仿制药专利挑战机制解释学分析与进路选择

仿制药专利挑战机制是我国药品专利链接制度的核心环节。在现有规范体系下进行制度构建，存在同现行《专利法》抵触的问题，通过立法或释法活动化解这种冲突具有必要性。在解释学范式下对仿制药品专利挑战侵权拟制、侵权解释两种立法进路进行推演和反思，并辅之以制度体系、国际比较、法律政策、经济分析等视角，可得出拟制进路更为可行的结论。在拟制进路下进行制度构建，应遵循法律拟制技术规范，并妥善处理制度配套问题。

Patent Challenge Mechanism of Generics: Legal Interpretation and Approach Analysis

The generic patent challenge mechanism is the core of the pharmaceutical patent link system.While the construction of generic patent challenge mechanism under the existing norm system may be a conflict with the current Patent Law, it is necessary to resolve such dispute through legislation or legal interpretation.Under the paradigm of statutory interpretation, the two legislative approaches to the infringement interpretation of generic patent challenges are deduced and reflected, supplemented by the perspectives of institutional systems, international obligations, legal policies, and law and economics.The holding is that the approach of legal fiction is more feasible.In the system construction under the proposed method, the technical norms of legal fiction should be emphasized, and the supporting system should be properly handled.