ed information / for such test data of the first
applicant?
SAINT LUCIA
A. PATENTS
1. In your law, are patents available for all categories of products? In particular, are all
pharmaceutical products patentable? Are there any exceptions? If so please explain in detail what
these exceptions are and how they comply with Article 27 of the TRIPS Agreement.
2. Does your law, in accordance with Article 27.1 in combination with Article 31 of the
TRIPS Agreement, consider importation as “working a patent” (and therefore preclude compulsory
licensing, if a product is being imported)?
3. Does your law make compulsory licenses subject to all the conditions enumerated in
Article 31 of the TRIPS Agreement? Please cite the relevant provisions of law.
4. 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
5. Please explain in detail if your legislation ensures that undisclosed and confidential test data
or other data submitted by an applicant to the responsible State agency in the procedure for marketIP/C/W/239
Page 7
authorisation of a pharmaceutical or of an agricultur al chemical product is protected against disclosure
and against unfair commercial use by a competitor, for example by prohibiting 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 your legislation provide for
exceptions to this? If yes, under what conditions would such exceptions apply? Does your legislation
provide for a defined period of protection for undisclo sed information / for such test data of the first
applicant?
SURINAME
A. PATENTS
1. In your law, are patents available for all categories of products? In particular, are all
pharmaceutical products patentable? Are there any exceptions? If so please explain in detail what
these exceptions are and how they comply with Article 27 of the TRIPS Agreement.
2. Does your law, in accordance with Article 27.1 in combination with Article 31 of the TRIPS
Agreement, consider importation as “working a patent” (and therefore preclude compulsory licensing,
if a product is being imported)?
3. Does your law make compulsory licenses subject to all the conditions enumerated in
Article 31 of the TRIPS Agreement? Please cite the relevant provisions of law.
4. 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
5. Please explain in detail if your legislation ensures that undisclosed and confidential test data
or other data submitted by an applicant to the responsible State agency in the procedure for market
authorisation of a pharmaceutical or of an agricultur al chemical product is protected against disclosure
and against unfair commercial use by a competitor, for example by prohibiting 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 your legislation provide forexceptions to this? If yes, under what conditions would such exceptions apply? Does your legislation
provide for a defined period of protection for undisclo sed information / for such test data of the first
applicant?
VENEZUELA
A.
PATENTS
1. Please explain whether, in the field of patents, the relevant Articles of Decision 486 of the
Commission of the Andean Community - the Common Industrial Property Regime – is directlyapplicable in your legislation or whether you ha ve adopted national implementing legislation.  If
through national legislation, please specify the relevant legislation.
B.
PROTECTION OF UNDISCLOSED INFORMATION
2. 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 if and how your law prevents the responsible AuthoritiesIP/C/W/239
Page 8
or a second applicant from relying on or referring to  the original data of the first applicant for the
market authorisation procedure of a second product e quivalent to the product of the first party.  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 a second applicant.
__________