Made available in DSpace on 2016-03-15T19:34:26Z (GMT). No. of bitstreams: 1 Henrique Romanini Subi.pdf: 1009215 bytes, checksum: 5ca95369df8dd46db7fb1f12851fa832 (MD5) Previous issue date: 2015-08-13 / Intellectual property rights have been object of expansion in recent decades, when they began to be recognized on things and innovations hitherto immune to private appropriation, like living organisms, business methods and even the human genome. We live, as well, a second "enclosure movement" of the property, led by high-tech industry rooted in developed countries and aims to ensure the highest possible financial return on their investments in R&D. The extension of these rights creates situations of abuse that, besides diverting their purpose, cause damage to other principles applicable to the market, such as free competition and free enterprise. International treaties play an important role in this reality, with the TRIPS Agreement as the main one and that, despite his attempt to prevent such abuses, turns out to be too open in their terms and indirectly empower them and give them legal lair. / Os direitos de propriedade intelectual vêm sendo objeto de ampliação nas últimas décadas, quando passaram a ser reconhecidos sobre coisas e inovações até então imunes à apropriação privada, como organismos vivos, processos de negócios e até o genoma humano. Vivemos, assim, um segundo movimento de cercamento da propriedade, capitaneado pela indústria de ponta radicada nos países desenvolvidos e que visa a garantir o maior retorno financeiro possível aos seus investimentos em pesquisa. O alargamento desses direitos gera situações de abuso que, além de desviarem sua finalidade, causam prejuízos a outros princípios caros ao mercado, como a livre concorrência e a livre iniciativa. Os tratados internacionais têm participação importante nessa realidade, sendo o Acordo TRIPS o principal deles e que, a despeito de sua tentativa de evitar tais abusos, acaba por ser demasiadamente aberto em suas cláusulas e indiretamente os autoriza e lhes dá guarida jurídica.

<p>For many years pharmaceutical patents and their impact on prices have been at the centre of the international debate over insufficient access to lifesaving HIV/AIDS medicines in developing countries. The conflict has largely revolved around the implementation of an intellectual property system in the developing world, subsequent the adaptation of the TRIPS Agreement, which has made a 20 year pharmaceutical patent protection mandatory for these countries and consequently contributed to high drug prices for patented medicines as well as limited the use of generic drugs.</p><p>Developing countries, where patents are already in place, have sought to reduce high drug prices by making use of compulsory licensing, a safeguarding practice allowing the production or importation of a generic medicine without the consent of the patent holder. Compulsory licences are allowed under the TRIPS Agreement, but disagreements about the conditions, under which compulsory licences are available for ‘essential medicines’, have restricted their use. A definition of the extent to which compulsory licensees can export generic drugs to developing countries unable to manufacture their own has been missing, but on 30 August 2003 the WTO announced that it had resolved this problem by lifting the TRIPS Agreement’s restrictions on exports and permitting exports of drugs produced under a compulsory license as an exception to a patent right. The main question is whether the compulsory licensing system as prescribed in the recent Decision is an ample means of improving access to patented AIDS medicines in the developing world.</p><p>By means of legal and economic reasoning this master thesis argues that the 30 August Decision on lifting TRIPS’ restrictions on exports of patented pharmaceuticals produced under compulsory licences provides complex and uncertain rules, rendering an unreliable employment of compulsory licensing. It is desirable that further recommendations are given on which generic producing companies should be awarded compulsory licences and also on which premises. In reality, the debate about compulsory licensing is part of a much wider structural problem in development policy. The solution to the inaccessibility problem requires a mix of courses of action with a functioning compulsory licensing system included. However, disagreements such as how necessary funding should be divided equitably between developed countries could protract the reaching of a pragmatic solution.</p>

