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La pandemia de COVID-19 demostró que las políticas públicas relacionadas con la propiedad intelectual y el derecho de la competencia no fueron adecuadas o suficientemente articuladas para permitir el acceso oportuno de la población a las vacunas de manera equitativa, debido a distorsiones en su fabricación, distribución y venta cuando éstas estuvieron disponibles durante la pandemia. Esta investigación tiene como objetivo analizar, desde una perspectiva jurídica, si los problemas observados se originan en una inadecuada aplicación de la legislación que regula la propiedad intelectual y su relación con otras políticas públicas vinculadas a la competencia, o, eventualmente, en el ejercicio abusivo de tales derechos, y que, como consecuencia, distorsionaría el proceso de competencia en los mercados nacionales y regionales.
The COVID 19 pandemic demonstrated that public policies related to intellectual property and competition law were not adequate or sufficiently articulated to allow timely access to vaccines in an equitable manner, due to distortions in the manufacture, distribution, and sale of COVID-19 vaccines when they were available during the pandemic. This research aims to analyze, from a legal perspective, whether the observed problems originate in an inadequate application of intellectual property legislation and its relationship with other public policies related to competition, or, eventually, in the abusive exercise of such rights, which, as a consequence, would distort the process of competition in national and regional markets.
A pandemia de COVID 19 demostrou que as políticas públicas relacionadas com a propriedade intelectual e o direito de competência não foram adequados ou suficientemente articulados para permitir o acesso oportuno da população às vacinas de maneira equitativa, devido a distorções na fabricação, distribuição e venda de vacinas COVID-19, quando estavam disponíveis durante a pandemia. Esta investigação tem como objetivo analizar, desde uma perspectiva jurídica, se os problemas observados se originam em uma inadequada aplicação da legislação que regula a propriedade intelectual e sua relação com outras políticas públicas vinculadas à competência ou, eventualmente, no exercício abusivo de tais direitos, e que, como consequência, distorceria o processo de competência nos mercados nacionais e regionais.
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The development of single Chinese materia medica is an important direction of technological innovation in the field of Chinese materia medica at present, and the study of its comprehensive intellectual property protection system is of great significance to the intellectual property protection of the whole chain of innovative enterprises of single Chinese materia medica. Based on this, this paper takes the comprehensive protection system of intellectual property of Callicarpa nudiflora constructed by Jiuzhitang Pharmaceutical as a model to conduct empirical research, analyzes the protection forms applicable to intellectual property of Chinese materia medica, such as patents, administrative protection, trademarks, designs and intangible cultural heritages, and discusses the valuable and insufficient aspects of the protection system currently constructed by Jiuzhitang Pharmaceutical and puts forward the following suggestions:①paying attention to patent applications for planting/processing methods of raw medicinal materials, ②emphasizing the protection of geographical indications, authentic medicinal herbs, and new plant varieties, ③actively promoting product and technology upgrades, ④applying for data protection during product iteration, ⑤emphasizing the layout timing of patent and administrative protection, ⑥focusing on improving goodwill, ⑦enhancing awareness of intellectual property protection and promoting deep integration of industry, academia, and research. We hope that innovative enterprises engaged in the development of single Chinese materia medica can learn from the experience of the case, and optimize the strategy to better protect related products.
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Medical institutions are not only the research and development end, but also the application end of innovative achievements, which makes the transformation of medical scientific and technological achievements different from the others in colleges and universities. It also faces new problems and challenges in ethical governance. Meanwhile, the ethics of promoting the transformation of medical scientific and technological achievements also needs to be paid attention to and maintained. Improving people’s health level and quality of life are the ultimate ethical goals of process supervision. The objectives, systems, and behaviors of ethical evaluation need to have their own emphasis to avoid repeated evaluation, improve evaluation efficiency, and ensure the ethics of evaluation work itself. This paper discusses the specific classification and common forms of ethical challenges in the supervision of the transformation process of achievements in medical institutions. It is suggested to focus on ethical values to improve the legal system, clarify the relationship between the public welfare and transformation profitability of medical institutions, and explore new positions of the transformation advantages in medical institutions.
