RESTRICTEDWORLD TRADE
ORGANIZATIONIP/C/W/221
10 November 2000
(00-4758)
Council for Trade-Related Aspects of
Intellectual Property RightsOriginal:  Spanish
REVIEW OF LEGISLATION
Replies by Peru to Questions Posed by Japan and Switzerland
By means of a communication from the Permanent Mission of Peru, dated 6 November 2000,
the Secretariat has received the following replies to the questions posed by Japan and Switzerland,which were circulated in documents IP/C/W/208 and IP/C/W/207 respectively.
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Note:  Decision 344 has been replaced by Decision 486 – Common Industrial Property Regime –
 which will enter into force on 1 December 2000.  Consequently, the replies are based on the
provisions in Decision 486.
JAPAN
A. GENERAL
1. Please explain how Decisions 344, 345, 351 a nd 391 of the Commission of the Cartagena
Agreement are implemented in your country, indicating whether they are applied directly or
through national legislation.
The Decisions of the Commission of the Cartagena Agreement on the Common Industrial
Property Regime (Decisions 344 and 486), the Common Regime for the Protection of Plant Breeders'
Rights (Decision 345), the Common Copyright and Related Rights Regime (Decision 351) and the
Common Regime of Access to Genetic Resources (Decision 391) are applied directly in Peruvianlegislation, as provided by Article 55 of Peru's Political Constitution, which specifies that treaties
concluded by the State and  in force form part of national legislation.
Likewise, Article 3 of the Treaty Establishing the Court of Justice of the Andean Community
provides that Decisions of the Andean Council of Ministers for Foreign Affairs or the Commissionapply directly in the member countries as of their date of publication in the Agreement's Official
Journal, unless the Decisions themselves specify a later date.
B. 
COPYRIGHT
2. Please explain exceptions or exemptions from national treatment and most-favoured-
nation treatment under the Copyright and Neighbouring Rights Law, if any, as permitted in
Articles 3 and 4 of the TRIPS Agreement.
Peru's domestic legislation on copyright and neighbouring rights (Decision 351 and
Legislative Decree No. 822) does not allow exceptions from application of the principles of nationalIP/C/W/221
Page 2
treatment and most-favoured-nation treatment provided in Articles 3 and 4 of the TRIPS Agreement
respectively.
C. INDUSTRIAL DESIGNS
3. Please explain how Article 25.2 of the TRIPS Agreement, which provides protection for
textile designs, is implemented in your country, whereas Article 58 of Decision 344 stipulates
that "industrial designs relating to clothing shall not be registerable".
Decision 486 does not contain the exemption previously found in Article 58 of Decision 344,
referred to in this question.
Article 116 of Decision 486 – Common Industrial Property Regime – lists the designs that
cannot be registered but does not include industrial designs relating to clothing, thus they are
protected under the industrial property regulations.
4. Please explain how Article 26.3 of the TRIPS Agreement, which requires protection of
industrial designs for at least ten years, is implemented in your country, whereas Article 65 of
Decision 344 stipulates that the registration of an industrial design shall have a term of eight
years counted from the filing date of the application.
Article 128 of Decision 486 specifies that the term of registration of an industrial design shall
be ten years as of the date of filing of the application in the member country, in conformity with the
protection granted under Article 26.3 of the TRIPS Agreement.
It should also be noted that the term of ten years for protection of industrial designs is covered
by Article 109 of Legislative Decree No. 823 (Industrial Property Law of 24 April 1996).
SWITZERLAND
D. PATENTS
1. Are all categories of products subject to patent protection under your law or are there
any exceptions?  If so, please explain in detail what these exceptions are and how they apply.  In
particular, are all pharmaceutical products patentable?
Article 14 of Decision 486, the Common Industrial Property Regime, states that patents are
granted for inventions, whether products or processes,  in all areas of technology that are new, involve
an inventive step and are industrially applicable.
Pursuant to Article 15, the following shall not be considered inventions:(a) Discoveries, scientific theories and mathematical methods;(b) all or part of living beings as found in nature, natural biological processes, biological
material existing in nature or capable of being separated, including genomes or
germplasm of any living being;
(c) literary and artistic works or any other work protected by copyright;
(d) plans, rules and methods for the pursuit of intellectual activities, playing games or for
economic and business activities;IP/C/W/221
Page 3
(e) computer programs or software, as such;  and methods of presenting information.
In addition, Article 20 states that the following shall not be patentable:(a) Inventions whose commercial exploitation in the territory of the respective member
country is necessary to protect public order or morality.  For this purpose,
the commercial exploitation of an invention shall not be considered as contrary to
public order or morality solely because there is a legal or administrative provision
which prohibits or regulates the exploitation;
(b) inventions whose commercial exploitation in the respective member country is
necessary to protect human or animal health or life or to conserve plants or theenvironment.  For this purpose, the commercial exploitation of an invention shall not
be considered as contrary to human or animal life or health or the conservation of
plants or the environment solely because there is a legal or administrative provision
which prohibits or regulates the exploitation;
(c) plants, animals and essentially biological processes for the production of plants or
animals other than non-biological or microbiological processes;
(d) therapeutic or surgical methods for the treatment of humans or animals, as well as
diagnostic methods applicable to human beings or animals.
