OFFICIAL GAZZETE OF THE FEDERAL GOVERNMENT  
Published on: 09/03/2021 | Edition: 168 | Section: 1 | Page: 1  
Acts of the Legislative Power  
Law number  14,200, of September 2, 2021  
Amends Statute  9,279 of May 14, 1996 (Brazilian Patent Statute),  to 
address the  compulsory license of patents and patent  applications in cases 
of a declaration of national or  international emergency or public interest, or 
declaration of  state of nationwide public calamity.  
THE PRESIDENT OF THE REPUBLIC  
I inform that the National Cong ress decrees and I enact the following Law:  
Article 1. This Law amends Statute  9,279 of May 14, 1996 (Brazilian 
Patent Statute), to address the compulsory license of patents and patent 
applications in cases of a declaration of national or international eme rgency 
or public interest, or declaration of state of nationwide public calamity.  
Article 2. Article 71 of Statute  9,279 of May 14, 1996 (Brazilian Patent 
Statute), is hereby amended as follows, with its sole paragraph numbered as 
Paragraph 1:  
“Article 7 1. In cases of a declaration of national or international emergency 
or public interest, declared by law or an act of the Federal Executive 
Branch, or a state of nationwide public calamity declared by the National 
Congress, a temporary and non -exclusive com pulsory license may be 
granted, ex officio, for the exploitation of a patent or patent application, 
without prejudice to the rights of the respective holder, provided that the 
patent or patent application holder or its licensee does not meet these needs.  
Paragraph 1. The act of granting the compulsory license will establish its 
term and the possibility of extension.  
Paragraph 2. In the cases provided in this Article’s chapeau , the Federal 
Executive Branch shall publish a list of patents or patent appli cations 
potentially useful for facing the situations  referred to in this Article’s 
chapeau , with the secrecy term provided in Article 30 of this Statute not 
being applicable, in a term of up to 30 (thirty) days from the publication of 
the referred de claration of emergency or public interest, or nationwide 
public calamity, excluded patents and patent applications that are subject of 
transfer of technology agreements for its production or voluntary licensing capable of ensuring the fulfilment of interna l demand, in the terms 
provided by regulation.  
Paragraph 3. Public entities, educational and research institutions, and other 
representative entities of society and the industrial sector must be consulted 
in the process of drafting the list of patents or p atent applications that could 
be subject to a compulsory license, in the terms provided by regulation.  
Paragraph 4. Any public or private institution may submit a request to 
include a patent or patente application in the list provided in Paragraph 2 of 
this Article.  
Paragraph 5. The list provided in Paragraph 2 of this Article shall contain 
sufficient information and data to allow an individualized evaluation 
regarding the utility of each patent and patent  application and shall 
contemplate, at least:  
I – the individualized number of patents or patent applications which may 
be subject to compulsory license;  
II – the identification of the respective holders; and  
III – the specification of the objectives for which each compulsory 
licensing will be authorized.  
Paragraph 6. From the list published pursuant to Paragraph 2 of this 
Article, the Federal Executive Branch shall carry out, within a term of 30 
(thirty) days, extendable for an equal period, the individualized evaluation 
of the listed inventions and utilit y models and will only grant the 
nonexclusive compulsory license, for manufacturers with proven technical 
and economic capacity for the production of the subject matter of the patent 
or patent application, as long as it concludes that it is useful in facin g the 
situation that underlies it.  
Paragraph 7. Patents or patent applications, which have not yet been the 
subject of a compulsory license, may be excluded from the list defined in 
Paragraph 2 of this Article in cases in which the competent authority 
designated by the Federal Executive Branch considers that its holders have 
made objective commitments capable of ensuring fulfilment of domestic 
demand under conditions of volume, price, and time -limit compatible with 
the needs of the national or international  emergency, of the public interest, 
or of the state of nationwide public calamity, through one or more of the 
following alternatives:  
I – direct exploitation of the patent or patent application in the country;  II – voluntary licensing of the patent or pate nt application; or  
III – transparent contracts for the sale of a product associated with the 
patent or patente application.  
Paragraph 8 (VETOED).  
Paragraph 9 (VETOED).  
Paragraph 10 (VETOED).  
Paragraph 11. Public institutions that have information, data, an d 
documents related to the subject matter of the patent and patent application 
are obliged to share all the elements useful for the reproduction of the 
licensed object, in which case the rules relating to data protection are not 
applicable, nor the provisi ons of item XIV, chapeau , Article 195 of this 
Statute.  
Paragraph 12. In defining the compensation for the patent or patent 
application holder, the circumstances of each case shall be considered, 
necessarily in light of the economic value of the license granted, the 
duration of the license, and the estimates of investments necessary for its 
exploitation, as well as the production costs and sales price in the national 
market of the product associated with it.  
Paragraph 13. The compensation of the h older of a patent or patent 
application subject to compulsory license shall be fixed at 1.5% (one point 
five percent) on the net selling price of the product associated with it until 
its value is effectively established.  
Paragraph 14. The compensation of t he holder of a patent application 
subject to a compulsory license shall be due only if the patent is granted 
and its payment, corresponding to the entire period of the license, shall be 
carried out only after the patent is granted.  
Paragraph 15. The compet ent authority will give priority to the analysis of 
patent applications that are subject of a compulsory license.  
Paragraph 16. The products that are subject to the sanitary surveillance 
regime shall comply with all requirements set forth in sanitary legis lation 
and may only be sold after the authorization has been granted by the federal 
sanitary surveillance authority, whether definitively or for use on an 
emergency basis, in the terms provided by regulation.  
Paragraph 17 (VETOED).  Paragraph 18. Regardless  of a compulsory license grant, the government 
will prioritize the execution of technical cooperation agreements and 
contracts with the patent holder for the acquisition of productive 
technology and the process for transferring it.  
Article 3 (VETOED).  
Article 4. The Statute n° 9,279 of May 14, 1996 (Brazilian Patent Statute), 
is hereby amended  with the addition of Article 71 -A: 
“Article 71 -A. For humanitarian reasons and under the terms of 
international treaties to which the Federal Republic of Brazil is a party, 
compulsory licenses of patents of products destined for exportation to 
countries with insufficient or no manufacturing capacity in the 
pharmaceutical sector for the demand of its own population may be 
granted.”  
Article 5. The implementation of the  provisions of this Law does not 
exempt the Executive Branch from making efforts along with other 
countries and international agencies for the purposes of international 
cooperation in order to allow for the universal access to the pharmaceu tical 
products, vaccines, and therapies necessary for the fight against the new 
coronavirus (SARS -CoV -2) and other epidemics or severe public health 
crises.  
Article 6. This Bill shall enter into force on the date of its of publication.  
Brasilia, September 2, 2021; 200th of the Independency and 133rd of the 
Republic.  
JAIR MESSIAS BOLSONARO  
Carlos Aberto Franco França  
Paulo Guedes  
Marcelo Antônio Cartaxo Queiroga Lopes  
Marcos César Ponte