식약청 판매허가와 특허권의 연계를 위한 특허심판의 당사자 적격

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.