浅析药物化合物专利的事实认定对制药领域的影响(二)——对补充药物效果试验证据的思考

On the Influence of Fact-Finding of Pharmic Compound Patent on Pharmaceuticals (Ⅱ)——The supplyment of pharmic effect experimentation evidence

由于化学领域具有的微观特性和较低的可预见性,实验数据通常是化学领域科学研究中不可缺少的组成部分,实验数据对于要求保护的技术方案的证明,也是在审查、确权、诉讼等环节中受到各方重视的焦点。本文以两个药物化合物专利权无效案为线索,基于案件中涉及的相关争论焦点,分析在实验数据的事实认定方面常见的一些观点,特别是申请日之后补交效果实验数据的事实认定,并进一步分析事实认定的不同思路对药物领域专利策略的影响。

Because of the microcosmic nature and unpredictability of chemistry, experiment data is indispensable for proving supporting evidence for the technical proposal in chemical study, and it is also the focus in examination, confirming the right and appeal concerning chemical patent. Basing on the bone of contention in two pharmic compound patent litigation cases, the fact-finding of supplyment of pharmic effect experiment evidence after the date of application and the influence of different fact-finding way of thinking on patent strategy in pharmacy field was expatiated.