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Resumo A covid-19 jogou luz sobre o impacto negativo da propriedade intelectual na saúde e deu nova relevância à Ação Direta de Inconstitucionalidade 5529/DF, que, acatada pelo Supremo Tribunal Federal em 2021, culminou na extinção da extensão automática de patentes no Brasil. Este estudo busca analisar o efeito do julgamento histórico da ADI 5529/DF sobre pedidos de patente e as patentes de interesse das Parcerias para Desenvolvimento Produtivo (PDP). Trata-se de um estudo com base em uma pesquisa documental de análise do andamento, até 31 de dezembro de 2020, de 90 pedidos de patente relacionados a 15 medicamentos objetos de PDP. Nos sites do Instituto Nacional de Propriedade Industrial, do Ministério da Saúde, da Anvisa e da Câmara de Regulação do Mercado de Medicamentos, foram pesquisadas variáveis para comparar o cenário patentário dos medicamentos com o das PDP. De 88 pedidos válidos, 28 patentes foram concedidas, das quais dezessete foram estendidas para mais de vinte anos (média de 24 anos e nove meses). A decisão do STF resultou em mais de 68 anos de monopólio perdidos, potencialmente desanuviando alternativas para a produção de genéricos no país. Neste momento de retomada das PDP, estratégias para a superação de barreiras patentárias deveriam ser incorporadas à política.
Abstract The COVID-19 pandemic has shed light on the negative impact of intellectual property on health and has given new relevance to the Direct Action of Unconstitutionality 5529/DF, which was ruled by the Supreme Court in 2021, resulting in the extinction of automatic patent extensions in Brazil. This documentary case study analyzes the effects of the judicial decision on patent applications and patents of interest for Productive Development Partnerships (PDP), investigating the progress of 90 patent applications related to 15 PDPs drugs of interest until Decembre 31, 2020. Variables for comparing the drug patent scenario with that of the PDPs were researched on the websites of the National Institute of Industrial Property, the Ministry of Health, ANVISA, and the Brazilian Medicines Market Regulation Chamber. Of 88 valid applications, 28 patents were granted, 17 of which had been extended to more than 20 years (24 years and 09 months average). The court decision resulted in a loss of over 68 years of monopoly, potentially opening alternatives for generic production. This resumption of the PDP policy should incorporate strategies to overcome patent barriers.
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Propiedad Intelectual de Productos y Procesos Farmacéuticos , Acceso a Medicamentos Esenciales y Tecnologías Sanitarias , Complejo Económico-Industrial de la Salud , Política de SaludRESUMEN
Resumo Este artigo procurou contribuir para a literatura e para o debate nacional e global sobre a superação de uma polarização relacionada ao aspecto jurídico e administrativo do processo de inovação, procurando se concentrar nas patentes como um fator condicionante das trajetórias tecnológicas que viabilizam o aprendizado em âmbito produtivo. Baseou-se em um arcabouço teórico e político relacionado à inovação e ao acesso a medicamentos, especialmente quanto aos direitos de Propriedade Intelectual, e na análise crítico-reflexiva de instrumentos de Propriedade Intelectual utilizados em Parcerias para o Desenvolvimento Produtivo (PDP), desenvolvidas por um instituto de tecnologia em fármacos sintéticos, público e nacional. Os resultados demonstram a relevância da compatibilização dos direitos de patentes com a construção de uma capacidade tecnológica e de inovação no país, vinculada ao acesso universal, especialmente quando envolverem produtos que se destinam ao tratamento de doenças graves, de alta complexidade tecnológica e de alto custo. Conclui-se que, para superação da dependência tecnológica e ampliação do acesso a medicamentos no Brasil, o Estado deve buscar o equilíbrio entre os interesses públicos e privados na área da saúde, a articulação entre os instrumentos jurídicos legais existentes e o alinhamento entre suas políticas de saúde, industriais, de CT&I e Propriedade intelectual.
Abstract This article aims to contribute to the literature and to the national and global debate on overcoming the polarization related to the legal and administrative aspect of the innovation process, seeking to focus on patents as a conditioning factor of the technological trajectories that enable learning in the productive scope. It was based on a theoretical and political framework related to innovation and access to medicines, especially regarding Intellectual Property rights, and on a critical-reflexive analysis of Intellectual Property instruments used in Productive Development Partnerships (PDP), developed by a public national institute for synthetic drug technology. The results demonstrate the importance of making patent rights compatible with the construction of technological and innovation capacities in the country, which are linked to universal access, especially when they involve products that are intended to treat serious, technologically complex and high-cost diseases. In conclusion, to overcome technological dependence and expand access to medicines in Brazil, the State must seek a balance between public and private interests in the healthcare area, articulate the existing legal instruments and align its health, industry, ST&I and intellectual property policies.
