制药企业产品跳转行为的法律规制——基于产品创新与产品垄断的视角

Legal Regulation of Pharmaceutical Enterprises’ Product Hopping from the Perspective of Product Innovation and Product Monopoly

根据产品跳转的时机、方式以及后果,制药企业产品跳转行为或属于产品创新,或表现为产品垄断。我国与西方国家在规制制药企业产品跳转行为的路径上存在着优先顺序上的差异。在国家促进仿制药市场健康发展的背景下,我国规制制药企业产品跳转行为的合理路径应是优先适用专利法,严格遵守专利授予标准,并推进专利法与反垄断法、药品管理制度等法律规范的和谐共生。

According to the timing,method and consequence of product hopping, the product hopping behavior of the pharmaceutical enterprise either belongs to the product innovation or the product monopoly. There are different priorities between China and western countries in regulating pharmaceutical enterprises’ product hopping.Under the background of promoting the sound development of China’s generic drug industry, the reasonable way to regulate pharmaceutical enterprises’ product hopping in China is to give priority to the patent law,strictlyapply the standard of patent grant and promote the harmonious symbiosis among patent law, anti-monopoly law, drug management system and other legal norms.