Since the implementation of Directive 2004/48 EC on the Enforcement of Intellectual Property Rights in Sweden there is today a possibility for pharmaceutical companies holding a patent to issue interim injunctions against a generic company on the grounds of an attempt or preparation to a pharmaceutical patent infringement. It has been shown that one of the earliest steps in which a generic company may infringe a pharmaceutical patent is to offer the generic drugs onto the market. However, since the implementation of the attempt and preparation rule in the Swedish Patent Act questions have been raised as to in what stage interim injunctions may be issued against an attempt or preparation to offer generic drugs onto the market made by generic companies. This thesis has therefore intent to investigate at what stage interim injunctions may be applied for against a generic company on the grounds of an attempt or preparation to offer generic drugs. In the thesis the writer argues that in order for an attempt or preparation to offer generic drugs to exist an overall assessment must be made of the particular situation and that there is no specific principles to follow in order to determine either an attempt or a preparation to offer generic drugs. However, some guidance might be brought from Danish case law in order to establish a preparation to offer generic drugs in Sweden.

Made available in DSpace on 2015-05-07T14:27:05Z (GMT). No. of bitstreams: 1 arquivototal.pdf: 2044681 bytes, checksum: 09d18643545c26dd327be8c0d35cd1d2 (MD5) Previous issue date: 2010-04-27 / Coordenação de Aperfeiçoamento de Pessoal de Nível Superior / It is a study focused on the medicament patent from the analysis of the existing tensions among the pharmaceutical industry and the population necessities regarding medicine access. It is well-known the inner nature of the fundamental rights the condition of its social function. In this context, reasoning regarding the protection limits conferred to human nature property is posed, the so-called intellectual property, particularly in the health field, in a concentrated pharmaceutical industry context in the hands of transnational economic conglomerates. Drug Patent-letters are industrial property titles of core application in this universe, as they confer the temporal exclusivity right of exploration in the registered invention. The exercise of the patent right confronts itself with the necessity of the drug access of the population. The Trade-Related Aspects of Intellectual Property Rights (TRIPS) and the Intellectual Property Act rise as rigid diplomas for protecting these rights. The tenet of intellectual property shows a path for a well limited protection, from its technical requisites. In the Mercosur context, a need for enhancement on the mechanisms of regional protection, and the political articulation maintenance is seen, in the sense of avoiding the adherence to bilateral instruments which foresees more rigid protective conditions than the existing ones at the TRIPS. Data stress the importance of a severe protection for an innovation process, at the same time that it is questioned. The drug access becomes more important in situations for the AIDS and other epidemics treatment. At the same time, the sense of investments of the pharmaceutical industry points to the negligence of the P&D on tropical diseases, privileging researches on the high incident diseases of cold countries, or global diseases. The fall on the drug prices is shown, due to the introduction of the generics, and also the way the piracy implies into barrier towards the population access to the drugs. The necessity of a more objective legal mechanism definition is stated aiming to avoid the me-too drug patenting, with a consequent time gap lag on the temporal exclusivity patent right. The formation of the PPP for the realization of P&D of medicament in the industrial phase and the concession technology transferring definition in one of the requisites to form partnerships and international acquisitions, is also shown as relevant. The creation of a new useful capitalism to the reduction of the regional inaqualities passes for the process to endow with flexibility the rights on the pharmaceutical patents. / Trata-se de um estudo