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Propiedad Intelectual , Política Nacional de Ciencia, Tecnología e Innovación , Complejo Económico-Industrial de la Salud , BrasilRESUMEN
Objective:To promote clinical innovation and patent transformation, Ningbo First Hospital built a medical device innovation and transformation management information platform to optimize the supply of clinical innovation and transformation resources and explore a new path of clinical innovation and transformation management.Methods:A series of processes of medical device innovation research, patent declaration, and transformation were managed by the cloud data platform based on Springboot micro-service architecture. The functions and practices of the medical device innovation and transformation management information platform were elaborated on in detail, and the problems in the platform construction were discussed.Results:The medical device innovation and transformation management information platform has been accepted and recognized by clinical care, enterprises, and third-party agents for shortening the research and development and transformation time of innovative projects.Conclusions:The medical device innovation and transformation management information platform can promote the output and achievement transformation of clinical innovative projects.
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Objective:To analyze the patent development status of 13 general hospitals in Beijing, for reference in promoting the management and translation of intellectual property rights of public hospitals.Methods:13 tertiary general hospitals in Beijing as one of the top 100 hospitals in China in terms of science and technology evaluaton metrics in 2020 were selected as the research subjects. The patent application and authorization information of 13 hospitals was retrieved from the IncoPat technology innovation intelligence platform, during the period from January 1, 2012 to December 31, 2021. The patent application and authorization status, international patent classification distribution, inventor information, patent validity, and registration of patent transfer were analyzed.Results:The numbers of patent applications and authorizations from 13 hospitals increased from 123 and 13 in 2012 to 2 053 and 2 368 in 2021, respectively. From 2012 to 2021, 13 hospital applied for 10 050 patents and authorized 6 896 patents, including 906 authorized invention patents, 5 863 utility model patents, and 127 appearance design patents. Valid patents amounted to 5 925, accounting for 85.92%, and valid authorized invention patents amounted to 796, accounting for 13.43%. 110 of these patents were transferred or licensed, accounting for 1.60% of the authorized patents.Conclusions:Aapplied and authorizated patents were rising year by year, but the ratios of invention patents and patient translation remained at a low level. The author suggestted that hospitals should highlight the value orientation of patents, strengthen-industry-academia-research cooperation, establish a professional management team and standardized management system for intellectual property, cultivate high-value patents, conduct pre patent application evaluation and screening, and improve patent conversion and technological innovation capabilities.
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In recent years, the State has intensified efforts to develop folk Traditional Chinese Medicine (TCM). Shaanxi Province is a large province with rich TCM resources. However, the certificate holding rate of folk TCM in Shaanxi is low, the inheritance of medical skills is not optimistic; the core skills of folk TCM are lack of protection; the traditional folk diagnosis and treatment technology is lack of corresponding standards, and the clinical promotion is difficult, which makes the advantages of folk TCM not fully play. It was suggested that strengthen the assessment of Shaanxi Province’s real expertise, take measures to promote the inheritance, enhance the intellectual property protection of folk TCM in the province, intensify the research and formulation of local folk TCM screening and evaluation standards, and vigorously promote the clinical application of folk TCM in the province, so as to promote the inheritance, protection and development of folk TCM in Shaanxi Province.
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Buscando compreender como as epidemias de zika e chikungunya incitaram o desenvolvimento tecnológico, este estudo realizou levantamento de dados epidemiológicos e prospecção tecnológica, utilizando dados do Instituto Nacional da Propriedade Industrial (INPI) e do Orbit Intelligence. Ainda, analisou produtos desenvolvidos e em desenvolvimento a nível mundial e aqueles registrados no Brasil por meio da Agência Nacional de Vigilância Sanitária (Anvisa). No ano de 2016, observou-se o maior número de casos totais para ambas as doenças. A prospecção tecnológica nacional revelou que há interesse global em desenvolver tecnologias para essas doenças e depositar suas patentes no Brasil, tendo as empresas como principais depositantes. Por sua vez, a prospecção tecnológica global mostrou que o ano de 2016 configura-se como importante marco na evolução do número de patentes para zika e chikungunya, sugerindo que as epidemias brasileiras estimularam o mundo no desenvolvimento de novos insumos para a saúde. Os Estados Unidos e a China são as principais jurisdições, tendo as universidades como maiores depositantes. A análise de produtos a nível global revelou que apenas dois chegaram ao mercado para zika e um para chikungunya, e as vacinas estão na categoria principal. A busca na Anvisa revelou que há mais produtos registrados para zika do que em comparação à chikungunya. Os principais fabricantes legais são empresas brasileiras, com pedidos de registro realizados principalmente pelas empresas DiaSorin S.p.A., ECO Diagnóstica Ltda. e Chembio Diagnostics Brazil Ltda. Apesar do visível estímulo à pesquisa, desenvolvimento e patenteamento gerado pelas epidemias de zika e chikungunya no Brasil, isso não garantiu a chegada de novos produtos ao mercado nem acesso da população a eles.
