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| Title: | 上市要求與專利保護的法規競合對研發高階醫療器材投資之衝擊：磁振造影引導高強度聚焦超音波系統 |
| Other Titles: | The Impact of Competing Regulatory Requirements of Pre-Market Registration and Patent Protection on Investing In the Research and Development of High-End Medical Device: Magnetic Resonance Image Guided High Intensity Focused Ultrasound System |
| Authors: | 鄭匡善
Cheng, Kung-Shan |
| Keywords: | 專有排他;專利組合;專利無效;臨床前測試;臨床試驗
Exclusive Right;Patent Portfolio;Patent Invalid;Pre-Clinical Test;Clinical Trial |
| Date: | 2011-12 |
| Issue Date: | 2016-08-31 17:10:18 (UTC+8) |
| Abstract: | 高階醫療器材（簡稱高階醫材）在國際市場具相當發展潛力，為切入此市場，政府於民國98年通過並啟動「台灣生技起飛鑽石行動方案」，以搶食此市場，並增高質人才就業機會。然具專利保護之醫材無上市許可證則不能上市營利，而上市產品無專利保護則易為競爭者之相似產品侵蝕利潤，此二法規間存競合關係。本文針對擬投資研發高階醫材者，分析上述法規影響。先簡介醫材一般科學研發流程與特性，次予高階治療用醫材－「磁振造影引導高強度聚焦超音波系統」－之國際研發試驗、上市概況與法規簡述；並分析以下主要問題：適應症、製造廠、臨床試驗、專利及專利與上市法規競合，並於分析各類問題時提供合宜解法，彙述如次：一、投資者最晚切入時點宜為醫材進入法規要求之大規模臨床試驗申請前；二、投資前宜聘專家評估研發團隊之「臨床前測試」與其他試驗和專利佈局之資料；三、未於臨床試驗前申請醫材專利將蒙顯著的專利無效風險；四、對臨床試驗法定之運作成本與潛在傷害賠償預為準備；五、審慎評估醫材之適應症對通過上市法規之難度；六、於上市審查前預先規劃具優良製造證書之廠；與七、妥切規劃於世界各國上市順序，以善用既有之簡化上市審查途徑。
The high-end advanced medical devices (abbreviated as advanced MDD) have shown considerable global market potential for growth. To make inroads into global MDD market, our government approved and implemented `Biotech Take-Off Diamond Plan` to compete for this market, and has created more employment opportunities for high-quality personnel since 2009. Nevertheless, MDD protected by patents still cannot engage in profit seeking if it is not approved for marketing, and MDD without patent protection the market profit will be stroke down by the competitor launching of a similar product. The regulatory requirements of patent application and pre-market registration are competing for priorities and resources. This report analyzes the impact of pertinent laws and regulations on research and development (R&D) of the high-end MDD in Taiwan for use by the interested investors in their investment appraisal model. First, the procedure and characteristics of MDD R&D are briefly introduced. Second, ”Magnetic Resonance Image-Guided Ultrasound System” is used as an example of MDD to show case of its international R&D effort, clinical trial, market development, and compliance to its related international regulations. Lastly, the main regulations on manufacture, clinical trial, patent, and the competing regulatory requirements that high-end MDD investors might encounter are provided and analyzed. The analyses suggest the following for the interested investors in the high-end MDD: First, the latest point of entry of investment would be right before applying the permission of conducting the mandatory large-scale ”clinical trial” for MDD; second, need to hire a team of experts to evaluate the research documents on pre-clinical tests, other related experiments and/or trials, and the plan of filing patent (s) applications; third, not applying patent (s) of MDD before conducting clinical trial would result in significant risk of patent invalid; fourth, prepare to fund the mandatory cost of conducting clinical trial (s) and the liability insurance for its potential harm to the volunteering test subject; fifth, carefully evaluate the difficulty of passing pre-market registration hurdles caused by the indication for use of the MDD; sixth, have ready a medical device manufacturer conforming to the internationally recognized Quality System or having Good Manufacture Product certification from the future market country authority; seventh, decide the proper order of the application for specific market registration over the world to take advantages of potential abbreviated regulatory market paths. |
| Relation: | 政大智慧財產評論, 9(2), 99-135
NCCU Intellectual Property Review |
| Data Type: | article |
| Appears in Collections: | [智慧財產評論] 期刊論文
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