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中文题名:

 制药领域产品跳跃的反垄断问题研究    

姓名:

 朱晓平    

保密级别:

 公开    

论文语种:

 中文    

学科代码:

 035101    

学科专业:

 法律(非法学)    

学生类型:

 硕士    

学位:

 法律硕士    

学位类型:

 专业学位    

学位年度:

 2019    

校区:

 北京校区培养    

学院:

 法学院    

研究方向:

 经济法与环境资源法    

第一导师姓名:

 肖松    

第一导师单位:

 北京师范大学法学院    

提交日期:

 2019-06-04    

答辩日期:

 2019-05-20    

外文题名:

 A STUDY OF ANTITRUST ISSUES ON PRODUCT HOPPING IN THE FIELD OF PHARMACEUTICAL    

中文关键词:

 品牌药 ; 仿制药 ; 产品跳跃 ; 反垄断    

中文摘要:
新世纪以来,美国、欧盟等国家和地区制药领域出现了一系列由产品跳跃引起的反垄断诉讼,各级法院和反垄断执法机构也纷纷通过判决或者声明表明自己的立场,但各方意见远没有达到统一的程度,学术界对此问题也日益关切。如今,产品跳跃已经成为制药领域非常值得关注的问题。 我国国内尚未出现典型的产品跳跃案件,学术界对此问题的研究也很少。作为一个仿制药生产大国,我国的仿制药生产企业在与具有主导地位的国外专利药生产企业的市场竞争中没有优势,且有可能受到国外专利药生产企业的产品跳跃压制。长远来看,随着我国制药领域创新能力的提高,国内制药企业之间也可能会出现品牌药企业通过产品跳跃的形式阻碍仿制药参与市场竞争的问题。产品跳跃有可能阻碍竞争、阻碍医药创新,并最终损害消费者利益,不利于国家医药事业的发展和人民生活的稳定提高。因此,制药领域产品跳跃的反垄断问题有非常重要的研究价值。 本文共分为六个部分: 第一部分为绪论,介绍本文的选题意义、国内外研究综述和本文的研究方案。 第二部分对产品跳跃的概念及其产生背景进行介绍。首先根据不同学者对产品跳跃这一行为的表述归纳出了产品跳跃的基本概念与表现形式。然后介绍了产品跳跃在美国产生的法律背景,包括美国早期的仿制药管理制度、Hatch-Waxman法案和州药品替代法。 第三部分对美国产品跳跃引发的反垄断诉讼进行了介绍和评析。该部分选取了雅培诉梯瓦案、沃尔格林诉阿斯利康案、纽约州诉阿特维斯案、迈兰制药诉华纳奇考特案等典型产品跳跃案例。 第四部分介绍产品跳跃垄断行为违法性分析的理论及其发展。首先对合理原则和本身违法原则这两个反垄断法基本理论的适用范围和分析方法做了梳理。其次根据国外学者的最新研究,对利润牺牲检验、无经济意义测试和临床效益标准等新生理论进行了介绍和评析。 第五部分是对我国进行产品跳跃反垄断规制的前瞻性思考。首先,介绍了对产品跳跃进行反垄断规制的必要性;其次,对我国产品跳跃反垄断的法律制度的完善提出了建议;最后,根据国外的实践经验和理论成果,对产品跳跃垄断行为违法性的认定构建出新的理论框架。 第六部分概述了本文的研究结论,并指出本研究尚存在的不足之处。
外文摘要:
Since the beginning of this century, there have been a series of anti-monopoly lawsuits caused by product hopping in the US,the EU,and other countries and regions. Courts and anti-monopoly law enforcement agencies have made their positions known through judgments and statements. However, the opinions of all parties are far from reaching a unified level, and the academia is increasingly concerned about this issue. Nowadays, product hopping has become a very noteworthy issue in the pharmaceutical field. There are no typical product hopping cases in China, and there are few studies on this issue in domestic academic circles. As a large generic drug manufacturer, China's generic drug manufacturers have no advantage in the market competition with the leading foreign brand-name drug manufacturers, and may be suppressed by the product hopping of foreign brand-name drug manufacturers. In the long run, with the growth of the innovation capability of China's pharmaceutical companies, there may be problems with product hopping among domestic pharmaceutical companies. Product hopping may hinder competition, hinder pharmaceutical innovation, and ultimately harm consumers' interests, which is not conducive to the development of the national pharmaceutical industry and the steady improvement of people's lives. Therefore, the anti-monopoly problem of product hopping in the pharmaceutical field has very important research value. This article includes six chapters: The first chapter introduces the significance of this product, the overseas and domestic research status, and the research plan of this paper. The second chapter introduces the concept of product hopping and its background. First of all, according to the different scholars' expression of product hopping, the basic concepts and forms of product hopping are summarized. It then introduces the legal background of product hopping in the United States, including the early US generic drug management system, the Hatch-Waxman Act, and the State Drug Substitution Act. The third chapter introduces and evaluates the anti-monopoly lawsuits in America caused by product hopping. Cases of typical product hopping such as Abbott Laboratories v.Teva Pharmaceuticals USA,Inc., Walgreen Co. v. AstraZeneca Pharmaceuticals L.P., People of the State of New York v. Actavis PLC, Forest Laboratories, LLC,, and Mylan P-harmaceuticals,Inc. v.Warner Chilcott Public Limited Co. were selected. The fourth chapter introduces the basic theory of monopoly analysis and the new theory of academic circles. First of all, the analysis method of the reasonable principle and the scope of application of its own illegal principle is sorted out. Secondly, it introduces and evaluates the new theory of profit sacrifice test, no economic significance test and clinical benefit standard. The fifth chapter is the prospective thinking on product anti-monopoly regulation in China. It includes three aspects: the first aspect introduces the necessity of anti-monopoly regulation for product hopping; the second aspect,it puts forward some Suggestions for the improvement of the current situation of China's product hopping anti-monopoly system; the third part analyzes the functional positioning of China's anti-monopoly law in product hopping cases and constructs a reasonable analytical framework. The sixth chapter summarizes the research conclusions of this paper and points out the shortcomings of this research.
参考文献总数:

 55    

馆藏号:

 硕035101/19022    

开放日期:

 2020-07-09    

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