This study aims to understand how the zika and chikungunya epidemics incited technological development. We surveyed epidemiological data and technological prospecting, using data from Brazilian National Institute of Industry Property (INPI) and Orbit Intelligence, and analyzed products developed/under development worldwide and products registered in Brazil by Brazilian Health Regulatory Agency (Anvisa). In 2016, the highest number of total cases was observed for both diseases. Brazil's technological prospection revealed the existence of a global interest in developing technologies for these diseases and filing their patents in Brazil, with companies as the main depositors. Global technological prospecting showed that 2016 is an important milestone in the evolution of the number of patents for zika and chikungunya, suggesting that Brazilian epidemics stimulated the world in the development of new health inputs. The United States and China are the main jurisdictions, with universities as the largest depositors. Global product analysis revealed that only two products reached the market for zika and one for chikungunya, and vaccines are in the top category. A research in Anvisa revealed more products registered for zika compared to chikungunya. The main legal manufacturers are Brazilian companies, with DiaSorin S.p.A., Eco Diagnóstica Ltda., and Chembio Diagnostics Brazil Ltda. leading the registration requests. Despite the visible stimulus to research, development, and patenting generated by the zika and chikungunya epidemics in Brazil, such stimulus did not guarantee the arrival of new products on the market and population access to these products.
Con el fin de comprender cómo las epidemias de zika y chikunguña estimularon el desarrollo tecnológico, este estudio realizó la recopilación de datos epidemiológicos y la prospección tecnológica, utilizando datos del Instituto Nacional de la Propiedad Industrial (INPI) y Orbit Intelligence, y analizó los productos desarrollados y en desarrollo en todo el mundo y productos registrados en Brasil por la Agencia Nacional de Vigilancia Sanitaria (Anvisa). En 2016 se observó el mayor número de casos para ambas enfermedades. La prospección tecnológica nacional reveló que existe un interés mundial por desarrollar tecnologías para estas enfermedades y depositar sus patentes en Brasil, con las empresas como los principales depositantes. La prospección tecnológica mundial mostró que 2016 fue un hito importante en la evolución del número de patentes de zika y chikunguña, lo que sugiere que las epidemias brasileñas estimularon el desarrollo mundial de nuevos insumos para la salud. EE.UU. y China son las principales jurisdicciones, con las universidades como las mayores depositantes. El análisis global de productos reveló que solo 2 han llegado al mercado para zika y 1 para chikunguña, y las vacunas están en la categoría superior. La búsqueda en Anvisa reveló la existencia de más productos registrados para zika que para chikunguña. Los principales fabricantes legales son empresas brasileñas, con las solicitudes de registro realizadas principalmente por DiaSorin S.p.A., Eco Diagnóstica Ltda. y Chembio Diagnostics Brazil Ltda. Aunque hubo una notable promoción a la investigación, desarrollo y patentamiento generado por las epidemias de zika y chikunguña en Brasil, esto no implicó la llegada de nuevos productos al mercado y el acceso a ellos por parte de la población.
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O presente artigo apresenta resultados de uma pesquisa bibliográfica que teve como objetivo realizar uma reflexão crítica sobre a relação entre a questão ambiental e a discussão internacional sobre sustentabilidade, evidenciando, a partir de acordos multilaterais da globalização econômica, a geopolítica internacional de interesses contraditórios defendidos no âmbito da Convenção sobre a Diversidade Biológica (CDB) e o Acordo sobre Aspectos Comerciais Relativos aos Direitos de Propriedade Intelectual (Agreement on Trade-Related Aspects of Intellectual Property Rights TRIPS), estabelecido pela Organização Mundial do Comércio (OMC). Entre os principais resultados, aponta-se que os princípios de proteção da natureza e dos conhecimentos das populações tradicionais estabelecidos na CDB estão em confronto com os interesses do sistema internacional de propriedade intelectual na arena de disputa pelo acesso aos recursos da natureza e ao conhecimento das populações tradicionais pela indústria mundial de biotecnologia
This article presents the results of a bibliographical research, which aimed tocarry out a critical reflection on the relationship between the environ-mental issue and the international discussion on sustainability, highlighting, from multilateral agreements on economic globalization, the international geopolitics of contradictory interests defended within the scope of the Convention on Biological Diversity (CBD) and the intellectual property agreement (TRIPS) established by the World Trade Organization (WTO). Among the main results, it is pointed out that the principles of protecting nature and the knowledge of traditional populations established in the CBD are in conflict with the interests of the international intellectual property system, through the dispute for access to natural resources and knowledge of traditional populations by the global biotechnology industry
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AmbienteRESUMEN
Copyright is a right given by the law to creators of literary, dramatic, musical and artistic works and producers of cinematograph films and sound recordings. In fact, it is a bundle of rights including, inter alia, rights of reproduction, communication to the public, adaptation and translation of the work. There could be slight variations in the composition of the rights depending on the work.
