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I. Introduction : Status and Problems
Compulsory patent license (mandatory permission) system is an important system of intellectual property restrictions , often referred to as non-voluntary license , it refers to the national patent authorities in accordance with national public health situation , without permission of the patentee Win , while others implement their patent granted to a legal system . Drug patents are an integral part of the patent system , compulsory licensing system is also suitable for pharmaceutical patents . In recent years , as the international community, especially the developing countries or LDCs, such as public health crisis is urgent national emergency or other circumstances become increasingly prominent , such as AIDS , tuberculosis , malaria and other communicable diseases and other related issues increasingly the more serious for developing countries , and this situation has brought a heavy burden on society , but also severely restricts local economic and social development . Among them, to cause a public health crisis in these countries although the reasons attributed to many factors , but most patients in developing countries unable to pay expensive medical costs are causing a public health crisis is one of the most important reason . Thus, factors make drug patent protection and public interest conflicts are becoming increasingly prominent. Among them, the drug patent compulsory licensing system is an effective way to resolve this contradiction one . However, since the relevant national obvious conflict of interest between , especially in the Western developed countries with particular emphasis on the protection of private rights and developing the patent claims the protection of fundamental human rights exists between the fundamental conflicts of interest , therefore , TRIPS Agreement and the Doha Declaration on drug patents compulsory license under the terms of developed and developing countries has become the focus of concern and controversy .Now, with the international community, human development trend , in particular international and national domestic legislation have been showing a humanistic spirit . Field of intellectual property is no exception, from intellectual property protection Trips agreement to 2006 " Doha Declaration " (Doha Declaration ) characterization of the development process of the international community to developing and least developed countries and the protection of human rights concerns , and the progressive realization patent protection of private rights and public health benefits of coordination and balance.
专利强迫允许（mandatory permission）制度是对知识产职权范围制的一项关紧制度，一般被称为非自愿允许，它是指国度专利主管部门依据各国社会形态公共康健的具体事情状况，不经专利权益人的允许，而颁赠别人实行其专利的一种法律制度。药品专利是专利制度中的组成局部，强迫允许制度也适合使用于药品专利。近年来，随着国际社会形态特别是进展中国度或最不发达国度的公共康健危机等国度紧急事态还是其它火急的事物样子一天比一天凸显，如艾滋病、结石病、脾寒以及其它带有传染性质的疾病等有关问题等越来越严重，这一目前的状况给进展中国度和社会形态带来了沉重的负担，也严重抑制着当地经济和社会形态的进展。
Second, patent protection and conflict of interest between compulsory licensing and balance processes: from protocol to the Doha Declaration on Trips
专利保护与强制许可之间利益冲突与平衡的进程：从Trips协议到Doha宣言
( one) Trips Agreement on the public interest of the limited attention - to the developed countries as the center
Trips协议对公共好处的有限关审——以发达国度为核心从这两者之间好处协调和均衡过程可以看出，Trips协议在其会谈进展开始的一段时间，仅只表达出了对公共康健好处的有限的关心注视和照顾。
From this coordination and balance between the interests of the process can be seen , Trips agreement in their negotiations early stage of development , only showed limited interest to public health concern and care. GATT ministerial meeting in Uruguay , Switzerland and other countries to make proposals and asked to " trade in services ", " investment protection" and " intellectual property" as one of three new issues to negotiate satisfactory range . U.S. representative at the time even if you do not raise the issue of intellectual property issues such as the new person is satisfied that they would refuse to participate in the eighth round of negotiations and as a threat to its own interests to consider . Representatives of some developing countries that do not belong to the GATT intellectual property issues regulate and manage the content should not be satisfied that the person negotiations. The representative of Brazil has pointed out that if the intellectual property issues into the GATT opinions as input to a computer virus as a result of international trade will only further exacerbate the imbalance that already exists . "But many of the problems the international community is far from theoretical issues , such as not to break the deadlock in the Uruguay Round , the majority of the country's foreign trade practices will be affected ." From the essence, , Trips agreement was developed with the mission of birth . In addition , the agreement concerns the interests of public health is also reflected in each of its members to implement the provisions of the specific conditions of the agreement , rights, restrictions and transitional arrangements . Restrictions on the rights of which system is most typical .
( Two ) Doha Declaration and the implementation of paragraph 6 of significance for the balance of interests between the two
Doha Declaration on the meaning is positive. It identifies the public health takes precedence over private property rights , and explicitly take advantage of WTO membership agreement elastic provision. It will allow developing countries to use for public health purposes Trips Agreement elastic terms , trade sanctions against countries or the threat of legal action , but also for developing countries on a bilateral or regional trade agreements negotiated terms of intellectual property protection the important criteria .