<p>This paper seeks to discern the political factors that determine the results of negotiations in international cooperation. On the one hand, it makes a contribution to the broader theoretical debate on international regimes by combining regime theory and theories on globalisation into an integrated framework for the analysis of international policy results, or in this case treaties (theoretical objective). More generally, globalisation theory will help us understand why it has become important to initiate international cooperation, and regime theory to elucidate how these international cooperations emerge. To many observers, it is the large transnational corporations of the rich North, which have done best out of free trade. Through the huge influence they wield over governments at the WTO (World Trade Organisation), these corporations have won the freedom to move around the globe without restriction, making use of cheap labour, and locating wherever they can best tap into the largest and most lucrative markets. Suprastate global governance, such as the WTO and its TRIPs (Trade Related Intellectual Property Rights) regime, is the response to deal with the reality in which we live - the globalised reality. But global governance comes to a price. States have lost their supreme sovereignty in the face of globalisation and the power of the globalised economy and transnational corporations. </p><p>This paper presents evidence that it does not seem likely that the parties to both the TRIPs Agreement and the Convention on Biological Diversity, in reality, can meet the obligations set out by these two agreements. Furthermore, this study points to those negative impacts the TRIPs Agreement poses to an enhancing of biological diversity and protection of indigenous knowledge.</p>

For many years pharmaceutical patents and their impact on prices have been at the centre of the international debate over insufficient access to lifesaving HIV/AIDS medicines in developing countries. The conflict has largely revolved around the implementation of an intellectual property system in the developing world, subsequent the adaptation of the TRIPS Agreement, which has made a 20 year pharmaceutical patent protection mandatory for these countries and consequently contributed to high drug prices for patented medicines as well as limited the use of generic drugs. Developing countries, where patents are already in place, have sought to reduce high drug prices by making use of compulsory licensing, a safeguarding practice allowing the production or importation of a generic medicine without the consent of the patent holder. Compulsory licences are allowed under the TRIPS Agreement, but disagreements about the conditions, under which compulsory licences are available for ‘essential medicines’, have restricted their use. A definition of the extent to which compulsory licensees can export generic drugs to developing countries unable to manufacture their own has been missing, but on 30 August 2003 the WTO announced that it had resolved this problem by lifting the TRIPS Agreement’s restrictions on exports and permitting exports of drugs produced under a compulsory license as an exception to a patent right. The main question is whether the compulsory licensing system as prescribed in the recent Decision is an ample means of improving access to patented AIDS medicines in the developing world. By means of legal and economic reasoning this master thesis argues that the 30 August Decision on lifting TRIPS’ restrictions on exports of patented pharmaceuticals produced under compulsory licences provides complex and uncertain rules, rendering an unreliable employment of compulsory licensing. It is desirable that further recommendations are given on which generic producing companies should be awarded compulsory licences and also on which premises. In reality, the debate about compulsory licensing is part of a much wider structural problem in development policy. The solution to the inaccessibility problem requires a mix of courses of action with a functioning compulsory licensing system included. However, disagreements such as how necessary funding should be divided equitably between developed countries could protract the reaching of a pragmatic solution.

