美国专利诉讼中反向支付协议的反垄断法规制研究
发布时间：2018-07-14 12:55
【摘要】：知识产权有利也有弊,一方面能促进创新,另一方面也能为了限制竞争滥用权利。医药行业对知识产权有极高的依赖性,如果品牌药商滥用了专利权,会让消费者花费更多的成本去购买品牌药,不利于医疗事业的发展、保障公共健康。在美国药品专利诉讼中,反向支付协议是一种常见的现象,是《药品价格竞争与专利期补偿法》的特殊产物。制药公司研发出一种新药后就可获得专利保护,成为专利权人,他可以排除任何制药商制造出相同或类似药物进入市场而产生对自己的影响,当仿制药商通过有关程序向美国食品和药物管理局(FDA)申请批准仿制药时,品牌药商即专利权人花费大笔资金以换取仿制药商延迟进入市场的时间,获得自己在一定时间内对市场的独占权。反向支付协议涉及专利法对私权保护和反垄断法对公权保护之间的利益平衡问题:一方面,品牌药商和仿制药商签订反向支付协议有利于专利持有人保护其专利,既用和解的方式解决了专利纠纷,也鼓励了技术创新;另外一方面,双方签署的反向支付协议阻碍了仿制药及早进入市场,会让消费者花高价购买药物、支付更高的医疗成本,强化了品牌药商的独占地位。由于签订的反向支付协议阻碍了仿制药进入药品市场,因而受到美国反垄断执法机构的关注。在美国实践案例中,主要适用本身违法原则、推定违法原则、合理原则对反向支付协议进行审查,并创新地运用了专利排他测试法对其规制。针对药品专利的创新性和专利诉讼的复杂性,经过不断地探索,审查反向支付协议案件时适用合理原则更为合适。中国是一个仿制药生产和使用的大国,品牌药和仿制药保持良好的竞争,有利于我国药品行业健康发展。目前,中国已经开始出现反向支付协议的现象,因此有必要采取措施规制反向支付协议,怎样规制、如何规制是我们需要面对的一大问题,而本文主要讨论的是如何从反垄断法的层面对反向支付协议进行规制。用反垄断法规制反向支付协议,能更好地维持药品市场的公平竞争,保持药品价格的稳定,防止品牌药商对药品价格的垄断,能维护药品市场正常的竞争秩序。在审查时,可以先确定合理原则的具体实施标准,具体分析个案时全面考虑各种因素并适用合理原则,这样更有利于实体正义。此外,还需完善有关法律,增加确认专利有效性的程序,并在司法实践中不断探索、不断完善有关规则。
[Abstract]:Intellectual property rights also have advantages and disadvantages. On the one hand, it can promote innovation. On the other hand, it can also limit the right of abuse of competition. The pharmaceutical industry has a high dependence on intellectual property. If the brand drugmaker abuses patent rights, it will allow consumers to spend more cost to buy brand medicine, disadvantageous to the development of medical services, and protect public health. In national drug patent litigation, the reverse payment agreement is a common phenomenon, a special product of "drug price competition and the patent period compensation law". A pharmaceutical company can obtain a patent protection after developing a new drug and become a patenton. He can exclude any pharmaceutical manufacturer from making the same or similar drugs into the market and producing it to himself. When a generic drug dealer applies to the US Food and Drug Administration (FDA) to approve a generic drug through the process, the brand drugmaker, the paten, spends a lot of money in exchange for the time when the imitated drugmaker is delayed into the market and obtains its own exclusive rights to the market for a certain time. The reverse payment agreement involves the patent law for private rights protection. The balance of interests between protection and antitrust law on the protection of public rights: on the one hand, the signing of the reverse payment agreement between the brand pharmacists and the counterfeit pharmacists will help the patent holders to protect their patents, solve the patent disputes in a conciliatory way and encourage the technological innovation; on the other hand, the reverse payment agreement signed by both sides hinders the generic drugs. Early entry into the market will allow consumers to buy drugs with high prices, pay higher medical costs, and strengthen the exclusive position of brand drugmakers. As a result of the reverse payment agreement, it hinders the entry of generic drugs into the drug market and is concerned by the anti monopoly law enforcement agencies of the United States. The principle, the reasonable principle, the reverse payment agreement is reviewed, and the patent exclusion test method is used to regulate it creatively. In view of the innovation of the drug patent and the complexity of the patent litigation, it is more appropriate to apply the reasonable original when examining the case of the reverse payment agreement. The good competition between the big powers, brand drugs and generic drugs is conducive to the healthy development of the pharmaceutical industry in China. At present, China has begun to appear the phenomenon of reverse payment agreement. Therefore, it is necessary to take measures to regulate the reverse payment agreement, how to regulate and how to regulate it, and the main discussion of this article is as follows. How to regulate the reverse payment agreement from the antitrust law. The reverse payment agreement is regulated by the antitrust law, which can better maintain the fair competition in the drug market, maintain the stability of the drug price, prevent the monopoly of the drug price from the brand drugstore, and maintain the normal competition order of the drug market. In the examination, the reasonable original can be determined. The specific implementation of the standard, the specific analysis of cases in the specific case and the application of reasonable principles, which is more conducive to substantive justice. In addition, it is necessary to improve the relevant laws, increase the validity of patent procedures, and continue to explore in the judicial practice, and constantly improve the rules.
