在实现国家知识产权战略背景下,探讨修改专利法或其司法解释,明确药品专利不侵权诉讼案件的受理条件。基于专利法基本理论,运用案例分析、法条分析、经济分析及国内外法律制度比较分析等论证方法,剖析我国专利不侵权诉讼制度。根据国家知识产权战略,结合我国医药产业发展实际水平,适当拓宽药品专利不侵权诉讼的受理范围,提高药品的可及性。 Under the background of realizing the national intellectual property strategy, this paper discusses whether to amend the patent law or its judicial interpretation and clarify the conditions for accepting patent infringement cases. Based on the basic theory of patent law, this paper analyzes the non-infringement litigation system in China based on the case analysis, the law analysis, the economic analysis and comparative analysis of the domestic and foreign legal systems. According to the national intellectual property strategy, combined with the actual level of the development of China’s pharmaceutical industry, appropriately broaden the acceptance scope of non-infringement lawsuits for pharmaceutical patents and improve the accessibility of medicines.