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目的:在不违反专利保护的条件下中如何鼓励制药企业研发新药。方法:借鉴美国在仿制药品的注册中处理专利相关问题的经验,提出一些建议。结果:我国2007年版的《药品注册管理办法》虽然较以前的版本在专利保护问题上取得了较大的进步,但仍然存在一些问题。结论:药品行业是个特殊的行业,必须加强专利保护,但在专利保护的同时也不能忽略消费者的权利和利益,应该在保护制药企业的新药研发积极性和消费者权利之间找到一个平衡点。
OBJECTIVE: To encourage pharmaceutical companies to develop new drugs without violating the patent protection. Methods: Drawing on the experience of the United States in dealing with patent-related issues in the registration of generic drugs, some suggestions are put forward. Results: Although China’s 2007 version of the Measures for the Administration of Drug Registration has made great strides in patent protection over previous versions, some problems still remain. Conclusion: The pharmaceutical industry is a special industry. Patent protection must be strengthened. However, the patent protection can not ignore the rights and interests of consumers. A balance should be found between protecting the enthusiasm of the pharmaceutical companies in R & D of new drugs and consumers’ rights.