药品专利纠纷早期解决机制下首制药专利挑战研究

Research on First Pharmaceutical Patent Challenges under the Early Resolution Mechanism for Drug Patent Disputes

摘要: 我国现行专利法律体系创立了仿制药专利挑战制度，成为仿制药企和原研药企专利纠纷早期解决机制的核心组成部分，并形成了符合本土特色的专利挑战机制。虽然该机制在发展过程中面临着专利挑战法律依据不明确、首仿药独占期难以实现、确认专利保护范围之诉的风险等问题。因此，在不断完善仿制药专利挑战制度的发展中，应注重与其相关的节点，如专利信息登记平台、PTE、数据保护、无效时机等，以促进仿制药和原研药之间的平衡发展。

Abstract: China’s current patent legal system has established a generic drug patent challenge system, which has become a core component of the early resolution mechanism for patent disputes between generic drug companies and original drug companies, and has formed a patent challenge mechanism that conforms to local characteristics. Although in the process of development, the mechanism faces problems such as the unclear legal basis for patent challenges, the difficulty in realizing the exclusivity period of the first generic drug, and the risk of litigation to confirm the scope of patent protection. Therefore, in the development of the patent challenge system for generic drugs, attention should be paid to the nodes related to it, such as the patent information registration platform, PTE, data protection, invalidation timing, etc., so as to promote balanced development between generic drugs and original drugs.