Trips And Drug Patents Under Compulsory License To Amend The Law Trend Study

Health care related Intellectual Property Rights are deemed the internationaleconomic legal issues as international, special and complex, which distinguishthemselves from other kinds of Intellectual Property Rights with their particularnatures and different legal provision, economic background, culture, and cover awide range of subjects from different countries. Which is more important for usbetween private patent right and the public health care under the differentdevelopment of medicine industies? How to balance and harmonize the conflictsbetween patent protection and the fulfillment of right to health? It is an importanttopic that has been concerned and discussed by many international institutes formany years.The right to a healthy environment is a kind of basic human rights. One of theobjectives provided in the preamble of the "Marrakesh Agreement Establishing TheWorld Trade Organization" expressly stipulates the Members to the Agreement:"Recognizing that their relations in the field of trade and economic endeavour shouldbe conducted with a view to raising standards of living, ensuring full employmentand a large and steadily growing volume of real income and effective demand, andexpanding the production of and trade in goods and services, while allowing for theoptimal use of the world's resource in accordance with the objective of sustainabledevelopment, seeking both to protect and preserve the environment and to enhancethe means for doing so in a manner consistent with their respective needs andconcerns at different levels of economic development." The Preamble to the TRIPsAgreement commences with a statement of the desire of Members: "to reducedistortions and impediments to international trade, and taking into account the needto promote effective and adequate protection of intellectual property rights, and toensure that measures and procedures to enforce intellectual property rights do notthemselves become barriers to legitimate trade."Economic development is less important than our public health environmentexactly. The crisis of public health environment evidences the conflicts andimbalance of international economic development among the Members. TRIPs is themost far-reaching intellectual property agreement yet enacted on a global level. Asthe TRIPs Agreement is one of the annexes of the WTO, in the Preamble of theTRIPs Agreement, Members recognise the underlying public policy objectives ofnational systems for the protection of intellectual property. They also recognise thespecial needs of the least-developed country Members in respect of maximumflexibility in the domestic implementation of laws and regulations in order to enablethem to create a viable technological base. In this context, patent rights cannot beparamount to overarching public policies, in particular for the needs of public healthpolicies. Whenever Governments deem it appropriate, a number of the provisions ofthe TRIPS Agreement can be applied in order to ensure access to medications.The WTO's TRIPs Agreement is an attempt to narrow the gaps in the way theserights are protected around the world, and to bring them under common internationalrules. It establishes minimum levels of protection that each government has to give tothe intellectual property of fellow WTO members. In doing so, it strikes a balancebetween the long term benefits and possible short term costs to society. Society benefitsin the long term when intellectual property protection encourages creation and invention,especially when the period of protection expires and the creations and inventions enterthe public domain. Governments are allowed to reduce any short term costs throughvarious exceptions, for example to tackle public health problems.Article 7 of TRIPs Agreement is a key provision that defines the objectives ofthe TRIPs Agreement. It clearly establishes that the protection and enforcement ofintellectual property rights are supposed to benefit society as a whole and do not aimat the mere protection of private rights. In Article 8, the TRIPs Agreement affirmsthat Members may adopt measures necessary to protect public health and nutrition.Although there were some resistances and debates during the negotiations anddiscussions of the Members of the WTO to the imposition of this particularframework, the TRIPs Agreement still included the developed and developing statesin a universalizing discourse of the intellectual property, and de-legitimisedcompeting methods of valuing or conceptualizing useful knowledge. The TRIPsAgreement tries to conduct a singular globalised, trade-related, and world-wideAgreement of the legitimate protection of intellectual property through theharmonization and balance of the legal impacts between the private interests andpublic health across Members of the WTO. The developed states stressed tocomplete the justificatory schema which underlies their view of the worth ofintellectual property-the need for efficient allocation of resources implying therights of knowledge owners and the codification of un-authorised use as theft. All ofwhich the developed states and developing states argued and concluded after manyyears support further development and transference of technology for the publics.But there are some conflicts and discriminations between the views of TRIPsAgreement of developing states and developed states concerning the role of patentsprotection. This conflict is due to the imbalance of the private patent interests andpublic health benefits. There is one outstanding issue of TRIPs Agreement fordeveloped