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Abstract: An Act to amend and consolidate the law relating to trademarks, to provide for registration and better protection of trademarks for goods and services and for the prevention of the use of fraudulent marks. A trademark (popularly known as brand name) in layman's language is a visual symbol which may be a word signature, name, device, label, numerals or combination of colours used by one undertaking on goods or services or other articles of commerce to distinguish it from other similar goods or services originating from a different undertaking.
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Propósito/Contexto. En este artículo se analizan los distintos factores que han afectado el acceso a las vacunas para la prevención de la infección por SARS-CoV-2, con particular atención a los intereses que atraviesan las negociaciones. Se detalla un análisis de los procesos de investigación, producción, contratación, distribución y comercialización de vacunas, así como las normas éticas internacionales que orientan estas prácticas. Metodología/Enfoque. De igual modo, se identifican un marco de excepciones científicas, metodológicas, éticas y legales para la investigación, la producción y la comercialización de vacunas, al tiempo que se ha mantenido y profundizado, sin excepciones, las normas impuestas por el sistema global de mercado en lo referente a protección de propiedad intelectual (Adpic), negociaciones y contratos, defensa de intereses privados y de las empresas. También se pone en evidencia el rol que han tenido los países más ricos, acumulando más dosis de las necesarias, lo cual impactó seriamente en el acceso de los países de bajos ingresos. Resultados/Hallazgos. Se analizan las normas éticas internacionales y los acuerdos realizados por los gobiernos que deberían limitar conductas como estas, evitar sus consecuencias y que no han sido cumplidas. Discusión/Conclusiones/Contribuciones. Se concluye con una propuesta concreta que podría aliviar la situación actual y se incluye una reflexión sobre el impacto en la vida y la salud de los países y los grupos más vulnerables, si el orden internacional sigue regido por el sistema global de mercado en lugar de un nuevo pacto global más justo.
Purpose/Context. This article discusses the various factors that have affected access to vaccines for the prevention of SARS-CoV-2 infection, with particular attention to the interests involved in the negotiations. An analysis of the processes of vaccine research, production, procurement, distribution, and marketing is detailed, as well as the international ethical standards that guide these practices. Methodology/Approach. Similarly, a framework of scientific, methodological, ethi-cal and legal exceptions for research, production and commercialization of vaccines is identified, while the rules imposed by the global market system regarding intellec-tual property protection (TRIPS), negotiations and contracts, defense of private and corporate interests have been maintained and deepened without exceptions. It also highlights the role played by the richest countries, accumulating more doses than necessary, which seriously impacted the access of low-income countries. Results/Findings. The international ethical norms and agreements made by gover-nments that should limit conducts such as these, avoid their consequences and that have not been complied with, are analyzed. Discussion/Conclusions/Contributions. It concludes with a concrete proposal that could alleviate the current situation and includes a reflection on the impact on the life and health of the most vulnerable countries and groups, if the international order continues to be governed by the global market system instead of a new and fairer global agreement.
Finalidade/Contexto. Este artigo discute os vários factores que afectaram o acesso às vacinas para a prevenção da infecção pelo SRA-CoV-2, com especial atenção para os interesses envolvidos nas negociações. Detalha uma análise dos processos de investigação, produção, aquisição, distribuição e comercialização de vacinas, bem como as normas éticas internacionais que orientam estas práticas. Metodologia/Aproximação. Do mesmo modo, é identificado um quadro de excepções científicas, metodológicas, éticas e legais para a investigação, produção e comercialização de vacinas, enquanto as regras impostas pelo sistema de mercado global em termos de protecção da propriedade intelectual (Adpic), negociações e contratos, defesa de interesses privados e empresariais foram mantidas e aprofundadas sem exceções. Salienta também o papel desempenhado pelos países mais ricos, acumulando mais doses do que as necessárias, o que teve um sério impacto no acesso dos países de baixos rendimentos. Resultados/Findings. Normas e acordos éticos internacionais feitos pelos governos que deveriam limitar comportamentos como este e evitar as suas consequências são analisados e não têm sido cumpridos. Discussão/Conclusões/Contribuições. Conclui com uma proposta concreta que poderia aliviar a situação actual e inclui uma reflexão sobre o impacto na vida e saúde dos países e grupos mais vulneráveis, se a ordem internacional continuar a ser regida pelo sistema de mercado global em vez de um novo pacto global, mais justo.
