. /.RESTRICTEDWORLD TRADE
ORGANIZATIONIP/C/W/207/Add.2
11 December 2000
(00-5368)
Council for Trade-Related Aspects
of Intellectual Property RightsOriginal:  English
REVIEW OF LEGISLATION
Follow-up questions posed by Switzerland to Colombia, Peru and Turkey 1
Addendum
By means of a communication from the Permanent Delegation of Switzerland, dated
29 November 2000, the Secretariat has received th e following follow-up questions addressed to
Colombia, Peru and Turkey, respectively.
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COLOMBIA
A. PATENTS
1. Does Article 66 of Decision 486 of the Comm ission of the Andean Community, which should
enter into force on 1 December 2000, explicitly state, as required by Article 31(k) of the TRIPS
Agreement, that only once an anti-competitive practice has been duly determined by judicial or
administrative process can a Member refrain from applying the conditions set forth in subparagraphs
(b) and (f) of the same article?
2. Could you please provide us with more detailed information on the principal of the reversal of
burden of proof in a process patent litigation as enshrined in Title XV "De las Acciones por Infracción
de Derechos" of Decision 486 of the Andean Community?
B. PROTECTION OF UNDISCLOSED INFORMATION
1. 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
agrochemical product, please explain whether a nd how your legislation prevents the responsible
Authorities or a second applicant from relying on or referring to the original data of the first applicant
for the market authorization 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 reliedupon or referred to by the Authorities or a second applicant.
                                                     
1 The legislation of Colombia, Peru and Turkey was reviewed at the Council meeting of
27-30 November 2000.  The questions put to these countries by Switzerland and the responses given have beencirculated in IP/C/W/223, IP/C/W/221 and IP/C/W/227, respectively.IP/C/W/207/Add.2
Page 2
PERU
A. PATENTS
1. Pursuant to Article 15(e) of Decision 486, the Common Industrial Property Regime,
"computer programs or software, as such" shall not be considered inventions.  Could you please
explain whether in practice this general exception means that in the field of software, no patents will
be granted even if the requirements of patentability are fulfilled (i.e. if it is new, involves an inventive
step and is industrially applicable?) or please indicate under what conditions a patent in this field will
be granted.
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 authorization of a pharmaceutical or of an
agrochemical product, please explain whether a nd how your legislation prevents the responsible
Authorities or a second applicant from relying on or referring to the original data of the first applicant
for the market authorization 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.
TURKEY
A. P
ATENTS
1. Article 31(c) of the TRIPS Agreement requires that the scope and duration of use without the
authorization of the right holder shall be limited to the purpose for which it was authorized.  You
explain that in the Turkish legislation, this TRIPS requirement is complied with by general principles
of law and the principles of bonafide behaviour.  Could you please explain in more detail what
general principles will be applied in order to determine the limitations of the scope and duration of
such use and what will be considered bonafide behaviour in this context?
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 authorization of a pharmaceutical or an
agrochemical product, you mention that Article 36 of the Regulation on Pharmaceutical Products
holds the Ministry of Health responsible not to divulge the information and the test data submitted byan applicant during the application for the marketing permission.  Please confirm that such
information will be not relied upon by the Ministry for another party's request for marketing approval
of an equivalent product and cannot either be relied upon by a second applicant after the first
applicant has actually received marketing authorization.  Please indicate also, whether your legislation
provides for a time-limit before the expiration of which the information and the test data of the firstapplicant will not be relied upon for the mark eting approval of a second equivalent product.
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