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The global fight against the epidemic calls for a development-oriented pharmaceutical patent system

Release Time：

2022-07-29

The 12th Ministerial Conference of the World Trade Organization (WTO) held in Geneva, Switzerland, in mid-June achieved a number of important results, among which the ministerial decision on intellectual property exemptions for COVID-19 vaccines attracted much attention. This meeting not only boosted the confidence of all parties in the multilateral trading system and 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 to firmly grasp the intellectual property system. development orientation.

1. The WTO exemption decision is a reform and improvement of the intellectual property system.

According to public information disclosed by the World Trade Organization and others, developing countries will benefit from the decision to exempt COVID-19 vaccines from intellectual property rights in aspects such as vaccine production. This decision is expected to allow developing countries to waive some obligations on patent protection under the World Trade Organization’s Agreement on Trade-Related Aspects of Intellectual Property Rights, authorize the production of COVID-19 vaccines without the permission of the patentee, and provide other eligible developing countries with National exports. In particular, developing countries are allowed greater flexibility in implementing new coronavirus vaccine intellectual property licensing methods, notification obligations, and providing appropriate remuneration to patent holders. For example, developing countries can authorize through various means such as legislation, administrative orders, emergency decrees, etc., can notify the World Trade Organization after authorization, and can consider humanitarian and non-profit purposes when determining the remuneration of the rights holder. While the production of COVID-19 vaccines is being achieved, developing countries are expected to extend the World Trade Organization's exemption decisions to therapeutic and diagnostic supplies in the future.

Affected by many factors, the decision on intellectual property exemption for the new coronavirus vaccine went through a long process from proposal to final approval. In the second half of 2020, developing countries including South Africa proposed a temporary exemption from intellectual property rights regulations related to COVID-19 vaccines and COVID-19 treatments at the World Trade Organization. On November 20, 2020, the relevant council held a meeting to review the above proposal. 140 countries, including China, were in favor of this proposal, but it was opposed by developed countries led by the United States and the European Union. In April 2021, more than 100 Nobel Prize winners and more than 60 politicians publicly signed a petition calling for exemption of intellectual property rights for COVID-19 vaccines, calling for the initiation of exemption procedures within the World Trade Organization. Thanks to the unremitting efforts of developing countries including China, the decision on intellectual property exemption for the COVID-19 vaccine was reached at the 12th Ministerial Conference of the World Trade Organization. As a major producer and supplier of COVID-19 vaccines, China has made important contributions to the decision on intellectual property exemptions for COVID-19 vaccines, which has been highly praised by World Trade Organization Director General Iweala and other relevant parties.

The exemption of intellectual property rights for COVID-19 vaccines is related to the vital interests of a few vaccine manufacturing companies in developed countries. According to relevant statistics, the expected revenue of the 2022 COVID-19 vaccine from the four vaccine manufacturing companies Pfizer, Moderna, AstraZeneca and Johnson & Johnson totals more than 60 billion US dollars. It is conceivable that developing countries without vaccine R&D and production capabilities will be restricted by the supply of vaccines from companies in developed countries and the impact of the current intellectual property system. Professor Stiglitz, the Nobel Prize winner in economics, even claimed that the intellectual property system of pharmaceutical companies in Western countries is a legal maze composed of patents, copyrights, proprietary industrial designs and "exclusive rights" to trade secrets. Maximize profits by maintaining as much market control as possible for as long as possible.

In fact, in addition to intellectual property exemptions for COVID-19 vaccines, some countries around the world have been calling for the breaking of broader drug patent barriers and taking various measures to ensure the supply of medical supplies needed to fight the COVID-19 epidemic, including patent holders (i.e. original drugs). Factory) promises to give up the use of patents, voluntarily license the patentee on a voluntary basis, compulsory patent licenses, etc. In addition to the bilateral model, voluntary patent licensing also has a "public pool" model. The patent “public pool” for anti-epidemic drugs includes not only patented technologies, but also cell lines, regulatory test data, proprietary technologies, copyrights, etc. Some countries have even suggested that intellectual property rights related to anti-epidemic technologies should be opened to WHO member states for licensing through a "public pool" to promote the research and development and sharing of results of various new technology products needed to fight the epidemic. It should be said that compared to compulsory patent licensing with complicated procedures, COVID-19 vaccine intellectual property exemption is more friendly and convenient for developing countries.

