[Fast track patent program for COVID-19 in BrazilProceso rápido de concesión de patentes para enfrentar la COVID-19 en Brasil]. / Concessão rápida de patentes para enfrentamento da COVID-19 no Brasil.

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.

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.

Concessão rápida de patentes para enfrentamento da COVID-19 no Brasil

[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 moda- lidade 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 themsel- ves. 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 Nacio- nal 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 presen- tación de la solicitud de priorización, un tiempo considerablemente inferior al promedio exigido en los procesos habituales.

Concessão rápida de patentes para enfrentamento da COVID-19 no Brasil / Fast track patent program for COVID-19 in Brazil / Proceso rápido de concesión de patentes para enfrentar la COVID-19 en Brasil

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.

Inventive step assessment of top selling monoclonal antibodies in Brazil.

Introduction: The patent system is fundamental for the pharmaceutical industry development, providing a return on the large investment of time and financial resources. Among the patentability requirements, understanding how to comply with the inventive step is especially important for patent applicants. Regarding mAbs, due to the high affinity and specificity for their molecular therapeutic target, minimal structural changes can lead to unexpected properties, being a common issue among Patent Offices.Areas covered: The present research investigated the Brazilian patents covering top-selling mAbs.Expert Opinion: The more complete and detailed the mAb when the patent application is filed, the greater the chance of the patent being granted. It is necessary to disclose, at least, the six CDRs, the complete variable region, and/or the hybridoma. The Applicant shall specify faced obstacles during mAb generation, mainly if it is a common issue and resulted in improved properties. If it is possible, the Applicants shall compare the claimed mAbs to previous ones, focusing on the achieved unexpected or improved properties. After an objection by BRPTO, the Applicant shall submit data with quantitatively data about qualitative information disclosed at the Specification when filed. If applicable, show different epitope-binding and highlight clinical advantages of successful mAbs.

Revisiting the concept of Innovative Developing Countries (IDCs) for its relevance to health innovation and neglected tropical diseases and for the prevention and control of epidemics.

INTRODUCTION: Countries have traditionally been split into two major groups: developed or industrialized ("the North") and developing or underdeveloped ("the South"). Several authors and organizations have challenged this classification to recognize countries that have reached an intermediate stage of social and economic development. As proposed by Morel and collaborators in 2005, the concept of Innovative Developing Countries (IDCs) defines a group of nations with impactful scientific programs. Here, IDCs are reexamined by a variety of metrics to highlight their role in health innovation through research and development (R&D) programs on neglected tropical diseases (NTDs) that also positively impact epidemic preparedness. RESULTS: To address the global changes due to expanding globalization we updated the original indicator of the number of USPTO patents deposited by individual countries per GDP and per capita to the number of international patents applications, related to applicant residence and deposited under the Patent Cooperation Treaty (PCT) per GNI (or GDP) and per capita. A comparison of the originally described ranking of top innovative countries to those in the present study revealed new members that updated the list of IDCs and showed a prominent role now played by China. Analyzing scientific publications in international journals since the introduction of the IDC concept in 2005 we found that IDCs do prioritize Neglected Tropical Diseases (NTDs) as an area of research. Finally we investigated the role of IDCs in two major public health emergencies between 2012 and 2016, the outbreaks of Ebola in West Africa and Zika in South America. An analysis of the co-authorship country networks demonstrated an important role for IDC infrastructure and personnel in the prevention and control of these epidemics. DISCUSSION AND CONCLUSIONS: Different techniques can be used to evaluate and measure innovative performance of countries. Country rankings published by traditional indexes, such as the Bloomberg Innovation Index (BII) and the Global Innovation Index (GII), only include high income economies among the top 20 performers. This is in sharp contrast to our approach, which identified 8-9 IDCs among the first 25 with China occupying the top position. Through an analysis of the pros and cons of the different methodologies, the IDC concept challenges more conventional approaches to address and estimate the innovative capacity of countries.

[How much does the backlog on drug patents cost for health in Brazil?] / Quanto custa o atraso na concessão de patentes de medicamentos para a saúde no Brasil?

The backlog in processing patent applications in Brazil has persisted since the enactment of Law 9,279/1996, when the country resumed granting patents on drugs. The agencies responsible for granting such patents, namely the Brazilian National Patent and Trademark Office (INPI) and the Brazilian National Health Surveillance Agency (Anvisa) cite technical and administrative reasons for the backlog. However, little research has focused on the economic impacts for health due to the inefficiency of the Brazilian patent system. The current study thus proposes a methodology to estimate the extent to which government procurement of medicines is burdened by the backlog in drug patent applications. According to the results, a total of more than BRL 14 million (USD 4.5 million) is spent unnecessarily per year by the Federal Government on just one antiretroviral drug due to the extension of the respective patent's life. Measures to resolve this situation are urgently needed in the three branches of government. These include hiring more staff for the INPI, analysis of bills of law under review in the two houses of the Brazilian Congress to amend the Industrial Property Law, and ruling on direct class action claims of unconstitutionality to suppress the legal mechanisms that allow extending the life of patents.