Kasmet pasaulyje nuo infekcinių ligų miršta milijonai žmonių. Ironiška, kad dauguma šių ligų yra išgydomos šiuolaikiniais vaistais, tačiau dauguma žmonių neturi priėjimo prie šių vaistų, ypač besivystančiose šalyse. Šią problemą įtakoja daugelis faktorių, tačiau dažnai vaistų prieinamumas būna apribojamas dėl aukštų vaistų kainų, kurios dažnai būna stiprios intelektinės nuosavybės apsaugos pasekmė. Šiame darbe analizuojama vaistų prieinamumo problema intelektinės nuosavybės ir žmogaus teisių kontekste. Ieškoma atsakymo į klausimą, ar išradimų, susijusių su vaistų gamyba, patentinė apsauga, nepažeidžia žmogaus teisių į sveikatos priežiūrą. Ypatingas dėmesys skiriamas Sutarčiai dėl intelektinės nuosavybės teisių prekyboje (TRIPS Sutartis) ir jos daromai įtakai vaistų prieinamumui. Ši sutartis susilaukė didelės kritikos dėl nesugebėjimo išlaikyti pusiausvyros tarp patentinės apsaugos ir vaistų prieinamumo. Išanalizavus problemą, buvo nustatyta, kad egzistuoja paradoksalus ryšys tarp patentų teisės ir vaistų prieinamumo. Patentų teisės suteikiama apsauga veda prie patentuotų vaistų prieinamumo apribojimų dėl išaugusių jų kainų, todėl egzistuoja riba, kurią pasiekus yra tikslinga apriboti išradimų, susijusių su vaistų gamyba, patentinę apsaugą, siekiant užtikrinti vaistų prieinamumą visuomenei. Patento savininko teisės gali būti apribotos pasinaudojant TRIPS Sutartyje įtvirtintomis priemonėmis, tokiomis kaip priverstinis licencijavimas ar lygiagretus importas, o įvykus žmogaus... [toliau žr. visą tekstą] / Each year millions of people die from infecious diseases. Ironically, mosto f these diseases are curable with modern medicines, but most people don‘t have access to these drugs, especially in developing countries. The are many reasons for the lack of access to medicines, but in many cases the high price of drugs is a barrier to needed medicines and the unaffordable prices are often the result of strong intellectual property protection. This paper analyses the problem of access to medicines in the context of human rights and intellectual property. It tries to answer the question whether patents for pharmaceutical inventions infringe on the human right to health. Particular attention is paid to the Agreement on trade related aspects of intellectual property (TRIPS Agreement) and the impact it has on access to medicines. TRIPS is widely criticized for failing to maintain a balance between patent protection and access to medicines. Previously in many countries patents for pharmaceutical inventions were not allowed or they were limited but after TRIPS everything changed. The Agreement widened the scope of patentability and included pharmaceutical inventions. Now patent protection has to be granted for any inventions, whether product or processes, in all fields of technology under the conditions that they are new, involve an inventive step and are capable of industrial application Analysis shows that a paradoxical relationship exists between patent law and access to medicines... [to full text]

The overall objective of this study is to promote the human rights to health of Nigerian women to have access essential medicines, to enhance their human capabilities for human development. This thesis argues for an improvement of women’s access to medicines within the context of patent law and rights in the international IP regime of the Trade Related Aspect of Intellectual Property (TRIPS) Agreement and Nigeria’s national patent system. Towards this goal, the thesis makes the point that patent law and its exclusive rights, both the TRIPS Agreement and national law of Nigeria, do not exist in a social welfare vacuum. The legal text of patent law, which confers rights on inventors when enforced, translates to many other things outside the sphere of property rights; indeed, it can be a matter of life and death. It is argued in this regard that patent right could, in effect, interfere with access to medicines and therefore, the right to health and prospects for human development. The thesis therefore argues that, in the construction, interpretation and enforcement of patent law in Nigeria, there is a need to take into consideration its impact on public health. It is against this backdrop that the research assesses the legal framework of pharmaceutical patents and the implications for women’s access to medicines, from a right to health and human development perspective. This interdisciplinary study is with a view to suggesting ways in which Nigeria’s patent system can be more human development and human rights friendly in the interest of public health, particularly, the use of the TRIPS flexibilities to enhance access to life-saving medicines in Nigeria. Since Nigeria as a member of the World Trade Organisation, is bound by its treaty obligation to adopt the provisions of the TRIPS Agreement, the thesis makes proposals for ways in which the Nigerian government and law-makers, can adapt the patent rules and the flexibilities to suit development objectives and promote public health within the benchmark allowed in TRIPS. In this respect, this thesis critically investigates the practical implications of the available flexibilities and options in the TRIPS Agreement that can be used to address the effects of patents on access to medicines. While this thesis concedes the view that the hindrances to accessibility of essential drugs in Nigeria are multi-faceted and demand a multi-dimensional approach for a lasting solution, it is specifically argued that the TRIPS flexibilities are significant means for addressing the challenges of affordable access to important health treatments within the context of patent law. However, it is emphasised that utilising the flexibilities will require that Nigeria’s patent system is strategically designed to take full advantage of the available safeguards and options. To this end, this study recommends ways to incorporate the flexibilities to enhance access to medicines in Nigeria while avoiding the technical and regulatory pitfalls that have trailed the enforcement of the flexibilities by other developing countries.