【学位授予单位】：南京师范大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：D971.2;D913
本文编号：2121715
[Abstract]:Intellectual property rights also have advantages and disadvantages. On the one hand, it can promote innovation. On the other hand, it can also limit the right of abuse of competition. The pharmaceutical industry has a high dependence on intellectual property. If the brand drugmaker abuses patent rights, it will allow consumers to spend more cost to buy brand medicine, disadvantageous to the development of medical services, and protect public health. In national drug patent litigation, the reverse payment agreement is a common phenomenon, a special product of "drug price competition and the patent period compensation law". A pharmaceutical company can obtain a patent protection after developing a new drug and become a patenton. He can exclude any pharmaceutical manufacturer from making the same or similar drugs into the market and producing it to himself. When a generic drug dealer applies to the US Food and Drug Administration (FDA) to approve a generic drug through the process, the brand drugmaker, the paten, spends a lot of money in exchange for the time when the imitated drugmaker is delayed into the market and obtains its own exclusive rights to the market for a certain time. The reverse payment agreement involves the patent law for private rights protection. The balance of interests between protection and antitrust law on the protection of public rights: on the one hand, the signing of the reverse payment agreement between the brand pharmacists and the counterfeit pharmacists will help the patent holders to protect their patents, solve the patent disputes in a conciliatory way and encourage the technological innovation; on the other hand, the reverse payment agreement signed by both sides hinders the generic drugs. Early entry into the market will allow consumers to buy drugs with high prices, pay higher medical costs, and strengthen the exclusive position of brand drugmakers. As a result of the reverse payment agreement, it hinders the entry of generic drugs into the drug market and is concerned by the anti monopoly law enforcement agencies of the United States. The principle, the reasonable principle, the reverse payment agreement is reviewed, and the patent exclusion test method is used to regulate it creatively. In view of the innovation of the drug patent and the complexity of the patent litigation, it is more appropriate to apply the reasonable original when examining the case of the reverse payment agreement. The good competition between the big powers, brand drugs and generic drugs is conducive to the healthy development of the pharmaceutical industry in China. At present, China has begun to appear the phenomenon of reverse payment agreement. Therefore, it is necessary to take measures to regulate the reverse payment agreement, how to regulate and how to regulate it, and the main discussion of this article is as follows. How to regulate the reverse payment agreement from the antitrust law. The reverse payment agreement is regulated by the antitrust law, which can better maintain the fair competition in the drug market, maintain the stability of the drug price, prevent the monopoly of the drug price from the brand drugstore, and maintain the normal competition order of the drug market. In the examination, the reasonable original can be determined. The specific implementation of the standard, the specific analysis of cases in the specific case and the application of reasonable principles, which is more conducive to substantive justice. In addition, it is necessary to improve the relevant laws, increase the validity of patent procedures, and continue to explore in the judicial practice, and constantly improve the rules.
【学位授予单位】：南京师范大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：D971.2;D913
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