No description available.

「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.

Após 15 anos de sua adoção pelos Membros da Organização Mundial do Comércio, o Acordo sobre os Aspectos da Propriedade Intelectual Relacionados ao Comércio (TRIPS) ainda permanece como um dos pilares das modernas instituições do sistema internacional da propriedade intelectual e merece contínua análise de seus efeitos sobre países em desenvolvimento. Nesse sentido, tendências expansionistas e níveis mais elevados de proteção dos direitos de propriedade intelectual, nas distintas esferas do multilareralismo, bilateralismo e regionalismo, são, no entanto, confrontadas com as necessidades reais dos países em desenvolvimento, que ainda devem explorar as flexibilidades existentes no Direito Internacional da Propriedade Intelectual. Isso parece ser evidente após a fase de transição do Acordo TRIPS. A implementação de obrigações relacionadas à proteção substantiva e procedimentos de aplicação efetiva da proteção (observância) dá lugar para controvérsias resultantes das demandas pelo acesso aos bens do conhecimento - bens da tecnologia e informação na ordem internacional. O presente trabalho oferece contribuição para o estudo do Direito Internacional da Propriedade Intelectual na Era Pós-OMC e propõe uma análise e reavaliação de seus elementos, princípios e objetivos. Enfatiza a tarefa imperativa de redefinição do equilíbrio intrínseco da propriedade intelectual e a manutenção e expansão do domínio público, concebidos como valores de ordem pública internacional. Nesse contexto, o trabalho propõe analisar os objetivos futuros de um regime internacional da propriedade intelectual, em parte consolidados pelos proponentes da Declaração de Doha sobre TRIPS e Saúde Pública e a Agenda da OMPI para o Desenvolvimento. Em sua estrutura, o trabalho divide-se em três partes. A primeira parte (Status Quo: O Presente e o Passado dos Direitos de Propriedade Intelectual na Ordem Internacional) analisa as políticas e objetivos justificam o regime internacional da propriedade intelectual, seus fundamentos no Pós-OMC/TRIPS e convergência das competências relacionadas à propriedade intelectual na ordem internacional. A segunda parte (O Passado Revisitado rumo ao Futuro dos Direitos de Propriedade Intelectual) aborda as implicações das tendências expansionistas e fortalecimento dos padrões de proteção da propriedade intelectual, concentrando-se em dois casos principais: a harmonização substantiva e os sistemas globais de proteção e observância dos direitos de propriedade intelectual. A terceira parte (Futuro dos Direitos de Propriedade Intelectual na Ordem Internacional) propõe a redefinição dos princípios e objetivos centrais do Direito Internacional da Propriedade Intelectual no Pós-OMC (equilíbrio, transparência, cooperação internacional e transferência de tecnologia) e a manutenção e expansão do domínio público, flexibilidades e opções para acesso aos bens da tecnologia e informação. / After 15 years from its adoption by the Member States of World Trade Organization, the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) still remains as one of the main pillars of the modern institutions of international intellectual property system and deserves a continuous assessment analysis of its overall impacts on developing countries, their innovation systems and developmental concerns. In this sense, expansionist trends and higher levels of protection of intellectual property rights (IPRs) in multilateral, regional and bilateral levels - are nevertheless confronted with the actual needs of developing countries in exploring existing and pending flexibilities within the international intellectual property legal regime. This appears to be true particularly after the post-transitional phase of TRIPS Agreement, where implementation of the multilateral obligations related to substantive protection and enforcement procedures gave rise to considerable contentious issues emerging from demands for access to global public goods, knowledge goods. This Doctoral Thesis offers a contribution to the current debate on International Intellectual Property Law in Post-WTO Era and proposes an analysis and reappraisal of its elements, principles and objectives. The work aims at focusing the imperative task of redefining the intrinsic balance of intellectual property and maintenance and expansion of the public domain as values of an international ordre public. In this context, we analyze the systemic objectives of a prospective international intellectual property regime, which were in part consolidated by the proponents of Doha Declaration on TRIPS and Public Health of 2001 and WIPO Development Agenda. In the first part (Status Quo: Past and Present of Intellectual Property in International Order) we analyze the main development of the current international intellectual property regime, its foundations in Post WTO/TRIPS, and convergent intellectual property related competences in international legal order. The second part (Present revisited towards the future of intellectual property rights) approaches the implications of expansionist trends and strengthening of standards of IP protection. In this case, our work focuses on two particular cases: the substantive harmonization and global protection systems and enforcement of intellectual property rights. The third part (Future of Intellectual Property Rights in International Legal System) further analyses core objectives and principles of International Intellectual Property Law in Post-WTO (balance, transparency, international cooperation and transfer of technology) and proposals for the maintenance and expansion of public domain, flexibilities and options for the access to the knowledge goods.