Quanto custa o atraso na concessão de patentes de medicamentos para a saúde no Brasil? / How much does the backlog on drug patents cost for health in Brazil? / ¿Cuánto cuesta el atraso en las patentes de medicamentos para la salud en Brasil?

Resumo: O backlog na análise de pedidos de patentes é um problema que persiste desde a promulgação da Lei nº 9.279/1996, quando o Brasil passou a conceder patentes para medicamentos novamente. Os órgãos responsáveis pela concessão dessas patentes, Instituto Nacional da Propriedade Industrial (INPI) e Agência Nacional de Vigilância Sanitária (Anvisa), alegam motivos técnico-administrativos para justificar o atraso. No entanto, os impactos econômicos para a saúde devido à ineficiência do sistema de patentes brasileiro ainda foram pouco investigados. Assim sendo, este trabalho propõe uma metodologia para estimar o quanto as compras públicas de medicamentos são oneradas em função da morosidade na análise dos pedidos de patentes no país. Os resultados mostram que mais de R$ 14 milhões são gastos desnecessariamente anualmente pelo Governo Federal com apenas um medicamento antirretroviral por causa da extensão da vigência das patentes. Conclui-se que medidas governamentais de controle dessa situação são prementes no âmbito dos Três Poderes. Dentre elas, destacam-se a contratação de servidores para o INPI, análise dos projetos de lei que tramitam na Câmara dos Deputados e Senado Federal para a alteração da Lei da Propriedade Industrial, e julgamento das Ações Diretas de Inconstitucionalidade para a supressão do dispositivo legal que possibilita a extensão da vigência das patentes.

Abstract: The backlog in processing patent applications in Brazil has persisted since the enactment of Law 9,279/1996, when the country resumed granting patents on drugs. The agencies responsible for granting such patents, namely the Brazilian National Patent and Trademark Office (INPI) and the Brazilian National Health Surveillance Agency (Anvisa) cite technical and administrative reasons for the backlog. However, little research has focused on the economic impacts for health due to the inefficiency of the Brazilian patent system. The current study thus proposes a methodology to estimate the extent to which government procurement of medicines is burdened by the backlog in drug patent applications. According to the results, a total of more than BRL 14 million (USD 4.5 million) is spent unnecessarily per year by the Federal Government on just one antiretroviral drug due to the extension of the respective patent's life. Measures to resolve this situation are urgently needed in the three branches of government. These include hiring more staff for the INPI, analysis of bills of law under review in the two houses of the Brazilian Congress to amend the Industrial Property Law, and ruling on direct class action claims of unconstitutionality to suppress the legal mechanisms that allow extending the life of patents.

Resumen: El atraso en el procesamiento de solicitudes de patentes en Brasil ha persistido desde la promulgación de la Ley 9.279/1996, cuando el país reanudó la concesión de patentes sobre drogas. Los organismos encargados de otorgar las patentes, a saber, la Oficina Nacional de Patentes y Marcas (INPI) y la Agencia Nacional de Vigilancia Sanitaria (Anvisa), alegan motivos técnico-administrativos para justificar el retraso. Sin embargo, poca investigación se ha centrado en los impactos económicos para la salud debido a la ineficiencia del sistema brasileño de patentes. El presente estudio propone una metodología para estimar el grado en que la contratación pública de medicamentos está cargada con el atraso en las solicitudes de patente de medicamentos. De acuerdo con los resultados, el gobierno federal gasta innecesariamente un total de más de BRL 14 millones (USD 4.5 millones) por un solo medicamento antirretroviral debido a la extensión de la vida de la respectiva patente. Las medidas para resolver esta situación son urgentemente necesarias en las tres ramas del gobierno. Estos incluyen la contratación de más personal para la INPI, el análisis de los proyectos de ley en revisión en las dos cámaras del Congreso brasileño para enmendar la Ley de Propiedad Industrial, y la decisión sobre demandas de acción colectiva directa de inconstitucionalidad para suprimir los mecanismos legales que permiten extender la vida de las patentes.

Enabling policy planning and innovation management through patent information and co-authorship network analyses: a study of tuberculosis in Brazil.

