法学院知识库

摘 要

药品专利反向支付协议是在医药领域出现的一种可能导致限制竞争效果的和解协议。本文从药品专利反向支付协议的界定出发，阐述了其法律性质和产生背景，分析了反向支付协议将会在我国大量产生的制度和产业基础，介绍了我国司法实践中已出现的相关案例。因药品专利反向支付协议中专利权的滥用会引发严重的限制竞争问题，故有必要对其进行反垄断法规制。但就我国现阶段立法情况来看，对反向支付协议的法律规制还存在诸多的局限性。结合域外已有的执法、司法实践，可总结出我国规制该问题的经验。

我国应从激励创新、促进公平竞争以及提高药品可及性的价值目标出发，结合反垄断法制度体系、实施体制，以我国反垄断法对横向垄断协议“禁止+豁免”的基本框架为蓝本，构建具体的规制路径。在禁止层面，基于药品专利依强度可分为基础专利和次级专利的特点，分别适用美国合理原则和可抗辩的推定违法原则进行反垄断审查，以实现竞争利益的内部平衡；在豁免层面，缔约各方可适用比例原则限制下的公共政策抗辩进行个案豁免。同时，可从建立药品专利反向支付协议反垄断行政执法与专利诉讼的沟通机制、完善反垄断审查的豁免条款以及反垄断法私人执行制度三个方面对其反垄断规制进行完善，以期能全面、有效地应对药品专利反向支付协议问题。

Abstract

Drug patent reverse payment agreement is a settlement agreement that may lead to the effect of restricting competition in the field of medicine. Starting from the definition, this paper expounds its legal nature and background, analyzes the system and industrial basis of reverse payment agreement, and introduces the relevant cases in China's judicial practice. Because the abuse of patent right will lead to serious problems of restricting competition, it is necessary to regulate it by anti-monopoly law. However, there are still many limitations. Combined with the existing extraterritorial law enforcement and judicial practice, we can summarize the experience of regulating this problem in China.

China should set out from the value goal of encouraging innovation, promoting fair competition and improving the accessibility of drugs, combined with the system and implementation system of anti-monopoly law, and build a specific regulation path based on the basic framework of "prohibition + exemption" of China's anti-monopoly law on horizontal monopoly agreements. At the level of prohibition, based on the characteristics that drug patents can be divided into basic patents and secondary Patents according to the intensity, the case analysis and EU analysis methods are applied to infer the violation of law respectively, so as to achieve the internal balance of competitive interests; At the level of exemption, the contracting parties can apply the public policy defense limited by the principle of proportionality for individual exemption. At the same time, we can improve its antitrust regulation from three aspects: establishing the communication mechanism between antitrust administrative law enforcement and patent litigation of drug patent reverse payment agreement, perfecting the exemption clause of antitrust review and the private execution system of antitrust law, in order to comprehensively and effectively deal with the problem.