WORLD TRADE  
ORGANIZATION  IP/Q/BRA/1 
IP/Q2/BRA/1 
IP/Q3/BRA/1 
IP/Q4/BRA/1 
24 February 2004 
 (04-0789) 
Council for Trade-Related Aspects of Intellectual Property Rights Original:  English/ 
                 Spanish
* 
 
 
  
REVIEW OF LEGISLATION 
 
BRAZIL
1 
 
 The present document reproduces the introductory statement made by the delegation of Brazil, the questions put to it and the responses give n in connection with the review of legislation 
undertaken at the Council's meeting of 27 to 28 November 2001.
2 
 
_______________ 
 
 
I. INTRODUCTORY STATEMENT 
A. INTRODUCTION  
My delegation is pleased to have this oppor tunity to present the Brazilian laws and 
regulations related to intellectual property rights for review in the TRIPS Council.  We have received 
a number of questions from the European Comm unities, Japan, Switzerland and the United States 
regarding our regime of intellectual property protec tion.  The great majority of the more than 102 
questions have been answered and are available to  all Members in documents IP/C/W/303  and its 
addenda. 
 In this introductory statement, we will conf ine ourselves to a few relevant points of the 
Brazilian legal system in the field of intellectual property rights, with particular reference to its 
legislative history, to give Members a broad perspective.   As a preliminary remark, it is worth recalling that Brazil does not consider the protection of 
intellectual property rights as an end in itself.  From  the perspective of Brazil, the exercise of IPRs is 
only meaningful if its exercise by right holders is conducive to overarching public interest policies.  
As has been widely noted, the rules on patents seek to ensure that the protection of the rights of patent 
holders is conducive to fulfilling the need of indu stries and society as a whole to have access to new 
and improved knowledge. 
It should be noted that protection for intellect ual property rights was introduced in Brazil as 
early as 1809; Brazil is also one of the original si gnatories of the Convention of Paris of 1883 and the 
Berne Convention of 1886 and is a founding Memb er of WIPO.  Traditionally, Brazil has had an 
                                                     
 
* English, except Spanish for Section C of Brazil's introductory statement. 
1 As regards laws and regulations notified by Brazil under Article 63.2 of the Agreement, reference is 
made to documents IP/N/1/BRA/1, IP/N/1/BRA/2, IP/N/1/BRA/C/1, IP/N/1/BRA/C/2, IP/N/1/BRA/I/1, 
IP/N/1/BRA/I/1/Add.1, IP/N/1/BRA/P/1, [IP/N/1/BRA/P/2] (to be circulated once the English translation of the 
legal text concerned is available) , IP/N/1/BRA/P/3, IP/N/1/BRA/P/4. 
2 The minutes of this meeting have been circulated as document IP/C/M/34. IP/Q/BRA/1, IP/Q2/BRA/1, 
IP/Q3/BRA/1, IP/Q4/BRA/1 Page 2 
 
 active participation in the development of interna tional legislation on intellectual property rights, 
including the TRIPS Agreement. 
Brazilian legislation on intellectual property rights  is fully consistent with the provisions of 
the TRIPS Agreement and, in certain areas, provides more extensive protection than is required by the 
Agreement, such as in the areas of pate nts and copyrights, in particular.   
In accordance with our commitments to th e TRIPS Agreement, Brazil provides for the 
enforcement of the protection of intellectual property rights.  The Industrial Property Law, for instance, provides for a whole Chapter on crimes ag ainst industrial property rights.  The Criminal 
Code of Brazil also defines violations against co pyrights, specifically unauthorized reproduction of 
any protected works.  Some Bills currently un der discussion in the Congress may elaborate and 
improve further criminal legislation on this ma tter. The Brazilian Government has also recently 
established an Inter-Ministerial Committee on Combat Against Piracy in March 2001. 
We would like to note that Brazil proceeded to a timely and complete notification of its 
national legislation to the TRI PS Council in February 2000. 
Brazil is pleased to note that the Doha Minist erial Conference has issued a Declaration on 
TRIPS and Public Health, in which all Minister s agree that "the TRIPS Agreement does not and 
should not prevent Members from taking measures to protect public health" and that accordingly, 
while reiterating their commitment to the TRIPS Agre ement, they affirmed that "the Agreement can 
and should be interpreted and impl emented in a manner supportive of WTO Members' right to protect 
public health and, in particular, to promote acce ss to medicines for all." We believe that this 
Declaration provides an example as to the ade quate way of interpreting and implementing the 
provisions of the TRIPS Agreement. 
Taking into account the experience of Brazil in implementing the TRIPS Agreement, we 
believe that the provisions of the Agreement still may require clarification – and, where necessary, 
modifications – to avoid a situation where existi ng ambiguities or their interpretation may have a 
negative effect on areas such as health, technolog y transfer, environment, nutrition or other 
development needs. In this respect, we note that  the implementation of the TRIPS Agreement in 
Brazilian legislation is supportive of and does not ru n counter to the objectives of the Convention on 
Biological Diversity – as mandated by Article 16. 5 of this Convention, among other provisions. 
In order to provide more specific information of  the incorporation of our obligations under the 
TRIPS Agreement, with your permission, Mr. Chai rman, I would like to pass the floor to other 
members of this delegation who came from the Capital for this occasion. Allow me to introduce Mr. 
José Graça Aranha, President of the National Institu te of Industrial Property, who will briefly present 
the relevant Brazilian legislation on industrial property rights. Sub sequently, Mr. Otávio Afonso dos 
Santos, Coordinator for Copyrights of the Minist ry of Culture, will make a short presentation on the 
area of copyrights. 
B. I
NDUSTRIAL PROPERTY  
The TRIPS Agreement was incorporated in to Brazilian legislation in December 19943, 
together with the other Agreements resulting fro m the Uruguay Round. Regarding industrial property 
rights, TRIPS was implemented in May 1996 by the Law on Industrial Property (Law 9.279 of 
                                                      
3 Legislative Decree no. 30 of 15 December, 1994 and Decree no . 1.355 of 30 December 1994. IP/Q/BRA/1, IP/Q2/BRA/1, 
IP/Q3/BRA/1, IP/Q4/BRA/1 
Page 3 
 
  
14 May 1996, hereinafter referred to as "LPI"), whic h revoked the former Industrial Property Code of 
1971
4.  
The LPI regulates rights and obligations under the main areas of industrial property. The 
protection of such rights, considering the soci al interest and the technological and economic 
development of Brazil, is extended to the followi ng areas: of invention an d utility model patents; 
industrial designs; trademarks; geographi cal indications; and unfair competition5. 
1. Patents 
Regarding patents, Brazil has fully implemente d the provisions of the TRIPS Agreement.  
The former Industrial Property Code of 1971 did no t provide patent protection to some areas of 
technology, such as pharmaceutical and chemical process and products.  Subject to the exceptions 
allowed by the TRIPS Agreement, the new Industria l Property Law has eliminated discrimination of 
patentability in all fields of technology.  Regard ing the period of protection of patents, while the 
former Industrial Property Code provided for 15 year s of protection, the new Industrial Property Law, 
in accordance with the TRIPS Agreem ent, has extended this period to 20 years.  Administratively, the 
National Institute of Industrial Pr operty is making its best efforts to improve services for its users. 
INPI has also increased the number of administrative decisions regarding patent applications: during the nineties, the number of decisions was on averag e 4,500 per year. In 1999, however, it increased to 
11,000 and, in 2000 the number of decisions has reached 20,000. 
In this respect, the delegation of Switzerland has addressed a follow-up question to Brazil 
regarding the consistency of Article 10 IX of th e LPI with Article 27.1 of the TRIPS Agreement. 
Article 10 IX of the LPI establishes that "all or pa rt of natural living beings and biological materials 
found in nature, even if isolated therefrom, includi ng the genome or germplasm of any natural living 
being, and the natural biological processes", are not c onsidered to be inventio ns or utility models.  
The question by Switzerland is not clear regarding th e reference to "inventions related to such subject-
matter". According to Article 8 of the LPI, "an inven tion is patentable if it satisfies the requirements 
of novelty, inventive step, and industrial applicati on". The scope of Article 10 IX relates to subject 
matter that does not fulfill the basic criteria for pate ntability set out in Article 27.1, as it relates to 
naturally-occurring subject matter, including those that  were merely isolated from nature.  Therefore, 
Article 10 IX is fully consistent with  Article 27.1 of the TRIPS Agreement. 
Concerning the follow-up question number 39, th e European Communities request a copy of 
Law 10.196 of 14 February 2001 which modified an article of the patent law.  Brazil would like to 
call the attention to the EC delegation that the Law was notified to the WTO Secretariat on 
17 September 2001, which was circulated to the TRIPS Council as document IP/N/1/BRA/I/1/Add.1 
on 4 October 2001. 
 