sobre as patentes de medicamentos a partir da análise de tensões existentes entre os interesses da indústria farmacêutica e as necessidades das populações no tocante ao acesso aos remédios. Sabe-se ser inerente ao direito de propriedade uma função social, devendo servir à promoção de justiça social. Neste contexto, são tecidos questionamentos sobre os limites de proteção conferidos à propriedade decorrente da criação humana, a chamada propriedade intelectual, particularmente na área da saúde, em um contexto de concentração da indústria farmacêutica nacional em poder de conglomerados econômicos transnacionais. Cartas-patentes de medicamentos são títulos de propriedade industrial de utilidade chave neste universo, pois conferem o direito de exclusividade temporal de exploração da invenção registrada. O exercício do direito patentário defronta-se com a necessidade de acesso das populações a medicamentos. O Tratado sobre os Direitos de Propriedade Intelectual Relacionados com o Comércio (TRIPS) e a Lei de Propriedade Industrial despontam como diplomas rígidos de proteção destes direitos. Os princípios da propriedade intelectual fornecem um caminho para uma proteção bem delimitada, a partir de requisitos técnicos. No contexto do Mercosul verifica-se a necessidade de aprimoramento dos mecanismos de proteção regional e da manutenção de uma articulação política no sentido de não ser realizada a adesão a instrumentos bilaterais que prevejam condições mais rígidas de proteção do que as previstas no TRIPS. Dados enaltecem a importância de uma severa proteção para um processo de inovação, ao mesmo tempo que a põe em dúvida. O acesso aos fármacos torna-se mais premente em situações de medicamentos para o trato de epidemias, como a AIDS. Ao mesmo tempo, o sentido dos investimentos da indústria farmacêutica indica a negligência de P&D sobre doenças tropicais, privilegiando pesquisas sobre doenças de maior incidência em países de clima temperado, ou doenças globais. Demonstra-se a queda de preços de medicamentos em função da introdução de genéricos e como a pirataria implica em uma barreira ao acesso da população aos fármacos. Constata-se a necessidade de definição de mecanismos jurídicos objetivos com a finalidade de evitar-se o patenteamento de drogas ―me-too‖, com o consequente prolongamento do lapso temporal do direito de exclusividade patentário. A formação de Parcerias Público-Privadas (PPPs) para a realização de P&D de medicamentos em fase industrial e a definição da concessão de transferência de tecnologia como um dos requisitos para a formatação de parcerias e aquisições internacionais, mostra-se igualmente relevante. A criação de um novo capitalismo útil à redução das desigualdades regionais passa pelo processo de flexibilização dos direitos sobre as patentes de medicamentos.

Intellectual property laws bestow a time bound individual right to a right holder, which after a certain period dissolves into the society for the betterment of all. In theory it is meant to be a win-win situation for both individuals and the society but in practice it is not so. The purpose of this research paper is to investigate the reason of Intersection of IPR with Human Rights in the context of Pharmaceutical Patenting and access to medicine.’   In the body part of this paper, research questions have been distributed and discussed in separate chapters, starting from chapter 2. The chapters start from the legal framework of patent protection and right to health provisions enshrined in different international, regional instruments. The paper further continues with the discussion about the positive and negative sides of the patent protection of pharmaceuticals, in third chapter. Then in fourth chapter it tries to examine the situation of access to medicine in developed countries, United States of America and European Union and in developing countries, India and Brazil. In the fifth chapter, the paper discusses and examines about, who should be accountable for providing access to medicine. Moreover, the sixth chapter discusses the efforts provided by TRIPS flexibilities and the court cases in harmonizing intellectual property law to provide medicines’ accessibility and affordability. With summary, conclusion and recommendations in the end.

