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作者姓名(中文):林宛萱
作者姓名(英文):Wan-Hsuan Lin
論文名稱(中文):生物製劑專利延續案申請策略之研究
論文名稱(外文):A Study on Strategy of Patent Continuation application for Biologics
指導教授姓名(中文):蔡鴻文
指導教授姓名(英文):Hung-Wen Tsai
口試委員姓名(中文):王丞浩
謝玠揚
口試委員姓名(英文):Ch'eng-Hao Wang
Chieh-Yang Hsieh
學位類別:碩士
校院名稱:國立臺灣科技大學
系所名稱:專利研究所
學號:M10224001
出版年(民國):104
畢業學年度:103
學期:2
語文別:中文
論文頁數:99
中文關鍵詞:生物製劑延續案專利申請
外文關鍵詞:BiologicsPatent continuation applicationPatent filing strategy
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新藥物自研發到上市平均耗費時間10至15年和8.68億美元,藥廠在上市後,可在專利期間內以獨佔市場之姿銷售全球,故獲得專利是製藥產業獲利的基礎。然而,一旦專利期屆滿,學名藥廠競爭湧現,造成原廠藥售價跌降至原價的十分之一。如何有效地在專利期限內增加保護範圍,申請專利的策略及方向成為關鍵因素。
近十年發展快速的生物製劑藥物,在專利申請上有別於以往小分子藥物僅以單一專利保護發明,而是在專利母案之後,以不同類別之延續案形態多方位擴展其專利範圍。基於以上現象,本論文自2013年藥品銷售排行中挑選三種生物製劑,探討國際藥廠對於生物製劑專利申請之策略,特別針對延續案申請類型與專利標的進行分析,除了具體列出不同國際藥廠申請專利架構之態樣,亦歸納申請延續案之手法包含:(1)專利標的轉換、(2)組合藥物使用、(3)治療步驟順序變換、(4)特殊序列或來源的組合、(5)新適應症開發。
另一方面則藉由單一個案分析的方式,進一步研究生物製劑申請專利延續案過程中,申請人與美國專利局之答辯資料,整理審查委員易核駁之理由與申請人回應策略。並且探究該藥物之專利訴訟,釐清相似生物製劑間之爭點與法院判決。本文多方面探究生物製劑藥廠在申請延續案的方式,建立初步分析國際藥廠在生物製劑之專利延續案申請方向。
Developing a new drug would take almost 10 to 15 years averagely and costs averagely $ 868 million. The pharmaceutical company will monopolize the market during the certain period.Patent right protection secures the profit of pharmaceutical industry. However, once the patents expired, the pharmaceutical competition would emerge and cause the drug price fell down to one-tenth of the original one due to the generic pharmaceutical companies appeared. Thus, the effective filing strategy for patents becomes a key factor to assure maximum advantages during the patent protection period.

The biologics have been rapidly developed in the recent decade. The patent filing strategy of the biologics is generally different from small molecule drugs by single patent protection. The biologics usually submitted different types of patent to extend their patent scopes. Based on the mentioned reasons, threebiologics selected from the best-selling drugs in 2013 have been invesgated.The practical filing strategies of patent for each biologic including the different types of continuation applications and contents are discussed in this thesis. It not only realizes the aspects of various patent application architectures, but also concludes the five methods for filing process. The first one isswitch the targets as process and manufacture patents in turn. The second is combination of plural drug uses. The third is transformation of treatment steps. The forth is combination of special sequences or different sources. And the last is development of new indications.