2. Trademarks 
 In the area of trademarks, not only has Brazil fully incorporated its obligations under the 
TRIPS Agreement, but we have also simplified th e procedures for the benefit of the users of the 
system – and we are currently making efforts to fu rther simplifications.  Brazil has incorporated the 
international classification of marks, which has c ontributed to simplify procedures.  The Industrial 
Property Law establishes protection of well-known mark s, in accordance with the TRIPS Agreement, 
as well as of collective marks and certification marks.  In addition, we are considering the adoption of 
the WIPO system for the international registrati on of trademarks, namely the Madrid Protocol. 
                                                     
 
4 Law 5.772 of 21 December 1971. 
5 Article 2 of the LPI. IP/Q/BRA/1, IP/Q2/BRA/1, 
IP/Q3/BRA/1, IP/Q4/BRA/1 Page 4 
 
 
3. Industrial designs 
 Concerning industrial designs, it should be noted that Brazil has eliminated the requirement of 
examination of applications, which only takes place in case of challenges. Brazil has also adopted the 
international classification of industrial designs. 
 
4. Geographical indications 
 In the area of geographical indications, the Law on Industrial Property of Brazil has 
introduced geographical indications as a specific indu strial property right.  The INPI has established a 
Division to cover this area of protection and th e INPI has already approved protection to some 
products – in particular, to the French Cognac  and to the vinho verde  (green wine) of Portugal. 
 
5. Unfair competition 
 Finally, the National Institute of Industrial Property implements the area of unfair competition 
since 1992.   
C. C
OPYRIGHT  
 Current Brazilian legislation on copyright and re lated rights is in line with the principles of 
the TRIPS Agreement.  The new law was enacted on 19 February 1998, in response to the impact of 
new technology and the importance of economic aspects relating to authorship, as well as the 
ratification of the TRIPS Agreement which took place in December 1994.   Hence, Brazilian legislation is compatible with  the substantive provisi ons of the 1971 revision 
of the Berne Convention and that Agreement.  The listing of protected works, which is purely 
illustrative in the spirit of the Convention, includes so ftware as a protected wo rk in the same way as a 
literary work in accordance with the Convention, and it protects databases according to the criteria of 
selection and content as intellectual creations.  Howe ver, this protection does not include the data 
themselves.  
 Many of the earlier definitions were amended to  include the new forms of use of works, in 
particular in the digital environment.  The defin itions of phonogram, reproduc tion etc., therefore, are 
now adapted to the new technology.  Likewise, a re ntal right has been introduced in a broad manner 
for all categories of protected works and not only for cinematographic works and software.  
 Authors of works have all the necessary rights to be able to benefit from public use of their 
intellectual creations.  Brazilian law confers, inter alia , upon authors the right of reproduction, rental, 
distribution and communication to the public, as well as the right to make their work available to the 
public, which is a new right needed to enable author s to authorize use of their work on the internet. 
 
 These rights may, if it is in the interest of the owner, be licensed, assigned, granted or 
transferred "inter vivos" in any other way provided for by law.   The term of protection for works protected by  copyright and related rights has been extended 
to 70 years, with the general rule that this pe riod begins to run from the 1 January following the 
author's death.  This period is granted for all categories of works (including owners of neighbouring 
rights) with the exception of software, which is protected for 50 years. 
  The limitations and exceptions adopted are in lin e with the principles set out in Article 9.2 of 
the Berne convention, in other words the so-called three-step test:  special  cases, cases that do not IP/Q/BRA/1, IP/Q2/BRA/1, 
IP/Q3/BRA/1, IP/Q4/BRA/1 
Page 5 
 
  
conflict with normal exploitation of the work, and c ases that do not harm the legitimate interests of 
authors.  
 The use of works protected by copyright and neighbouring rights in Brazil depends, as a 
general rule, except in special cases provided for in the law, on prior and express authorization by the 
author, such as, for example, total or partial re production, editorial purposes, adaptation and inclusion 
in databases or computer memories inter alia . 
 
 In the area of neighbouring rights, Brazil gran ts protection that goes beyond the international 
standard, establishing exclusive rights for perfo rmers, producers of phonograms and broadcasting 
entities.  As we mentioned earlier, the term of pr otection of neighbouring rights in Brazil is 70 years 
running from 1 January following fixation, in the case of phonograms, transmission in the case of 
broadcasting companies, and public performance in other cases. 
 
 In line with the international trend, Braz il has also adopted civil penalties for anyone 
attempting to suppress or render inoperative in any way technical devices inserted into examples of 
protected works and productions to prevent or restri ct copying of such works, in other words, so-
called technological measures.  
 The adaptation of Brazilian legislation, has been rounded off with the adoption of national 
treatment, an important principle for legal internali zation, where provision has been made for granting 
the same rights to foreign authors as are granted to nationals.  D. S
OFTWARE  
In order to provide some additional inform ation concerning the protection of computer 
programs, it should be recalled that according to  the Article 10 of the TRIPS Agreement, the 
protection of computer programs is the one granted to literary works. 
Nevertheless, Brazil has also a specific law c oncerning the protection of computer programs 
(Law 9.609 of 1998), which establishes some special pr ovisions in that respect.  So, for the protection 
of computer programs, both the Copyright and Re lated Rights Law and the Computer Program Law 
are applied. 
 In the specific law, as already stated, the term  of protection differs from other kinds of work. 
The term of protection is fifty years from 1 January of the year following its publication or, if publication is unavailable, following its creation.  
 As to literary works, there is no requirement for registration, but if it is done, the computer 
program itself or its portion are kept confidential, except upon a court order or at the discretion of its 
titleholder. The registration can be done at th e National Institute of Industrial Property. 
  The rental right, as established by Article 11 of  the TRIPS Agreement, is provided and it is 
not exhausted by the sale, licensing or any other form of transfer of the computer program. 
 
 The law also establishes some exceptions or lim itations to the rights, all in accordance to the 
TRIPS Agreement or the Berne Convention, like, for instance, the possibility of making a backup 
copy.  
 Finally, there are provisions related to guarantees for users of computer programs, to the 
licensing for the use of them, and some special  rules concerning infractions and penalties. 
 IP/Q/BRA/1, IP/Q2/BRA/1, 
IP/Q3/BRA/1, IP/Q4/BRA/1 Page 6 
 
 
II. RESPONSES TO QUESTIONS POSED BY CANADA 
1. What recourse do right holders have in respect of wilful trademark counterfeiting or 
copyright piracy on a commercial scale, as required by Article 61 of the TRIPS Agreement? 
  The Brazilian legislation estab lishes mechanisms for effec tive action against trademark 
counterfeiting and copyright and related rights pir acy through applicable sp ecial and general laws. 
The following are examples of provisions in Braz il's legislation that deal with the matter: 
(a) Articles 189, 190 and 196 through 207 of Law No. 9.279 of 1996; (b) Articles 12 and 13 of Law 9.609 of 1998; 
(c) Articles 184 to 186 of the Penal Code , as well as its general part, covered by 
Articles 1 through 120; 
(d) Articles 394 to 405, 498 to 502, 524 to 530 and 593 to 603 of the Penal Process Code. 
2. What protection does your Copyright legislation afford to "foreign works"? 
 
Exactly the same protection granted to "nati onal" works, as established by Article 2 of 
Law 9.610 of 1998 in accordance with the Berne Convention. 
III. RESPONSES TO THE QUESTIONS POSED BY THE EUROPEAN COMMUNITIES 
AND THEIR MEMBER STATES 
A. G
ENERAL PROVISIONS  
1. Please describe if your legislation includes measures necessary to protect public health 
and nutrition, and to promote the public interes t in sectors of vital importance to your socio-
economic and technological development as mentioned under Article 8 of the TRIPS Agreement.  If yes, please explain how such me asures are consistent with the provisions of the 
TRIPS Agreement.  
The Brazilian legislation includ es measures in conformity with Article 8 of the TRIPS 
Agreement, in which specific ag encies, according to their comp etence, are res ponsible for the 
marketing approval of some products .  For instance, pharmaceutical, agricultural chemical, alimentary 
products, and others that occasionally affect the pub lic health or the environment may have their 
marketing restricted. 
 
