从专利保护的角度看中药新药研制的方法学

A Discussion on Methodology of New Chinese Drug Development from Viewpoint of Patent Protection

本文从专利保护角度分析了当前中药新药研制在选题和立项方法学方面存在的问题，并提出了相应的对策。作者提出，为达到市场垄断性目标，新药研制必须注重立项前专利文献检索和开发后获得专利保护，而选题原则应改变当前所奉行的注重以往所公开的课题研究，忽视专利保护可能性研究的做法，努力把选题的目标投向开创性的新药开发。

The problem concerning the methodology of new pharmaceutical development in China is analyzed from the viewpoint of patent protection, and solutions thereof are provided. Searching patent documents prior to the devdlopment and obtaining patent rights after the development are two imoprtant means for the purpose of dominating the pharmaceutical market after the new drug is successfully devdloped. The principle of selecting items for new drug development should be changed from the current practice that emphasizes on how much basic work relating to the popject had already been done and published bdfore but neglects the possible protection patent rights may provide in future, to the objective of creating novel drugs that have not been studied and published before.