INTRODUCTION: New tools and approaches are necessary to facilitate public policy planning and foster the management of innovation in countries' public health systems. To this end, an understanding of the integrated way in which the various actors who produce scientific knowledge and inventions in technological areas of interest operate, where they are located and how they relate to one another is of great relevance. Tuberculosis has been chosen as a model for the present study as it is a current challenge for Brazilian research and innovation. METHODOLOGY: Publications about tuberculosis written by Brazilian authors were accessed from international databases, analyzed, processed with text searching tools and networks of coauthors were constructed and visualized. Patent applications about tuberculosis in Brazil were retrieved from the Brazilian National Institute of Industrial Property (INPI) and the European Patent Office databases, through the use of International Patent Classification and keywords and then categorized and analyzed. RESULTS/CONCLUSIONS: Brazilian authorship of articles about tuberculosis jumped from 1% in 1995 to 5% in 2010. Article production and patent filings of national origin have been concentrated in public universities and research institutions while the participation of private industry in the filing of Brazilian patents has remained limited. The goals of national patenting efforts have still not been reached, as up to the present none of the applications filed have been granted a patent. The analysis of all this data about TB publishing and patents clearly demonstrates the importance of maintaining the continuity of Brazil's production development policies as well as government support for infrastructure projects to be employed in transforming the potential of research. This policy, which already exists for the promotion of new products and processes that, in addition to bringing diverse economic benefits to the country, will also contribute to effective dealing with public health problems affecting Brazil and the World.

[Specificities of patent protection in the pharmaceutical industry: modalities and traits of intellectual property]. / Especificidades do patenteamento no setor farmacêutico: modalidades e aspectos da proteção intelectual.

Different forms of protection for inventions in the pharmaceutical industry point to strategies for the perpetuation of patent protection. Based on a literature review showing the specificities of patenting in the industry, the article provides a brief history of drug patents in Brazil, a discussion of patentable and non-patentable inventions, and the modalities and traits of patent protection that aim to extend the temporary monopoly granted under the patent. Such strategies include patents targeting polimorphs and optical isomers of drugs and drug combinations and specific clinical preparations, increasingly present in the drug patent claims filed by pharmaceutical companies. The study's objective is to discuss the specificities of drug patent claims in order to help develop expertise in the area and discuss the impact of expanding the scope of patent protection. In conclusion, while the tendency to expand towards more a permissive protective scope could produce opportunities for Brazilian national inventors, it could also be harmful to a policy for access to medicines.

Especificidades do patenteamento no setor farmacêutico: modalidades e aspectos da proteção intelectual: [revisão] / Specificities of patent protection in the pharmaceutical industry: modalities and traits of intellectual property: [review]

As formas de proteção das invenções no setor farmacêutico apontam para estratégias de perpetuação da proteção patentária. Com base em uma revisão bibliográfica mostrou-se as especificidades do patenteamento no setor, perpassando por um breve histórico sobre a concessão de patentes farmacêuticas no Brasil, uma abordagem sobre invenções patenteáveis e não-patenteáveis, e pelas modalidades e aspectos da proteção patentária que visam à extensão do monopólio temporário conferido pela patente. Dentre essas estratégias estão as patentes direcionadas a polimorfos e isômeros ópticos de fármacos; combinações de fármacos e segundo uso médico, cada vez mais presentes nas reivindicações dos pedidos de privilégio de invenção das indústrias farmacêuticas. O objetivo do trabalho é mostrar algumas especificidades dos pedidos de patente farmacêuticas, de modo a contribuir para a formação de expertise na área e para a discussão sobre o impacto da ampliação dos escopos de proteção das patentes. Conclui-se que se por um lado a tendência de escopos de proteção mais permissivos pode desvelar oportunidades para os inventores nacionais, por outro, pode ser danosa para uma política de acesso a medicamentos.

Different forms of protection for inventions in the pharmaceutical industry point to strategies for the perpetuation of patent protection. Based on a literature review showing the specificities of patenting in the industry, the article provides a brief history of drug patents in Brazil, a discussion of patentable and non-patentable inventions, and the modalities and traits of patent protection that aim to extend the temporary monopoly granted under the patent. Such strategies include patents targeting polimorphs and optical isomers of drugs and drug combinations and specific clinical preparations, increasingly present in the drug patent claims filed by pharmaceutical companies. The study's objective is to discuss the specificities of drug patent claims in order to help develop expertise in the area and discuss the impact of expanding the scope of patent protection. In conclusion, while the tendency to expand towards more a permissive protective scope could produce opportunities for Brazilian national inventors, it could also be harmful to a policy for access to medicines.