In some cases, the Brazilian Government fo resees specific measures related to the 
development of some technological sectors that are considered important to the industrial 
development.  B. C
OPYRIGHT AND RELATED RIGHTS  
2. Please state how your legislation provides for the protection of the exclusive rights of 
authors in relation to their literary and artistic works, as specified in Article 9 of the TRIPS 
Agreement which requires Members to comply with  Articles 1-21 of the Berne Convention and 
the Appendix to the Berne Convention (1971).  
 Please see Law No.  9.610 of 1998, in particular Articles 22 up to 45. 
 IP/Q/BRA/1, IP/Q2/BRA/1, 
IP/Q3/BRA/1, IP/Q4/BRA/1 
Page 7 
 
  
Follow-up question
: 
  Please quote the Articles of Law No. 9.610 of 1998 in which the provisions corresponding 
to the Articles of the Berne Convention indicated below appear: 
  Article 2(1) - the definition of "literary and artistic works";   Article 3;  
 
 Article 4(b);  and    Article 5.  
Article 2(1) of the Berne Convention does not offer any definition stricto sensu  of "literary 
and artistic works".  Instead, there is a list of examples, numerus abertus .  The Brazilian law uses the 
same pattern as established in Article 2(1) of th e Berne Convention.  So, please see Article 7 of Law 
No. 9.610 of 1998, which calls forth the principle of generality of the protection to all works of the 
literary and artistic domain, and does not impose th at the protection is conditioned to the way and 
form of expression. 
 
Concerning the provisions 2, 4(b), and 5, taking account that Article 2 of Law No. 9.610 of 
1998 establishes that titleholders shall enjoy the protec tion as settled in international conventions in 
force in Brazil, and that the Berne Convention, which was ratified through the Presidential Decree 
No. 75.699 of 1975, establishes the obligation of nati onal treatment and, moreover, that Article 2, 3, 
and 4 of the Berne Convention are valid and in fu ll force in Brazil, such works and titleholders are 
duly protected in Brazil. 
 
3. Please describe the protection accorded to authors of computer programs, databases or 
compilations of data.   
 Please see Article 7, XII of Law No. 9.610 of 1998.  See also the specific law concerning the 
protection of computer programs, Law No. 9.609 of 1998. 
 
 Concerning original compilations of data and da tabases, please refer to Article 7, XIII of Law 
No. 9.610 of 1998, and its paragraph 2.  
4. Please state whether your legislation provides fo r a rental right and, if so, the works to 
which it applies. 
  The rental right, in Brazil, is applied to all kinds of works. 
 
Follow-up question
: 
 
 Please cite the precise provision for a rental right, in compliance with Article 11 of the 
TRIPS Agreement, in respect of:   (a) cinematographic films in Law No. 9.610 of 1998;  and    (b) computer programs in Law No. 9.609 of 1998. 
 
 Please see Article 5, IV, of Law No. 9.610 of  1998, and Article 2, paragraph 5, of Law 
No. 9.609 of 1998. IP/Q/BRA/1, IP/Q2/BRA/1, 
IP/Q3/BRA/1, IP/Q4/BRA/1 Page 8 
 
 
5. Please describe the rights granted to p erformers, producers of phonograms (sound 
recordings) and broadcasting organisations under your legislation.  
Please see Articles 90, 92, 93 and 95 of Law No. 9.610 of 1998. 
 
6. Please state whether your legislation provides for any limitation or exception in relation 
to each of the rights described above in acco rdance with the relevant provisions of the Berne 
and Rome Conventions and in light of Ar ticle 13 and 14.6 of the TRIPS Agreement. 
 
 Concerning the neighbouring rights, the Braz ilian legislation does not establish any exception 
or limitation based on the ones allowed by the Rome Convention.   The provisions of Article 18 of the Berne Convention are also applied.  7. Please state the terms of protection of ea ch right described above and the work or 
subject matter to which it applies.  
 Please see Articles 41 up to 44, and Article 96 of Law No . 9.610 of 1998. 
 
8. Please clarify how the fourth paragraph of Article 2 of Law No. 9609 on the protection 
of software, which submits such a protection to a reciprocity principle, is in accordance with the 
relevant provisions of the TRIPS Agreement (Articles 3 and 9) and of the Berne Convention (Article 5) on national treatment.  
 The protection system for intellectual property of computer programs is the one granted to literary works by the copyright and related ri ghts legislation, in accordance with the Berne 
Convention and the TRIPS Agreement.  Therefore, Article 2, paragraph 4, of Law No. 9.609 of 1998 
shall be read combined with the command established in its own caput and the caput of Article 2 of 
Law No. 9.610 of 1998.  In that sense, the nationa l treatment established by Law No. 9.610 of 1998, 
the Copyright Law, is applied.  
 
9. Please describe how Article 112 of Law 9.610 on the retroactive protection of works in 
the public domain, is in accordance with Article 18 of the Berne Convention and Article 14.6 of 
the TRIPS Agreement.  
 In order to answer the question, the Government of Brazil needs a clarification of what is the 
understanding of the European Community of Article 18 of the Berne Convention in relation to the 
reference to retroactive protection in question a nd, consequently, what the European Community 
understands to be retroactive protection.   Nevertheless, it is to be said that, since th e new law has prompt and general effect, it does 
affect the later parties of pending facts, when not offending the "ato jurídico perfeito", the "direito 
adquirido" and the "coisa julgada", as established in Article 6 of the Law of Introduction to the Civil 
Code (Decree-law No. 4.657 of 4 September, 1942). 
 IP/Q/BRA/1, IP/Q2/BRA/1, 
IP/Q3/BRA/1, IP/Q4/BRA/1 
Page 9 
 
  
C. T
RADEMARKS6 
10. Please give the definition of a sign under your national legislation and explain under 
what conditions it is protectable. 
  According to the Brazilian Industrial Prope rty Law (No. 9.279 of 1996) any visually 
perceptible sign, distinctive and not prohib ited by Law shall be registrable as a mark. 
 
11. Please confirm whether or not services are a protectable subject matter in your 
trademark law.  Please confirm if signs, such as  trade names, are protectable.  Please describe if 
elements such as sound, perfumes and containers are protectable.  
 Service marks are protected according to the Br azilian Industrial Property Law (No. 9.279 of 
1996). 
 
 It is said that some signs, such as trade names,  may be registered as marks, may be registered 
under the commercial register, as well as protect ed by the Commercial Code, including the 
Competition Law (No. 8.848 of 1994).   Sounds and perfumes, as well as any other sign that cannot be visually perceptible, must not 
be protected.  Containers may be registered as trademarks provided they do not fall into the 
prohibitions established in Article 124, XXI and XXII of Law No. 9.279 of 1996. 
 
12. Please explain what the requirements of use are, if any, as a condition for a trademark 
registration.  Please explain the definition of  use and the conditions of maintenance of a 
registration in that respect. 
 
Brazil adopts the first-to-file rule and the only possible exception would be a prior use in 
good faith of an identical or similar mark for at l east six months, in Brazil, before the application is 
filed by a third person.  In this case, the prio r user shall have precedence to the registration. 
 
Titleholders are supposed to start effective use in  Brazil within five years from registration of 
the mark and cannot interrupt its use for more than  five consecutive years without legitimate reasons, 
under the risk of forfeiture if required by a third party.  
13. Please confirm whether or not your legislation permits that the registration of 
trademarks be indefinitely renewable. 
 
 Yes. 
  
14. Please describe the special requirements, if any, prescribed by your legislation 
concerning the use of a trademark. 
 
There are no special requirements concerning the use as such.  Nevertheless, in order to prove 
the use of a trademark, the titleholder must present legal documents regarding the sale of the product 
of the rendering of the service (including import perm its or equivalents), which may be complemented 
by any other evidence of use, such as, but not lim ited to, advertisements, co mpany papers showing the 
mark, etc. 
                                                     
 
6 Although the Industrial Property  Law adopts the term "sinal" (signal) and not "signo" (sign), we 
chose to use the English term "sign" because this is the term used in the original English version of the TRIPS 
Agreement, by the accepted Brazilian translation and beca use this is how it was referred to in the questions. IP/Q/BRA/1, IP/Q2/BRA/1, 
IP/Q3/BRA/1, IP/Q4/BRA/1 Page 10 
 
 D. G
EOGRAPHICAL INDICATIONS  
15. Please explain whether or not your tr ademark registration authority refuses a 
trademark application if it contains a geographical indication.  
 Please see Article 124, IX and X of Law No. 9.279 of 1996. 
 
