药品专利权期限补偿研究-兼议《专利法》征求意见稿第42条第2款

Study on Drug Patent Term Extension: Comment on Article 42(2) of Patent Law Opinion Soliciting Draft

摘要:

专利权期限补偿能够激发制药企业进行新药创新和上市销售的积极性,但同时会限制仿制药的竞争速度,基于中国国情设计专利权补偿期具有十分重要的意义。通过对世界主要发达国家和地区药品专利期限补偿制度的适用对象、申请流程和补偿期限的对比和研究,发现创新能力和药品结构导致了各国家和地区对于药品专利权期限进行补偿的形式和内容均有所不同。中国应立足于满足本土制药企业的利益和患者用药质量,对药品专利权期限补偿的适用对象和激活条件进行有针对性的设计,同时应具体化申请流程和补偿期的计算方法。

关键词:药品;专利;补偿期

Abstract:

Patent term extension can encourage pharmaceutical companies to innovate and sale, but it may be restrict competition from generics. It is the great significance to design patent term extension based on China"s national conditions. The paper studies applicable object, applying process and compensation period of patent term extension of major developed countries and regions, and finds the different innovation ability and product structure of developed countries and regions lead to different the form and content of patent term extension. Based on local enterprises’ benefits and patients’ drug demands, China should carefully design applicable object and activation condition meanwhile, should concretize applying process and calculation method of compensation period.

Key words:drug; patent; compensation period