Statement of the issue: Facing large HIV-infected populations, Sub-Saharan African countries are producing antiretroviral (ARV) drugs under provisions of the World Trade Organization’s Agreement on the Trade-Related Aspects of Intellectual Property (TRIPS). Article 7 states that the protection of intellectual property should increase technology transfer to developing countries. This clause and the debate over domestic manufacturers’ ability to provide low-cost ARVs need examination. Methods: Case studies from ARV manufacturing initiatives in Tanzania and South Africa analyzed conditions affecting two outcomes: the type of technology transfer arrangement entered (voluntary license or imitation) and the affordability of ARVs. Data were collected and analyzed from documents, key-informant interviews, and observation. Chi-squared and phi correlation statistics were then conducted across developing countries to test the association of voluntary ARV licensure with TRIPS-compliant patents and domestic firm ownership (state or private). Results: Tanzania’s weak patent system and poorly-financed, partially state-owned firm dissuaded industry investment, but attracted a non-government organization to transfer technology through imitation. Donor-financed ARV tenders, however, restrict competition to international quality-accredited products not produced by the firm. Without large volumes and manufacturing capacity, it cannot achieve economies of scale to reduce prices below imported ARVs. In South Africa, civil society challenged the strong patent system and poor government commitment that inhibited an ARV rollout. This and a well-financed, publicly-traded firm leveraged voluntary licenses. With international quality approval, the firm increased first-line ARV affordability; however, limited domestic competition keeps treatment prices above those of neighbouring countries. A multi-country analysis found 321 generic ARV manufacturing initiatives in 86 firms across 25 developing countries. Voluntary ARV licenses had a strong positive association with TRIPS-patent compliance (ф=.56, p<.0001) and a weak negative association with state-ownership (ф=.19, p<.0001). Firms in South Africa and India were granted 77% of licenses and accounted for most quality accredited generic ARVs. Conclusion: Despite positive association, technology transfer does not readily result from patent protection, particularly to state-owned firms. Developing countries must enact policies to enable affordable ARVs; yet, they must be cautious using local production to increase ARV access, as most initiatives cannot compete with high-volume generic manufacturers.

Statement of the issue: Facing large HIV-infected populations, Sub-Saharan African countries are producing antiretroviral (ARV) drugs under provisions of the World Trade Organization’s Agreement on the Trade-Related Aspects of Intellectual Property (TRIPS). Article 7 states that the protection of intellectual property should increase technology transfer to developing countries. This clause and the debate over domestic manufacturers’ ability to provide low-cost ARVs need examination. Methods: Case studies from ARV manufacturing initiatives in Tanzania and South Africa analyzed conditions affecting two outcomes: the type of technology transfer arrangement entered (voluntary license or imitation) and the affordability of ARVs. Data were collected and analyzed from documents, key-informant interviews, and observation. Chi-squared and phi correlation statistics were then conducted across developing countries to test the association of voluntary ARV licensure with TRIPS-compliant patents and domestic firm ownership (state or private). Results: Tanzania’s weak patent system and poorly-financed, partially state-owned firm dissuaded industry investment, but attracted a non-government organization to transfer technology through imitation. Donor-financed ARV tenders, however, restrict competition to international quality-accredited products not produced by the firm. Without large volumes and manufacturing capacity, it cannot achieve economies of scale to reduce prices below imported ARVs. In South Africa, civil society challenged the strong patent system and poor government commitment that inhibited an ARV rollout. This and a well-financed, publicly-traded firm leveraged voluntary licenses. With international quality approval, the firm increased first-line ARV affordability; however, limited domestic competition keeps treatment prices above those of neighbouring countries. A multi-country analysis found 321 generic ARV manufacturing initiatives in 86 firms across 25 developing countries. Voluntary ARV licenses had a strong positive association with TRIPS-patent compliance (ф=.56, p<.0001) and a weak negative association with state-ownership (ф=.19, p<.0001). Firms in South Africa and India were granted 77% of licenses and accounted for most quality accredited generic ARVs. Conclusion: Despite positive association, technology transfer does not readily result from patent protection, particularly to state-owned firms. Developing countries must enact policies to enable affordable ARVs; yet, they must be cautious using local production to increase ARV access, as most initiatives cannot compete with high-volume generic manufacturers.