16. Please give the definition of a geographical indication in your legislation. 
 
 Please see Articles 176 up to 180 of Law No. 9.279 of 1996.  
17. Please describe and explain the provisions of your legislation establishing a link, if any, 
between the characteristics of an indication and its geographical origin.  
 Please see Article 178 of Law No. 9.279 of 1996. 
 18. Please describe how additional protection is granted by your legislation to wines and 
spirits.  Please mention other types of products, if any, covered by this additional protection. 
 
The additional protection established by the TRIP S Agreement is given to all geographical 
indications, whether or not they are related to wines and spirits.  19. Please explain how exceptions under Article 24 of the TRIPS Agreement are used in 
your jurisdiction.  Please provide examples of the use of the exceptions by courts or lists of names considered as generic in your jurisdiction. 
  Since the Law No. 9.279 of 1996 has establis hed new definitions and concepts concerning 
geographical indications, there is no knowledge of ju dicial decisions that applied the exceptions under 
Article 24 of the TRIPS Agreement.  E. I
NDUSTRIAL DESIGNS  
20. Please explain whether or not your legislation extends to the protection of designs 
dictated essentially by technical or functional considerations.  Please explain how textile designs 
are protected.  
No.  Textile designs are protected when presen ted in a visually perceptible plastic form. 
 
21. Please explain how your legislation protects right holders of a design against importing 
of articles bearing embodied or copied design.  
 Please see Article 188 and Articles 207 up to  210 of Law No. 9.279 of 1996. 
 
22. Please state whether or not your legislation pr ovides for the right to issue a compulsory 
licence for industrial designs 
 
There is no compulsory licence for industrial designs. 
 
23. Please indicate for what period of time your legislation grants protection for industrial 
designs.  
 Please see Article 108 of Law No. 9.279 of 1996.  IP/Q/BRA/1, IP/Q2/BRA/1, 
IP/Q3/BRA/1, IP/Q4/BRA/1 
Page 11 
 
  
F. P
ATENTS  
24. Please describe how your legislation defines the notions of: novelty, inventiveness and 
industrial application. 
 
Please see Article 11, 13, and 15  of Law No. 9.279 of 1996. 
 
25. Please explain whether or not in your legislation, patent or otherwise, patent rights are 
enjoyed without any exclusions.  If exclusions  are provided for, please describe in detail how 
these exclusions are applied in legal as well as practical terms. 
 
 The only possible ones are those allowed by the TRIPS Agreement. 
 
26. Please explain whether your legislation provid es for the exclusion of inventions from 
patentability based on ordre public or morality.  If so, please explain the relevant section of 
your legislation and explain its formulation.  Pl ease also explain if it has been applied in 
practice. 
 
 Yes.  Please see Article 18 of Law No. 9.279 of 1996.  Up to now, there is no case of patent 
application that has been considered to transgress order public of morality. 
 
27. Please explain whether or not diagnostic, th erapeutic and surgical methods are excluded 
from patentability in your legislation. If so, pl ease explain the relevant section of your legislation 
and explain its formulation.  
 Yes.  Please see Article 10, VIII, of Law No. 9.279 of 1996. 
 
28. Please explain whether or not plants, anim als and essentially biological processes are 
excluded from patentability in your legislation. If so, please explain the relevant section of your legislation and explain its formulation.  
 Yes.  In accordance to the provisions established by Article 10, IX, of Law No. 9.279, of 
1996.   
29. Please describe how micro-organisms, non-essentially biological processes, 
microbiological processes and plant varieties are prot ected in your legislation. Please explain, in 
this respect, the relevant sections of your legislation. 
 
Concerning micro-organisms, non-essentially biological processes, microbiological processes 
and plant varieties, please see Article 18, III, of La w No. 9.279 of 1996.  Plant varieties are protected 
by Law No. 9.456 of 1997. 
 
30. Please explain how your legislation protects patent right holders against the importing 
and against the offering for sale of a patented invention.  
 Please see Articles 42 and 184, II, of Law No. 9.279 of 1996. 
 31. Please state if your legislation provides for patent product protection of pharmaceutical 
and agricultural chemical products.  In the a ffirmative, please indicate the legal reference. 
 
 Please see answer to question 25. 
 IP/Q/BRA/1, IP/Q2/BRA/1, 
IP/Q3/BRA/1, IP/Q4/BRA/1 Page 12 
 
 
32. Please clarify if the patent protection of a pr ocess, as provided for in your legislation, 
covers the product obtained directly by that process.  
 Yes.  Please see Article 42 of Law No. 9.279 of 1996. 
 
33. Please explain the additional conditions, if any, in your legislation other than the 
sufficient disclosure of the invention in Articl e 29 of the TRIPS Agreement (e.g. submission of 
justification for access to genetic material or prior inform consent to its use).  If such additional 
conditions exist, please point out the relevant legi slations and describe the additional conditions 
in detail.  
 In the Brazilian Law System, the granting of a property right may be put in question if the 
means used to create or to obtain the subject matter of the referred right are done in an illegal manner. 
 34. Please describe if your legislation provides for limited exceptions to the exclusive rights 
conferred by a patent.  If affirmative, pl ease make a reference to relevant legislation. 
 
 Yes.  Please see Articles 43 up to 45 of Law No. 9.279 of 1996. 
 
Follow-up question
: 
 
 Having examined Articles 43 to 45 of Law No . 9.279 of 1996, the European Communities 
are concerned as to how Article 43(iii) would be in terpreted in Brazil.  A medicine prepared in 
accordance with a medical prescription could be so prepared for many thousands of "individual 
cases".  Please confirm that Article 43(iii) will be  interpreted in Brazil in accordance with both 
the letter and spirit of Article 30 of the TRIPS Agreement.  
 
 Yes. Article 43, III, of Law No 9.279 of 1996 is applicable only to individual cases. Therefore, there is no sense in the questioning , since it refers to a exception that does not 
unreasonably conflict with a normal exploitation of  the patent and does not unreasonably prejudice 
the legitimate interests of the patent owner, taking acc ount of the legitimate interests of third parties. 
 35. Please explain whether or not your legislatio n provides for compulsory licensing. If so, 
please explain in detail the conditions under which a compulsory licence may be granted.  In 
particular, please explain how your national le gislation considers individual merits in the 
authorization of such use.  
Follow-up question
: 
  Although no response has been received to  this question, the European Communities 
have examined the provisions of Articles 68 to 74 of Law No. 9.279 of 1996 and no provisions 
are immediately apparent corresponding  to the wording of Article 31(a), (b), (e), (f), (j), (l)(ii) or 
(l)(iii) of the TRIPS Agreement.   Please cite the Articles of Law No. 9.27 9 in which phraseology corresponding to the 
quoted Articles of the TRIPS Agreement are to be found.  
 
 As established in Article 1 of the TRIPS Agre ement, "Members shall be free to determine the 
appropriate method of implementing the provisions of this Agreement within their own legal system 
and practice", so that the provisions of Article 31 is not reproduced phrase by phrase in our law.  
Notwithstanding, Articles 68 usque  74 of Law No. 9.279 of 1996 bring the scope of such Article. 
 IP/Q/BRA/1, IP/Q2/BRA/1, 
IP/Q3/BRA/1, IP/Q4/BRA/1 
Page 13 
 
  
36. Please explain how your legislation explicit ly ensures that a proposed user has made 
efforts to obtain authorization from the ri ght holder on reasonable commercial terms and 
conditions and that such efforts have not been su ccessful within a reasonable period of time. In 
this context, how do you define "reasonable p eriod of time".  Please also explain how your 
legislation ensures that the use of a compulsory licence shall be authorised predominantly for the supply to the domestic market of the Member authorizing such use.  
In the Brazilian legislation, there is no definiti on of "reasonable period of time".  Therefore, it 
is to be decided in a case by case basis.  Usually, in other national legislation, it is also to be decided 
in a case by case basis. 
 Concerning the second part of the question, please refer to answer to question 35. 
 
37. Please state if your legislation grants additional protection for innovations after the 20 
years of patent protection has lapsed.  
Yes.  Please see Article 40, sole paragraph, of Law No. 9.279 of 1996. 
 
38. Please explain how your legislation provides for the enhanced patent protection of 
patents or patent applications pending on 1 January 1995. 
 