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In China and abroad, Traditional Chinese Medicine (TCM) have been applied and developed. That is depended on doctors and scholars of the past dynasties to inseparable from the inheritance, protection, development, and innovation of Traditional Knowledge of Chinese Medicine. With the progress of modern society and people's awareness of traditional culture protection, people are also improving the understanding of TCM. Through the analysis of the situation and significance of the protection of Traditional Knowledge of Chinese Medicine and the development of Japanese Kampo medicines, recognized that the development of Kampo medicines ignored the source. Their original intention and purpose of protection the Traditional Knowledge of Medicine are completely different from China. The protection of Traditional Knowledge of Chinese Medicine should be in accordance with the basic national conditions, and the system of the protection of Traditional Knowledge of Chinese Medicine should be formulated and perfected to ensure the sustainable development of TCM.
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Objective:To analyze the intellectual property risk of international cooperative scientific research involving human genetic resources, explore possible risk control measures regarding to intellectual property.Methods:By means of literature review, this paper analyzes the special attributes and strategic position of human genetic resources, reviews the policies and systems involving human genetic resources in international cooperative scientific research, identifies the intellectual property risk points, and puts forward suggestions on risk management and control from the perspective of intellectual property protection.Results:The management of human genetic resources in China is evolving quickly. However, there is still a lack of practical guidelines on intellectual property protection and development, more substantial engagement and contribution of Chinese investigators in the international collaborative research should be promoted, and the perception and awareness of the significance of human genetic resources should be enhanced.Conclusions:In the international cooperative scientific research involving human genetic resources, we should clarify the operating rules at the level of intellectual property protection, improve the substantive participation of Chinese investigators, enhance the strategic awareness and risk awareness of human genetic resources, and provide support at the level of executive management institutions.
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As an important part of Chinese history and culture, traditional medicine is the sum of diagnosis and treatment knowledge, skills and practice methods that have been verified to be effective and of great value through thousands of years of practice. Since the global outbreak of the COVID -19 epidemic, "traditional medicine" has flourished in China, but has also been doubted by different cultural fields overseas. Based on traditional medicine, facing the realistic situation of "ice and fire", focusing on the contrasting four pairs of traditional medicine "contradictions", it was proposed that the approach choice of the strategic mode of intellectual property rights of traditional medicine should aim at "precision", "institutionalization" and "internationalization", and jointly promote it from the three-dimensional perspective of macroscopic pattern "strategic depth, strategic breadth, strategic height", so as to explore the strategic protection mode of intellectual property rights of traditional medicine with "Chinese characteristics and world level".
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RESUMO Com o objetivo de estimular a produção e o licenciamento de novas tecnologias, o Instituto Nacional da Propriedade Industrial (INPI), autarquia responsável pela concessão de patentes no Brasil, criou uma modalidade de trâmite prioritário para processos de patentes relativos a inovações que possam ser usadas no combate à COVID-19. Os primeiros efeitos dessa medida institucional foram avaliados no presente trabalho, a partir da identificação e análise do tempo dos processos prioritários de patente solicitados por ofício pelo Ministério da Saúde ou por meio de petição pelos próprios depositantes. Os resultados demonstram que o INPI foi capaz de atender de forma exitosa à emergência de saúde pública, concedendo patentes em um período médio de 5,3 meses a contar do pedido de priorização, um tempo consideravelmente inferior à média exigida nos processos usuais.
ABSTRACT With the objective of stimulating the production and licensing of new technologies, the National Institute of Industrial Property (INPI), the agency responsible for granting patents in Brazil, created a priority or fast track procedure for patent processes related to innovations that can be used against COVID-19. The first effects of this institutional measure are assessed in the present work, based on the identification and analysis of the time elapsed between fast track requests by the Ministry of Health or through petition by the depositors themselves. The results demonstrate that the INPI was able to successfully respond to the public health emergency by granting patents on average 5.3 months after the fast track request, a time considerably shorter than the average required in usual processes.
