의약품 허가-특허 연계제도와 특허법의 조화

• 영문명: The approval-patent linkage system
• 발행기관: 세창출판사
• 저자명: 이헌희(Lee, Heonhui)
• 간행물 정보: 『창작과 권리』2014년 봄호 (제74호), 2~36쪽, 전체 34쪽
• 주제분류: 법학 > 법학
• 파일형태: PDF
• 발행일자: 2014.03.01

영문 초록

The approval-patent linkage system was firstly introduced in the United States as a part of 'Hatch-Waxman Act'. so this paper analyses the process in the operation of this system and problems caused after the introduction of this system in the United States. and any possible problems brought about after the entry into force of the KORUS FTA. In this paper I examined articles of KORUS FTA concerning about medicines, and examined what should be prepared to satisfy these articles by Korean government. For this purpose I looked into the patent law containing the article 96 and the pharmaceutical affairs law containing the approval-patent linkage system. Finally I suggested some ideas which would be necessary for amendment to minimize the damage to Korean pharmaceutical industry caused by KORUS FTA and to support Korean pharmaceutical industry for the development.

목차

Ⅰ. 들어가며

Ⅱ. 허가-특허연계제도의 개념 및 국내법상 수용

Ⅲ. 특허법상 상업적 목적의 연구ㆍ시험의 범위

Ⅳ. 허가특허연계제도의 특허법과의 조화

Ⅴ. 마치며

참고문헌

Abstract