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FDA是个自我执行条文,它要求申请人在进行新药申请时提出一个要求5年期、3年期保护的声明。同时,你必须要提出你的新药注册申请应该获得5年或者是3年数据保护的理由。FDA将会在新药获得批准的当时或者之后很快告诉申请人获得数据保护的消息。另外,关于专利的关系也应在新药生产时提交。为什么要提交两次信息呢?有时你可能认为你提交的药以前已经存在了,但是你可以去申请它的另外一种用途,在这种情况下就会涉及到NDA的专利问题。为取得专属权的资格而对提供的药品保护适宜需要专门跟美国药监局进行协商。
The FDA is a self-executing provision that requires applicants to file a five-year, three-year protection claim when making a new drug application. At the same time, you have to ask why your new drug application should receive 5 or 3 years of data protection. FDA will promptly notify applicants of data protection on or after the drug’s approval. In addition, the patent relationship should also be submitted at the time of new drug production. Why submit a message twice? Sometimes you may think that the medicine you submitted already existed before, but you could apply for another use of it, in which case it would involve the NDA’s patent. Appropriate protection of the medicines provided to qualify for exclusive rights needs to be specifically negotiated with the U.S. Food and Drug Administration.