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Research On Compulsory License System Of Pharmaceutical Patents Under TRIPS Agreement

Posted on:2011-12-08Degree:MasterType:Thesis
Country:ChinaCandidate:J MaFull Text:PDF
GTID:2166360305457114Subject:International Law
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Recent years, public health problems caused by AIDS, tuberculosis, malaria, respiratory disease and other infectious disease, heart disease, diabetes, tumor and other chronic non-communicable diseases are already severe. The public health problem in developing and lest developed countries is become a focus of international community. The public health problem is tightly connect to the Agreement on Trade-Related Aspects of Intellectual Property Rights (hereafter TRIPS) settled by World Trade Organization(hereafter WTO).High price of medicines is the greatest obstacle preventing access to the essential drugs in developing countries in the increasing public health crisis. At the same time, developing countries are unable to control the spread of crisis and the loss of life due to the lack of essential drug. The international Intellectual Property Right Regime which tend to be stricter has restricted developing countries'freedom of design domestic Intellectual Property Right Regime according to their only condition and aggravate difficulty of access to drug. The Ministerial Declaration announced on DOHA WTO MINISTERIAL 2001, WTO Decision on Implementation of Paragraph 6 of the DOHA DECLARATION on the TRIPS passed on 2003 and the Amendment of the TRIPS Agreement, show the concern and attention on this problem by international community. As a developing country China also face the challenge of public health. So we shall earnestly thinking about how to give better protection on public health under WTO in a way that also give respect to the IP right of drug patentee.As an important system of patent law, the compulsory license system for patents (CLSP) is generally codified both in international laws and internal laws of different countries. The purpose of the system is to prevent the patentee from abusing patent rights, hindering the application of the patent and impairing public interest. The system totally reflects one of substantial character of Intellectual Property Law, that is balance of interests. The interests of the patentee and the public should be kept in a dynamic balance.The paper does comprehensive research on the compulsory license system of pharmaceutical patents under WTO through literature studies, case studies, comparative research methods, to promote the implementation of compulsory license system of pharmaceutical patents. This paper contains three parts:The first part introduces the outline of the compulsory license of patents, including:firstly, from the concept of compulsory license of patents, also it describes the characteristics and type of compulsory license of patents, compulsory license of patents system widespread in almost all countries before the Uruguay Round negotiations. Secondly, it describes the historical process of compulsory license system of patents. The evolvement of compulsory license of patents fall into the private rights. On the one hand, one country may regard the granting of patent monopoly as the incentive for the inventors, on the other hand, the compulsory license was used for overcoming the defects arising out of patent monopoly. Thirdly, this part introduces the influence of patent protection for pharmaceutical on research and development of the drug, and the influence of patent protection for pharmaceutical on the access to pharmaceuticals of developing and least developed countries. On the one hand, patent protection for pharmaceutical is favorable for pharmaceutical research and development, promotes the enthusiasm of pharmaceutical manufacturers. On the other hand, patent protection for pharmaceutical increases the prices of patented drugs, doesn't good for the access to medicines of developing and least developed countries.The second part introduces the structure of compulsory license system of pharmaceutical patents under WTO. Firstly, it is the brief analysis of TRIPS Agreement Article 31. The regardless of the developed countries or developing countries, should be liable for protecting the pharmaceuticals and corresponding manufacturing methods. The TRIPS Agreement is vital for research and development of the pharmaceutical technologies, the protection for the pharmaceuticals and the corresponding manufacturing methods. Secondly, in June 2001, TRIPS Council passed the special public health related declaration unprecedentedly, namely the Doha Declaration. It had led the TRIPS Agreement and the access to medicines to a new progress. Notwithstanding the reaching of Doha Declaration has been an important triumph won by the developing countries in intellectual property, there will be a long way to go to find the solution. Tough bargaining between the developed and developing countries focused on the topic of the patent compulsory license in Paragraph 6 of the Doha Declaration. Thirdly, till August 30,2003, WTO Council passed the Decision on the Implementation of Paragraph 6 of the Doha Declaration. On account of its burden and inefficiency to prevent the production of generic drugs with comparatively lower price by the competent manufacturers, the Decision arising out of the implementation of the Doha Declaration, has been criticized by the developing countries. Finally, that is introduction of the TRIPS Agreement Amendment. The implementation of Amendment safeguard the human rights, ease the public health crisis. Amendment make compulsory license system enter into a new place. And it's a triumph of developing and least developed countries. The meaning and effect of these documents have also been discussed.The third part introduces the practice of compulsory license of pharmaceutical patents. This part presents some typical cases handled by DSB under the WTO on pharmaceutical patents and health care. One is AIDS pharmaceutical disputes between the USA and South Africa, South Africa face the grim domestic situation and the high cost of patented drugs, forced to take corresponding measures to alleviate the pressure of domestic public health. Although the United States and other developed countries attempt to sanctions, the support of the international community, the U.S. withdrawal the case is the first dispute for the international society's response to the problem for developing countries'obtaining pharmaceuticals, and is of highly reference value and profound impacts. The other is Anthrax crisis of USA and Canada. The case reflects the double standards of the USA about the compulsory license system. When their country under crisis, when hope in the compulsory license, but in order to maintain their dignity, but had to rely on consultation solution. The final part presents China's legislation development in pharmaceutical patent and the public health crisis encountered in China's public health crisis and the access to pharmaceuticals.Finally, through compulsory license of system of pharmaceutical patents under WTO have been research and analysis. The same as patent protection system, compulsory license of system of pharmaceutical patents is essential. While protect the Personal interest of the patentee, make restrictions on certain conditions. Compulsory license system of pharmaceutical patents is only a kind of effective method, the achieving public health is the goal.
Keywords/Search Tags:Compulsory License, Public Health, TRIPS Agreement
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