허가 - 특허 연계 제도 법률안 의 검토 < 안암 법 학회 < KISS 
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 허가 - 특허 연계 제도 법률안 의 검토 
 Korea ’ s Patent Linkage Bill and Its Analysis 
 이원복 ( Won Bok Lee ) 
 페이지 : 389 - 442 ( 54 pages ) 
 Ⅱ . 후발 의약품 판매 제한 제도 
 Ⅲ . 후발 의약품 진입 지연 에 대한 책임 
 Ⅳ . 최초 후발 의약품 우선 판매 제도 
 Ⅴ . 특허 목록 제도 
 Ⅵ . 허가 특허 연계 심판 
 Ⅶ . 맺 는 글 
 한미 FTA Korea - US FTA 약사법 Pharmaceutical Affairs Act 허가 - 특허 연계 patent - registration linkage 에버 그리닝 evergreening 시판 방지 marketing prevention 특허 목록 Green List 허가 특허 연계 심판 위원회 Patent - Registration Linkage Appeals Commission 신약 new drug 제네릭 의약품 generic dru 
 The Korea - US Free Trade Agreement stipulates that Korea should adopt patent - registration linkage by March of 2015 . The patent listing ( Green List ) , marketing prevention and generic exclusivity mechanisms recently proposed in a bill by the Korean government all have shortcomings . This article explores those shortcomings and possible fixes . The bill also should have established mechanisms through which a pioneer drug company will compensate for undue delay it causes in the marketing of a generic drug . In addition , the special appeals commission envisioned in the bill is not justified based on the nature of the actions to be taken by the Korean drug regulator under the bill . The bill appears to have largely been modeled after the Hatch - Waxman Act . In light of the differences in the legal institutions and health care market between Korea and the U . S . , Korea ’ s patent linkage implementation should look at other examples , such as Canada and Australia , and will eventually have to stand on its own . 
 I 410 - ECN - 0102 - 2015 - 300 - 000408039