 Please see Articles 229 and 229-B of Law No.9.279  of 1996, pursuant to the modifications 
made by Law No. 10.196 of 2001.  Follow-up question
: 
  Please provide a copy of Article 229-B of Law No. 9.279 of 1996 which was inserted pursuant to the modifications made by Law No. 10.196 of 2001.  
 As explained in the review by Brazil duri ng the session of the TRIPS Council in November, 
2001, the law was already notified in September 2001.  39. Please explain how your legislation provides for the reversal of the burden of proof in 
relation to process patents. 
 
 Please see Article 42, paragraph 2, of Law No. 9.279 of 1996.  G. L
AYOUT -DESIGNS (TOPOGRAPHIES ) OF INTEGRATED CIRCUITS  
40. Please describe how your legislation protects Topographies. 
 
 Unfair competition provisions may be applied.  Besi des that, it is to be said that there is a bill 
on this subject in Congress.  IP/Q/BRA/1, IP/Q2/BRA/1, 
IP/Q3/BRA/1, IP/Q4/BRA/1 Page 14 
 
 
Follow-up question
: 
  Please advise whether:  
 (a) the Bill has been passed by Congress;  and 
  (b) the Bill is in compliance with Ar ticles 35 to 38 of the TRIPS Agreement.  
 
 The Bill is still being examined in Congress. 
 
41. Please explain what protection your national legislation grants to right holders against 
the unlawful importation, sale or distribut ion for commercial purposes of topographies 
including integrated circuits or other articles  in which a topography is incorporated in 
accordance with Article 36 of the TRIPS Agreement. 
  Please see answer to question 40. 
 
42. Please explain how your legislation provides for the derogation from Article 36 of the 
TRIPS Agreement as specified in Article 37 of the TRIPS Agreement where a person has no 
knowledge or reasonable grounds to know when ac quiring an integrated circuit or an article 
incorporating such an integrated circuit that it contains an unlawful topography.   
 Please see answer to question 40. 
  43. Please state the term of protection granted by your legislation to topographies. 
 
 Please see answer to question 40. 
 
Follow-up to questions 41, 42 and 43
: 
 
 The follow-up questions are the sa me as in relation to question 40.  
 
 Please see answer to follow-up question to question 40.  
H. U
NDISCLOSED INFORMATION  
44. Please explain whether or not your legislation grants a defined period of time for the 
protection of undisclosed information. If so, please give the time span.  
 The period of time is not defined. 
 
45. Please explain how your legislation defines "undisclosed information". 
 
There is no legal definition. 
 46. Please explain how your legislation defi nes data submitted to governments or 
governmental agencies. 
 
 There is no legal definition.  IP/Q/BRA/1, IP/Q2/BRA/1, 
IP/Q3/BRA/1, IP/Q4/BRA/1 
Page 15 
 
  
I. E
NFORCEMENT  
47. Please describe how your legislation provides fo r effective action against infringement of 
intellectual property rights. 
 
The Brazilian legislation foresees effective ac tion against infringement of intellectual 
property rights as by applicable special and general laws.  Therefore, the following are examples of 
the provisions concerning the question: 
 
a) Articles 183 up to 210 of Law No. 9.279 of 1996;  
b) Article 37 of Law No. 9.456 of 1997; c) Articles 102 up to 110 of Law No. 9.610 of 1998; d) Articles 12 up to 14 of Law No. 9.609 of 1998; e) Articles 184 up to 186 of the Penal Code , as well as its general part, covered by 
Articles 1 up to 120; 
f) Articles 394 up to 405, 498 up to 502, 524 up to 530, and 593 up to 603 of the Penal 
Process Code; 
g) Articles 159 up to 179, and Articles 1056 up to 1061 of the Civil Code; h) Articles 129, 131, 591, 798, 813, 822, 839, 844, 846, 867 up to 873, 888, I of the 
Civil Process Code. 
48. Please explain whether or not your legislat ion provides for a mechanism to appeal to 
judicial bodies of final administrative decisions.  
 The Federal Constitution establishes, in its Artic le 5, XXXV, that "the law shall not exclude 
any injury or threat to a right from the considerati on of the Judicial Power", so that all administrative 
decisions may be judicially argued. 
 
49. Please describe how your legislation authorizes judges to order production of evidence 
by the opposing party.  Please give precise info rmation on what measures are taken to ensure 
the protection of confidential information.  
 The Brazilian judicial system establishes that the burden of proof is on the one who alleges, 
except in the case of an omissive proof, case in which there will be a reversal of the burden of proof.  
Nevertheless, the judge may order the production of proofs of facts that are important to solve the 
judicial case (Article 155 of the Civil Process Code).   There is the possibility of the proceedings being 
held in camera  (Article 155 of the Civil Process Code, Ar ticle 206 of Law No. 9.279 of 1996, and 
Article 14, paragraph 4, of Law No. 9.609 of 1998). 
 
50. Please quote provisions of your legislation that  authorize judges to order a defendant to 
desist from an infringement.  
 Please see Article 209, paragraph 1, of Law No. 9.279 of 1996, and Articles 213, 813 up to 
881, 275, I, and 276 up to 281 of the Civil Process Code. 
 IP/Q/BRA/1, IP/Q2/BRA/1, 
IP/Q3/BRA/1, IP/Q4/BRA/1 Page 16 
 
 
51. Please quote what provisions of your legisl ation authorize judges to order the payment 
to the right holder of adequate damages to compensate the injury he suffered. 
 
 The Civil Code establishes, in its Article 159, that the one who by action or voluntary 
nonfeasance violates a right or causes prejudice to so mebody else will be obliged to compensate the 
damage.   Besides that, Article 204, 208, 209 and 210 of Law No. 9.279 of 1996, Article 37 of Law 
No. 9.456 of 1997, Article 14, paragraph 5, of La w No. 9.609 of 1998, and Articles 102, 103, 105, 
107, 108 and 109 of Law No. 9.610 of 1998 are supplementary to the provisions concerning 
compensation of the suffered damage.  
52. Please quote what provisions of your legisl ation authorize judges to order the payment 
of the right holder's expenses by the infringer. 
 
Please see Article 20 of the Civil Process Code. 
 
53. Please explain if and how judges have the authority to order that infringing goods are 
placed outside channels of commerce or destroyed.  
 Yes, by means of a judicial writ. 
 
54. Please quote what provisions of your legislation authorize judges to indemnify a 
defendant in the event of abuse by the plaintiff.  
In the event of abuse by the plaintiff, the j udicial authority may sentence the bad faith litigant 
to compensate the damages (Articles 16, 17, 18, and 35 of the Civil Process Code). 
 Please see also Article 259 of the Civil C ode, Article 204 of Law No. 9.279 of 1996, and 
Article 14, paragraph 5, of Law No. 9.609 of 1998. 
 
55. Please explain how your legislation implemen ts Article 50 of the TRIPS Agreement. 
 
Please see Articles 1 up to 120, and Articles 184 up to 186 of the Penal Code, Articles 183 up 
to 194 of Law No. 9.279 of 1996 and Articles 12 up to 14 of Law No. 9.609 of 1998. 
 
56. Please identify the competent authorities in your jurisdiction who receive requests from 
right holders for an application to suspend the release of counterfeit goods by the customs authorities.  
 The ultimate competent authority to suspend the release of goods submitted to import or 
export procedure is the Judicial Power.  There is  also a possibility to the customs authority, as 
established by Article 198 of Law No. 9.279 of 1996. 
 
57. Please indicate whether or not procedures are available to suspend the exporting of 
counterfeit goods.  
 The export of counterfeit goods is not regulated  under the TRIPS Agreement so, in that sense, 
it is a subject-matter that is fought in conformity to internal rules applied to goods in general. 
 IP/Q/BRA/1, IP/Q2/BRA/1, 
IP/Q3/BRA/1, IP/Q4/BRA/1 
Page 17 
 
  
58. Please quote what provisions of your legislation authorize the competent authorities to 
order the destruction or disposal of infringing goods.  
 The Presidential Decree No. 91.030 of 1985, Cu stoms Regulation, in its Article 514, VIII, 
establishes that goods, in specific situations, may be arrested to future destruction or other legal 
destination.  Besides that, please see also Article  202, II of Law No. 9.279 of 1996 and Article 106 of 
Law No. 9.610 of 1998. 
 
59. Please indicate whether or not your legislation provides for a de minimis imports 
exception.  
Yes, there is a regulation for a de minimis  import established by Presidential Decree 
No. 91.030 of 1985, Customs Regulation, in its Article 228 up to 231 combined with the Ministerial 
Ordinance No. 39 of 1995 from the Ministry of Finance related to luggage. 
60. Please explain how your legislation implemen ts Article 61 of the TRIPS Agreement. 
 
