| Summary: | 碩士 === 國立雲林科技大學 === 科技法律研究所 === 103 === Patent linkage system involves linking generic drug marketing approval with the originator drug’s patent status and refusing marketing approval until the relevant patent expires. However, generic pharmaceutical marketing as main market in Taiwan, and there is no patent linkage system in Taiwan, so there are still doubts about bringing in patent linkage system. For solve these question, first we discuss the legislative history and Current status of patent linkage system in US and the regulation of Biomedical and pharmaceutical in Taiwan. And then we discuss the impact of patent linkage on marketing of Generic drugs through the case “Novo Nordisk A/S v. Caraco Pharm. Labs, Ltd.”. In the end, we analysis the impact of patent linkage on Taiwan’s marketing of Generic drugs and discuss our government whether can introduce patent linkage system into Taiwan or not.
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