专利无效程序中药物化合物的创造性及其举证责任分配——兼评替格瑞洛化合物专利无效案

Inventiveness of Pharmaceutical Compound Patent in Invalidation Proceedings and the Distribution of Burden of Proof——Review on the Invalidation Case of the Compound Patent of Ticagrelor

药物化合物是药物专利中最为重要的专利之一。在无效程序中应当严格按照规定确定其所要解决的技术问题,合理认定"结构上接近的化合物",才能够更加准确、客观地评价药物化合物的创造性。根据"谁主张、谁举证"的证据规则,无效宣告请求人应该对其质疑创造性的观点承担举证责任,否则,就应当承担举证不能的后果。只有严格按照规定,才能实现最大程度的公平,平衡专利权人和社会公众的正当权益。

Compound patent is one of the most important patents for pharmaceutical filed. In the invalidation proceedings, the practical issue of the compound invention to solve should be determined in strict accordance with the provisions, and ＂the close compounds in chemical structure＂ should be reasonably affirmed, so that the inventiveness of the pharmaceutical compounds can be more accurately and objectively evaluated. According to the principle that who claims and who raises evidence, the person making the request for invalidation should bear the burden of proof for the negative review on the inventiveness, otherwise he shall bear the unfavorable effect. Only in this way, a maximum fair can be achieved, and the legitimate interests of the patentee and the public can be maintained.