药品数据保护与专利保护期补偿制度的回顾与探讨

Review and Discussion on Drug Data Protection and Patent Protection Period Compensation

对于新药的专利保护,各国经过多年的探索,已形成了一个较为完善、科学的体系。由于开发周期长,加上审评过程的耽误,使得上市后的专利保护期大大缩短,医药市场较成熟发达的国家相继制订了专利期调整以及专利期补偿制度,有力地保护了创新药;仿制药“独占期”等制度安排则鼓励了首仿药的积极上市,药品保护与反垄断相互平衡。从国外药品专利保护与行政保护入手,回顾了我国对于新药和仿制药在不同的时期的不同行政保护措施,介绍了具有我国特色的《中药保护条例》。结合新版的《药品管理法》和《药品注册管理办法》中对于药品定义的重新界定,同时借鉴人用药品技术要求国际协调理事会(ICH)的成熟做法,根据行业发展与政策环境的需要,提出药品市场监管与准入应有的专利政策设计。此外,提出对不同类型的药品创新活动应给予适当保护等建议,旨在为新版《药品管理法》的相关配套措施的不断完善提供参考,在保护创新动力的同时,鼓励仿制药上市参与良性竞争,促进行业良性发展。

After years of exploration,relatively complete and scientific systems for patent protection of new drugs have been established in various countries.Due to the long development cycle of new drugs and their lengthy evaluation timelines,the postmarketing patent protection period is significantly shorter.Countries with more mature and better developed pharmaceutical markets have already implemented Patent Term Adjustment and Extension mechanisms,which can effectively protect innovative drugs.In addition,institutional arrangements such as an"exclusivity period",encourage the marketing of first-copy generic drugs,which provide a balance between innovation and antitrust.This article starts with foreign drug patents and administrative protection,reviews different administrative protection measures in China for new and generic drugs in different periods,and introduces the Regulations on the Protection of Traditional Chinese Medicines.Combining with the redefinition of drug in the new version of the Drug Administration Law and Drug Registration Management Measures,and utilizing the experienced practices of International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use(ICH)as required by industry development and policy environment,the article puts forward the patent policy design for drug market supervision as well as suggestions including one that different types of drug innovation activities should be given appropriate protection,with an aim to provide a reference for continuous improvement of relevant supporting measures of the new version of the Drug Administration Law,and to encourage the competition of generic drugs and promote the healthy development of the industry while protecting innovation.