基于医疗数据支撑的医学专利临床经济价值评估体系研究

Most of the core patents included in key technologies in medical field are highly reliant on imports in China. The medical invention patents authorization of 2014 account for more than 30 thousand pieces while the conversion rate is lower than 8%.Our country is not lack of the creative ability but the transformational capability in the clinical fields, which is an urgent status to breakthrough. The inefficiency of application and conversion of medical achievements is due to multiple reasons, which one of the most important is the deficiency of a scientific and reliable evaluation system for the economic value of the medical research results in clinical fields. The solution to the problem of confirming the economic value of the patent contributed to the expected medical products has not been found out. The unique feature of transformation for the medical scientific and technical achievements is that the innovation source and users of the final health care products both exist in the progress of clinical treatment according to our practical and academic research. Based on health care date and elements distribution theory, this research will establish a theoretic evaluation system to confirm the range of the economic value of the patent contributed to the expected medical products. Gompertz curve and profit-sharing model are employed in this study, covering such sections: First, to construct the economic influence factors of medicine patents including the inventors’ features (medical staff) will be carried out. Second, obtain the model parameters objectively. Third, set up an economic assessment mechanism for the medicine patents. Fourth, verify the validity of the mechanism through empirical research and form the evaluation system. This research will break the evaluation bottleneck of patents in bio-medical field by providing a theoretical method for confirming the range of the medicine patents’ economic value and improve the conversion rate.

我国医疗关键技术的核心专利大部分依赖进口，2014年国内生物医药授权发明专利达3万多件，但转化率低于8%，因此我国缺乏的不是创新实力，而是转化能力，此现状亟待突破。医学转化率低，虽然涉及政策和专利质量等多方因素，但本质原因在于缺乏一套供需双方均认可的针对医学专利临床经济价值的评估体系，专利技术在预期形成的医疗产品中的价值贡献度确认问题未得到科学解决。课题组基于多年理论研究和转化实践认识到，医学专利特殊性在于发明来源和最终产品用户均存在于临床诊疗过程中。因此本研究以医疗数据为支撑，在要素分配理论指导下，使用Gompertz曲线和收益分成模型等方法，构建体现发明人（医务人员）特征的医学专利价值评价指标体系，推导模型参数，建立评估机制，通过实证研究验证机制的有效性，形成医学专利临床经济价值评估体系，突破生物医药领域专利技术价值评估瓶颈，为确定医学专利价格区间，提升医学转化率提供理论和实践支撑。

我国医疗关键技术的核心专利大部分依赖进口。医学转化率低，本质原因在于缺乏一套供需双方均认可的针对医学专利临床经济价值的评估体系，专利技术在预期形成的医疗产品中的价值贡献度确认问题未得到科学解决。本研究以医疗数据为支撑，运用文献研究，德尔菲专家咨询和因子分析方法构建了体现发明人（医务人员）特征的医学专利价值评价指标体系，包括4项一级指标，8项二级指标，26项三级指标；使用Gompertz曲线和收益分成模型，开展“一种眼表缓释给药装置及其制造方法”价格评估分析，并实现该专利的申请权转让；运用市场法，基于51例医学成果转化案例合同金额数据，开展医学专利临床经济价值评估机制的实证研究，为医学专利个案评估提供新测算工具，突破生物医药领域专利技术价值评估瓶颈。负责人发表论文3篇，投稿SCI论文1篇，作为副主编，编著《现代临床医学知识产权战略与实务》，获得计算机软件著作权1项，著作权1项，申请发明专利1项；搭建全国首个生物医药知识产权运营掌上平台，并接入上海市级医院互联网总平台，供全市医务人员使用；入选2019年度上海市人才发展资金和上海市医学会医学科研管理分会青年委员。