The Latin America, the richest continent in the planet's biodiversity, has been subject to expropriation by multinational corporations seeking access to plants and animals or knowledge related to biodiversity, produced by indigenous peoples or traditional communities, which will give support to the scientific findings used by large industries in the production of medicines, cosmetics and a wide variety of products available in the market, for wich the industries claimed intellectual property rights, with the exclusion of traditional populations. In this scenario, there are overlaps between The CBD and TRIPs Agreement in multilateral settings, where the possibility of protecting biodiversity shares space with the same tendency to your merchandization. Although the The CBD and TRIPs Agreement structure different international issues, this norms interact from the granting of intellectual property rights on biodiversity products. Because of this, the research aims to comprehend the extent to which intellectual property rights under the WTO model, notably patents, impact on biodiversity protection by the Latin American countries. Investigates the multilateral regulation of biodiversity protection and intellectual property with the central analysis, respectively, in the CBD and TRIPs. Then, the structures of the multilateral system are confronted with a sui generis system, in order to find out if they are alternatives to protect biodiversity in Latin America. Thus, was possible to conclude that the Latin American countries have their possibilities to care of the biodiversity limited by international regime of intellectual property, which allows private ownership of biodiversity in the form of biotechnologies. This provides two contrary ways: to maintain the international regime of intellectual property that ensures the trade of bio-merchandise with patents, or to structure a regulatory framework to care of biodiversity, in the Conference of the Parties to the CBD and negotiations in the Council for TRIPs. However, the strong opposition of the North countries to the interests of Latin American countries leads to investigate a sui generis system, to articulate a unified position in Latin America for the international confrontation and have for basis the guarantee of rights to the traditional peoples on their traditional knowledge. / A América Latina, continente com maior riqueza em biodiversidade do planeta, tem sido submetida à expropriação por empresas multinacionais que buscam acesso a espécies de plantas e animais ou a saberes dos povos indígenas ou comunidades tradicionais sobre a biodiversidade, que darão suporte a descobertas científicas utilizadas por grandes indústrias na produção de medicamentos, produtos cosméticos e os mais variados bens disponíveis no mercado, para os quais são reivindicados direitos de propriedade intelectual, em exclusão das populações tradicionais. Nesse cenário, ocorrem as sobreposições entre a CDB e o TRIPs nas regulações multilaterais, a partir do que a possibilidade de proteção da biodiversidade compartilha espaço simultâneo com a tendência à sua mercantilização. Embora estruturem questões internacionais distintas, a CDB e o TRIPs interagem a partir da concessão de direitos de propriedade intelectual sobre produtos da biodiversidade. Em razão disso, a pesquisa buscou compreender em que medida os direitos de propriedade intelectual sob o modelo da OMC, notadamente as patentes, interferem na proteção da diversidade biológica pelos países da América Latina. Investiga-se a regulação multilateral de proteção da biodiversidade e de propriedade intelectual com a análise centralizada, respectivamente, na CDB e no TRIPs. Em seguida, são confrontadas as estruturas do sistema multilateral a um sistema sui generis, com o objetivo de descobrir se constituem alternativas de proteção da biodiversidade pela América Latina. Assim, foi possível concluir que os países latino-americanos têm suas possibilidades de cuidar da biodiversidade limitadas pelo regime internacional de propriedade intelectual, que permite a apropriação privada da biodiversidade em forma de biotecnologias. A partir disso surgem dois caminhos opostos: manter o regime internacional de propriedade intelectual que assegura o comércio de biomercadoria patenteada; ou estruturar um marco regulatório para o cuidado da biodiversidade, nas Conferências das Partes da CDB e em negociações no Conselho TRIPs. Porém, uma forte oposição dos países do Norte aos interesses dos países latino-americanos leva à investigar um sistema sui generis, que articule uma posição unificada da América Latina para o embate internacional e tenha por fundamento a garantia de direitos aos povos tradicionais sobre seus conhecimentos.

