我国仿制药专利挑战制度研究

Research on the Patent Challenge System of Generic Drug in China

我国现行专利法律体系初创了仿制药专利挑战制度,成为仿制药企与原研药企专利纠纷早期解决制度的核心组成部分。我国的专利挑战制度包含无效宣告激励制度和行政、司法“双轨”救济机制等内容。该制度既体现创新激励与尊重人权相统一的设计理念,也具有矫正正义与优化效率的价值意蕴。但作为其组成部分的通知制度和滥诉赔偿制度存在缺乏督促机制、适用条件不明等问题,使得该制度仍存在较大运行风险。在未来相关法律修改上,建议完竣专利挑战通知制度,限缩滥诉赔偿中的“主观恶意”认定标准,以实现仿制药企、原研药企与社会公众的多元利益平衡。

China’s current patent legal system has initiated the patent challenge system of generic drug, which has become the core component of the early resolution system of patent disputes between generic drug companies and original drug companies. China’s patent challenge system includes the invalidation announcement incentive system and the administrative and judicial "dual track" relief mechanism. This system not only embodies the design concept of the unity of innovation incentive and respect for human rights, but also has the value implication of correcting justice and optimizing efficiency. However, as for the notification system and compensation system for indiscriminate litigation, there are some problems such as lack of supervision mechanism and unclear application conditions, which make the system remain greater operational risks. In terms of future amendments to relevant laws, it is suggested to complete the patent challenge notification system and limit the identification standard of "subjective malice" in indiscriminate litigation compensation, so as to achieve the balance of multiple interests among generic drug enterprises, original drug research enterprises and the public.