All pharmaceutical products are thus patentable provided that they meet the requirements of
patentability, i.e. they are new, involve an inventive step and are industrially applicable, and are not
covered by the provisions of the aforementioned Articles 15 and 20.
2. Does your law, in accordance with Articl e 27.1 in combination with Article 31 of the
TRIPS Agreement, recognize importation as "working a patent" (and therefore preclude
compulsory licences)?
According to Article 60 of Decision 486, exploitation shall be understood to mean the
industrial manufacture of the patented product or the full use of the patented process, including the
distribution and marketing of the results thereof, on a scale sufficient to satisfy the demands of themarket.  Exploitation shall also be understood to mean the import of the patented product, including
its distribution and marketing, where this is done on a scale sufficient to satisfy the demands of the
market.  Where the patent refers to a process that does not result in a product, the marketing and
distribution requirements shall not be enforced.  Pursuant to Article 59 of Decision 486, exploitation
may be in Peru or in any other member country of the Andean Community.
The compulsory licensing regime shall apply when a patent has not been exploited in
conformity with Article 60.
Compulsory licensing does not therefore apply where a patented product is imported,
distributed and marketed.
3. Does your law make compulsory licences subject to the conditions enumerated in
Article 31 of the TRIPS Agreement?  If exception s are provided for, please describe in detail
what these exceptions are and how they apply in your law.
The requirements set out in Article 31 of the TRIPS Agreement concerning "Other Use
Without Authorization of the Right Holder" are incorporated in Title II "On Patents", Chapter VII
"On the Regime of Compulsory Licensi ng", Articles 61-69, of Decision 486.IP/C/W/221
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Peru's legislation does not allow for exceptions to the requirements enumerated in Article 31
of the TRIPS Agreement.
4. Does your legislation provide for the principle of the reversal of the burden of proof in a
process patent litigation?  Please name the relevant law and explain the relevant sections.
According to Article 240 of Decision 486, in cases where infringement of a process patent is
claimed, defendants must prove that the process used to obtain the product is different to the process
protected by the patent whose infringement is claimed.  Unless otherwise proven, it is presumed that
any identical product produced without the consent of the patent owner has been obtained using the
patented process, if:
(a) The product obtained by means of the patented process is new;  or
(b) there is a strong likelihood that the identical product was manufactured through the
patented process and the patent owner is unable, despite reasonable efforts, to
determine the process effectively used.
In the presentation of evidence to the contrary, consideration shall be given to the legitimate
interests of the defendant insofar as the protection of their business secrets is concerned.
E. 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 authorization of a pharmaceutical or of an agricultural chemical product is
protected against disclosure and against unfair commercial use by a competitor, for example, byprohibiting a second applicant from relying on or fr om referring to the original data of the first
applicant when applying subsequently for market authorization for his own product.  Does your
legislation provide for exceptions to this?  If yes, under what conditions would such exceptions
apply?
Article 266 of Decision 486 states that when one of the conditions imposed by
member countries for the approval of marketing of pharmaceutical or agricultural chemical productswhich utilize new chemical entities is the submission of undisclosed test or other data whose
preparation requires a considerable effort, they shall protect these data against unfair commercial use.
In addition, member countries shall protect such data against disclosure, except where necessary to
protect the public or unless steps are taken to ensure that the data is protected against unfair
commercial use.
In addition, Article 35 of Legislative Decree No. 757 – Framework Law for the Promotion of
Private Investment – provides that documentation and information given to public sector entities may
not be disclosed if it might affect national security and foreign relations, or is simply for information
and circulation within the public administration, is restricted information concerning privateindividuals, or refers to commercial or technological secrets.
Regarding unfair trade use, the authorities which authorize the marketing of pharmaceutical
and agro-chemical products are non-profit-making pub lic sector entities whose functions are clearly
spelled out in the law.  In this respect, use of su ch data by these authorities within their institutions
and in fulfilment of their statutory legal function to authorize the marketing of such products does not
constitute commercial use or unfair use.  Such utilization is non-commercial State use and, by
definition, is thus lawful use because it is required by the laws governing the terms of reference and
functioning of these authorities.   Regarding disclosure, use of data by the aforementioned authorities
within their institutions and in fulfilment of their legal function, irrespective of the origin of the data,IP/C/W/221
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does not imply disclosure of the data to the extent that it does not allow third persons access to them,
except in the special cases mentioned in Article 266 of Decision 486, which correspond to the terms
of Article 39.3 of the TRIPS Agreement.
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