药品专利诉讼中反向支付的因与果:以竞争法为视角

Causes and Consequences of Reverse Payment in Drug Patent Litigation:The Perspective of Competition Law

反向支付协议是指在药品专利侵权诉讼中,创新药厂向仿制药厂转移利益以结束专利诉讼的和解协议。该协议的出现是药品行业的特性、法律政策的推动、专利制度的缺陷、经济利益的诱惑等多种原因共同作用的结果,私法自治、激励创新药厂创新、仿制药厂的风险规避是该协议存在的合理性基础。反向支付协议的内容通常为限制条款(包括不挑战条款和不竞争条款)+利益转移条款(包括货币支付条款、不授权条款、附带交易条款、加速条款)模式。美国、欧盟等国家或地区的司法实践表明反向支付协议可能产生限制竞争的效果,需要根据具体的利益转移条款,并结合限制条款对其施以反垄断审查。为促进中国药品市场的健康发展,应针对反向支付协议产生原因及其典型条款,通过完善专利制度、建立上市药品目录集异议制度、设置药品专利诉讼和解通报制度、健全反垄断审查程序与规则等措施对反向支付协议加以预防和规范。

Reverse payment settlement refers to the agreement in which brand pharmaceutical companies transfer interests to generic pharmaceutical companies to end patent litigation in drug patent infringement litigation.The emergence of the agreement is the result of the combination of the characteristics of the pharmaceutical industry,the promotion of legal policies,the defects of the patent system,and the temptation of economic interests.The private law autonomy,the innovative incentives of brand pharmaceutical companies,and the risk aversion of generic companies are the rationality of the existence of the agreement.The content of the reverse payment agreement is usually a restriction clause(including non-challenge clause and non-compete clause)+benefit transfer clause(including currency payment terms,non-authorization clauses,incidental transaction terms,acceleration clauses).Judicial practices in countries such as the United States and the European Union indicate that reverse payment settlements may have the effect of restricting competition,and they should be subject to antitrust review in accordance with specific interest transfer clauses and in combination with restrictions.In order to promote the healthy development of China’s pharmaceutical market,the patent system,the listed drug directory opposition system,the drug patent litigation settlement notification system,antitrust review procedures and rules and other measures should be established and perfected to prevent and regulate reverse payment settlement according to its cause and typical terms.