As discussões sobre as relações entre o Acordo TRIPS e a Convenção sobre a Diversidade Biológica (CDB) encontram-se na agenda internacional desde a realização da IV Conferência Ministerial da Organização Mundial do Comércio, ocorrida em novembro de 2001, em Doha no Catar. Apesar da considerável atenção que o tema tem recebido nos fóruns internacionais, o debate sobre o tratamento adequado da questão persiste sem solução. A presente tese apresenta uma abrangente análise das conexões que existem entre a proteção dos direitos de propriedade intelectual e a conservação da diversidade biológica. Além disso, a partir de uma análise de conceitos de propriedade intelectual como patentes, indicações geográficas, transferência de tecnologia e propriedade comunitária de conhecimentos tradicionais, destacam-se elementos necessários para o uso sustentável e conservação dos recursos biológicos. / The goal of establishing a positive relationship between the TRIPS Agreement and the Convention on Biological Diversity has been on the international agenda since the fourth Ministerial Conference of the World Trade Organization (WTO), in Doha, Qatar, in November 2001. Despite a considerable amount of attention in the international forums, the debate about the appropriate parameter of this relationship persists without resolution. This thesis provides a comprehensive analysis of the relationship between the protection of intellectual property rights and the conservation of biological diversity. Furthermore, that upon analysis of concepts of intellectual property such as patents, geographical indications, technology transfer and communal property over traditional knowledge, issues are identified to support the conservation and sustainable use of the biological resources.

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「被忽視」的熱帶疾病(NTDs)中的寄生蟲疾病(Parasitic Diseases; PDs)除對非洲人群健康之危害甚鉅外，並進而對非洲地區社經體系造成嚴重衝擊與造成巨大的「失能調整人年」損失。由於不易取得治療PDs傳統基本藥物的問題，許多非洲民眾便以其部落社區的傳統治療師所採用的傳統草藥來進行PDs的治療，雖然這些傳統草藥容易取得，但是成分的內容和藥效品質甚或產生嚴重的致命副作用。雖然TRIPS協定第31條和杜哈宣言的第五和第六段對於製藥能力不足或大部分皆無製藥能力的貧窮國家，可以基於「國家緊急危難或其它緊急狀況」的事由，以強制授權方式取得專利藥或較便宜的學名藥以解決造成國家危難的特定公共健康事件，但是國際大藥廠認為無利可圖，不願意花費資金投注於預防或治療此類疾病藥物的相關研發外，高收入的國家為保護其大藥廠的藥物專利，也往往使用一些經濟制裁手段逼迫上述國家就制定國內專利法以保護其藥物專利。雖然經杜哈宣言修正TRIPS協定第31(f)條有關強制授權對外出口的障礙，但是出口國對於強制授權程序與是否能取得政治上和藥廠業者的支持，仍充滿困難。應用「專利池」可以減少交易成本或法律爭議而可調和「強制授權」與解決「權利耗盡」的爭議，有助於解決非洲開發中國家取得專利藥物的困境。PDs造成非洲開發中國家民眾失能等長期痛苦與健康生活損失，類推適用SARS模式，可依TRIPS協定第31條(b)與杜哈宣言第五段(c)將之視為「造成國家緊急危難或其它緊急狀況」的重大公共健康的事由而可行使強制授權。雖然「生醫專利池BVGH」的「非獨家個別授權與免授權費」的操作模式與傳統電信技術專利池不盡相同，但因藥廠不願投入治療PDs的傳統基本藥物存在的副作用與抗藥性的新藥研發，為鼓勵對治療PDs的藥物進行創新研發， BVGH彈性的授權方式與免繳交授權費，將有利於解決開發中國家未來取得新專利藥的困境。除BVGH外，建議結合全球獎勵基金以「激勵拉拔」的方式獎助願意投入治療PDs新藥研發並將專利自願授權給BVGH的藥廠。鑒於全球暖化與最近中東難民潮大量湧進歐洲，罕見的PDs可預期會大量傳播開來，將嚴重衝擊歐洲等先進國家良好的公共衛生體系，而使得「NTDs尤其是PDs不再只是專屬於貧窮國家的疾病，亦將常現於富有的先進國家」。這些NTDs疾病將提供藥廠進行新藥研發的利基，然而在未來可能產生專利池的反競爭問題，導致支配市場獨占性的隱憂值得關注。 / Parasitic diseases (PDs) not only cause the huge health hazards to African populations, but also they further severely impact on African socio-economic system as resulting in huge economic and health losses as assessed by disability adjusted life-years. Since it is not easy for Africans to access the essential medicine to treat PDs, many of them will seek for the help of local healers in tribal communities to treat PDs. Although these traditional herbs are readily available, the content and quality of drug ingredients may even cause serious fatal side effects. Poor countries with insufficiencies or lacks of the pharmaceutical capacities may still access the patented medicines or cheaper generics to solve the national crisis caused by the specific public health events through compulsory licensing (CL) based on "national emergency or the other emergency situations" according to TRIPS Article 31 and Doha Declaration on the fifth and sixth paragraph due to that the large international pharmaceutical companies consider unprofitable, unwilling to spend money to invest on the research and development (R&D) of new drugs for prevention or treatment purpose. Moreover, the high-income countries also tend to exert some of the economic sanctions to force those poor countries to enact national patent law in order to protect drug patents. Furthermore, the mandatory obstacle of exportation authorized by CL from the amended TRIPS Agreement Article 31 (f) by the Doha Declaration has been improved; nevertheless, it is still fraught with difficulties in utilization of CL for the exporting countries because this should be dependent on whether they may actually get the supports from political and the pharmaceutical industry. Application of patent pools model may benefit to reduce transaction costs or legal dispute thus reconciling and resolving issues related to CL as well as doctrine of patent exhaustion and that it is beneficial to help solve dilemma for African countries to access patented drugs. Because Africans severely suffer from disabled caused by PDs thus leading to long-term pain and health life losses, African countries can grant CL as PDs may be regarded as national crisis like SARS causing "national emergency or the other emergency situations" as authorized from TRIPS Agreement Article 31 (f) and Doha Declaration paragraph 5 (c). Although the practice of individual licensing with royalty-free for BVGH is somewhat different from that of traditional patent pools, this licensing practice mode is beneficial to innovation in new drugs R&D to improve the side effects and drug-resistance of traditional essential medicines and help African countries to access patented new drugs in the future. Finally, it is recommended to cooperate with Award Foundation to encourage incentive for pharmaceutical companies which contribute most to new drugs R&D and voluntary licensing to BVGH. Owing to global warming and recent emergence of huge refugees into Europe rare PDs will be obviously spread out thus causing severe impacts on well-established public health system as leading to emergence of PDs in developed countries like Europe. Altogether, such situations definitely provide a good incentive in new drugs R&D for pharmaceutical companies; however, it guarantees concerns on anti-competitive and monopoly issues derived by biomedical pools in the future.

