On August 10th, it was published in the Brazilian Official Gazette Public Consultation #46/2020, which is open to receive comments and suggestions for the draft of the National Strategy of Intellectual Property (ENPI). The initiative is the result of a work group that includes various public administration entities and is coordinated by the Intellectual Property Interministerial Group (GIPI), which is presided by the Ministry of Economy.
ENPI’s objective is to set the grounds for a balanced and effective National System of Intellectual Property (SNPI), which should be broadly used and foster creativity, investments in innovation and access to knowledge, aiming at promoting competition and Brazilian social and economic development.
The Public Consultation will be open until August 30th. Comments and suggestions should be submitted via electronic forms and should include ENPI’s form of General Definitions. Contributions should be made following ENPI’s seven structural axes: (i) IP for Competition and Development; (ii) IP Dissemination, Training and Qualification; (iii) Governance and Strengthening Institutions; (iv) Modernization of Non-Statutory Law and Legal Landmarks; (v) Compliance and Legal Certainly; (vi) Intelligence and Future’s perspective; and (vii) Brazil’s inclusion in the Global System of Intellectual Property. These forms do not have an obligatory fulfilling; party submits it according to its interest.
The draft suggests several actions to be implemented and follows a general guideline that IP is a general tool to foster innovation and attract investments, including the establishment of new IP regulatory landmarks that should prepare the country for a 4.0 Economy enabling the companies’ digital transformation.
We would like to highlight the following actions which embedded risks should be carefully managed:
In “Governance and Strengthening Institutions” (Structural Axis 3), it proposes the development of an IP policy within the Ministry of Health, which would help in establishing a connection and a continuation of strategic actions, or actions that will be implemented (short-term, middle-term or long term strategies) by stakeholders and public administration entities.
Among the proposed actions in “Modernization of Non-Statutory Law and Legal Landmarks” (Structural Axis 4), there are considerable issues that may impact the pharmaceutical area, as the proposal to support measures to adjust patent granting on drugs that are considered strategic to the Brazilian Health System (SUS). It aims at (i) enabling changes to the minimum medication price, established by Law #10,742/2003, observing a patent’s remaining term; (ii) reviewing the Resolution #02/2004 of Drug Market Regulation Chamber – CMED - (Brazilian FDA Department) to include patent evaluation before allowing the commercialization of the first generic medicine; and (iii) reviewing the Ordinance #2/GM/MS/2017, Chapter III, Annex XXVII, that institutes the National Policy of Medicine.
Furthermore, it proposes the creation of a technical group at GIPI to evaluate and eventually propose adjustments in intellectual property legal landmarks that affects public health and innovation policy in the health sector, considering the (i) sole paragraph of article 40 of Law #9.279/96, which states that a patent will be valid for at least ten years from the date of the patent’s granting; (ii) article 229C of #9.279/96 establishing ANVISA’s (the Brazilian FDA) previous 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) evaluate repositioning of medical uses (second use patents.)
“Brazil’s inclusion in the Global System of Intellectual Property” (Structural Axis 7) expects to empower the Brazilian participation in IP international forums, stimulate the presence of Brazilian companies abroad and promote a local business environment beneficial for foreign investments. It also seeks to set ground for promoting Brazil’s inclusion in the Global Patent Prosecution Highway´s (GPPH) pilot program. Accordingly, it 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 the stakeholders’ contributions, the National Strategy of Intellectual Property will be consolidated and should last for 10 years. Its execution will be divided in Action Plans with their own 2-year schedule and be related to the government’s future actions for the IP sector. GIPI will be responsible for ENPI’s governance and implementation.
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