| 摘要: | 骨質疏鬆症(Osteoporosis)為好發於中年以上族群的全身性骨骼疾病，也是高齡化社會所需面臨的老化疾病，因此骨質疏鬆的預防與治療乃是各國一重要的醫療支出。本研究先彙整目前美國FDA核可之8大類骨質疏鬆症藥物專利現況，並進一步於四大資料庫檢索相關骨質疏鬆專利：中華民國專利資料庫(TIPO)140筆、美國專利資料庫(USPTO)218筆、歐洲專利資料庫(EPO)122筆、以及於世界智慧財產權組織專利資料庫(WIPO)檢索骨質疏鬆症相關專利128筆。將檢索結果依蝕骨細胞、成骨細胞、前驅細胞之作用機轉進行分析治療骨質疏鬆症之藥物專利，除先前研發已知之雙磷酸鹽類與荷爾蒙類藥物外，本次檢索專利技術增加MMP抑制劑、PTPase抑制劑、蝕骨細胞抑制劑、NADPH抑制劑、AMPK調節素、P2X7受器調節等新的研發標的；從知名藥廠有關骨質疏鬆藥物專利佈局來看其中以Merck、Novartis、Eli Lilly掌握主要關鍵技術專利。此外，針對目前骨質疏鬆症治療藥物專利各所屬藥廠檢索其美國專利歸納藥廠所持有之臨床用藥將陸續於2015-2020年到期的專利資料。最後，透過檢索美國國立衛生研究院臨床試驗網站，整理已進行的骨質疏鬆症治療相關臨床試驗登錄，以完整了解目前骨質疏鬆症治療之趨勢。根據本文各項資料提供可做為想要進入此骨質疏鬆症藥物之醫藥產業「再研發」。而台灣醫藥研發具有佔優勢的「中草藥」領域，搭配科學研究方法得到高功效的中草藥萃取物並以專利保護外可於臨床試驗挑戰門檻較高的Phase 0與Phase I，加強執行早期臨床試驗能力，並同時尋求臨床醫師與臨床研究護士投入之意願，方能增加台灣執行早期臨床試驗之競爭力發展骨質疏鬆治療藥物之契機。
Osteoporosis, a systemic bone disease, usually course in middle-aged people, which is also a kind of aging diseases that aging society needs to face and thus both of the prevention and the treatment of osteoporosis are major medical expenses in many countries. We firstly archived patent situations of eight osteoporosis medicines that currently approved by FDA and further conducted searches for the osteoporosis-related patents in four database, includes Taiwan Intellectual Property Office (TIPO) amounts to 140 records, United States Patent and Trademark Office (USPTO) amounts to 218 records, European Patent Office (EPO) amounts to 122 records and World Intellectual Property Organization (WIPO) database amounts to 128 records in total and then we classified the search results to analysis the treatment strategies for osteoporosis, especially focusing on mechanism of osteoclasts, osteoblasts and progenitor cells. Except for the known bisphosphonates and hormone medicines, we further searched new patent techniques such as MMP inhibitor, PTPase inhibitor, osteoclasts inhibitors, NADPH inhibitors, AMPK regulator and P2X7 modulators; among the patent portfolios of osteoporosis medicines, the famous pharmaceutical companies such as Merck, Novartis and Eli Lilly respectively processes the key osteoporosis-related patents. Furthermore, we searched the US patents of medicines for treating osteoporosis pertained to the pharmaceutical companies for collecting the patents of clinical drugs thereof in osteoporosis treatment that will be expired during 2015 to 2020. At last, we searched the clinical trials for treating osteoporosis at the US National Institutes of Health website “ClinicalTrials.gov” to comprehensively investigate the current strategies for osteoporosis treatment. Thus, several potential “re-investigation” targets or suggestions about developing generic drugs of osteoporosis may be learned from these collected data. Further, by integrating the Chinese medicinal herb developed by Taiwanese medicine with the scientific researches, it is capable of obtaining high efficiency Chinese medicinal herb extracts, getting the patent protection and operating high threshold clinical trials of phase 0 and phase I to enforce the early stage clinical trial capability, further seeking the willingness of doctors and nurses to devote to the clinical trials so as to strengthen the competitiveness of enforcing Taiwanese early stage clinical trials in the area of developing osteoporosis-related medicines. |
