Banca de QUALIFICAÇÃO: LARISSA PIEROZAN
Uma banca de QUALIFICAÇÃO de MESTRADO foi cadastrada pelo programa.STUDENT : LARISSA PIEROZAN
DATE: 10/05/2024
TIME: 14:00
LOCAL: https://meet.google.com/rtt-imeb-axr
TITLE:
“AGRO É POP, AGRO É TECH, AGRO É TUDO”: an analysis of the protection of test data submitted to government entities for approval of the marketing of pesticides
KEY WORDS:
Pesticides; Intellectual Property; Undisclosed Information.
PAGES: 56
BIG AREA: Ciências Sociais Aplicadas
AREA: Direito
SUBÁREA: Direitos Especiais
SUMMARY:
Test data protection is crucial for organizations that develop products that require state approval for commercialization. The protection of this data originates from the chapter on the protection of undisclosed information in the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). In Brazil, the protection of such data is ensured by prohibiting unfair competition, specifically, against the disclosure, exploitation, or use of this data without the authorization of its holder (art. 195, XIV, Law 9,279/1996). There are discussions about the scope of this protection for the commercialization of generic products. In Brazil’s pharmaceutical area, it is allowed that generic medicines demonstrate that they have pharmaceutical equivalence and bioequivalence (Resolution n. 16/2007, Anvisa) to reference medicine. Therefore, for the registration of the generic medicine, there is no need to submit efficacy, safety, and quality tests, as they have already been submitted for approval of the reference medicine. In the area of pesticides, there is legislation that establishes a period of exclusive use of data submitted for approval of the commercialization of these products. Third parties seeking to register a generic pesticide must redo the tests if they do not have authorization from the holder of the reference pesticide during the protection period. Despite discussions about the exclusive period protection of test data being widely debated in the pharmaceutical industry, there is a scarcity of publications in the field of pesticides. Although there is literature on the protection of test data for pesticides, its content is limited to exposing the legal aspects of the protection granted. In this context, questions arise about how test data is protected. Is all data protected? Can they be publicized? If so, how would this be done? How is the confidentiality of this data guaranteed? How do organizations exploit this test data? Do organizations exploit this data beyond being a requirement to register a pesticide? Therefore, this research objective is to comprehend how the protection of test data submitted for approval of the marketing of pesticides in Brazil occurs, investigating the economic-strategic value of these data for the organizations that produce them. A qualitative and exploratory approach will be adopted. The research will be divided into two stages. In the first stage, the data will be collected using techniques of documentary research, systematic literature review, and semi-structured interviews. In the second stage, the analysis and interpretation of the data collected will be carried out according to the specific objectives proposed in this research. It is expected that, at the end of the research, it will be verified whether all data submitted is subjected to protection for an exclusive period by Law 10,603/2002. It also seeks to identify how the exclusive period of protection of reference product data is guaranteed by government entities and what measures are taken to ensure the confidentiality of this information by organizations that produce pesticides. Finally, it aims to obtain data on the economic-strategic value of the test data, beyond being a requirement for the approval of the commercialization of pesticides.
COMMITTEE MEMBERS:
Interna - 004.321.979-90 - KELLY LISSANDRA BRUCH - UFRGS
Externa à Instituição - CLAUDIA INÊS CHAMAS - Fiocruz - RJ
Externa à Instituição - PATRICIA DE OLIVEIRA AREAS - UNIVILLE
Externo à Instituição - DANIEL ALVES LEASTRO