歐美葡萄酒貿易協定於2006年3月10日經歐美雙方簽署後，對於延宕多年之數項關於雙方葡萄酒貿易上之爭議，達成了一定程度之妥協。然雙方所妥協之內容均與WTO協定之規範有衝突之處；然從另一方面觀之，該協定卻有助於美國在其葡萄酒產品使用歐盟地理標示之爭議上，朝向與TRIPS協定較為合致之方向去修正。 歐美葡萄酒貿易協定最主要之爭議可分為兩大部分，一為歐盟關於葡萄酒釀造製程上之規範；另一是美國葡萄酒產品使用歐盟地理標示，本文主要將針對此二議題與WTO協定間之合致性進行探討，以了解該協定所妥協之部分與WTO協定間之合致性。由於歐盟與美國係為WTO內最具影響力之兩大會員，本文最後將探討該協定對於WTO多邊架構以及爭端解決機制上之所衝擊與影響。 / The EU-US agreement on trade in wine was signed on March 10, 2006, marking the end of a first phase in wine trading discussions began in 1983. The Agreement addresses several key issues, such as oenological practices, import certification, the use of European geographical indication on the wine label which produced in US and other labeling issues. This thesis is to analyze the most controversial parts of this agreement. This agreement compromises 17 provisions, there are two parts most controversial: one is the mutual acceptance of the EU-US oenological practice regulations, which would facilitate the trading of wine between the two parties. And the other is that finally U.S. agreed to prohibit new brands from using these names on non-European wine and grandfather those existing uses. The oenological regulation of EU is more strictly and conservative compare to the related international standard. Moreover, EU ban the import of wine which is not conform with its oenological regulation unless the exporting country meet the Derogation requirement to allow the wine to be imported and circulated in the territory of EU. This article is to analyses the consistency of the EU oenological regulation with the TBT agreement, and the MFN treatment with this derogation. And the U.S. had allowed the use of specific EU geographical indications, which is called semi-generic names in U.S. regulation, on the wine label for the wine producing in the U.S in its labeling regulation. According to the TRIPS Agreement, the use of EU’s GI is in a continuous matter before 1994 can be excepted from the regulation of additional for GI. This thesis would like to clarify which part of the use of those semi-generic names may or may not except from the context of TRIPS agreement about GI. Since the wine agreement settle down several issues which violate the WTO agreement, this thesis would like to discuss the impact of the wine agreement to the WTO multilateral system.

