우리나라 제약기업의 의약품 허가 및 특허출원 관련요인 분석

• 영문명: Factors Associated with Drug Approvals and Patent Issues of the Korean Pharmaceutical Firms
• 발행기관: 대한약학회
• 저자명: 문계주(Gae-ju Moon) 이진이(Jinnie Rhee)
• 간행물 정보: 『약학회지』제56권 제1호 (2012년), 60~65쪽, 전체 6쪽
• 주제분류: 의약학 > 기타의약학
• 파일형태: PDF
• 발행일자: 2012.02.28

영문 초록

This study examines factors associated with drug approvals and patent issues of the Korean pharmaceutical firms. The 22 firms were selected based on 2006 year's publicly noticed sales amount. Number of approved drugs was identified through Korea Food and Drug Administration and the information regarding the patents that each firm has issued during the year 2000~2006 was collected from the Korea Patent Office. The number of approved drugs has increased annually, especially after the introduction of substance patent system in 1987 and in 2000 again with the policy change into the separation of drug prescribing and dispensing practice. The number of initial approval of NCEs as well as the number of patents per firm decreased during the year 2000~2006. The 12 firms with larger revenue occupied more than 80% of the patents being issued. There was a positive relationship between share of prescription drugs out of approved drugs and the average number of patents issued. However, number of approved drugs did not show positive association with the number of patents issued per firm. Therefore, the study results imply that firms need to invest more in increasing number of approvals for their specific prescription drugs in order to achieve a good performance in the future.

키워드

drug approval patent issue Korean pharmaceutical firm