Please see Articles 183 up to 194 of Law No. 9.279 of 1996, Articles 12 up to 14 of Law 
No. 9.609 of 1998, Articles 1 up to 120 and Ar ticles 184 up to 186 of the Penal Code, and 
Articles 394 up to 405, 498 up to 502, 524 up to  530 and 593 up to 603 of the Penal Process Code. 
 
IV. RESPONSES TO QUESTIONS POSED BY JAPAN 
A. C
OPYRIGHT AND RELATED RIGHTS  
1. Please explain exceptions or exemptions of the National Treatment and Most-Favoured-
Nation Treatment under Law No. 9.610 of February 19, 1998, if any, as permitted in Articles 3 
and 4 of the TRIPS Agreement.  
 Brazil makes use of the exception foreseen by Article 3.1 of the TRIPS Agreement. 
 
B. P
ATENTS  
2. (1) Please describe how Law No. 9.279 of 14 May, 1996 defines the notion of 
"invention," in the light of Article 27.1 of the TRIPS Agreement stipulating that patents shall be 
available for any "inventions" in all fields of technology, provided that they are new, involve an inventive step and are capable of industrial applic ation. What is the reasoning that the subject 
matters prescribed in Article 10(IX) are deemed non-inventions; is it because they exist in 
nature or because they are related to  living thing or biological material? 
 
 Please see Article 8 of Law No. 9.279 of 1996.  Concerning Article 10, IX of Law No. 9.279, 
it is because they are not considered ne w since they already exist in nature. 
 
(2) If a living thing, its part or biological material that has no previously recognized 
existence has been first isolated or purified artifi cially from its surroundings in nature (i.e., if it 
involves "human intervention"), is it deemed an invention under Article 10(IX) of Law No. 
9.279? Otherwise, is it automatically deemed a non-invention regardless of the extent of human 
intervention involved? 
 
 No.  Please refer to the previous question.  Howe ver, it is to be said that the related process 
may be patentable, if the requirements establishe d by Article 8 of Law No. 9.279 are satisfied. 
 IP/Q/BRA/1, IP/Q2/BRA/1, 
IP/Q3/BRA/1, IP/Q4/BRA/1 Page 18 
 
 
(3) Where a particular type of chemical s ubstance exists in nature but is neither a 
part or whole of living thing nor a biological material (such as carbon beads isolated from the oil residue which is produced through the oil ref inement process when lamp oil and light oil are 
removed from crude oil), is it de emed an invention under Article 10 of Law No. 9.279 if it is first 
isolated or purified artificially from its surroundings? 
No. 
3. Please explain whether or not the below-lis ted subject matters are deemed inventions 
under Article 10(IX) of Law No. 9.279. If any of those subject matters is deemed a non-
invention, please specify the reason. Please suppose that  (a), (h), (i), (l), (m), (n), and (o) have 
been no previously recognized existences and have  been first isolated or purified artificially 
from their surroundings in nature, and that all of those listed meet other requirements for patenting, such as novelty (in the sense that th ey have not been known to the public), an 
inventive step, and industrial applicability. 
 
(a) Human insulin isolated or purified from beta cells of a human pancreas 
(b) A gene which encodes  the said human insulin 
(c) An expression vector which carries the said gene 
(d) Escherichia coli transformed by the said expression vector 
(e) A process for producing human insulin by  culturing the said Escherichia coli 
(f) Recombinant human insulin obtained by the said process 
(g) A mutant obtained by genetically modi fying the said recombinant human insulin 
(h) Baker's yeast isolated or purified arti ficially from its surroundings in nature 
(i) A microorganism which is isolated or purifie d artificially from its surroundings in 
nature and produces an antibiotic mycin X 
(j) An antibiotic mycin X produced by the said microorganism 
(k) A mutant obtained by artificially muta ting the said microorganism with UV ray 
(l) A hybridoma which produces an antibody recognizing antigen A 
(m) Human hepatocyte Y 
(n) Human liver tissue Z 
(o) Carbon beads isolated from the oil residue which is produced through the oil refinement 
process when lamp oil and light oil are removed from crude oil  
No, referring to items (a), (b), (h), (i), (j), (m) and (n) because they are not new, to item (o) 
because it is a discovery, and to item (k) because it is not subject to industrial application (non-
repetitive). 
 Yes, concerning items (c), (d), (e), (f), (g) a nd (l) provided that the requirements established 
by Article 8 of Law No. 9.279 of 1996 are established. 
 
4. Articles 10(IX) and 18(III) of Law No. 9.279  appear not to permit the grant of patents 
for "microorganisms" found in nature even if th ey are new, invole inventive step and are 
capable of industrial applications.  Please ex plain how Articles 10(IX) and 18(III) of Law No. 
9.279 comply with Articles 27.1 and 27.3(b) of the TRIPS Agreement. 
 
 Article 10, IX of Law No. 9.279 of 1996 is related to subject matte rs found in nature and 
Article 18, III of the same Law allows the pa tentability of transformed microorganisms. 
 IP/Q/BRA/1, IP/Q2/BRA/1, 
IP/Q3/BRA/1, IP/Q4/BRA/1 
Page 19 
 
  
5. Please explain the additional conditions, if any in your legislation, other than the 
sufficient disclosure of the invention provided in Article 29.1 of the TRIPS Agreement (e.g. 
submission of a copy of the contract for access to  biological material or a copy of the documents 
certifying the authorization to use traditional knowledge).  If such an additional condition 
exists, please point out the relevant provisions and describe the additional condition. 
 
 In the Brazilian legal system, the granting of a property right may be put in question if the means used to create or to obtain the subject-matter of the referred right are done in an illegal manner. 
 
6. Article 18(II) of Law No. 9.279 stipulates th at substances, materials, mixtures, elements 
or products of any kind, as well as the modifica tion of their physical-chemical properties and 
the respective processes for obtainment or  modification, when resulting from the 
transformation of the atomic nucleus, are not patentable.  Please explain how Article 18(II) 
complies with Article 27 of the TRIPS Agreement. 
 
 Please see Articles 27.2 and 73 of the TRIPS Agreement. 
 
V. RESPONSES TO QUESTIONS POSED BY SWITZERLAND 
A. P
ATENTS  
1. In your law, are patents available for all ca tegories of products? In particular, are all 
pharmaceutical products patentable? Are there an y exceptions? If so please explain in detail 
what these exceptions are and how they comply  with Article 27 of the TRIPS Agreement. 
 
 According to Article 8 of the Brazilian Industr ial Property Law (Law 9.279 of May 14, 1996), 
patents are enjoyable for inventions that meet the requirements of novelty, inventive step and 
industrial application. The only excep tions to patentability are defined in Article 10 of the Law, which 
fully complies with Article 27 of the TRIPS Agreement.  
 Follow-up question
: 
 
 In your answer, you mention that under Article 10 IX of the Brazilian Industrial 
Property Law (Law 9.279 of May 14, 1996) all or part of natural living beings and biological 
materials found in nature, even if isolated theref rom, including the genome or germoplasm of 
any natural living being are not considered to be inventions.  Does this mean that inventions relating to such subject matter, even if fulfillin g the conditions of patentability, i.e. novelty, 
inventive step and industrial applicability,  are nevertheless excl uded from patentability 
according to your law?  If so, please explain ho w this complies with the obligation of Article 27.1 
of the TRIPS Agreement prohibiting discrimination  as regards patentability between different 
fields of technology.  
 
Article 10 IX of Brazil's Industrial Property Law (Law 9.279 of May 14, 1996) establishes 
that "all or part of natural living beings and biol ogical materials found in nature, even if isolated 
therefrom, including the genome or germoplasm of any natural living being, and the natural biological 
processes", are not considered to be inventions or utility models.  The ques tion by Switzerland is not 
clear regarding the reference to "inve ntions related to such subject ma tter".  According to Article 8 of 
the Industrial Property Law, "an i nvention is patentable if it satis fies the requirements of novelty, 
inventive step, and industrial application".  The scope  of Article 10 IX relates to subject matter that 
does not fulfill the basic criteria of patentability set out in Article 27.1, as it relates to naturally-
occurring subject matter, including those that were me rely isolated from nature.  Therefore, Article 10 
IX is fully consistent with Artic le 27.1 of the TRIPS Agreement.  IP/Q/BRA/1, IP/Q2/BRA/1, 
IP/Q3/BRA/1, IP/Q4/BRA/1 Page 20 
 
 
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 
requirement 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?  
 