Brasil e Estados Unidos têm apresentado posições políticas divergentes em relação à propriedade intelectual desde a década de 1970. O contencioso das patentes farmacêuticas na OMC foi iniciado em 2000 com um pedido de consulta dos Estados Unidos em relação à lei de patentes brasileira e está inserido nesse contexto de divergência entre os dois países. O contencioso foi solucionado por meio de um acordo no qual os Estados Unidos retiraram a queixa contra o Brasil em 2001. O envolvimento político de redes transnacionais de ONGs levou o assunto ao conhecimento da opinião pública mundial, fato que parece ter influenciado o resultado do contencioso. Sob o marco teórico da transnacionalidade, este estudo tem o objetivo de dimensionar o grau de influência política das ONGs organizadas em redes e seu impacto no resultado do contencioso. Para isso, (1) identifica as principais ONGs envolvidas na campanha global de acesso a medicamentos essenciais no período compreendido entre 1997 e 2001; (2) resgata o conflito em propriedade intelectual existente entre Brasil e Estados Unidos desde as décadas de 70 e 80; analisa (3) as estratégias das redes transnacionais de ONGs dentro da campanha de acesso a medicamentos essenciais e (4) os principais condicionantes do papel das ONGs na política mundial. Com base no estudo empírico da campanha de acesso a medicamentos essenciais, a conclusão reflete um esforço em dimensionar o papel das redes transnacionais de ONGs no contencioso entre Brasil e Estados Unidos na OMC, interpretando-o como parte de um movimento transnacional anti-hegemônico que gerou resultados benéficos em questões de propriedade intelectual aos países em desenvolvimento entre 1997 e 2001. / Brazil and the United States appear to have defended divergent intellectual property policies since the 1970s. The controversy on pharmaceutical patents at the World Trade Organization (WTO) started back in 2000 with a complaint by the United States about the Brazilian patent law and it is part of this context of divergence between both countries. The controversy was solved by means of an agreement in which the United States withdrew the complaint against Brazil in 2001. The political engagement of transnational NGOs networks leveraged this issue to the concern of global public opinion. This fact appears to have influenced the outcome of the case at the WTO. Based on theoretical approaches on transnationalism, this study aims to dimension the degree of political influence of networkbased NGOs and its impact on the conflict outcome at the WTO. For this purpose, the research work (1) identifies the main NGOs engaged in and involved by the Global Access to Essential Medicines Campaign between 1997 and 2001; (2) reviews the conflicts on intellectual property between Brazil and the United States which have been taking place since the 1970s and 80s; analyses (3) the transnational NGOs networks’ strategies in the scope of the Global Access to Essential Medicines Campaign and (4) the main conditioning factors to the role of NGOs in world politics. Based on the empirical study on the Global Access to Essential Medicines Campaign, the conclusion reflects an effort to dimension the role of transnational NGOs networks in the controversy between Brazil and the United States at the WTO, interpreting it as part of an anti-hegemonic transnational movement that generated beneficial outcomes on intellectual property issues to developing countries between 1997 and 2001.

O objetivo geral da tese é aprofundar a reflexão sobre a regulação e o exame de qualidade de patentes farmacêuticas no Brasil, em um contexto de implantação de dispositivos legais conhecidos como TRIPS-Plus ao redor do mundo. Para isso, são discutidos os mecanismos jurídicos e políticos de proteção à saúde relacionados à propriedade intelectual. Analisam-se especificamente do ponto de vista sociológico as experiências de anuência prévia para pedidos de patentes envolvendo produtos e processos farmacêuticos da Agência Nacional de Vigilância Sanitária (Anvisa) e o uso do subsídio ao exame técnico. Em termos metodológicos, consideram-se as ações do Governo brasileiro entre 1996 a 2012, propostas de mudança da Lei de Propriedade Industrial brasileira e controvérsias ligadas a algumas modalidades de reivindicação, como polimorfos, patentes de seleção e segundo uso médico. As técnicas de pesquisa utilizadas também incluem o levantamento de material de imprensa, textos de leis, documentos e decretos relativos a medicamentos e propriedade intelectual, assim como de pedidos de patentes e de decisões judiciais concernindo à temática. Optou-se ainda por realizar entrevistas com gestores, examinadores de patentes, juristas e membros de ONGs. As conclusões indicam que as práticas regulatórias ligadas ao setor saúde não podem ser reduzidas ao simples corpo de regras formais presentes neste domínio, mas sim entendidas como agenciamentos entre atores, tipos distintos de saberes e de ferramentas de intervenção. A regulação dos direitos de propriedade intelectual relativos a produtos e processos farmacêuticos no Brasil está ligada a um processo, onde se verifica a disputa em torno de diferentes projetos e visões de mundo de grupos com maior ou menor poder para direcionar este processo. Os dispositivos da anuência prévia e do subsídio ao exame técnico apresentam-se como elementos reguladores da propriedade intelectual de medicamentos e de impacto sobre exame de qualidade de patentes farmacêuticas, contribuindo para a consideração de questões de saúde pública ao