의약품의 승인목적시험의 특허권 침해여부에 관한 연구

• 영문명: Pharmaceutical Experimental Use and Patent Infringement
• 발행기관: 한국사법학회(구 한국비교사법학회)
• 저자명: 박준우
• 간행물 정보: 『비교사법』비교사법 제10권 1호, 675~703쪽, 전체 29쪽
• 주제분류: 법학 > 법학
• 파일형태: PDF
• 발행일자: 2003.03.01

영문 초록

This article deals with the issues on whether generic drug manufacturers should be allowed to use the patented subject matter of brand name drug manufacturers during their patent term for government review purposes, and whether it should be allowed by amendment or interpretation of the Patent Act. My argument is that generic drug manufacturers should be allowed to test the patented pharmaceutical subject matter before its patent expiration, and that it should be allowed by amendment of the Patent Act, though the same purpose can be achieved by its interpretation. Part II of this article introduces the 'Drug Price Competition and Patent Term Restoration Act of 1984: and parts III and IV examine the decisions in the U.S. cases on pharmaceutical experimental use for the FDA approval. Parts V and VI evaluate there decisions and legislative solutions on the pharmaceutical experimental use issues. Finally, part VII discusses whether Korea should allow the pharmaceutical experimental use by amendment or interpretation of the Patent Act.

목차

1. 서론

2. '의약품가격경쟁및특허기간연장법'의 개요

3. '시험적 사용'예외의 연원

4. 의약품산업과 '시험적 사용'예외

5. '시험적 사용'예외의 한계

6. 입법부에 의한 해결의 검토

7. 우리법의 검토

8. 결론

참고문헌

Abstract