韓美FTA와 醫藥品 許可-特許 連繫制度

다국어 초록 (Multilingual Abstract)

With the effectuation of the Korea-US FTA(Korea-US Free Trade Agreement) most parts of the Korean Industry will be influenced. Especially Korean pharmaceutical industry where the generics occupied major portion in the market is considered to have a serious damage. To minimize the damage to Korean pharmaceutical industry caused by Korea-US FTA, the proper fallback should be prepared on a nationwide scale, by industry as well as by Korean government.
In this study I examined articles of Korea-US FTA concerning about medicines, and examined what should be prepared to satisfy these articles by Korean government and Korean pharmaceutical industry. For this purpose I looked into the Hatch-Waxman Act containing the patent term restoration and ANDA(abbreviated New Drug Application), and Indian patent law containing the article about supporting the generic industry. Finally I suggested some ideas which would be necessary for lawmaking to minimize the damage to Korean pharmaceutical industry caused by Korea-US FTA and to support Korean pharmaceutical industry for the development.

목차 (Table of Contents)

• 제1장 서론 1
• 제2장 의약품 특허와 제네릭 의약 4
• 제1절 개발의약과 제네릭 의약 4
• I. 신약(개발의약) 4
• II. 의약 특허 6
• III. 제네릭 의약 10
• 제2절 국내 의약 허가절차 13
• I. 신약의 개발과정 및 허가절차 13
• II. 제네릭 의약품 허가절차 17
• 제3장 한미FTA 의약품 관련규정 22
• 제1절 한미FTA 관련규정 22
• I. 의약품 및 의료기기 관련규정 22
• II. 의약품 허가-특허 연계제도 26
• 제4장 의약품 허가-특허 연계제도 32
• 제1절 서론 32
• 제2절 미국의 의약품 독점권 및 허가제도 33
• I. 미국의 의약품 판매독점권 33
• II. 한국의 의약품 판매독점권 36
• III. 미국 의약품 판매 허가제도 38
• 제3절 Hatch-Waxman Act 40
• I. Hatch-Waxman Act의 개요 40
• II. 특허권 존속기간 연장(Patent Term Restoration) 41
• III. 약식 신약신청(Abbreviated New Drug Application) 44
• IV. Patent Evergreening 대책 57
• 제5장 결론 62
• 참고문헌 65
• ABSTRACT 68