한미 FTA 허가-특허연계제도의 바이오의약품 적용여부에 대한 고찰

Abstract

It is necessary to protect and develop our domestic biopharmaceutical industry according to the changes of global environment by KORUS FTA. Especially, it is urgent to make our domestic biopharmaceutical companies entry into the markets of USA. At the same time, it is necessary to prepare safeguards for the rushes of USA biopharmaceutical companies into our domestic market. Thus, it is the aim of this research to provide the effective legal and governmental protections for our domestic biopharmaceutical industry through examining biologics approval-patent linkage system. On top of it, this paper will be used as the basic source for the reasonable implementing methods of FTAs. I found that the approval-patent linkage system was not working well in the area of biologics unlike small-molecule drugs through the research. Because BPCIA repealed the Orange Book requirement in the application of biosimilars unlike generic drugs. This means that the regulation of biologics including biosimilars would be executed by agency regulation rather than patent protection. There’s no explicit provision on the biologics approval-patent linkage system in KORUS FTA. However, there’s possibility to discuss this issue in the near future due to the enactment of BPCIA. And the biologics approval-patent linkage system has been implemented in Korea through the Green List. Thus, we have to develop and execute the proper mechanism well fitted in our regulatory system regardless of KORUS FTA.