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標題: | 從品牌藥的生命週期探討次級專利布局策略:以重磅炸彈藥為例 The secondary-patenting strategy during brand drugs’ life cycle: A study of Blockbuster drugs |
作者: | Hsuan-Chih Chen 陳璿之 |
指導教授: | 王俊傑(Chun-Chieh Wang) 王俊傑(Chun-Chieh Wang | wangcc@ntu.edu.tw | ), |
關鍵字: | 重磅炸彈藥,生命週期,次級專利,製藥公司,藥物治療領域, Blockbuster drugs,Life cycle,Secondary patents,Pharmaceutical companies,Therapeutic classification, |
出版年 : | 2022 |
學位: | 碩士 |
摘要: | 品牌藥在核准上市後開始經歷生命週期,當生命週期即將結束,會面臨的專利到期或學名藥競爭。次級專利是製藥公司為了保護品牌藥免於面臨專利到期後的龐大損失,為品牌藥申請之涵蓋藥物活性成分以外的外圍特徵的專利,是製藥公司的重要策略。本研究以年收十億美金以上的重磅炸彈藥為例,逐一查看2015年至2021年的重磅炸彈藥的次級專利資料並加以分類,將次級專利分為:新配方(New formulation)、新適應症(New indication)、相關化學結構 (Related chemical structures)、組合物(Composition)、其他(The others)五類型,以卡方獨立性檢定探討重磅炸彈藥生命週期中各類型次級專利的連結及差異,並進一步以製藥公司及藥物治療領域的角度切入探討。重磅炸彈藥傾向於研發期申請大量次級專利,新適應症次級專利為主要申請類型。重磅炸彈藥以抗腫瘤與抗感染為主,製藥公司專注於其優勢藥物治療領域。值得一提的是,製藥公司對於重磅炸彈藥與非重磅炸彈藥的專利申請態度相同。本研究亦針對製藥產業與學術領域中提出對藥物的次級專利策略建議。 Brand drugs go through life cycle after approval. When the life cycle is about to end, brand drugs will face patent expiration or generic drug competition. Secondary patents are patents covering peripheral features rather than active ingredient of drugs in order to protect brand drugs from huge losses after patent expiration. Secondary patenting is an important strategy for pharmaceutical companies. This study takes blockbuster drugs as example, examines and classifies every secondary patent of blockbuster drugs from 2015 to 2021, and divides secondary patents into five types: new formulation, new indication, related chemical structure, composition, and the others, discussing the connection and differences of secondary patents in blockbuster drugs’ life cycle by Chi-Squared Tests of Independence, and the perspective of pharmaceutical companies and therapeutic classification is also discussed. Blockbuster drugs tend to gain a large number of secondary patents during the R&D period, with new indication secondary patent as the main type. Blockbuster drugs are mainly for oncology and infectious diseases, and pharmaceutical companies focus on their dominant drug therapeutic classification. It is worth mentioning that pharmaceutical companies have the same attitude towards their blockbuster drugs as non-blockbuster drugs. This study also proposes drug secondary patenting strategies for pharmaceutical industry and academia. |
URI: | http://tdr.lib.ntu.edu.tw/jspui/handle/123456789/83354 |
DOI: | 10.6342/NTU202203661 |
全文授權: | 未授權 |
顯示於系所單位: | 生物產業傳播暨發展學系 |
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U0001-2009202216593400.pdf 目前未授權公開取用 | 2.22 MB | Adobe PDF |
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