According to the case studies, the respondent information over the process of related continuation applications of biologics during the the United States Patent Office examination would be further discussed. Meanwhile, the drug's patent litigation and the points of dispute between the similar biological agents are identified. In this thesis, it preliminarily analyzed the continuation applications’ filing strategies of some pharmaceutical companies. Based on the results, it proposed a helpful suggestion of patent filing direction of continuation application for reference.
摘要
Abstract
誌謝
目 錄
圖目錄
表目錄
第一章 緒論
1.1 研究動機
1.2 研究目的與方法
第二章 製藥產業與趨勢
2.1 藥廠研發流程
2.2 藥物種類─小分子藥物與生物製劑
2.3 生物製劑市場趨勢
第三章 藥品專利重要性
3.1 仿製藥相關法規
3.2 藥品專利保護策略
第四章 美國專利延續案在製藥產業之應用
4.1 延續案簡介
4.2 延續案的策略
4.3 延長專利權
第五章 申請策略個案分析
5.1 亞培公司藥物─Humira
5.2 羅氏藥廠集團藥品─Rituxan
5.3美國安進公司藥品─Neulasta
第六章 答辯方向與訴訟之個案分析─Humira
6.1 答辯方向
6.2 專利訴訟─嬌生v.亞培
6.3 亞培公司與Centocor公司之專利佈局
第七章 結論
參考資料
期刊論文
[1] 鍟宇生技法律公司,FDA生物相似性蛋白質藥草案引發各界關注,生技與醫療器材報導期刊,154,2008。
[2] 陳亭妤,劉瑞芬,淺談生物製劑之發展,當代醫藥法規,31,p.3,2013。
[3] Murray Spruill, Strategies for extending the life of patents, Biopharm International, 2005.
[4] Christopher P. Adams and Van V. Brantner,Estimating The Cost Of New Drug Development: Is It Really $802 Million?, Health Aff, 25(2), p.420-428, 2006.
[5] Dimasi, j. A., & Grabowski h. G., The cost of biopharmaceutical R&D: is biotech different, Managerial and decision economics, 28, p.469-479, 2007.
[6] Jack DeRuiter and Pamela L. Holston, Drug Patent Expirations and the “Patent Cliff”, U.S. Pharm., 37(6), p.12-20, 2012.

碩士論文
[1] 陳翠華,我國醫藥專利權期間延長制度之探討,世新大學法學院碩士論文,2007。
[2] 曾烱昇,製藥業在地主國經營策略之研究:以印度與以色列廠商在美國為例,國立政治大學AMBA碩士論文,2008。
[3] 高鼎懿,美國專利延續案與布局策略之分析,國立交通大學管理學院碩士在職專班科技法律組碩士論文,2008。

專書
[1] 經濟部智慧財產局,美國專利須知,經濟部智慧財產局,p. 30,2004年五月。
[2] 藥品非臨床試驗安全性規範,行政院衛生署食品藥物管理局,四版,2013年五月。
[3] 寇怡衡、陳秋玲、賴瓊雅,抗體藥物研發及生產新趨勢探討,生物技術開發中心,p.2,2014。
[4] 羅淑慧、陳麗敏,藥品再創價值的策略運用與發展趨勢,生物技術開發中心,p.27,2014。
[5] John Hammond, Staying in the game: strategic use of continuation applications, The rochester engineer, p.10, Apr. 2012.

網路資料
[1] 黃蘭閔,USPTO祭出兩項試辦計畫 欲解決RCE積案問題,北美智權,2012,網址:http://www.naipo.com/Portals/1/web_tw/Knowledge_Center/Laws/US-51.htm,最後瀏覽日:2015/07/21。
[2] FDA, What are "biologics", Source: http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CBER/ucm133077.htm, Last view: 2015/07/21.
[3] USPTO patent technology monitoring team, U.S. patent statistics chart calendar years 1963 - 2013, Source: http://www.uspto.gov/web/offices/ac/ido/oeip/taf/us_stat.htm, Last view: 2015/07/21.
[4] IMS Health (Midas), Humira sales data, Feb. 2014, Source: http://www.drugs.com/stats/humira, Last view: 2015/07/21.
[5] IMS Health, The trillion dollar market for medicines: characteristics, Dynamics and outlook, 2014, Source: http://www.jhsph.edu/research/centers-and-institutes/center-for-drug-safety-and-effectiveness/academic-training/seminar-series/MUrray%20Aikten.pdf, Last view: 2015/07/23.
[6] FDA approved drug products, Humira label information, Source: http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125057s367lbl.pdf, Last view: 2015/07/21.
[7] CMS pharma, What is driving the biotech sector: examining key trends and M&A deals, p.5, 2013, Source: http://www.cms-pharma.com/2013-06-04%20Asia%20Biotech%202013.pdf, Last view: 2015/07/23.
[8] PHRMA, Overview: medicines in development biologics, p.4-5, 2013, Source: http://phrma.org/sites/default/files/pdf/biologicsoverview2013.pdf, Last view: 2015/07/23.
全文檔公開日期:2020/08/18 (本校及區域網路)
全文檔公開日期:2025/08/18 (校外網際網路)
全文檔公開日期:2025/08/18 (國家圖書館)
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