The decision on intellectual property exemption for the COVID-19 vaccine and the open licensing of intellectual property related to other anti-epidemic technologies are essentially a balance between public interests, individual interests and incentives for innovation. The balance between individual interests and public interests related to intellectual property rights has actually been the focus of international organizations such as the United Nations, World Intellectual Property Organization, World Health Organization, and World Trade Organization. The joint report of the World Health Organization, the World Intellectual Property Organization, and the World Trade Organization emphasizes that the individual interests of intellectual property creators cannot be overemphasized, and it is necessary to ensure a sufficient balance between the interests of intellectual property creators and the broad application of the public. This means that technological innovation and the realization of public interests often involve market entities adjusting or transferring their rights. From a historical and comparative perspective, this decision on the intellectual property exemption for the COVID-19 vaccine has opened a new window in the intellectual property system related to human health. It can be regarded as a benchmark event in the history of the intellectual property system, and it also provides opportunities for reform in developing countries. It provides a new reference for improving the intellectual property rights system led by developed countries, especially the pharmaceutical patent system.

2. System design must ensure both public interests and incentives for innovation

The logic of the existing intellectual property system is that the cost of technological innovation activities requires a certain period of patent monopoly to compensate, and generic drugs may affect the enthusiasm of intellectual property creators. However, in the area of COVID-19 vaccines, which has an important impact on public interest, we have seen the support of the World Trade Organization and its members for intellectual property exemptions from the perspective of public interest priority. In the current COVID-19 vaccine research and development process, public funding and funds obtained through international crowdfunding play a key role. The popular intellectual property protection and the logic of compensation for intellectual property creators are not relevant to the discussion of COVID-19 vaccine intellectual property rights. So appropriate. Historically, drugs that have made important contributions to human health, such as penicillin and sulfonamides, have not even applied for patents. At one time, Indian laws only protected the pharmaceutical process, but not the patents of compounds; there were strict standards for the efficacy of drug patent applications, a wider scope of compulsory licensing of drugs, and strict supervision of drug selling prices.

In fact, apart from the consideration of the balance of interests, in the pharmaceutical industry, overly strict intellectual property protection does not necessarily ensure that more chemicals are discovered. More and more empirical studies have shown that in some industries and fields, overly strict intellectual property protection not only does not necessarily lead to more innovation, but is 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 "cumulative" characteristics, the impact and restriction of the abused intellectual property system on technological innovation may be greater. In industries such as pharmaceuticals, integrated circuits, and aircraft manufacturing, problems such as patent thickets, patent trolls, and patent evergreening all have varying degrees of manifestation and impact. The World Intellectual Property Organization also acknowledges 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 they also have corresponding problems. On the one hand, developed countries benefit from their dominant intellectual property systems. In the past decade or so, 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, within developed countries, the problem of intellectual property abuse is relatively serious, and its impact on technological innovation and large-scale mass production is increasingly apparent. Companies even fight over patent rights. The cost of vicious patent litigation reaches tens of billions of dollars every year, but it fails to be converted into corresponding R&D investment. Historically, with strong government intervention, the United States used the "patent box" method to solve the complex patent ownership issues involved in aircraft manufacturing. In response to the requirements of technological innovation cooperation and knowledge sharing mechanisms, an intellectual property system represented by the Linux operating system and characterized by openness has emerged in reality.

My country's intellectual property system, especially the drug patent system involving public interests, must adhere to a development orientation to avoid rent-seeking orientation, and design relevant details prudently. Since the outbreak of the COVID-19 epidemic, my country has always put people and life first, organized the research, development and production of COVID-19 vaccines, provided free vaccination services to all the people, and provided important material guarantees for the lives and safety of 1.4 billion Chinese people. At the same time, my country has also provided more than 2.2 billion doses of COVID-19 vaccines to more than 120 countries and international organizations, greatly expanding the scope of public interests and making China's contribution to building a human health community. Facing the future, our country must continue to properly handle the relationship between intellectual property protection, technological innovation, and public interests. In some key industries and fields (such as pharmaceuticals and other industries that have a significant impact on life and safety), relevant departments should carefully formulate and differentiate designs. Relevant policy details, especially the scope, term and standards of patents, etc. Various forms of alternative measures, such as reward systems for intellectual property creators, should be encouraged and used.

The effective operation of the intellectual property system is inseparable from the positive interaction between the government, enterprises and stakeholders, and relevant parties must strengthen coordination and overall planning. On the one hand, in terms of technological innovation, in addition to mobilizing the enthusiasm of market entities, the government has greater room to play in the creation of knowledge communities, especially in R&D investment. For research results funded by public funds, scientific research equipment purchased with funds, etc., the government can require that they be shared with the public free of charge or at cost. On the other hand, various market entities that abuse the intellectual property system should be strictly regulated. At the same time, relevant departments should strengthen coordination in the design and implementation of domestic intellectual property systems and strengthen coordination with developing countries in the formulation of international rules. In short, governments, enterprises and stakeholders must learn from the experiences and lessons of intellectual property systems in various countries around 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.

Source: Guangming Daily

Author: Zhou Jianjun, associate researcher at the Research Center of the State-owned Assets Supervision and Administration Commission of the State Council

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