我们前面所讨论的日本特许厅 (JPO) 什么关于“剂量和给药”化学实体的可专利的“药用”审查指南. 在这篇文章中, 我们将看一下日本特许厅的标准对药材的专利 (细胞, 等) 从生物体这些公知的衍生.
虽然日本专利法 (马来西亚, 在这方面) 不允许专利的手术方法, 治疗或人或动物体的诊断, 它仍然是可以取得专利的某些类别的药用材料使用的. 让我们看到了允许专利的一些例子:
- 药材 (细胞, 等) 从生物体它们是衍生 公开已知, 但由此药用新颖.
例如, (专利声明) 植入物材料用于治疗心肌梗死,其中包含由A-细胞的细胞片. 这是申请专利的,如果, from the state of the art as of the patent application filing date, it is not possible to predict that cardiac function is recoverable and the symptom of cardiac infarction is reduced by transplantation of A-cells, although it is publicly known that cell sheets are obtained from A-cells and that they are used as implant materials.The relationship between the A-cell and recovery of cardiac function should not have been known at the date of filing of the patent application and there is no motivation or suggestion for use of cell sheets consisting of A-cells for treatment of cardiac function. - Medicine characterized in a medicinal use of cells specified by 制造工艺.
例如. (专利声明) An anti-cancer agent comprising cells as an active ingredient obtained by the following process consisting of the steps of:
- culturing W-cells obtained from a human body in medium A containing 0.1–0.2 weight % X蛋白对 5 至 10 小时并加以收集, 和
- 传播收集的细胞,在步骤 (我) 上的细胞外矩阵Y,它们含有培养基B培养 0.1 - 0.2 重量 % 蛋白质 2 为 24 至 48 小时, 并加以收集.
这样的发明具有专利性,如果:
- it is found that the anti-cancer agent containing cells obtained by the process consisting of the steps (我) 和 (二) as an active ingredient inhibited angiogenesis peculiar to a cancer tissue and diminished the cancer growth. This is patentable even though the use of the cells is known for conventional medicinal use (免疫抑制).
- the use of living cell lines for medicinal purposes is patentable provided it can be shown such use was not known at the date of filing the patent application. But the patent claims to be allowed need to be very specific in nature.
注意:
This article is intended only to provide an alert service on matters of concern or interest
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