countries trying to establish the more strict-protected and world-wideprotection system of their intellectual property, is that when US and the Europeandeveloped countries were at a similar stage of development governmental views ofpatnet protection for non-nationals were not dissimilar to the position of developingstates adopted prior to TRIPs Agreement. The patent protection systems were seldomif ever extended to non-nationals during the eighteenth and nineteenth centuries. Noowner's licenses to utilize or implement the patent technology into an private realbusiness with no payments to intellectual property owners in another differentcountry is exactly the developmental business strategy of developing states which isillegitimate as stipulated by TRIPs Agreement. The developing states argue for anexpansion of the public health principle to include 'the balance between rights andobligations, general interest, non-reciprocity, special and different treatment, and thefreedom of each country to determine the scope and level of protection.' (GATT1990a:12).The TRIPs Agreement is widely expected to promote the protection ofintellectual property rights in the international trade market. A reliable internationaleconomic legal system throughout the whole world for obtaining and enforcing validpatents must be established to promote research and development (R&D) of thetechnology, especially in scientific or technical fields where R&D is time-consuming,and expensive. Pharmaceutical products require the patentee's licensing of nationalauthorities;its immense cost can be recovered only if there is a limited butreasonable period of patent protection. Many developing countries have notsufficient local patent laws to protect the patentee's intellectual property rights;withthe consequence that patentee can not prevent any counterfeiting and infringementacts against his patent right. TRIPs agreement will improve this unreasonablesituation.Worldwide balance and harmonization of national laws is desired. Even if thepresent TRIPs Agreement is not perfect and has not completed the amendment inthis respect, it is still an important, international economic legal guideline for furtherdevelopment in harmonizing laws, legal decision and regulation, with no furtherdiscrimination or conflict against foreigners.The grounds for granting compulsory licences are as indicated in Article 31 ofTRIPs Agreement. Article 31 of TRIPs Agreement establishes a detailed regulatoryregime for the granting of licences where "the law of a Member allows for other useof the subject matter of a patent without the authorization of the right holder,including use by the government or third parties authorized by the government".This article deals with what are traditionally referred to as compulsory licences,non-voluntary licences or licences of right. It sets specific conditions for the grant,but does not list or define the cases where a licence may be granted (except forsemiconductor technology). Negotiators weighed both options and preferred to leaveopen the cases where compulsory licensing (defined here as use by governments orby third perties authorized by governments) may be allow. Instead, they establishedstrict safeguards. The first such principle is that licences must be granted only on acase-by-case basis. Compulsory licences under which certain categories ofinventions automatically become eligible for a licence would seem to violate thisprovision. Some of these grounds are alluded to in the various specific provisions inthis Article, such as national emergency, anti-competitive practices, publicnon-commercial use and dependent patent. Other grounds may be gleaned fromArticle 8 which enunciates general principles which are applicable to the TRIPsAgreement as a whole. Article 8.1 of TRIPs Agreement permits Members of WTO to"adopt measures necessary to protect public health and nutrition and to promote thepublic interest in sectors of vital importance to their socio-economic andtechnological development". Article 8.2 of TRIPs Agreement permits Members ofWTO to take "appropriate measures" to prevent "the abuse of intellectual propertyrights by rights holders or the resort to practices which unreasonably restrain trade oradversely affect the international transfer of technology".TRIPs is the most far-reaching intellectual property agreement yet enacted on aglobal level. TRIPs was signed at Marrakesh in April 1994 as an annex to theAgreement establishing the WTO, is probably the most significant development ininternational intellectual property law this century. The purpose of TRIPs is to set aminimum standard rather than to harmonise. However, since the minimum standardof patent protection required by TRIPs is high, reflecting the standard associatedwith industrialized countries, patent harmonization will in fact take place. Yet thebiggest influence of TRIPs on the global patent system might be the factual andconceptual linking of trade and patent law. The theme of this thesis is to study howto rebalance these legal and economic conflicts for the most important internationaleconomic system. Firstly, the thesis tries to study the backgrounds of thedevelopments of TRIPs Agreement. Secondly, compulsory licencing are importantinstruments to protect public health. The thesis surveys the real situation of themajor Parties' crisis of public health and their relevant regulations about thecompulsory licensing. Thirdly, analyze deeply to the defects of the provisions ofTRIPs Agreement about public health. Based on the above study, it is expected tofind the solution through the positive and philosophical analysis.