The thesis is focused on a specific area of intellectual property field, namely the system of protection of Intellectual property whose current form has been shaped by the international organizations, especially by the World Intellectual Property Organization (WIPO) and the World Trade Organization (WTO). There has therefore been allocated extra space in the thesis to make the reader familiar with these respective organizations, especially with their organizational structure, decision-making procedures and activities. Important part of the thesis is analysis of current relations between WIPO and WTO, including its negative aspects. The thesis also contains section devoted to possible future development of the relations between WIPO and WTO.

Due to the globalization of economy, the protection of intellectual property rights becomes very important, not only on a national and local basis but also on an international basis. The evidence is coming from the negotiation and ultimately the inclusion of the TRIPS Agreement, or Agreement on Trade Related Aspects of Intellectual Property Rights, into the World Trade Organization. In the TRIPS Agreement, one of the protections to a local intellectual property on an international level is the protection of geographical indications, and such protection can be found in Articles 22 through 24 of the TRIPS Agreement. Geographical indications identify goods as originating in a particular territory or region, and also indicate quality by letting consumers know that the goods come from an area where a given quality, reputation, or other characteristic of the goods is essentially attributable to their geographical origin. The protection of geographical indications has always been on the table and been mentioned in various international treaties, and eventually came together under the TRIPS Agreement. The different ways for geographical indications protection is examined in order to understand the different national regulations used in various countries as a tool to protect the geographical indications, hence, to protect intellectual property rights. The major issue regards the scope of protection is the extension of the TRIPS Article 23; diverse opinions and suggestions are coming from US and EU, the two biggest sovereignties. This also can be seen in the result of the WTO dispute case of EC – Trademarks and Geographical Indications. The future developments such as the negotiations for a multilateral system of register for geographical indications, the progress of developing countries toward protection of geographical indications and the involvement of the traditional knowledge, all play very crucial roles on the enforcement of geographical indications protection. This paper will explore all these matters.

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[pt] O objetivo principal da presente dissertação é discutir a dinâmica dos relacionamentos entre estados, e entre estado e sociedade, que giram em torno da produção e do acesso ao conhecimento, entendido como o estado da arte, da ciência e da tecnologia e as crenças e idéias de cada época a esse respeito. O exame desses relacionamentos será feito através do estudo do regime da Propriedade Intelectual, o que torna necessário discutir as teorias de regimes a fim de entender sua importância nas relações internacionais. Trata-se, portanto,de duas discussões interligadas, cada uma em seus aspectos substantivos, que levam a conclusões tanto a respeito da importância dos regimes como a respeito da dinâmica dos relacionamentos que giram em torno da produção e do acesso ao conhecimento. Minha proposta é discutir os dois temas centrais desse trabalho através da análise de como aconteceram as mudanças no regime internacional da propriedade intelectual e a mudança de regime. As mudanças serão identificadas a partir dos instrumentos legais que constituem o regime, dos debates sobre a adoção de agendas de revisão desses instrumentos legais, e do exame das coalizões formadas em função dos interesses particulares dos atores em cada um dos diferentes foros de negociações. Outra contribuição que esse estudo pretende trazer é uma pesquisa da literatura sobre o tema da propriedade intelectual que adota abordagens teóricas e ferramentas analíticas da disciplina de Relações Internacionais. / [en] The proposal of this work is to discuss the dynamics of interactions between states and between states and society, in which the main object is the production and access to knowledge - here understood as the state of the art, science and technology, and the beliefs and ideas about it. This dynamics is analyzed through the study of the Intellectual Property International Regime, what makes it necessary to discuss also regime theories and the meaning of regimes to International relations. Two separate and interconnected discussions will be developed, each one with its own aspects, and will bring us to conclusions both about the importance of regimes and about the dynamics of interactions on production and access to knowledge. The two main discussions are advanced through the analysis of regime changing. The changes are identified on the legal instruments which constitute the Intellectual Property regime, through the analysis of the debates over the agendas of revisions on these legal instruments, and through the exam of the coalitions created around particular interests of the actors in each of the different forum of negotiations. Another contribution this study intends to bring is a research on the literature about Intellectual Property that takes a theoretical approach and uses analytical tools of the discipline of International Relations.

