원문정보
초록
영어
The Korea-US Free Trade Agreement having been agreed, Korea shall introduce the so-called Korean version of the U.S. Orange Book system. Under the system, patentee (brand drug company) will be notified of generic drug application. Then upon the patentee’s taking a required action, KFDA may automatically stay its approval procedure. It will be very complicated to soft-land and operate the system, due to related complex KFDA procedure, litigation procedure and patent trial procedure. This paper discusses some issues relevant to such procedures: efficiency of preliminary injunction system on this matter, patentee’s or generic drug applicant’s standing on a patent trial or a patent litigation. This paper has profound that (1) patentee may have standing on a preliminary injunction procedure, but injunction order may be little probable, (2) patentee may have standing on a (positive) patent scope confirmation trial, (3) generic drug applicant may have standing on a (negative) patent scope confirmation trial, and (4) generic drug applicant may have standing on a patent invalidation trial. However the Supreme Court has not resolved its self-conflicting positions on the standing issue of patent trials. If the approval-patent linkage system is being introduced, brand drug companies or generic drug companies may habitually request such trials. Without resolution of the Supreme Court’s self-conflicting positions, the brand new approval-patent linkage system will cause many troubles to users and relevant authorities. To smoothly operate the approval-patent linkage system, to enhance function of patent trial system, and to harmonize with U.S. and Japanese precedents, the Supreme Court should widen the door for such trials.
목차
Ⅱ. 미국의 허가-특허 연계 관련 제도
1. 미국의 허가-특허 연계 관련 특허법 법리
2. 미국 FDA 판매허가 관련 제도: Orange Book 시스템
Ⅲ. 한국판 허가-특허 연계제도 예상도
1. 한ㆍ미 FTA 관련 규정
2. 한국판 허가-특허 연계 제도 예상
3. 허가-특허 연계제도 관련 특허법 법리
Ⅳ. 허가-특허 연계 관련 특허심판의 당사자 적격
1. 권리범위확인심판 일반
2. 당사자 적격 개요
3. 특허권자(신약 개발자)의 적극적 권리범위확인심판 당사자 적격
4. 복제약 신청자의 소극적 권리범위확인심판 당사자 적격
5. 복제약 개발자의 무효심판 당사자 적격
V. 결론
참고문헌
ABSTRACT