国家药品标准与药品专利链接关系简要分析

药品关系到每一位公民的健康和生命,必须符合法定标准,药品标准强调药品的有效性和安全性；专利对于药品亦尤为重要,药品作为一种化学产品,其专利授权的条件是新颖性、创造性和实用性.目前国家药品标准与药品专利的两种法律体系之间的链接还很不完善,制药企业是实践药品标准和药品专利的链接的主体,首先要把握时间序列,做到先后有序；重点是依据药品标准注册资料,遵从专利特别是药品专利规则,撰写申请文件,以取得专利权,为药品标准保驾护航之目的.

The Links between Medicine Standard and Medicine Patent

Medicine is a kind of commodity that relates to the health and life of every citizen, therefore it should accord with the legal standard which stresses on the effectiveness and security of medicine. Patent is crucial to medicine--a sort of chemical product, the condition of which is novelty, initiative and practicability. Since there is the lack of the link between medicine standard of the state with the patent of medicine, medicine manufacturers are the principal part to correlate them. In the first instance, they should understand the time sequence for the reason of precedence. The core point is to write the documents of application ac cording to the registered medicine standard and the rules of patent especially medicine patent in order to get the patent for sake of medicine standard.