Paragraph 6 Doha Declaration recognized the lack of manufacturing capacity in the pharmaceutical sector or no manufacturing capacity , members in the effective use of compulsory licensing under the Trips agreement may face difficulties , requested the Council to seek a rapid solution and at the end of 2002 before the report of the General Council . However, after arduous negotiations , until August 30, 2003 before WTO members reached an "Implementation Agreement and Public Health Declaration paragraph of the resolution" ( hereinafter referred to as "resolution" ) . The implementation of the "resolution" of the formation of the final marks of all members of the WTO in resolving conflicts pharmaceutical patents and public health issues has made meaningful consensus , mean that developing countries can finally enjoy some special treatment , but it is only a political manifesto , and in the presence of legal interpretation Shihai controversy occurred on a large uncertainty . However, in general terms , Trips Agreement and the resolution of relevant legislation has clearly reflects the interests of the public health concerns , such as "Trips Agreement and Public Health Declaration " Article 31 of the TRIPS Agreement was further applicable instructions and regulations , declaration pointed out , "Trips Agreement should not be and will not hinder member States to take measures to protect public health ," while the Declaration provides that " each member the right to decide what circumstances constitutes a" compulsory license as a prerequisite of the " national emergency or other circumstances of extreme urgency . "
" Doha Declaration " is the least developed countries as well as between the public health problem-solving on a preliminary victory to achieve a drug patent protection of private rights and public health benefits of preliminary coordination and balance. It stressed the Trips agreement in the future towards the fulfillment of the agreement to be established by the direction of the objectives and principles of development and progress , the international community in order to protect public health threat community suffered the fundamental interests of the public in order to achieve the rights and obligations of each member truly balanced and consistent . But, regrettably , the " Doha Declaration " Just have to clarify and explain the law of nature , it does not legally for the developing members create new rights . In addition, it does not address the lack of capacity or lack of members to produce and how to use the compulsory licensing issue. Thus, the balance of interests between the need of the international community 's efforts more step .
Third, intellectual property and life and health of the conflict between the choice of appropriate co-ordination and China
Patent system has an important public interest objectives , any successful patent system is critical in empowering proprietary and patent holders have an open and competitive market struck between the public interest in a delicate balance , that Steven B.Garland and Jeremy E called " the inventor of the patent system needs to be in the public interest and the interests of the general balance between ." Although in different countries at different times patentee 's monopoly interests and social public interests have focused on the balance between , and the patent law is not limited to all of the patentee 's monopoly interests and the balance between the public interest , but this balance is the most substantial . In patent law as the basis of the patent system is built on the basis of a reasonable balance of interests and sensible legal monopoly system .
Drug patents in the patent system is an important part of the patent compulsory licensing balance of interests of legal significance in the drug patent compulsory licensing is particularly evident. Pharmaceutical patentees private interests and public health need for a balance between the interests of mechanisms , drug patent compulsory licensing system is the right choice. 1878 Paris Conference confirmed the industrial property rights must be protected , but there is no limit patent monopolies may be detrimental to the public welfare , deal with patents for certain restrictions , the General Assembly resolution, thus creating a " public interest need to be imposed to the property principle " should apply to patents. TRIPS Agreement, Article 27 (2) expressly allows members of local governments to " protect human, animal or plant life or health or to avoid serious prejudice to the environment " and can exercise an exception for patent protection , and section 31 , for " without other purposes authorized by rights holders " specifies use of a patent without the authorization conditions and restrictions , in fact, makes provision for compulsory licensing concentrated . Several of these together constitute the compulsory licensing under the TRIPS agreement system .
For the United States , compulsory licensing is intended to prevent and limit the patentee abuse its patents, protection of national and social public interests , promote inventions implementation and application. From the perspective of the balance of interests can be further seen that compulsory licensing is to balance the patent holder a monopoly on the patented technology and the promotion of patented technology promotion and application of the system design . Patent law has an important public interest objectives . In the public interest considerations , the patent law must serve the national interest ; interests of patent holders in the public interest and national conflict , the public interest is a priority . Compulsory licenses in the public interest is coordinating the interests of patent holders and public interests and to make institutional arrangements, and has been " TRIPS Agreement " recognized . Therefore, developing countries like China , the United States should take advantage of the TRIPS Agreement , "Trips Agreement and Public Health Declaration " and "On Trips Agreement and Public Health sixth paragraph of the Doha Declaration on the implementation of the resolution ," which gives WTO members prevent the abuse of intellectual property , rights and other terms of the protection of public health to further improve the system of U.S. intellectual property law in order to safeguard the public interest, the relevant legislation should expressly provide for compulsory licensing system . Therefore, as soon as possible improve China's compulsory licensing system is an important way to balance the interests of all parties , it has an important American theoretical and practical value and significance. About the interests of both conflict and coordination problems , the United States in order to achieve the right to health , patents, should learn from international conventions and national legislation , need to adhere to the following principles: First, in the conflict of rights should be told " priority to the protection of legal interests " principle ; Second, the right coordination , should be implemented "benefit " benefit principle.
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