This paper seeks to discern the political factors that determine the results of negotiations in international cooperation. On the one hand, it makes a contribution to the broader theoretical debate on international regimes by combining regime theory and theories on globalisation into an integrated framework for the analysis of international policy results, or in this case treaties (theoretical objective). More generally, globalisation theory will help us understand why it has become important to initiate international cooperation, and regime theory to elucidate how these international cooperations emerge. To many observers, it is the large transnational corporations of the rich North, which have done best out of free trade. Through the huge influence they wield over governments at the WTO (World Trade Organisation), these corporations have won the freedom to move around the globe without restriction, making use of cheap labour, and locating wherever they can best tap into the largest and most lucrative markets. Suprastate global governance, such as the WTO and its TRIPs (Trade Related Intellectual Property Rights) regime, is the response to deal with the reality in which we live - the globalised reality. But global governance comes to a price. States have lost their supreme sovereignty in the face of globalisation and the power of the globalised economy and transnational corporations. This paper presents evidence that it does not seem likely that the parties to both the TRIPs Agreement and the Convention on Biological Diversity, in reality, can meet the obligations set out by these two agreements. Furthermore, this study points to those negative impacts the TRIPs Agreement poses to an enhancing of biological diversity and protection of indigenous knowledge.

Esta dissertação tem por escopo estudar a interface do Acordo TRIPS com o a Convenção sobre Diversidade Biológica, sob a perspectiva dos países em desenvolvimento. Para tanto, resgata a construção epistemológica Ocidental do conhecimento, direito, propriedade intelectual e desenvolvimento. Esta base teórica constituída é questionada pela CDB, que apresenta direitos relativos ao acesso de recursos genéticos e / ou conhecimento tradicional que subvertem a ordem estabelecida de geração do conhecimento e acumulação econômica. Tal subversão é parte integrante de movimento maior que questiona o próprio modelo de desenvolvimento e a relação Norte e Sul. Esta pesquisa contextualiza a estruturação legal e organizacional do tema e revisa as contribuições de autores que estudam este, sistematizando-as. Com este arcabouço, ela levanta hipóteses e reflete sobre as respostas destas, identificando paradoxos, compatibilidades e desafios. Apresenta (ndo) se, por fim, uma análise da governança institucional deste tema, através de uma nova configuração cognitiva e legal do mesmo. / This MA dissertation aims at studying the interface of the \'TRIPS Agreement\' with the \'Convention on the Biological Diversity\', under the view of the developing countries. As such, it ransoms the epistemologic building of the Ocidental knowledge, as well as the rights, intelectual property and development. This theoretical basis is questioned by \'CDB\', which presents rights related to the access of genetic resourses/ and the traditional knwledge, which subvert the established order of knowledge generation and economic accumulation. Such subvertion is part of a larger movement that questions its own development model and the North/ South relation. This research contextualizes the legal orgazing structuralization of the theme and revises the contributions of authors that study it, systematizing them. With this backbone, it rises hypotheses and thinks of these hypotheses, identifying paradoxes, compatibilities and challenges. It finally presents an analysis of the institutional governing of this theme, via a new cognitive and legal configuration of the same.

This master's thesis is concerned with the settlement of particular WTO disputes between Brazil and the United States. The aim of the thesis is to explain the importance of the Dispute Settlement Mechanism (DSM) for Brazilian trade strategy. To demonstrate the use of the mechanism the focus is placed on two specific disputes involving the United States and Brazil. These disputes, regarding patent protection and cotton subsidies, are analyzed using case-study methodology. Moreover, quantitative research based on WTO disputes data is included in the introductory chapter. The study of the disputes shows that Brazil has been one of the most active users of the DSM and that it has initiated cases predominantly against developed countries, the United States being the most frequent target. This strategy enables Brazil to pursue cases that are likely to have systemic implications and thus could have an impact on the international trade order. The two case studies are examples of disputes of potential systemic importance. They further reveal the complexity of disputes in terms such as the increasing role of NGOs, the concept of retaliatory suits, and the significance of timing and political pressure. The exposed dynamics of the settlement of disputes is useful for understanding other WTO cases as well.