RESUMEN Con objeto de estimular la producción y el otorgamiento de licencias de nuevas tecnologías, el Instituto Nacional de la Propiedad Industrial (INPI), entidad autónoma responsable de la concesión de patentes en Brasil, creó una modalidad de trámite prioritario para los procesos de concesión de patentes relativas a innovaciones que puedan emplearse en la lucha contra la COVID-19. En este trabajo se evaluaron los primeros efectos de esa medida institucional, al determinar y analizar la duración de los procesos prioritarios de concesión de patentes solicitados por medio de comunicación oficial del Ministerio de Salud o de una petición presentada por los propios solicitantes. Los resultados demuestran que el INPI pudo atender con éxito la emergencia de salud pública, al conceder patentes en un período promedio de 5,3 meses contados a partir de la fecha de presentación de la solicitud de priorización, un tiempo considerablemente inferior al promedio exigido en los procesos habituales.
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Resumo O texto contém uma proposta atualizada de política de Ciência, Tecnologia e Inovação em Saúde no Brasil e a pertinência da atualização decorre do desastre nas atividades nesse terreno verificadas no país desde o início do atual governo federal em 2019, bem como dos desafios colocados pela emergência da pandemia COVID-19 desde 2020. Ele está organizado em cinco seções, a saber: Pesquisa em Saúde; Inovação Produtiva; Avaliação e Incorporação de Tecnologias em Saúde; Propriedade Intelectual em Saúde; Novos desafios colocados pela Pandemia. Os autores fazem parte do Comitê de Assessoramento em Ciência, Tecnologia e Inovação da Abrasco.
Abstract The text presents an updated proposal for a Health Science, Technology and Innovation Policy in Brazil, following the huge political turmoil in the country since 2019 and the COVID-19 pandemic since 2020. The proposal is presented in five sections: Scientific Research; Productive Innovation; Health Technology Assessment and Incorporation; Intellectual Property in Health; New challenges posed by the Pandemic. The authors take part in the Advisory Committee in Science, Technology and Innovation of the Brazilian Association of Collective Health.
Asunto(s)
Humanos , Pandemias , COVID-19 , Tecnología , Brasil , SARS-CoV-2 , Política de SaludRESUMEN
Resumen: Artículo de carácter reflexivo y argumentativo que busca confrontar referentes conceptuales desde la Bioética y el derecho para dar solución a estos interrogantes: ¿son los derechos de propiedad intelectual la antítesis de otros derechos? ¿Existe un conflicto de principios bioéticos en dicha tensión? ¿Cómo abordar desde la Bioética este choque de miradas? ¿Es necesario un cambio de paradigma para transformar el individualismo imperante de la contemporaneidad y evitar los daños de una guerra de rapiñas que se enmascara detrás de un eufemismo de la competencia de mercados y la propiedad intelectual? Entre argumentos, cuestionamientos y disensos se busca un abordaje a estos dilemas con un enfoque bioético. Se deja sobre la mesa la cooperación con una base de empatía y compasión para desviarse del camino del individualismo pernicioso y la voracidad subsecuente del dinero y el poder. Por ello, la Bioética como puente hacia al futuro es la disciplina llamada manifestar dicha cooperación, no solo en los ámbitos disciplinarios, sino entre los diferentes actores sociales, entre los protagonistas de esta obra, para que su final no sea trágico, sino esperanzador y saludable.
Summary: This is a reflexive and argumentative article which intention is to confront conceptual references from bioethics and the right to solve the following questions: are intellectual property rights the antithesis of other rights? Is there a conflict of bioethical principles in this discussion? How to address from Bioethics this difference in point of views? Is a paradigm shift necessary to transform the prevailing individualism of contemporaneity and avoid the damages of a war of plunder masked behind a euphemism of market competition and intellectual property? Between arguments, questions and dissents, an approach to these dilemmas is sought with a bioethical approach. Cooperation is on the table based on empathy and compassion to divert it from the path of pernicious individualism and the subsequent voracity of money and power. Therefore bioethics, as a bridge to the future is the discipline called to manifest this cooperation, not only in disciplinary areas, but between the different social stakeholders, among those main players of this work, so that its end is not tragic, but hopeful and healthy.