 Provisional Measure 2014-1 fully complies with  Article 27.1 of the TRIPS Agreement. 
ANVISA is in possession of the necessary expertise to  pronounce itself on the novelty, inventive step 
and industrial application of pharmaceu tical inventions.  In this regard, we note that Article 1.1 of the 
TRIPS Agreement states that "[m]embers shall be free to determine the appropriate method of 
implementing the provisions of this Agreement within their own legal system and practice". 
 
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)? 
 
 Brazil does not agree with such an interpreta tion of Article 27.1 of the TRIPS Agreement.  
The rule that prohibits discrimination between produc ts that are imported and those that are locally 
produced derives from the rule of national treatment  of goods of the 1994 Marrakesh Agreement. 
Compulsory licences granted under Article 31 –  whic h deals exclusively with the conditions of use  
of compulsory licences and not the grounds for the issuing of compulsory licences –  are based, on the 
other hand, on Article 5 of the Paris Convention for the Protection of Industrial Property, and 
therefore aimed at preventing abuses of rights,  such as "for example, failure to work". 
 
4. Does your law make compulsory licenses s ubject to all the conditions enumerated in 
Article 31 of the TRIPS Agreement?  Please cite the relevant provisions of law.  
 
 Under the Brazilian Industrial Property Law, co mpulsory licences are subject to conditions 
enumerated in Article 31 of the TRIPS Agreemen t.  The relevant provisions can be found in 
Articles 71 to 74 of Law 9.279 of 1996.   
 
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. 
 
The TRIPS Agreement does not limit the grounds upon which to grant compulsory licences, 
but merely establishes procedural re quirements to be followed by Members.   Presidential Decree 3201 
defines facts of primary importance to the tec hnological or socio-economic development of the 
country as one possible situation of national interest that might lead to the issuance of a compulsory licence for public non-commercial use.  Therefore, the aim of Presidential Decree 3201 is merely to 
define terms that TRIPS does not explain, in orde r to allow the issuance of compulsory licences in a 
TRIPS-compatible manner.  These provisions of the Presidential Decree fully comply with the TRIPS 
Agreement, but they are also clearly based on its Ar ticle 8.1, which states that "[m]embers may, in 
formulating or amending their laws  and regulations, adopt measures necessary to protect public health 
and nutrition, and to promote the pu blic interest in sectors of vital importance to their socio-economic 
and technological development, provided that such m easures are consistent with the provisions of this 
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. 
 
 Yes. Please see Article 42, paragraph 2, of Law 9.279 of 1996.  IP/Q/BRA/1, IP/Q2/BRA/1, 
IP/Q3/BRA/1, IP/Q4/BRA/1 
Page 21 
 
  
B. P
ROTECTION 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 agricultural chemical product is 
protected against disclosure and against unfair comm ercial use by a competitor, for example by 
prohibiting a second applicant from relying on, or fr om referring to the original data of the first 
applicant, when applying subsequently for mark et 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 
undisclosed information / for such t est data of the first applicant? 
 
 Please see Article 195, XIV, of Law 9.279 of  1996, and Article 154 of the Penal Code. 
Concerning exceptions, see Article 195, paragraph 2, of the same Law. Furthermore, it should be 
noted that the period of time is not defined. 
 
Follow-up question : 
 
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 spec ify whether the responsible State Agency will 
require the same amount of data from a second applicant requesting market authorisation 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 app licant and will therefore not have to submit these 
data in his own application for market authorisation?  
 
 Please see Article 195, XIV, of Law No. 9. 279 of 1996, and Article  154 of Penal Code 
concerning violation of professional secrets.  Con cerning exceptions, see Article 195, paragraph 2, of 
the same Law.  Furthermore, it is to be said that the period of time is not defined. 
 
VI. RESPONSES TO QUESTIONS POSED BY THE UNITED STATES 
A. GENERAL  
1. With respect to each form of intellectual property covered by Part II of the TRIPS 
Agreement, including plant variety protection, pl ease explain the manner in which the laws of 
Brazil ensure that nationals of other WTO Me mbers receive national treatment and most-
favoured-nation treatment as requi red by Articles 3 and 4 of the TRIPS Agreement.  Please cite 
to the relevant provisions of law. 
In Brazil, national treatment and most-favour ed-nation treatment, as required by Articles 3 
and 4 of the TIRPS Agreement, are ensured by  Legislative Decree No. 30 of 15 December 1994, 
which approved the Uruguay Round Agreements , and by Presidential Decree No. 1,355 of 
30 December 1994, which sanctioned Legislative D ecree No. 30 and therefore incorporated into 
Brazil's legislation all the provisions of the TRIPS Agreement. IP/Q/BRA/1, IP/Q2/BRA/1, 
IP/Q3/BRA/1, IP/Q4/BRA/1 Page 22 
 
 B. C
OPYRIGHT AND RELATED RIGHTS  
2. Please describe in detail the operation of  the Brazilian sui generis database protection 
law that was recently enacted. 
No law has recently been enacted on this subject. 
3. Please explain how the copyright law of Br azil protects computer programs as literary 
works and complications of data as required  by Article 10 of the TRIPS Agreement. 
Article 2 of the Brazilian Law on Software (Law No. 9.609 of 1998) states that the protection 
of computer programs is the same conferred to  literary works, pursuant to the Copyright and 
Neighbouring Rights Law (Law No. 9.610 of 1998).  Regarding data compilations, the protection 
under Brazilian law is defined by Chapter VII of the Law on Copyright and Neighbouring Rights, in 
conformity with the requirements of Article 10 of the TRIPS Agreement. 
4. Article 11 of the TRIPS Agreement requires that rental rights for computer programs 
and cinematographic works be available.  Please cite to the corresponding provision of the 
copyright law of Brazil. 
Please see Article 2, paragraph 5, of Law No . 9.609 of 1998, and Article 5, IV, of Law 
No. 9.610 of 1998. 
5. Please state the length and terms of protectio n the copyright law of Brazil provides for a 
work other than a photographic work or a work of applied art and cite to the relevant provision of law. 
Please see Article 7, caput, Articles 41 up to 44, and Article 96 of Law No. 9.610 of 1998. 
6. Please describe the protection the copyright law of Brazil provides for performers, and 
the term of the protection. 
The protection provided by the Brazilian Copyright Law (Law No. 9.610 of 1998) for 
performers is described in Title V, Chapter II.  The term of protection is defined by Article 96 of this 
Law, and is of 70 years, counted from 1
st January of the year following the execution or public 
presentation. 
7. Article 14.2 of the TRIPS Agreement provides that producers of phonograms are to 
enjoy the right to authorize or prohibit the direct or indirect reproduction of their phonograms.  Article 14.2 requires that producers of phonogr ams are to have the right to authorize or 
prohibit the commercial rental to the public of originals or copies of their phonograms.  Please 
describe how the copyright law of Brazil implemen ts these obligations and indicate the term of 
protection. 
Please see Articles 93 and 96 of Law No. 9.610 of 1998. IP/Q/BRA/1, IP/Q2/BRA/1, 
IP/Q3/BRA/1, IP/Q4/BRA/1 
Page 23 
 
  
C. T
RADEMARKS7 
8. Please indicate whether all of the subject matter that is described under Article 15.1 of 
the TRIPS Agreement is protected under the Braz ilian trademark law.  Please explain in detail 
any conditions that are imposed upon the protectio n of any signs or combinations of signs under 
the Brazilian law, citing any relevant laws, regulations or judicial decisions. 
The Brazilian Industrial Property Law (No. 9.27 9 of 1996) establishes in its Article 122 that 
any visually perceptible sign, distinctive in relation to the product or service to which it is applied, is 
eligible for registration as a mark.  This Law forese es protection for product, service, certification and 
collective marks. 
9. Please describe the criteria that are used to determine whether a trademark or service 
mark is well known, citing to the rele vant provisions of law and regulations. 
Please see Article 126 of Law 9.279 of 1996. 
10. Please explain how the Brazilian law provid es for the protection of well-known marks 
for dissimilar products, as required by Article 16.3 of the TRIPS Agreement.  Please cite to the 
relevant provisions of the laws and regulations. 
Please see Article 160, I, of the Civil Code combined with Article 122 of Law No. 9.279 of 
1996. 
11. Please explain whether Brazilian law permits the registration of generic terms, which 
are in the English or Portuguese language, citing any relevant laws or regulations. 
According to Law 9.279 of 1996, Article 124, VI , signs of a generic nature, when related to 
the product or service to be distinguished, shall not  be registrable as marks, unless they are presented 
in a sufficiently distinctive manner. 
It is also to be said that it is not foreseen  the possibility of a sign acquiring distinctive 
character through use. 
D. P ATENTS  
12. Article 27.1 of the TRIPS Agreement requires th at, with specified exceptions, patents be 
available for any inventions, whethe r products or processes, in all fields of technology, if they 
are new, involve an inventive step and are capabl e of industrial application.  Please explain in 
detail how Article 10 of the Brazilian Industrial Property Law 9.279 of 1996, which makes computer programs unpatentable, is consistent with Article 27. 
The correct provision of the TRIPS Agreement to be addressed in this question is not 
Article 27, but rather Article 10, which states that computer programs "shall be protected as literary works under the Berne Convention (1971)".  This is th e case in the Brazilian legislation.  Article 2 of 
Law No. 9.609 of 1998 ("Software Law") states that computer programs are protected as literary works, as required by the TRIPS Agreement. 
                                                     