longo da concessão destas patentes. / The general aim of the thesis is to improve the reflection on the regulation and the quality of examination of pharmaceutical patents in Brazil, in the context of implementation of legal provisions known as TRIPS-Plus around the world. For this, we discuss the legal and political mechanisms to protect health related to intellectual property rights. It examines specifically from a sociological point of view the experiences of the prior consent for patent applications involving pharmaceutical products and processes of the National Health Surveillance Agency (ANVISA) and the use of the patent opposition mechanism (subsídio ao exame técnico). In terms of methodology, it considers the actions of the Brazilian Government from 1996 to 2012, the proposals to change the Brazilian Industrial Property Law and the controversies linked to some types of patent claims, such as polymorphs, selection patents and second medical use. The research techniques also include the analysis of press materials, texts of laws, decrees and documents related to medicines and intellectual property, as well as patent applications and judgments. Interviews with managers, patent examiners, lawyers and members of NGOs were also conducted. The conclusions indicate that the regulatory practices related to the health sector can not be reduced to a simple body of formal rules present in this area, but rather understood as assemblages between actors, different types of knowledge and intervention tools. The regulation of intellectual property rights related to pharmaceutical products and processes in Brazil is linked to a process in which there is a dispute around the different projects and worldviews of groups with more or less power to drive this process. The devices of the prior consent and the patent opposition appear as regulatory elements of the intellectual property rights of drugs and of impact on the quality of examination of pharmaceutical patents, contributing to the consideration of public health concerns along the granting of these patents.

Brasil e Estados Unidos têm apresentado posições políticas divergentes em relação à propriedade intelectual desde a década de 1970. O contencioso das patentes farmacêuticas na OMC foi iniciado em 2000 com um pedido de consulta dos Estados Unidos em relação à lei de patentes brasileira e está inserido nesse contexto de divergência entre os dois países. O contencioso foi solucionado por meio de um acordo no qual os Estados Unidos retiraram a queixa contra o Brasil em 2001. O envolvimento político de redes transnacionais de ONGs levou o assunto ao conhecimento da opinião pública mundial, fato que parece ter influenciado o resultado do contencioso. Sob o marco teórico da transnacionalidade, este estudo tem o objetivo de dimensionar o grau de influência política das ONGs organizadas em redes e seu impacto no resultado do contencioso. Para isso, (1) identifica as principais ONGs envolvidas na campanha global de acesso a medicamentos essenciais no período compreendido entre 1997 e 2001; (2) resgata o conflito em propriedade intelectual existente entre Brasil e Estados Unidos desde as décadas de 70 e 80; analisa (3) as estratégias das redes transnacionais de ONGs dentro da campanha de acesso a medicamentos essenciais e (4) os principais condicionantes do papel das ONGs na política mundial. Com base no estudo empírico da campanha de acesso a medicamentos essenciais, a conclusão reflete um esforço em dimensionar o papel das redes transnacionais de ONGs no contencioso entre Brasil e Estados Unidos na OMC, interpretando-o como parte de um movimento transnacional anti-hegemônico que gerou resultados benéficos em questões de propriedade intelectual aos países em desenvolvimento entre 1997 e 2001. / Brazil and the United States appear to have defended divergent intellectual property policies since the 1970s. The controversy on pharmaceutical patents at the World Trade Organization (WTO) started back in 2000 with a complaint by the United States about the Brazilian patent law and it is part of this context of divergence between both countries. The controversy was solved by means of an agreement in which the United States withdrew the complaint against Brazil in 2001. The political engagement of transnational NGOs networks leveraged this issue to the concern of global public opinion. This fact appears to have influenced the outcome of the case at the WTO. Based on theoretical approaches on transnationalism, this study aims to dimension the degree of political influence of networkbased NGOs and its impact on the conflict outcome at the WTO. For this purpose, the research work (1) identifies the main NGOs engaged in and involved by the Global Access to Essential Medicines Campaign between 1997 and 2001; (2) reviews the conflicts on intellectual property between Brazil and the United States which have been taking place since the 1970s and 80s; analyses (3) the transnational NGOs networks’ strategies in the scope of the Global Access to Essential Medicines Campaign and (4) the main conditioning factors to the role of NGOs in world politics. Based on the empirical study on the Global Access to Essential Medicines Campaign, the conclusion reflects an effort to dimension the role of transnational NGOs networks in the controversy between Brazil and the United States at the WTO, interpreting it as part of an anti-hegemonic transnational movement that generated beneficial outcomes on intellectual property issues to developing countries between 1997 and 2001.