Após 15 anos de sua adoção pelos Membros da Organização Mundial do Comércio, o Acordo sobre os Aspectos da Propriedade Intelectual Relacionados ao Comércio (TRIPS) ainda permanece como um dos pilares das modernas instituições do sistema internacional da propriedade intelectual e merece contínua análise de seus efeitos sobre países em desenvolvimento. Nesse sentido, tendências expansionistas e níveis mais elevados de proteção dos direitos de propriedade intelectual, nas distintas esferas do multilareralismo, bilateralismo e regionalismo, são, no entanto, confrontadas com as necessidades reais dos países em desenvolvimento, que ainda devem explorar as flexibilidades existentes no Direito Internacional da Propriedade Intelectual. Isso parece ser evidente após a fase de transição do Acordo TRIPS. A implementação de obrigações relacionadas à proteção substantiva e procedimentos de aplicação efetiva da proteção (observância) dá lugar para controvérsias resultantes das demandas pelo acesso aos bens do conhecimento - bens da tecnologia e informação na ordem internacional. O presente trabalho oferece contribuição para o estudo do Direito Internacional da Propriedade Intelectual na Era Pós-OMC e propõe uma análise e reavaliação de seus elementos, princípios e objetivos. Enfatiza a tarefa imperativa de redefinição do equilíbrio intrínseco da propriedade intelectual e a manutenção e expansão do domínio público, concebidos como valores de ordem pública internacional. Nesse contexto, o trabalho propõe analisar os objetivos futuros de um regime internacional da propriedade intelectual, em parte consolidados pelos proponentes da Declaração de Doha sobre TRIPS e Saúde Pública e a Agenda da OMPI para o Desenvolvimento. Em sua estrutura, o trabalho divide-se em três partes. A primeira parte (Status Quo: O Presente e o Passado dos Direitos de Propriedade Intelectual na Ordem Internacional) analisa as políticas e objetivos justificam o regime internacional da propriedade intelectual, seus fundamentos no Pós-OMC/TRIPS e convergência das competências relacionadas à propriedade intelectual na ordem internacional. A segunda parte (O Passado Revisitado rumo ao Futuro dos Direitos de Propriedade Intelectual) aborda as implicações das tendências expansionistas e fortalecimento dos padrões de proteção da propriedade intelectual, concentrando-se em dois casos principais: a harmonização substantiva e os sistemas globais de proteção e observância dos direitos de propriedade intelectual. A terceira parte (Futuro dos Direitos de Propriedade Intelectual na Ordem Internacional) propõe a redefinição dos princípios e objetivos centrais do Direito Internacional da Propriedade Intelectual no Pós-OMC (equilíbrio, transparência, cooperação internacional e transferência de tecnologia) e a manutenção e expansão do domínio público, flexibilidades e opções para acesso aos bens da tecnologia e informação. / After 15 years from its adoption by the Member States of World Trade Organization, the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) still remains as one of the main pillars of the modern institutions of international intellectual property system and deserves a continuous assessment analysis of its overall impacts on developing countries, their innovation systems and developmental concerns. In this sense, expansionist trends and higher levels of protection of intellectual property rights (IPRs) in multilateral, regional and bilateral levels - are nevertheless confronted with the actual needs of developing countries in exploring existing and pending flexibilities within the international intellectual property legal regime. This appears to be true particularly after the post-transitional phase of TRIPS Agreement, where implementation of the multilateral obligations related to substantive protection and enforcement procedures gave rise to considerable contentious issues emerging from demands for access to global public goods, knowledge goods. This Doctoral Thesis offers a contribution to the current debate on International Intellectual Property Law in Post-WTO Era and proposes an analysis and reappraisal of its elements, principles and objectives. The work aims at focusing the imperative task of redefining the intrinsic balance of intellectual property and maintenance and expansion of the public domain as values of an international ordre public. In this context, we analyze the systemic objectives of a prospective international intellectual property regime, which were in part consolidated by the proponents of Doha Declaration on TRIPS and Public Health of 2001 and WIPO Development Agenda. In the first part (Status Quo: Past and Present of Intellectual Property in International Order) we analyze the main development of the current international intellectual property regime, its foundations in Post WTO/TRIPS, and convergent intellectual property related competences in international legal order. The second part (Present revisited towards the future of intellectual property rights) approaches the implications of expansionist trends and strengthening of standards of IP protection. In this case, our work focuses on two particular cases: the substantive harmonization and global protection systems and enforcement of intellectual property rights. The third part (Future of Intellectual Property Rights in International Legal System) further analyses core objectives and principles of International Intellectual Property Law in Post-WTO (balance, transparency, international cooperation and transfer of technology) and proposals for the maintenance and expansion of public domain, flexibilities and options for the access to the knowledge goods.

