摘要
药品领域的反向支付协议集中体现了药品研发创新保护与药品市场自由竞争之间的博弈,对该类协议所实施的反垄断审查更是反映了药品专利法规与反垄断法规适用竞合与可能存在的冲突。通过对美国经验的考察,发现本身违法规则、合理规则以及可抗辩违法推定规则构成了现今对反向支付协议反垄断审查的主要适用规则。结合我国现阶段药品行业发展特征和竞争法治实施规律,认为可抗辩违法推定规则更加适合我国现实,且进一步主张以反垄断法为基石尽快建立药品市场上激励创新的自由竞争生态系统。
Summary：The reverse payment agreement in the pharmaceutical field embodies the game between the innovative protection of drug R＆D and the free competition in the pharmaceutical market.The anti-monopoly review carried out on this type of agreement reflects the application competition between drug patent laws and anti-monopoly laws.In American antitrust legal practice of reverse payment in the field of pharmaceuticals,in order to clarify whether the reverse payment agreement has a long-term effect that is unfavorable to competition,in the process of reviewing the illegality of reverse payment,we find that per se illegal rule,rule of reason,quick look rule and Scope of the Patent test have constituted the main rules for the antitrust review of the reverse payment agreement nowadays.However,no unanimous conclusion has been reached on this issue.On the one hand,this is due to the issue of the competing application of patent laws and anti-monopoly laws in reverse payment behaviors,which makes the value selection not easy.On the other hand,this is also based on the fact that different courts of the court,especially different federal circuit courts,enjoy greater autonomy in the choice of rules.The review of the judicial experience in the United States,in addition to providing relevant information,is more to provide useful lessons for the next step in the healthy and orderly development of China’s pharmaceutical market,especially the generic market.The selection of the judicial experience in the United States is based on the following factors.First,the selection of the U.S.experience as the object of investigation is determined by its world leading position in the application of antitrust laws,the development and application of the pharmaceutical industry,and its patent specifications.Second,the selection of the U.S.experience is related to the differences in the focus of antitrust enforcement mechanisms in the United States,and the European Union and its major countries.Third,the anti-monopoly review focused on reverse payment in the pharmaceutical field shows a competition and a value selection between the application of anti-monopoly laws and the application of patent laws of medicines essentially.It is difficult to draw on a fair and efficient judgment to rely on administrative agency alone.Strengthening a judicial supervision and review,or establishing a third-party review mechanism,may be a realistic and effective move.At present,the implementation of anti-monopoly laws in China is basically normal,and it is on the way to achieving specialization and refinement.The innovation protection and the competitive incentives in the pharmaceutical industry are an important part of the entire market competition law and its implementation system.The relevant institutional mechanisms need to be improved and the practice process must be promoted in an orderly manner.Taking the antimonopoly review of reverse payment as a breakthrough point,combining the extraterritorial experience with our country’s reality,and ensuring and satisfying people’s drug demands as the fundamental starting point,we should pay full attention to the balance between drug innovation protection and free competition.As the basic rule of anti-monopoly review of reverse payment,the rule of rebuttable illegality presumption provides both parties with full defense opportunities and encourages innovative development and free competition in the pharmaceutical sector with a sound system.Finally,it is worth emphasizing that China and the United States have different legal environments.It is hard to say that a specific experience and practice of the United States can directly apply to China.However,while investigating the U.S.experience,it is worthwhile to take seriously the cultivation and training of ideas and methods for thinking about similar issues.Specific to the anti-monopoly review of reverse payment,the problem of the value selection between drug patent innovation protection and market free competition,it is a good idea to use third-party evaluation platforms and operational mechanisms similar to the court and its judicial review mechanisms.This is not only conducive to the substantive solution to the problem,but also conforms to the design advocacy for the establishment and development of the third-party public service platforms from the top political level,and can effectively implement the landing.
作者
陈兵
Chen Bing(School of Law,Nankai University,Tianjin 300350,China)
出处
《上海财经大学学报（哲学社会科学版）》
CSSCI
北大核心
2018年第5期123-138,共16页
Journal of Shanghai University of Finance and Economics
基金
中国博士后科学基金2015-2017年度国际交流计划派出项目(20150029)的阶段性成果
南开大学百名青年学科带头人培养计划(2017-2023年)的资助
关键词
反向支付
反垄断审查
司法经验
可抗辩违法推定规则
自由竞争生态系统
reverse payment
anti-monopoly review
judicial experience
rule of rebuttable illegality presumption
eco-system of free competition
