- 學位論文
製藥公司的藥品創新競爭力：以美國FDA藥證及其連結之專利進行分析
Drug Innovation Competitiveness in Pharmaceutical Companies: An Analysis of Approved Drugs and Patent Linkage in U.S. FDA
摘要
新藥研發是製藥公司維持競爭力至關重要的一環，為全面性的了解製藥公司的創新競爭力，本研究同時觀察製藥公司提交至美國FDA的新藥申請資料與橘皮書中的專利連結進行分析。本文首先以新藥申請時製藥公司所提供的藥品治療效果和化學成分將新藥分成漸進式創新、技術突破、市場突破與激進式創新四種創新類型，接著透過製藥公司藥品的藥證及其專利連結資料，探討製藥公司不同創新類型藥品的藥證及其專利連結表現。在藥證方面，研究結果指出無論是何種創新類型，大型企業均有較為突出的表現，而在四種創新類型中，大型企業和中小企業擁有的藥證數差異最大的是漸進式創新，顯示大型企業仰賴漸進式創新的藥證以維持創新研發資本；而在專利方面，本文發現無論是何種創新類型的藥品，製藥公司均會積極地申請專利，以保護製藥公司的創新研發成果。最後，本文研究結果亦指出漸進式創新與市場突破的藥整表現與製藥公司營業額顯著相關，若製藥公司擁有越多的漸進式創新與市場突破式創新藥證，且其藥證所剩之獨賣期越長，將顯著且正向地影響製藥公司的營業額。
並列摘要
Drug development is the major competitive advantage for pharmaceutical companies to stay in business. To comprehend the innovation competitiveness in pharmaceutical companies, this study provides the analysis of U.S FDA-approved drugs and the patent linkage in Orange Book. First of all, this study breaks the efficacy of the drug therapeutically potential and chemical composition into four types, which are incremental innovation, technological breakthrough, market breakthrough, and radical innovation. It went on to discuss the four different types of drug application and the innovation performance of pharmaceutical companies. For FDA drug approval, the study pointed out that large enterprises have better performance in any type of innovation. The gapping differences of four innovation types that amount large size, mid-size and small-size enterprises is in the number of incremental innovation drugs. The result showed the large enterprises that hold the developing resources by relying on the way of incremental innovation. Last but not least, this study indicated that the revenue of pharmaceutical companies is highly related to incremental innovation and market breakthrough drugs. If the companies are having more incremental innovation and market breakthrough drugs and having longer exclusivity left, then it will greatly impact the revenue.