O objetivo geral da tese é aprofundar a reflexão sobre a regulação e o exame de qualidade de patentes farmacêuticas no Brasil, em um contexto de implantação de dispositivos legais conhecidos como TRIPS-Plus ao redor do mundo. Para isso, são discutidos os mecanismos jurídicos e políticos de proteção à saúde relacionados à propriedade intelectual. Analisam-se especificamente do ponto de vista sociológico as experiências de anuência prévia para pedidos de patentes envolvendo produtos e processos farmacêuticos da Agência Nacional de Vigilância Sanitária (Anvisa) e o uso do subsídio ao exame técnico. Em termos metodológicos, consideram-se as ações do Governo brasileiro entre 1996 a 2012, propostas de mudança da Lei de Propriedade Industrial brasileira e controvérsias ligadas a algumas modalidades de reivindicação, como polimorfos, patentes de seleção e segundo uso médico. As técnicas de pesquisa utilizadas também incluem o levantamento de material de imprensa, textos de leis, documentos e decretos relativos a medicamentos e propriedade intelectual, assim como de pedidos de patentes e de decisões judiciais concernindo à temática. Optou-se ainda por realizar entrevistas com gestores, examinadores de patentes, juristas e membros de ONGs. As conclusões indicam que as práticas regulatórias ligadas ao setor saúde não podem ser reduzidas ao simples corpo de regras formais presentes neste domínio, mas sim entendidas como agenciamentos entre atores, tipos distintos de saberes e de ferramentas de intervenção. A regulação dos direitos de propriedade intelectual relativos a produtos e processos farmacêuticos no Brasil está ligada a um processo, onde se verifica a disputa em torno de diferentes projetos e visões de mundo de grupos com maior ou menor poder para direcionar este processo. Os dispositivos da anuência prévia e do subsídio ao exame técnico apresentam-se como elementos reguladores da propriedade intelectual de medicamentos e de impacto sobre exame de qualidade de patentes farmacêuticas, contribuindo para a consideração de questões de saúde pública ao longo da concessão destas patentes. / The general aim of the thesis is to improve the reflection on the regulation and the quality of examination of pharmaceutical patents in Brazil, in the context of implementation of legal provisions known as TRIPS-Plus around the world. For this, we discuss the legal and political mechanisms to protect health related to intellectual property rights. It examines specifically from a sociological point of view the experiences of the prior consent for patent applications involving pharmaceutical products and processes of the National Health Surveillance Agency (ANVISA) and the use of the patent opposition mechanism (subsídio ao exame técnico). In terms of methodology, it considers the actions of the Brazilian Government from 1996 to 2012, the proposals to change the Brazilian Industrial Property Law and the controversies linked to some types of patent claims, such as polymorphs, selection patents and second medical use. The research techniques also include the analysis of press materials, texts of laws, decrees and documents related to medicines and intellectual property, as well as patent applications and judgments. Interviews with managers, patent examiners, lawyers and members of NGOs were also conducted. The conclusions indicate that the regulatory practices related to the health sector can not be reduced to a simple body of formal rules present in this area, but rather understood as assemblages between actors, different types of knowledge and intervention tools. The regulation of intellectual property rights related to pharmaceutical products and processes in Brazil is linked to a process in which there is a dispute around the different projects and worldviews of groups with more or less power to drive this process. The devices of the prior consent and the patent opposition appear as regulatory elements of the intellectual property rights of drugs and of impact on the quality of examination of pharmaceutical patents, contributing to the consideration of public health concerns along the granting of these patents.

