당뇨병 치료제의 우선판매품목허가 현황 분석 및 전략 수립

• 영문명: Analysis of the Status of Permission for Preferential Distribution of Items for Anti-diabetic Drugs and Establishment of Strategies
• 발행기관: 대한약학회
• 저자명: 홍진태(Jin Tae Hong) 전보명(Po Myoung Jun)
• 간행물 정보: 『약학회지』제69권 제4호(2025년), 411~420쪽, 전체 10쪽
• 주제분류: 의약학 > 기타의약학
• 파일형태: PDF
• 발행일자: 2025.08.31

국문 초록

Permission for Preferential Distribution of Items in Drug Approval-Patent Linkage System has been in effect from March, 2015, being a 10-year official process more or less and ensuring the competitiveness of pharmaceuticals industry; getting follow-on drugs on the market more rapidly, thus delivering patients’ better access to and expanded selections about the medicines. In contexts thereof, the research is intended to analyze the approval status of anti-diabetics where the most efforts to obtain the Permission for Preferential Distribution of Items are made and evaluate and take a look at the patent challenge cases for companies to get the approval. The 373 applications of anti-diabetics had been made to get the Permission for Preferential Distribution of Items from March 15, 2015 to December 31, 2023, of which 311 anti-diabetics obtained the approval. Their properties and patent strategies indicates that follow-on drugs are developed based on new salts, solvate form and co-crystal, different crystal form of active ingredient of the listed drugs, most of which were trial to confirm scope of rights accounting for 69% in all patent challenges. The number of getting the approval through receiving trial decision or judgment taking up 68% is more than that of the initial appeals and appeals within 14 days to trial to patent challenges. The research suggests the considerations when establishing strategies for the approval based on the findings.

목차

서 론(Introduction)

방 법(Methods)

결 과(Results)

고 찰(Discussion)

결 론(Conclusion)

Conflict of Interest

References

키워드

Permission for Preferential Distribution of Items, Drug Approval-Patent Linkage System, Anti-diabetic drug, Petition for a trial, Patent strategy, Patent challenge

참고문헌

• Korea Intellectual Property Institute
• IP Focus
• The Journal of Intellectual Property
• Anam Law Review