 
7 Although the Industrial Property  Law adopts the term "sinal" (signal) and not "signo" (sign), we 
chose to use the English term "sign" because this is the term used in the original English version of the TRIPS 
Agreement, by the accepted Brazilian translation and beca use this is how it was referred to in the questions. IP/Q/BRA/1, IP/Q2/BRA/1, 
IP/Q3/BRA/1, IP/Q4/BRA/1 Page 24 
 
 
13. Article 27.3 of the TRIPS Agreement allows  Members to except from patentability, 
plants and animals other than microorganisms.  It  is not clear from Article 10 of the Brazilian 
Industrial Property Law of 1996 whether microor ganisms are patentable.  Please explain 
whether and under what circumstances such mi croorganisms are patentable in Brazil. 
Article 10, IX, of Law No. 9.279 of 1996, refe rs to subject matters found in nature and 
Article 18, III, of the same law, allows the patentability of transformed microorganisms. 
14. Please explain whether Article 10 IX of the Brazilian patent law of 1996, which excludes 
from patentability all or part of natural human beings and biological materials found in nature, 
even if isolated therefrom, would exclude from  patentability a drug that was isolated from a 
plant, purified and determined to be biologically active. 
Article 10, IX, of Law No. 9.279 of 1996, refers  to subject matters that are not considered 
new since they already exist in nature.  However, it is to be said that the related process may be 
patentable, if the requirements established by Ar ticle 8 of Law No. 9.279 of 1996 are satisfied. 
15. Please explain in detail how each of the items indicated in Article 18 is consistent with 
Article 27 of the TRIPS Agreement. 
Article 18 is based upon Articles 8, 27.2, 27.3(b) and 73 of the TRIPS Agreement. 
16. Article 11 provides that an invention is not considered to be new if it became accessible 
to the public prior to the filing date of the pate nt application by means of a written or oral 
description, by use or by other means.  Please desc ribe in detail the evidence that is required by 
the Brazilian Patent Office to establish a bar to patentability based on oral prior art.  Please 
also describe in detail what may be cons idered other means under the Brazilian law. 
The oral description may be accepted, on a case-by-case basis, provided that it consists in a 
legally acceptable proof.  The same principle is valid to the "other means" me ntioned in the question. 
17. Our translation of Article 16 states that an invention or utility model is not considered 
susceptible of industrial application when they ca n be used in any kind of industry.  Please 
indicate whether this is an accurate translatio n of the Brazilian law.  If this translation is 
accurate, please explain in detail what is meant by produced in any kind of industry.  If this translation is not accurate, please provide an accurate translation. 
The Article in which the questions refers to sh all be 15, and not 16, and its translation should 
be, having in mind that national tongues may have differences in the meaning of words that are 
translated: 
"Article 15.  An invention and a utility m odel are considered susceptible of industrial 
application when they can be used or produced in any kind of industry." 
18. Article 34 requires that documents nece ssary to regularize the processing and 
examination of the application be submitted wi thin 60 days of the Brazilian Patent Office's 
request to avoid dismissal of the application.  Please describe in detail what is meant by 
documents necessary to regularize the processi ng and examination of the application. 
Those ones established by Law No. 9.279 of 1996 and by the PCT rules. IP/Q/BRA/1, IP/Q2/BRA/1, 
IP/Q3/BRA/1, IP/Q4/BRA/1 
Page 25 
 
  
19. Article 40 provides that a patent term is twen ty years from the date of filing.  Please 
confirm that this term applies to patents that is sued before the effective date of Law 9.279, as 
required by Article 70.2 of the TRIPS Agreement.  
Due to peculiarities of the Brazilian legal system, this subject is being considered by the 
Executive Power as well as, on a case-by-case basis, by the Judicial Power. 
20. Articles 60 and 62 provide that entries made by  INPI related to assignments, limitations 
on the application or patent, or changes in the name, headquarter or address of the applicant 
shall become effective with regard to third parti es beginning on the date of their publication.  
Please indicate the average period of time betwee n the filing of an assignment, or other entry, 
and its publication.  
Nowadays, the average time is four months. 
21. Please explain in detail how the exemptions fr om liability provided for in Article 43 of 
the Brazilian law are consistent with Article 30 of the TRIPS Agreement.  
Please better clarify what are the reasons that motivate you to the formulation of the question, 
considering that nothing exists, explicitly or implic itly, in relation to legal provision that seems to 
allow doubts concerning the compliance with Article 30 of the TRIPS Agreement. 
22. Articles 58-60 of the Brazilian patent law provide for the assignment of patent 
applications and the recording of assignments.  Please indicate the average time period between 
the date that an assignment is filed and the date that it is published. 
Nowadays, the average time is four months. 
E. P
ROTECTION OF UNDISCLOSED INFORMATION  
23. Please describe in detail how the Brazilian la w provides for the protection of undisclosed 
information that is secret as defined in Ar ticle 39.2 of the TRIPS Agreement and provide 
citations to the relevant provisions of law.  
Please see Article 195, XI and XII, of Law No. 9.279 of 1996, and Article 154 of the Penal 
Code. 
24. Please describe in detail the manner in which protection is provided for test data 
regarding pharmaceutical and agricultural chem ical products, which is submitted to the 
government in order to obtain marketing approval in Brazil, and cite to the relevant provisions of law. 
Please see Article 195, XIV, of Law No. 9.279 of 1996. 
25. Please explain whether applicants for marketing approval are permitted to rely on data 
submitted by an earlier applicant.  If so, how lo ng a period of exclusivity is given the earlier 
applicant before such reliance by others becomes possible. 
The general rule is that it is not allowe d, as established by Article 195, XIV, of Law 
No. 9.279 of 1996. IP/Q/BRA/1, IP/Q2/BRA/1, 
IP/Q3/BRA/1, IP/Q4/BRA/1 Page 26 
 
 F. E
NFORCEMENT  
26. Please describe the procedure for the prom pt notification of the importer and the 
applicant of the suspension of the release of  goods under Article 54 of the TRIPS Agreement, 
citing any relevant laws and regulations. 
The notification of the importer and the appli cant of the suspension of the customs release is 
judicially done by means of the official  gazette which makes public the decisions. 
27. Please provide statistical information related to civil copyright, trademark, geographical 
indication, industrial design, patent, integrated circuit layout-design, and trade secret enforcement for the year 2000, including the number of cases filed; injunctions issued; 
infringing products seized; infringing equipmen t seized; cases resolved (including settlement); 
and the amount of damages awarded. 
At the moment, there is no statistical data available. 
28. Please provide statistical information related  to criminal enforcement in the area of 
copyright piracy and trademark infringement fo r the year 2000, including the number of raids, 
prosecutions, convictions, and the amount of fin es and/or jail terms (including whether the fines 
were paid and whether the jail term was actu ally served or was suspended) and any other 
information establishing that the criminal system operates effectively to deter copyright piracy 
and trademark counterfeiting. 
At the moment, there is no statistical data available. 
29. Please provide the average time that it takes in Brazil for the authorities to investigate a 
reported copyright violation and for a prosecutor to  file a criminal copyright case.  Also, please 
provide the average time that is required to comp lete a criminal prosecution of a copyright case 
and to complete a civil copyright case on appeal. 
The Brazilian judicial system is variable as fo r the period of time of investigation.  The 
variation depends on the place where the crime occu rs, on the amount concerning the case, and other 
factors that determine whether the judicial pr oceedings will have a faster celerity or not. 
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