Submitted by Elesbão Santiago Neto (neto10uepb@cche.uepb.edu.br) on 2018-04-18T18:35:40Z No. of bitstreams: 1 PDF - Ana Cristina Costa Barreto.pdf: 48970193 bytes, checksum: 46e957d6b053cb258379855173a395dd (MD5) / Made available in DSpace on 2018-04-18T18:35:40Z (GMT). No. of bitstreams: 1 PDF - Ana Cristina Costa Barreto.pdf: 48970193 bytes, checksum: 46e957d6b053cb258379855173a395dd (MD5) Previous issue date: 2011-11-04 / CAPES / The global transformations occurring in modernity have led to the emergence of new challenges and the need to search for new perspectives on stakeholder participation in the international system. Particularly, the inclusion of new issues within the WTO rules, within the multilateral trading system is fundamental to the pursuit of well-being of people take a central role in the discussions, and sustainable development is achieved from the respect and balance between human beings and the market. The paper attempted to analyze the TRIPS Agreement and its relationship with the right to access to medicines, assessing the possibility that the relaxation of its rules be considered a demonstration of the relevance of human rights in international trade. To achieve this objective, the first analysis of the evolution of the system of protection of intellectual property was critical to understanding the formation of the international IP regime that culminated in the TRIPS Agreement. In sequence, the problem of access to medicines was presented from the considerations about the social responsibility of the pharmaceutical industry and the implications caused by the TRIPS Agreement, regarding the need to be envisioned an international policy aimed at ensuring universal access to products the pharmaceutical industry, thus revealing the existence of a relationship between the work of international organizations, including the World Trade Organization and Human Rights. Finally, from the point of view of modern cosmopolitanism from the demonstration that the internationalization of human rights can be understood as a reassertion of humanism found that to change the paradigms of intellectual property and particularly patent pharmaceutical, it is essential to define the social role of the pharmaceutical industry, understanding the conditions of access to drugs is regarded as a matter subject to humanitarian protection. / As transformações globais ocorridas na modernidade têm provocado o surgimento de novos desafios e a necessidade de busca por novas perspectivas na participação dos atores no sistema internacional. Particularmente, a inclusão de novos temas no âmbito das regras da OMC, dentro do sistema multilateral de comércio, é fundamental para que a busca pelo bem-estar do homem tome papel central nas discussões, e o desenvolvimento sustentável seja alcançado a partir do respeito e do equilíbrio entre ser humano e mercado. A dissertação se propôs a analisar o Acordo TRIPS e sua relação com o direito ao acesso a medicamentos, avaliando a possibilidade de que a flexibilização de suas normas ser considerada uma demonstração da relevância dos Direitos Humanos no âmbito do comércio internacional. Visando tal objetivo, inicialmente a análise da evolução do sistema de proteção da Propriedade Intelectual foi fundamental para compreender formação do regime internacional de PI que culminou com o Acordo TRIPS. Em sequência, a problemática do acesso a medicamentos foi apresentada a partir das considerações acerca da responsabilidade social da indústria farmacêutica e das implicações provocadas pelo Acordo TRIPS, no que tange à necessidade de ser vislumbrada uma política internacional que vise a garantia do acesso universal aos produtos da indústria farmacêutica, evidenciando assim a existência de uma relação entre a atuação de organismos internacionais, entre os quais a Organização Mundial do Comércio e os Direitos Humanos. Por fim, sob o ponto de vista do cosmopolitismo moderno, a partir da demonstração de que a internacionalização dos Direitos Humanos pode ser compreendida como a reafirmação do Humanismo constatou-se que para a mudança dos paradigmas relativos à propriedade intelectual e, particularmente, à patente farmacêutica, é imprescindível a definição do papel social da indústria farmacêutica, a compreensão de que as condições de acesso a medicamentos sejam consideradas matéria sujeita à proteção humanitária.