Article 76 of the Patent Law of the People’s Republic of China (2020 Amendment) establishes an early dispute resolution mechanism for pharmaceutical patent linkage. This mechanism aims to shift patent infringement conflicts to the generic drug approval stage, thereby reconciling the competing interests of originator and generic drug companies while accommodating public health imperatives. The framework establishes a comprehensive set of rules covering patent registration, patent declarations, dual-track dispute resolution, and first-generic exclusivity. However, in practice, a gap persists between the intended institutional design and its actual implementation. The mere transplantation of foreign rules has proven insufficient to address the specific context of China’s pharmaceutical sector. Consequently, challenges such as the constrained scope of patent registration review, procedural conflicts within the dual-track remedial system, and the prohibitive cost of patent challenges have become increasingly apparent. Moving beyond a restatement of statutory provisions, this paper utilizes China’s inaugural first-generic exclusivity case as a lens to analyse the systemic causes underlying these operational difficulties. It subsequently proposes actionable pathways for refinement, with the ultimate goal of advancing the system’s dual objectives: incentivizing pharmaceutical innovation and ensuring drug accessibility.
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Share and Cite
Xie, Y. (2026) A Practical Review and Improvement of the Early Dispute Resolution Mechanism for Pharmaceutical Patent Linkage in China. Journal of Disease and Public Health, 2(4), 8-13.