中美药品专利强制许可模式研究

Research on the compulsory licensing model of pharmaceutical patents in China and the United States

药品可及性问题一直是药品专利权人与社会公众利益冲突的引线,而药品专利强制许可制度作为知识产权保护与限制并存、针对二者平衡博弈的立法设计在我国一直有名无实。除了外部发达国家经贸压力限制以及出于创新激励机制破坏隐患考量外,制度内部规范粗糙笼统、缺乏实用性也是重要因素。阐述药品专利强制许可制度的理论基础、起源发展,通过对比美国对待该制度的态度,结合我国实际,从药品医保准入谈判前置、司法审议救济细化、调整许可期限终止申请负担等方面对我国制度的完善提出建议。

The issue of drug accessibility has always been the lead of the conflict of interest between drug patentees and the public, and the compulsory licensing system for drug patents has always been nominal in China as a legislative design for the coexistence of intellectual property protection and restrictions and for the balanced game of the two. In addition to the restrictions on economic and trade pressure in external developed countries and the consideration of hidden dangers destroyed by the innovation incentive mechanism, the rough and general norms and lack of practicality within the system are also important factors. Expounds the theoretical basis and origin of the compulsory licensing system for drug patents, and makes suggestions for the improvement of China’s system by comparing the attitude of the United States towards the system, combined with China’s actual conditions, from the aspects of pre-negotiation of drug medical insurance access, refinement of judicial review and relief, and adjustment of the burden of termination of the license period.