药品专利权期限补偿制度对新药研制的影响评析

Evaluation and analysis of the influence of patent term extension system on the development of new drugs

本文探讨了我国药品专利权期限补偿制度对药物创新体系的促进作用,以及对仿制药和创新药的不同影响。统计分析了中国药品专利权期限补偿制度对国内近期即将上市新药的影响。预测近期申报上市新药可能获得的平均专利补偿期限,并提出了创新药物企业申请补偿期限专利的策略和专利布局建议,旨在促进新药研发企业和业内人士对中国药品专利权期限补偿制度的深度理解,为企业选择申请药品专利权期限补偿策略和布局提供帮助。

This paper discusses the effect of drug patent term extension system in promoting drug innovation, as well as the different effects on generic drugs and original drugs. The authors analyzed the impact of China’s drug patent term extension system on new drugs to be launched in China in the near future.The average patent extension that may be obtained for new drugs submitted for listing in the near future was predicted, and strategies and patent layout suggestions for new drug companies to apply for patent term extension were proposed. The purpose of this paper is to promote the in-depth understanding of new drug R&D enterprises and industry insiders on the compensation system for the term of drug patent rights in China, and to provide favorable help for enterprises to choose the compensation strategy and layout for applying for patent term extension.