借鉴电子通信行业经验探讨制药行业专利标准化的实施路径δ-中国药房.pdfVIP

·药业专论· 借鉴电子通信行业经验探讨制药行业专利标准化的实施路径Δ 1，2＊ 1，2 1，2 1，2 1，2# 陈晓雨 ，李 洋 ，李莹辉 ，赵 晶 ，李红玉 （1.兰州大学药学院，兰州 730000；2.兰州大学生物医药 知识产权研究中心，兰州 730000） 中图分类号 R95 文献标志码 A 文章编号 1001-0408（2017）13-1729-04 DOI 10.6039/j.issn. 1001-0408.2017.13.01 摘 要 目的：为制定制药行业专利标准化实施路径提供参考。方法：针对制药行业专利标准化尚处于探索阶段、缺乏可行经验 的现状，借鉴电子通信行业中专利领先于标准制定、权威组织帮助实施专利标准化、行业联盟推动专利标准化发展等经验，结合标 准的发展周期，尝试制定出符合制药行业特点的专利标准化实施路径。结果与结论：制药行业的专利标准化实施路径分为标准形 成、推广、升级阶段，各阶段的主要路径分别为由专利开始至药品注册标准正式形成、以国家食品药品监督管理总局的政策法规为 导向通过药品仿制进行标准推广、通过专利替换来升级药品标准。 关键词 制药行业；电子通信行业；专利标准化；实施路径 Exploration of the Implementation Path of Patent Standardization in Pharmaceutical Industry by Learning from the Experience of Electronic Communication Industry CHEN Xiaoyu1，2，LI Yang1，2，LI Yinghui1，2，ZHAO Jing1，2，LI Hongyu1，2（1.School of Pharmacy ，Lanzhou Universi- ty ，Lanzhou 730000，China ；2.Intellectual Property Research Center of Biological Medicine ，Lanzhou Universi- ty ，Lanzhou 730000，China ） ABSTRACT OBJECTIVE ：To provide reference for developing the implementation path of patent standardization for pharmaceuti- cal industry. METHODS ：For the situation that pharmaceutical industry is still in the exploratory stage and lacks of viable experi- ence ，the mature experiences of electronic communication industry in patent leading standardization implementation ，authoritative organizations helping implementing patent standardization and industry alliance to promote the development of patent standardiza- tion were used as reference ，combining with standard development cycle ，trying to develop the implementation path of patent stan- dardization that met characteristics of pharmaceutical industry. RESULTS CONCLUSIONS ：The implementation path of patent standardization for pharmaceutical industry was divided into standard formation stage ，promotion stage and upgrade stage. The main path in each stage was from patent to registr