Dans les pays en développement (PED), les problèmes engendrés par le VIH/SIDA et l’inaccessibilité des antirétroviraux (ARV) s’avèrent être la cause de ravages extrêmement préoccupants à tous les niveaux (démographique, politique, social et économique). Dans le cadre de l’Organisation mondiale du commerce (OMC), et notamment de l’Accord sur les aspects des droits de propriété intellectuelle qui touchent au commerce (« Accord sur les ADPIC »), un nombre croissant de PED ont ou sont en train d’intégrer un standard international de protection des brevets de produits et de procédés pharmaceutiques à leur législation nationale. Cette intégration a eu et continue de jouer un rôle majeur dans la problématique de l’accès aux médicaments dans les PED. Les conditions et les effets du régime de protection des innovations suscitent de vifs débats entre les partisans d’une protection accrue des brevets et les défenseurs de l’accès aux médicaments essentiels. Une des principales motivations de notre travail de recherche est de fournir une étude permettant de trouver des solutions à la fois favorables à l’amélioration de l’accès aux médicaments et à la préservation de l’innovation. Le problème complexe de l’accès aux médicaments ARV dans les PED est influencé par la pluridisciplinarité et l’interdépendance de nombreux facteurs. Le système des brevets ne constitue pas « l’unique » solution au problème. Toutefois, il doit être plus sérieusement considéré dans sa fonction d’équilibrage entre l’intérêt privé et l’intérêt collectif. C’est un outil juridique précieux pour le développement économique et technologique des PED et la réalisation de l’intérêt commun contre la pandémie. / In developing countries, problems brought about by HIV/AIDS and inaccessibility of antiretrovirals (ARVs) are proving to be the cause of serious damages at all levels (demographic, political, social and economic). Within the context of the World Trade Organization, and in particular the Agreement on Trade-Related Aspects of Intellectual Property Rights (“TRIPS Agreement”), a growing number of developing countries have integrated or are in the process of integrating into their national law an international standard of patent protection for pharmaceutical products and processes. Such integration continues to play a major role in the issue of access to medicines in developing countries. The conditions and effects of the protection regime respecting innovations give rise to heated debates between supporters of an increased patent protection and defenders of the access to essential medicines. One of the main motivations for our research is to provide a study that helps to find solutions that are both in favour of improving access to medicines and protecting innovation. The complex problem of access to ARV drugs in developing countries is influenced by the multidisciplinarity and interdependence of many factors. The patent system does not solve the problem on its own. However, it should be seriously considered in its function of balancing the private and collective interests. It is a valuable legal tool for the economic and technological development of the developing countries and to achieve the common interest against the pandemic.

During the last two decades, there have been a number of policy and legislative changes in respect of South Africa’s intellectual property (IP) and the national system of innovation (NSI). In 2012, a Ministerial Review of the Science, Technology and Innovation (STI) landscape in South Africa made recommendations to improve the STI landscape and effectively the national system of innovation. The study provides a critical review of drafts of the national IP policy published in 2013 as well as the IP Framework released in 2016 for public comment. The review of the IP and the NSI are within the context of the National Development Plan (NDP), which outlines South Africa’s desired developmental goals. South Africa is part of the BRICS group of countries (Brazil, Russia, India, China and South Africa). The South African economy is characterised by a desire to move away from being dependent on resources and commodities, to becoming a more knowledge based and innovation driven economy. It is hoped that such a move would assist the country to address some of the social and economic development challenges facing South Africa, as captured in the NDP. South Africa has a functioning IP system, but its relationship with South Africa’s development trajectory is not established. More particularly, the extent to which the IP system relates to the innovation system and how these two systems must be aligned to enable South Africa to transition successfully from a country based on the production of primary resources and associated commodity-based industries to a viable knowledge-based economy is unclear. The Trade-related Aspects of Intellectual Property Rights (TRIPS Agreement) of the World Trade Organisation (WTO) provides that IP must contribute to innovation and to transfer of technology and knowledge in a manner that is conducive to social and economic welfare. Certain provisions set out the foundations of intellectual property systems within the context of each member state. This study has thus explored the complex, complementary and sometimes contested relationships between IP and innovation, with particular emphasis on the potential of an intellectual property system to stimulate innovation and foster social and economic development. The study has also analysed the interconnectivity of IP and innovation with other WTO legal instruments, taking into account South Africa’s positioning within the globalised economy and in particular the BRICS group of countries. The research involved a critical review of South Africa’s IP and innovation policies, as well as relevant legislation, instruments, infrastructure, IP and innovation landscape, and relationship with international WTO legal instruments, in addition to its performance, given the developmental priorities and the globalised economy. The research documents patenting trends by South Africans using European Patent Office (EPO), Patent Cooperation Treaty (PCT), United States Patents and Trademarks Office (USPTO) databases over the period 1996-2015. A comparative analysis of patenting trends amongst BRICS group of countries has also been documented. The study also documents new findings, observations and insights regarding South Africa’s IP and innovation systems. Some of these, particularly in relation to higher education and research institutions, are directly attributable to the Intellectual Property Rights from Publicly Financed Research and Development Act. More particularly, the public institutions are becoming relevant players in the NSI and are responsible for growth of certain technology clusters, in particular, biotechnology. At the same time, the study makes findings of a decline of private sector participation in patenting as well as R&D investment over the 20-year period. Recommendations are included regarding specific interventions to ensure coherence between the IP and innovation systems. Such coherence and alignment should strengthen the systems’ ability to stimulate innovation and foster inclusive development and competitiveness, which are relevant for addressing South Africa’s socio-economic development priorities. / Mercantile Law / LL. D.