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2010年2月19日,EPO扩大申诉委员会作出第G02/08号决定:新的欧洲专利公约Art.54(5)不仅将承认“用于新的疾病适应症用途”的已知药用化合物和组合物的新颖性,还将承认“用于已知疾病适应症的新的治疗方法”的已知药用化合物和组合物的新颖性,且其中的“新的治疗方法”包括“新的给药方案”。该决定同时裁定,今后EPO将不再承认制药用途(瑞士型)权利要求的合理性。该决定是在2007年底生效实施的EPC2000就有关“二次药用”的药品专利政策所作改革的基础上的又一重要政策变化。在分析上述药品专利政策的变化根源和背景的基础上,探讨其对我国专利及医药产业政策的影响和启示。
February 19, 2010, EPO Enlarged Appeals Committee Decision G02 / 08: New European Patent Art.54 (5) Not only will known pharmaceuticals that “recognize the use of a new disease indication” The novelty of the compounds and compositions will also recognize the novelty of the known pharmaceutical compounds and compositions as “new therapeutic approaches for known disease indications,” and in which “new treatment methods ”Including “ new dosing regimen ”. The decision also ruled that in the future the EPO will no longer recognize the rationale for claims for pharmaceutical use (Swiss type). The decision is another important policy change on the part of EPC2000, which came into effect in late 2007, on the reform of the patent policy on medicinal products. Based on the analysis of the root causes and background of the changes in the patent policy of the above drugs, this paper discusses the impact and enlightenment on the patent and pharmaceutical industry policies in our country.