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Health

Global anti epidemic calls for development oriented drug patent system

2022-07-28   

The 12th Ministerial Conference of the World Trade Organization (WTO) held in Geneva, Switzerland, in mid June achieved many important results, among which the Ministerial Decision on the exemption of intellectual property rights of covid-19 vaccine has attracted much attention. This meeting not only boosted the confidence of all parties in the multilateral trading system, reflected China's efforts and contributions to it, but also inspired us to think about the relationship between the intellectual property system, technological innovation and public interests, and firmly grasp the development orientation of the intellectual property system. 1. The WTO exemption decision is the reform and improvement of the intellectual property system. According to the public information disclosed by the world trade organization, developing countries will benefit from the covid-19 vaccine intellectual property exemption decision in vaccine production and other aspects. This decision is expected to allow developing countries to exempt some of the obligations of patent protection in the WTO Agreement on trade related aspects of intellectual property rights, authorize the production of covid-19 vaccine without the permission of the patentee, and export it to other eligible developing countries. In particular, developing countries allow greater flexibility in the implementation of covid-19 intellectual property rights authorization methods, notification obligations, and providing appropriate remuneration to patentees. For example, developing countries can authorize through legislation, executive orders, emergency decrees and other means, and can notify the World Trade Organization after authorization. Humanitarian and non-profit purposes can be considered when determining the remuneration of obligees. While achieving covid-19 vaccine production, developing countries are expected to expand the exemption decision of the world trade organization to therapeutic and diagnostic supplies in the future. Affected by many factors, the decision on intellectual property exemption of covid-19 has gone through a long process from the proposal to the final adoption. In the second half of 2020, developing countries including South Africa put forward a proposal to temporarily exempt the intellectual property provisions related to covid-19 vaccine and covid-19 treatment in the world trade organization. On November 20, 2020, the relevant Council held a meeting to consider the above proposal. 140 countries, including China, supported the proposal, but it was opposed by developed countries led by the United States and the European Union. In April 2021, more than 100 Nobel laureates and more than 60 politicians publicly signed a joint request for exemption from the intellectual property rights of covid-19 vaccine, calling for the start of the exemption process within the world trade organization. Through the unremitting efforts of developing countries including China, the decision on intellectual property exemption of covid-19 vaccine was reached at the 12th Ministerial Conference of the world trade organization. As a major producer and supplier of covid-19 vaccine, China has made important contributions to the decision on intellectual property exemption of covid-19 vaccine, which has been highly praised by the director general of the World Trade Organization yvira and other relevant parties. The intellectual property exemption of covid-19 is related to the vital interests of vaccine manufacturers in a few developed countries. According to relevant statistics, the expected revenue of covid-19 in 2022 of Pfizer, Moderna, AstraZeneca and Johnson & Johnson vaccine manufacturers totaled more than $60 billion. It is conceivable that developing countries without vaccine R & D and production capacity will be subject to the vaccine supply of enterprises in developed countries and the impact of the current intellectual property system. Professor Stiglitz, the Nobel Laureate in economics, claims that the intellectual property system of pharmaceutical enterprises in western countries is a legal maze composed of patents, copyrights, proprietary industrial designs and "exclusive rights" of trade secrets, which aims to maintain as much market control as possible for as long as possible to maximize profits. In fact, in addition to the exemption of intellectual property rights of covid-19 vaccine, some countries in the world have been calling for breaking the broader drug patent barriers and taking a variety of measures to ensure the supply of medical materials needed to combat the COVID-19, including the commitment of the patentee (i.e. the original pharmaceutical factory) to abandon the implementation of patents, voluntary licensing by the patentee on a voluntary basis, compulsory licensing of patents, etc. In addition to the bilateral mode, there is also the "public pool" mode of patent voluntary licensing. The patent "public pool" of anti epidemic drugs includes not only patented technology, but also cell lines, regulatory test data, proprietary technology, copyright, etc. Some countries even suggested that intellectual property rights related to anti epidemic technology should be licensed to WHO Member States through the "public pool" to promote the research and development of various new technology products required for anti epidemic and the sharing of achievements. It should be said that the intellectual property exemption of covid-19 vaccine is more friendly and convenient for developing countries than the compulsory patent license with complex procedures. The decision to exempt intellectual property rights of covid-19 vaccine and the open licensing of intellectual property rights related to other anti epidemic technologies are essentially a balance between public interests, individual interests and incentives for innovation. In fact, the balance between individual interests and public interests related to intellectual property has always been the focus of the United Nations, the world intellectual property organization, the World Health Organization, the World Trade Organization and other international organizations. The joint report of the World Health Organization, the World Intellectual Property Organization and the World Trade Organization stressed that the individual interests of intellectual property creators should not be overemphasized, and it is necessary to ensure a full balance between the interests of intellectual property creators and the wide application of the public. This means that technological innovation and the realization of public interests often involve the adjustment or transfer of market subjects' own rights. From a historical and comparative perspective, this covid-19 intellectual property exemption decision has opened a new window in the intellectual property system related to human health. It can be regarded as a benchmarking event in the history of the intellectual property system, and also provides a new reference for developing countries to reform and improve the intellectual property system dominated by developed countries, especially the pharmaceutical patent system. 