On August 10, 2020, a draft of the National Strategy of Intellectual Property (ENPI) was published in the Brazilian Official Gazette Public Consultation #46/2020. A copy of the ENPI can be found here: Eng_Annex-ii_enpi -public consultation. Publication of the draft of the ENPI set a 20-day period (which has now been extended) for the public to make comments and suggestions on the draft. The draft was produced by a working group that includes various public administration entities that are coordinated by the Intellectual Property Interministerial Group (GIPI), which is presided by the Ministry of Economy.
The objective of the ENPI is to set forth the grounds for a balanced and effective National System of Intellectual Property (SNPI), which will be broadly used to foster creativity, investments in innovation and access to knowledge with the aim of promoting competition and the social and economic development of Brazil. The ENPI is divided into seven structural axes : (i) Intellectual Property (IP) for Competitiveness and Development; (ii) Dissemination, Education, and Training in IP; (iii) Governance and Institutional Strengthening; (iv) Modernization of Legal and Infralegal Marks; (v) Legal Observance and Security; (vi) Intelligence and the Vision of the Future; and (vii) Inclusion of Brazil in the Global IP system.
As alluded to above, public comments and suggestions on the draft can be submitted until September 13, 2020 (extended deadline) and is completely voluntary. Specifically, any comments or suggestions should be submitted electronically and should use ENPI’s General Glossary of Terms. Specifically, comments and suggestions should be structured based on each of ENPI’s seven structural axes.
The draft proposes several actions to be implemented and follows the general guideline that intellectual IP is a general tool that is to be used to foster innovation and attract investments. Additionally, the draft proposes to establish new IP regulatory landmarks to prepare Brazil for a 4.0 Economy that will allow for digital transformation of Brazilian companies.
We would like to highlight several significant actions proposed by the draft:
In the section relating to “Governance and Institutional Strengthening” (Structural Axis 3), the draft proposes the development of an IP policy within the Ministry of Health. Development of such a policy would help to establish a connection and a continuation of strategic actions or actions that would be implemented (short-term, middle-term or long-term strategies) by stakeholders and public administration entities.
In the “Modernization of Legal and Infralegal Marks” (Structural Axis 4) section, several proposals are made which may impact the pharmaceutical area. For example, one proposal supports measures to adjust the patents granted on drugs that are considered strategic to the Brazilian Health System (SUS). Specifically, the proposal in the draft aims at (i) enabling changes to the minimum medication price, established by Law #10,742/2003, based on the remaining term of a patent; (ii) reviewing Resolution #02/2004 of the Drug Market Regulation Chamber – CMED – (Brazilian FDA Department) to include patent evaluation before allowing the commercialization of a first generic medicine; and (iii) reviewing Ordinance #2/GM/MS/2017, Chapter III, Annex XXVII, that institutes the National Policy of Medicine.
Also proposed is the creation of a technical group at GIPI to evaluate and (eventually) propose adjustments in several intellectual property legal “landmarks” that affect public health and innovation policy in the health sector. These adjustments will be directed at: (i) the sole paragraph of article 40 of Law #9.279/96, which states that a patent will have at least a ten year term from the date of grant; (ii) article 229C of #9.279/96 establishing ANVISA’s (the Brazilian FDA) prior consent for the granting of patents on pharmaceutical products and processes ; (iii) data protection for tests submitted to ANVISA for obtaining marketing authorization for drugs; and (iv) evaluating the repurposing/repositioning of medical uses (second medical use patents.)
“Brazil’s inclusion in the Global System of IP” (Structural Axis 7) is intended to empower its participation in IP international forums, stimulate the presence of Brazilian companies abroad and promote a local business environment beneficial for foreign investments. This section also seeks to set the groundwork for promoting Brazil’s inclusion in the Global Patent Prosecution Highway´s (GPPH) pilot program. Accordingly, this section intends to assess and stimulate Brazil’s participation in international agreements, such as: The Geneva Act of the Hague Agreement Concerning the International Registration of Industrial Designs; 1991 Act of the International Convention for the Protection of New Varieties of Plants); Patent Law Treaty – PLT; Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure; Singapore Treaty on the Law of Trademarks; WIPO Copyright Treaty – WCT; WIPO Performances and Phonograms Treaty – WPPT; Beijing Treaty on Audiovisual Performances; and Lisbon Agreement on Appellations of Origin and Geographical Indications.
After receiving comments and suggestions by September 13, 2020, the National Strategy of Intellectual Property will be finalized and implemented. The implementation should last about 10 years. Specifically, its execution will be divided into separate Action Plans having their own 2-year schedule which will be aligned with the government’s future actions for the IP sector. GIPI will be responsible for ENPI’s governance and implementation.
Please continue to watch BRICS & Beyond for updates on the National Strategy of Intellectual Property in Brazil.
This post was written by Lisa Mueller and Roberto Rodrigues Pinho and Ana Calil of Licks Attorneys.