On September 3, 2021, Brazilian President Jair Bolsonaro promulgated Law No. 14,200 (Lei No. 14.200, de 2 de Setembro de 2021), amending the Industrial Property Law, Law No. 9,279 of May 14, 1996 (Lei de Propriedade Industrial, Lei No. 9.279, de 14 de Maio de 1996). The new law provides for the compulsory licensing of patents or patent applications in cases of national or international emergency, public interest, or nationwide public calamity. Law No. 14,200 amended article 71 of Law No. 9,279, which determines that in cases 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 recognized by the National Congress, a compulsory, ex officio, temporary, and nonexclusive license may be granted “for the exploitation of the patent or patent application, without prejudice to the rights of the respective holder, provided that its holder or its licensee does not meet this need.” Law No. 14, 200 further details, inter alia, the procedures for the compulsory licensing (art. 71(§§ 2, 7)) and the remuneration of the patent holder or patent application (art. 71(§§ 12–14)).
The law was proposed in response to the COVID-19 pandemic in Brazil and international issues of unequal access to vaccines, diagnostic tests, and other COVID-19 medication. The initial bill mentions how international shortages in vaccine supplies and high vaccine prices have exacerbated COVID-19 in Brazil and abroad. (Senado Federal, Projeto de Lei, de 2021.) A technical note issued by the Legislative Consultancy for Brazil’s Chamber of Deputies details that COVID-19 vaccines can cost from $4 to $25 per dose. (Consultoria Legislativa – Câmara dos Deputados, Nota Técnica.) These high vaccine prices and the competition to purchase limited supplies have limited many low-income countries’ abilities to combat COVID-19 domestically. Consequently, the topics of compulsory licensing and the waiving of patents have been central to international conversations about making COVID-19 vaccine distribution more equitable, as outlined in an October 2020 proposal submitted by India and South Africa to the World Trade Organization.
In promulgating Law No. 14,200, President Bolsonaro vetoed certain sections (Veto No. 48/2021 em Mensagem No. 432, de 2 de Setembro de 2021) that require patent holders to provide technical knowledge, biological material, and other essential information to authorities to enable production of items like vaccines. (Law No. 14,200, art. 2(§§ 8–10).) He also vetoed a section that permits temporary compulsory licensing for patents that can help prevent and combat national or international public health emergencies during a nationally declared emergency. (Art. 2(§ 17).) Similarly, he vetoed an article that characterized COVID-19 as a national emergency. (Art. 3.) In response, the sponsor of Law No. 14,200, Senator Paulo Paim, stressed that overriding the presidential vetoes was essential for increasing vaccine production, saving lives, and increasing low-income countries’ access to vaccines.
As of October 12, 2021, a joint session of the Chamber of Deputies and the Federal Senate had not voted on the vetoes, meaning that the law remains in force while the vetoes are pending. (Veto No. 48/2021 (Quebra de patentes de vacinas e remédios para combate à pandemia de Covid-19).)
Background on Veto Procedure
If the president of Brazil considers a law approved by the National Congress to be unconstitutional or contrary to public interest, he or she can veto the entire law or certain parts, such as articles, paragraphs, or line items. (Constituição da República Federativa do Brasil de 1988, art. 66(§§ 1–2).) After receiving a law from Congress, the president has 15 days to decide on vetoes and 48 hours to communicate the rationale for any vetoes made. (Art. 66(§ 1).)
After receiving the president’s rationale, the Federal Senate and Chamber of Deputies have 30 calendar days to deliberate on the vetoes in a joint session. (Art. 66(§ 4).) If 30 days pass without deliberation, the law enters into effect with the vetoes pending until Congress’s final vote. (Art. 66(§ 6).) An absolute majority of both legislative bodies is needed to reject a veto, meaning that 257 of 513 deputies and 41 of 81 senators must vote against the veto. Vetoes are sustained if either legislative body fails to reject the veto with an absolute majority. If a veto is rejected, the approved legislation is forwarded to the president of Brazil to promulgate within 48 hours. (Art. 66(§ 5).) The Senate president or Senate vice-president can promulgate the law if the president of the republic fails to do so within the set time frame. (Art. 66(§ 7).)
Prepared by Elizabeth Marin, Law Library intern, under the supervision of Eduardo Soares, Senior Foreign Law Specialist