WORLD TRADE ORGANIZATION
ORGANISATION MONDIALE DU COMMERCE
ORGANIZACIÓN MUNDIAL DEL COMERCIOIP/N/1/BRA/P/1
19 September 2000
(00-3705)
Council for Trade-Related Aspects of
Intellectual Property RightsOriginal:  English/
anglais/
inglés
MAIN DEDICATED INTELLECTUAL PROPERTY
LAWS AND REGULATIONS NOTIFIED UNDER
ARTICLE 63.2 OF THE AGREEMENT
BRAZIL
The present document reproduces the text1 of Presidential Decree 3.201, as notified by Brazil
under Article 63.2 of the Agreemen t (see document IP/N/1/BRA/2).
Conseil des aspects des droits de propriété
intellectuelle qui touchent au commerce
PRINCIPALES LOIS ET RÉGLEMENTATIONS CONSACRÉES À LA
PROPRIÉTÉ INTELLECTUELLE NOTIFIÉES AU TITRE
DE L'ARTICLE 63:2 DE L'ACCORD
BRÉSIL
Le présent document contient le texte1 du Décret présidentiel 3.201, notifié par le Brésil au
titre de l'article 63:2 de l'Accord (voir le document IP/N/1/BRA/2).
Consejo de los Aspectos de los Derechos de PropiedadIntelectual relacionados con el Comercio
PRINCIPALES LEYES Y REGLAMENTOS DEDICADOS A LA
PROPIEDAD INTELECTUAL NOTIFICADOS EN VIRTUD
DEL PÁRRAFO 2 DEL ARTÍCULO 63 DEL ACUERDO
BRASIL
En el presente documento se reproduce el texto
1 del Decreto Presidencial 3.201, notificado
por el Brasil en virtud del párrafo 2 del artícu lo 63 del Acuerdo (véase el documento IP/N/1/BRA/2).
                                                     
1 In English only. The text in the original language is available for consultation by interested
Delegations at the WTO Secretariat./En anglais seulemen t.  Les délégations intéressées peuvent consulter le
texte dans sa langue d'origine, au Secrétariat de l'OM C./En inglés solamente.  Las delegaciones interesadas
podrán consultar en la Secretaría de la OMC el texto en su idioma original.IP/N/1/BRA/P/1
Page 2
DECREE No. 3,201 OF OCTOBER 6, 1999
Establishes rules concerning the granting, ex officio , of compulsory licenses in cases of
national emergency and public interest provided for in Article 71 of Law no. 9,279, of May
14,1996.
THE PRESIDENT OF THE REPUBLIC , using the prerogatives to which he is entitled by Article 84,
Item IV, of the Constitution, and in consideration of the provisions of Article 71 of Law no. 9,279, of
May 14, 1996.
D E C R E E S:
Article 1. The granting, ex officio , of a compulsory license, for non-commercial public use, in cases
of national emergency or public interest, provided for in Article 71 of Law no. 9,279, of May 14, 1996,
shall be ruled in accordance with this Decree.
Article 2. There may be granted, ex officio , a compulsory license for a patent, for non-commercial
public use, in cases of national emergency or public interest, thus declared by the Government,provided that it is ascertained that the patentholder or his licensee does not fulfill those needs.
Paragraph 1. A national emergency is understood to be a condition of impending danger to the
public, even if existing only in a part of the national territory.
Paragraph 2. There are considered to be within the public interest those facts, among others,
related to the public health, nutrition, protection of the environment, as well as those of primordial
importance to the technological or social and economic development of this country
Article 3. The act of the Federal Executive Power declaring the national emergency or the public
interest shall be performed by the Minister of State responsible for the subject matter in question andshall be published in the Federal Official Gazette.
Article 4. There having been ascertained the impossibility of the patentholder or his licensee to
fulfill the national emergency or public interest situation, the Government shall grant, ex officio,  the
compulsory license, which shall not be exclusive, and the respective act shall be immediately
published in the Federal Official Gazette.
Article 5. The act of granting the compulsory license for non-commercial public use shall establish,
among others, the following conditions:
I – the term of the license and the possibility of renewal;
II – those offered by the Union, particularly regarding the compensation to the titleholder;
III – the obligation of the titleholder, if needed, to transmit necessary and sufficient information to
the effective reproduction of the protected object, to the supervision of assembly and further technicaland commercial aspects applicable to the case in question.
Sole Paragraph. In order to determine the compensation to which the titleholder is entitled, there
shall be considered the relevant economic and market circumstances, the price of similar products
and the economic value of the authorization.
Article 6. The competent authority may request information as needed to support the granting of
the license or to determine the compensation due to the patentholder, as well as other pertinentinformation, from the federal, state and municipal, direct and indirect, public administration agenciesand entities.
Article 7. In case of national emergency or public interest characterizing extreme urgency, the
compulsory license provided for in this Decree may be implemented and the use of the patent may beeffected, irrespective of prior compliance with the conditions established in Articles 4 and 5 of thisDecree.
Sole Paragraph. If the competent authority has knowledge, without conducting a search, of the
existence of a patent in force, the titleholder shall be immediately informed on such use.
Article 8. The exploitation of a compulsorily licensed patent in accordance with the provisions of
this Decree may be initiated irrespective of the existence of an agreement on the conditions includedin Article 5.IP/N/1/BRA/P/1
Page 3
Article 9. The exploitation of a patent licensed in accordance with the provisions of this Decree
may be performed directly by the Union or by duly contracted third parties, and the reproduction of theobject thereof for other purposes being prohibited, under penalty of being considered illicit.
Article 10. In such cases where it might not be possible to fulfill the situations of national
emergency or public interest with the product placed on the domestic market, or the manufacture ofthe object of the patent by third parties, or by the Union, is found to be unfeasible, the latter mayproceed to import the product that is the object of the patent, provided that it was introduced onto themarket directly by the patentholder or with his consent.
Article 11. The contracting of third parties to exploit the compulsorily licensed patent shall be
performed by means of bidding, and the process thereof shall be performed in compliance with theprinciples of Law no. 8,666, of June 21, 1993.
Article 12. Once the national emergency or the public interest has been fulfilled, the competent
authority shall extinguish the compulsory license, respecting the terms of the contract executed withthe licensee.
Article 13. The competent authority shall inform the Instituto Nacional da Propriedade Industrial –
INPI (National Institute of Industrial Property), for purposes of entry, in respect of the licenses for non-commercial public use, granted on the basis of Article 71 of Law no. 9,279, of 1996, as well asconcerning changes and extinguishment of such licenses.
Article 14. This Decree enters into force on the date of its publication.
Brasília, October 6, 1999; 178
th year of Independence, 111th year of the Republic.
FERNANDO HENRIQUE CARDOSO
José Serra
Alcides Lopes Tápias
NOTICE: The English version of this law is provided only as a means of reference. It
is noted that the Portuguese version solely c onstitutes the official one, for any use the reader
may intend.
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