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文中简要回顾了中国专利法历次修改的背景和主要内容以及对医药领域技术创新的保护情况,重点介绍了专利法及其实施细则第三次修改的背景、思路和内容,并分析和预测了这些修改可能对医药企业所产生的影响,包括强化遗传资源保护,禁止“生物海盗”行为;提高专利授权门槛,推动药品企业研发升级;明确专利药品强制许可条件,服务公共健康开拓国际市场;开放专利药品和医疗器械实验研发,促进非专利药及早上市等。
The article briefly reviews the background and main content of the previous revision of the Patent Law of China and the protection of technological innovation in the field of medicine. It mainly introduces the background, ideas and contents of the third revision of the Patent Law and its Implementing Rules, and analyzes and predicts these Modify the possible impact on the pharmaceutical companies, including strengthening the protection of genetic resources, prohibiting “biological piracy ”; raise the threshold of patent authorization to promote the R & D and upgrading of pharmaceutical enterprises; clarify the conditions for compulsory licensing of patented drugs, serve public health and open up the international market; Open experimental research and development of patented drugs and medical devices and promote the sale of generic drugs to the public in the morning.