2. The system design should ensure the public interest and encourage innovation. The logic of the existing intellectual property system is that the cost of technological innovation activities needs a certain period of patent monopoly to compensate, and generic drugs may affect the enthusiasm of intellectual property creators. However, in the field of covid-19 vaccine, which has an important impact on the public interest, we have seen the support of the World Trade Organization and its members for intellectual property exemption from the perspective of public interest priority. In the current covid-19 vaccine research and development process, the funds obtained by public funding and international crowdfunding have played a key role. The popular intellectual property protection and the logic of compensation for the interests of intellectual property creators are not so appropriate for the discussion of covid-19 vaccine intellectual property. Historically, penicillin, sulfa and other drugs that have made important contributions to human health have not even applied for patents. At one time, Indian laws only protected pharmaceutical processes, not compound patents; In addition, there are strict standards for the efficacy of drug patent application, a wide range of compulsory licensing of drugs, and strict supervision on the price of drugs. In fact, in addition to the consideration of the balance of interests, in the pharmaceutical industry, too strict intellectual property protection does not necessarily ensure that more chemicals are found. More and more empirical studies show that in some industries and fields, over strict intellectual property protection does not necessarily bring more innovation, but also accompanied by many problems caused by over protection and abuse. Especially when the degree of technological innovation is more complex, that is, when technological progress has the characteristics of "accumulation", the abused intellectual property system may have a greater impact and restriction on technological innovation. In pharmaceutical, integrated circuit, aircraft manufacturing and other industries, patent jungle, patent hooligans, patent evergreen and other issues have varying degrees of performance and influence. The world intellectual property organization also recognizes that the relationship between patent protection and technology diffusion is not linear. Developed countries are the leaders and beneficiaries of the global intellectual property system, and there are also corresponding problems. On the one hand, developed countries benefit from it by virtue of their dominant intellectual property system. Over the past decade, the United States, the European Union and Japan have always been the largest sources of global intellectual property exports (paid use) and the biggest beneficiaries of the current intellectual property system. On the other hand, in developed countries, the abuse of intellectual property rights is relatively serious, and its impact on technological innovation and large-scale mass production is increasingly apparent. Enterprises even fight for patent rights, and the vicious patent litigation costs reach tens of billions of dollars per year, but they have not been converted into the corresponding R & D investment. Historically, with the strong intervention of the government, the United States used the "patent box" method to solve the complex patent ownership problems involved in aircraft manufacturing. In response to the requirements of technological innovation cooperation and knowledge sharing mechanism, an open intellectual property system represented by Linux operating system has emerged in reality. China's intellectual property system, especially the drug patent system involving public interests, should adhere to the development orientation to avoid rent-seeking orientation, and carefully design relevant details. Since the outbreak of the COVID-19, China has always adhered to the people first and life first, organized the research and development and production of covid-19 vaccine, provided free vaccination services for the whole people, and provided an important material guarantee for the life safety of 1.4 billion Chinese people. At the same time, China has also provided more than 2.2 billion doses of covid-19 vaccine to more than 120 countries and international organizations, which has greatly expanded the scope of public interests and made China's contribution to the construction of a human health community. Facing the future, China should continue to deal with the relationship between intellectual property protection, technological innovation and public interests. In some key industries and fields (such as pharmaceutical and other industries that have a significant impact on life and safety), relevant departments should carefully formulate policies and details related to differentiated design, especially the scope, duration and standards of patents. Various forms of alternative measures, such as the incentive system for the creators of intellectual property rights, should be encouraged and used. The effective operation of the intellectual property system cannot be separated from the benign interaction between the government, enterprises and stakeholders. All parties concerned should strengthen coordination and overall planning. On the one hand, in terms of technological innovation, in addition to mobilizing the enthusiasm of market players, the government has greater room to play in the creation of knowledge communities, especially in R & D investment. The government can require the research results funded by public funds and the scientific research equipment purchased by public funds to be shared with the society free of charge or at cost price. On the other hand, all kinds of market players who abuse the intellectual property system should be strictly regulated. At the same time, relevant departments should strengthen the coordination of the design and implementation of domestic intellectual property system, and strengthen the coordination with developing countries in the formulation of international rules. In short, governments, enterprises and stakeholders should learn from the experience and lessons of the intellectual property systems of all countries in the world, work together to build a fair, reasonable and development oriented intellectual property system, and contribute Chinese wisdom and energy to global intellectual property governance. (outlook new era)

Edit:sishi Responsible editor:xingyong

Source:https://epaper.gmw.cn/gmrb/html/

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