This thesis discusses the global regime complex concerning the management of plant genetic resources for food and agriculture, and how different regimes concerning these resources cooperate or stand in opposition to each other. Because of changes in US patent law and the establishment of TRIPS, patent claims over plant genetic resources has increased dramatically globally. This, amongst other things, in turn has lead to the development of CBD which in turn lead to the creation of access and benefit laws in many countries. To create a free flow of genetic resources for food and agriculture the ITPGRFA, with its multilateral system, were negotiated. The aim of this thesis is to investigate which consequences the regime complex concerning plant genetic resources for food and agriculture can have on the rights of small farmers, agricultural research and food security in the global South. The thesis shows how patents and strict access laws creates a situation where more and more actors has exclusive rights which excludes others from using these, for the global food security, essential resources. Further it is shown that there also are processes going on within the UPOV that risk to take away farmers right to save seeds, and thereby make them dependent on the more and more monopolistic global seed markets dominated by a few multinational corporations. It is established that ITPGRFAs multilateral system is an opening in this hyperownership of plant genetic resources for food and agriculture; but that the international community at the same time has to see to that the patent claims on plant genetic resources not violate farmers’ rights to their resources. / Denna uppsats behandlar det globala regimkomplexet för förvaltningen av växtgenetiska resurser för livsmedel och jordbruk, samt hur avtalen rörande dessa resurser samverkar eller står i motsättning till varandra. I och med förändringar i amerikansk patentlagstiftning och upprättandet av TRIPS har patentanspråk på växtgenetiska resurser ökat dramatiskt, vilket i sin tur påverkade tillkomsten av CBD vilken innefattar upprättandet av lagstiftning rörande tillträde till och den rättvisa fördelningen av nyttor härstammande från, genetiska resurser. För att möjliggöra ett relativt fritt flöde av växtgenetiska resurser har ITPGRFA med dess multilaterala system fram förhandlats. Syftet med denna uppsats är att undersöka vilka konsekvenser den nuvarande globala förvaltningen av växtgenetiska resurser för livsmedel och jordbruk kan få för jordbruksforskning, småbönders rättigheter och matsäkerhet i Syd. Uppsatsen visar på hur patent och tillträdeslagstiftningar skapar en situation där fler och fler parter innehar rättigheter att utestänga andra från att nyttja dessa, för den globala matsäkerheten, essentiella resurser. Vidare visas på hur det samtidigt pågår processer inom UPOV som riskerar att undanta bönder rätten att spara utsäde och därmed göra dem beroende av de i allt högre grad monopolartade frömarknaderna, vilka domineras av att fåtal multinationella företag. Här konstateras även att ITPGRFAs multilaterala system är en öppning i detta hyperägande, men att det internationella samfundet samtidigt måste försäkra att patentanspråk inte kränker bönders rättigheter till sina resurser.

No description available.

No description available.

[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.