Resumo: Artigo reflexivo e argumentativo que busca confrontar referências conceituais da Bioética e do direito para resolver as seguintes questões: os direitos de propriedade intelectual são a antítese de outros direitos? Existe um conflito de princípios bioéticos nessa tensão? Como abordar este choque de perspectivas a partir da Bioética? É necessária uma mudança de paradigma para transformar o individualismo predominante da contemporaneidade e evitar os danos de uma briga que se mantém mascarada por trás de um eufemismo de concorrência de mercado e propriedade intelectual? Entre argumentos, perguntas e dissensos, busca-se uma abordagem desses dilemas com uma abordagem Bioética. A cooperação é deixada sobre a mesa com uma base de empatia e compaixão para se desviar do caminho do individualismo pernicioso e da subsequente voracidade do dinheiro e do poder. Portanto, a Bioética, como ponte para o futuro, é a disciplina convocada a manifestar tal cooperação, não apenas nos campos disciplinares, mas entre os diferentes atores sociais, entre os protagonistas deste trabalho, para que seu fim não seja trágico, mas esperançoso e saudável.
RESUMEN
O direito de propriedade intelectual tem as suas exceções e os seus limites internos, previstos na lei. Nos últimos tempos, vem crescendo a discussão da sua compressão à luz de princípios gerais, como o interesse público, a liberdade de expressão ou a saúde pública. Dir-se-ia, pois, que estes direitos têm, também, uma função social, para além da proteção das prerrogativas dos seus titulares, o que é verdadeiro, sobretudo, para as patentes farmacêuticas. Grande parte desta discussão sempre passou, na verdade, pelas patentes farmacêuticas, sua concessão e exploração, em especial no que tange às patentes biotecnológicas. Esta discussão mais e mais se exacerbou quanto às patentes das vacinas destinadas ao tratamento contra a COVID-19. Não falta quem queira lançar mão dos meios previstos nas leis nacionais e internacionais para compelir às licenças obrigatórias das patentes e, até, à sua expropriação. Em causa, podem estar, no entanto, outros aspetos, como contratos mal negociados pela Comissão da União Europeia com algumas empresas farmacêuticas e os problemas logísticos na produção de vacinas. Por outro lado, centrar a discussão nas patentes poderá ser redutor, uma vez que há outros aspetos da propriedade intelectual a considerar. Contudo, a resposta estará, muito provavelmente, no equilíbrio entre os direitos dos titulares de patentes e o interesse público.
Intellectual property law has its exceptions and internal limits, as provided by law. In recent times, there has been a growing discussion of its compression in the light of general principles, such as public interest, freedom of expression or public health. It would be said, therefore, that these rights also have a social function, in addition to protecting the rights of their holders, which is especially true for pharmaceutical patents. Much of this discussion has always, in fact, passed through pharmaceutical patents, their granting and exploitation, especially regardingbiotechnological patents. This discussion has become increasinglyexacerbated regardingthe patents on vaccines intended for treatment against COVID-19. There is no shortage of people who want to use the means provided by national and international laws to compel mandatory patent licenses and even their expropriation. At issue, however, may be other aspects, such as contracts poorly negotiated by the European Union Commission with pharmaceutical companies and logistical problems in the production of vaccines. On the other hand, focusing the discussion on patents, can be reduced, there are other aspects of intellectual property to consider. However, the answer will most likely lie in the balance between the rights ofpatent holders and the public interest.
La ley de propiedad intelectual tiene sus excepciones y límites internos, según lo establece la ley. En los últimos tiempos, ha habido un creciente debate sobre su compresión a la luz de principios generales, como el interés público, la libertad de expresión o la salud pública. Se diría,por tanto, que estos derechos también tienen una función social, además de proteger los derechos de sus titulares, lo que es especialmente cierto para las patentes farmacéuticas. Gran parte de esta discusión siempre ha pasado, de hecho, por las patentes farmacéuticas, su concesión y explotación, especialmente en lo que respecta a las patentes biotecnológicas. Esta discusión se ha exacerbado cada vez más con respecto a las patentes de vacunas destinadas al tratamiento contra COVID-19. No hay escasez de personas que quieran utilizar los medios que brindan las leyes nacionales e internacionales para imponer licencias de patentes obligatorias e incluso su expropiación. Sin embargo, pueden estar en juego otros aspectos, como los contratos mal negociados por la Comisión de la Unión Europea con algunas empresas farmacéuticas y los problemas logísticos en la producción de vacunas. Por otro lado, centrar la discusión en las patentes, se puede reducir, hay otros aspectos de la propiedad intelectual a considerar. Sin embargo, lo más probable es que la respuesta esté en el equilibrio entre los derechos de los titulares de patentes y el interés público.