我国药品专利领域反垄断问题研究

发布时间：2018-02-06 02:23

本文关键词： 药品专利权反垄断反向支付协议药品强制许可制度　出处：《安徽财经大学》2016年硕士论文　论文类型：学位论文

【摘要】：药品专利权,是药品专利权持有人对药品专利的合法专属占有权,权利人拥有自行使用或者授权其他人使用该药品专利的权利。但过于绝对的专利权会导致市场发展失衡,药品专利权是一种绝对排他性的权利,一旦被垄断滥用会扰乱某一类或某一种药品市场,增加用药人群的经济负担。药品区别于一般消费品,其关系着人的生命健康权,药品专利权垄断行为不能以简单的商品专利垄断问题看待。药品专利的保护与反垄断之间的冲突是不可避免的,药品专利滥用产生各种限制竞争行为,包括滥用药品专利市场支配地位、药品专利拒绝许可垄断协议、人为延长专利保护期等限制竞争行为。这些行为将会破坏药品市场正常的竞争秩序,扰乱药品市场的公平竞争环境,损害药品消费者权益,所以会受到反垄断法律的规制。基于此,各国对于滥用药品专利引起的垄断都加以规制。美国作为世界上首个对药品专利垄断行为做出反垄断法规制的国家,制定了一系列法律来规制药品市场垄断,采取措施加快引进仿制药来促进药品市场竞争,颁布实施了著名的《药品价格竞争和专利期补偿案》。而印度、南非这样的发展中国家基于国家的公共健康和国内药品市场经济发展的考虑,利用TRIPS、TRIPS-plus协定的公共利益条款自治救济的方式建立了本国的药品强制许可制度,以对抗西方药品大国的药品专利垄断市场行为。其中印度更是依靠药品强制许可制度建立仿制药产业而成为了举世闻名的“世界药房”,不但解决了本国的公共健康药品需求的问题,更将印度药品推向了世界,促进印度药品经济发展繁荣。对药品专利市场的垄断行为进行反垄断法规制,我国作为一个正在深化经济改革的发展中国家,要考虑三个方面因素:第一,我国人口众多,药品专利垄断药品供给市场会损害社会公共健康,危及社会稳定;第二,药品专利垄断损害市场创新,垄断者利用法律和政策的漏洞延长药品专利保护期,有违专利法保护创新的初衷;第三,我国正在建立完善的社会主义市场经济体系,药品专利垄断妨碍了药品市场的良性竞争,不利于药品市场的健康成长。因此,在对我国药品专利领域进行反垄断法律规制时,既要借鉴美国药品专利反垄断法律规制的立法和司法经验,又要参考发展中国家基于公共健康而建立的药品专利强制许可制度。综上,笔者对于我国药品专利领域进行反垄断法律规制的建议包括三个方面:第一,建议建立我国药品专利权强制许可制度;第二,建议颁布药品专利权强制许可立法;第三,建议运用反垄断法对我国药品专利权滥用进行法律规制。
[Abstract]:Drug patent right is the legal exclusive possession right of drug patent holder. The right holder has the right to use the patent on his own or to authorize others to use the patent. But too absolute patent rights will lead to the imbalance of market development. Drug patent right is an absolute exclusive right. Once monopolized abuse will disturb a certain type or a certain drug market, increase the economic burden of drug users. Drugs are different from general consumer goods, which is related to the right to life and health. The monopoly behavior of drug patent cannot be viewed as a simple commodity patent monopoly. The conflict between the protection of drug patent and the anti-monopoly is inevitable, and the abuse of drug patent produces a variety of restrictive competition behaviors. These behaviors include abuse of the dominant position of drug patent market, monopoly agreement of drug patent refusal, artificial extension of patent protection period and so on. These behaviors will destroy the normal competition order of the drug market. Disrupting the fair competition environment of the drug market and harming the rights and interests of the drug consumers, it will be regulated by the antitrust law. The United States, as the first country in the world to regulate the monopoly of drug patent, has formulated a series of laws to regulate the monopoly of the drug market. Take measures to speed up the introduction of generic drugs to promote competition in the pharmaceutical market, promulgated the implementation of the famous "Drug Price Competition and Patent period compensation case". Developing countries such as South Africa take advantage of TRIPS on the basis of national public health and the development of the domestic drug market economy. The self-relief of the public interest clause of the TRIPS-plus Agreement establishes the compulsory licensing system of drugs in our country. In order to counter the monopolistic market behavior of drug patent in western countries, India has become a world-famous "pharmacy" by relying on the compulsory licensing system to establish the generic drug industry. It not only solves the problem of the demand for public health drugs in our country, but also promotes the development and prosperity of the pharmaceutical economy in India, and regulates the monopoly of the pharmaceutical patent market by anti-monopoly law. As a developing country that is deepening its economic reform, China should consider three factors: first, China has a large population, the monopoly of drug supply market will harm social public health and endanger social stability; Secondly, the monopoly of drug patent damages the market innovation, and the monopoly prolongs the period of patent protection by using the loopholes of law and policy, which is contrary to the original intention of patent law to protect innovation; Third, China is establishing a sound socialist market economy system, drug patent monopoly hinders the healthy competition of the drug market, is not conducive to the healthy growth of the drug market. In the field of drug patent in China, we should draw lessons from the legislative and judicial experience of the anti-monopoly legal regulation of drug patent in the United States. We should also refer to the compulsory licensing system of pharmaceutical patents based on public health in developing countries. In summary, the author's suggestions for the anti-monopoly legal regulation in the field of drug patents in China include three aspects: first. It is suggested that the compulsory licensing system of drug patent right should be established in China. Secondly, it is suggested that the compulsory licensing legislation should be enacted. Thirdly, it is suggested that anti-monopoly law should be used to regulate drug patent abuse in China.
【学位授予单位】：安徽财经大学
【学位级别】：硕士
【学位授予年份】：2016
【分类号】：D923.42;D922.294

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