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題名 美國專利連結制度對於藥廠間競爭行為影響之探究
Exploring the Competitive Behaviors among Pharmaceutical Companies under the U.S. Patent Linkage System作者 洪淑瑗
Hung, Shu-Yuan貢獻者 宋皇志
洪淑瑗
Hung, Shu-Yuan關鍵詞 專利連結
專利登錄
專利挑戰
藥廠競爭
橘皮書
Patent Linkage
Patent Listing
Patent Challenge
Competition in pharmaceuticals
Orange Book日期 2020 上傳時間 1-Dec-2020 15:03:32 (UTC+8) 摘要 隨著新興科技發展以及人口數成長趨動下，同時醫療及藥品的需求也不斷增加，藥品為藥廠帶來豐厚利潤，專利幫助藥品在市場中站穩優勢地位。美國擁有專利連結制度，將專利與藥品許可證做連結，達到鼓勵原廠創新，及促進學名藥廠挑戰原廠專利，幫助學名藥上市。美國將此制度作為簽訂雙邊或多邊貿易協定之籌碼，我國亦在2019年公告並正式實行專利連結制度，由於美國施行該制度已逾30年，台灣藥廠勢必會參考美國製藥產業競爭樣態，進行商業策略規劃。本研究試圖透過梳理專利制度與藥廠競爭行為影響，希望可以了解製藥產業在專利登錄及專利挑戰的競爭行為。利用深度訪談法與文獻分析法，藉以回答研究問題，企圖宏觀描述專利連結制度下之製藥產業的競爭行為與針對過去相關爭議進行探究。研究發現專利連結制度與美國藥廠競爭關係環環相扣，過去為之詬病的是有原廠會濫登專利或是原廠濫訴學名藥廠，進而拖延學名藥上市之現象。關於專利登錄問題，經過多次修法，已明確規定橘皮書可登錄專利類型，並且原廠必須切結誠實登錄專利。本研究認為由於登錄專利得以取得學名藥上市前通知，因此原廠希望盡可能地登錄專利，但伴隨不實登錄會有罰則，並且濫登之專利難以在未來訴訟中獲勝，實務上藥廠會考量到訴訟成本、效益以及股價變動等面向，並不是隨意興訟，受訪者亦認為現行美國原廠主要都會遵循法規。若真的對於專利與藥品的相關性存疑，在現行法律的規範下，若有爭議則由法院裁決。對學名藥廠來說，藥品專利公開減少檢索成本，降低學名藥上市後面臨侵權訴訟機會；但整體而言，透過專利挑戰使學名藥有機會在原廠藥仍有專利權時提前上市，可以獲取更大的利益，同時讓消費者更早獲取較廉價之藥品。現有的法律使得原廠與學名藥廠間相互抗衡，也因此可以刺激製藥產業不斷進步，藥廠亦可研發新藥與販售學名藥，藥廠間競爭關係不斷變動，如何在專利連結制度與競爭激烈的環境下獲利，是藥廠須持續關注的議題。
With the development of emerging technologies and the trend of population growth, the demand for medical therapy and drugs is also increasing. Brand drugs have brought huge profits to pharmaceutical companies, and patents help Brand drugs to monopoly the market. The United States has a patent linkage system, which links patents with drug licenses to encourage original manufacturers to innovate and promote generic drug companies to challenge brand drug patents. The United States uses this system as a bargaining chip for signing bilateral or multilateral trade agreements. Taiwan also announced and officially implemented the patent linkage system in 2019. Since the United States has implemented the system for more than 30 years, Taiwanese pharmaceutical companies will inevitably refer to the competition in the US pharmaceutical industry.This study attempts to sort out the impact of the patent system and the competitive behavior of pharmaceutical companies, hoping to understand the pharmaceutical industry`s competitive behaviors in patent registration and patent challenges. Using in-depth interviews and literature analysis methods to answer research questions, this study attempts to describe the competitive behavior of the pharmaceutical industry under the patent linkage system and explores related disputes.The study has found that the patent linkage system is closely related to the competition between American pharmaceutical companies. In the past, there was a controversial issue that the original manufacturer would abuse the patent and delay the generic drugs into the market by suing. The patent registration issue has been clearly stipulated after many amendments to the law. The Orange Book can register certain types of patents, and the original manufacturer must be responsible for the honest registration of the patent. In addition, the registered patent can obtain the pre-market notice of the generic drug. Although the original manufacturer wants to register the patent as much as possible, there are penalties for false registration. In practice, pharmaceutical companies will also consider litigation costs, benefits, and stock price changes before suing other companies. The interviewees also believe that the current US original companies will mainly follow regulations. If there is any doubt about the relevance of patents and medicines, this problem would get into the court, and the court shall decide. For generic companies, the disclosure of drug patents reduces search costs and reduces the opportunity for infringement litigation after generic drugs into the market. However, on the whole, through patent challenges, generic drugs have the opportunity to be listed in advance when the original drug still has patent rights. Therefore, the more generic drugs into the market, the cheaper drug and the bigger profit the consumers would obtain.In the pharmaceutical industry, the compete among original companies and generic companies is getting more and more fierce and complex. In the future, the pharmaceutical company may also develop new drugs and sell generic drugs. How to profit from the patent linkage system and face the fierce competition environment is an important issue that pharmaceutical companies must continue to pay attention to.參考文獻 Baker, B. K. (2008). Ending drug registration apartheid: taming data exclusivity and patent/registration linkage. American journal of law & medicine, 34(2-3), 303-344.Bansal, I. S., Sahu, D., Bakshi, G., & Singh, S. (2009). Evergreening–a controversial issue in pharma milieu.Bhardwaj, R., Raju, K., & Padmavati, M. (2013). The impact of patent linkage on marketing of generic drugs.Branstetter, L., Chatterjee, C., & Higgins, M. J. (2016). Regulation and welfare: evidence from paragraph IV generic entry in the pharmaceutical industry. The RAND Journal of Economics, 47(4), 857-890.Chen, M.-L., Shah, V., Patnaik, R., Adams, W., Hussain, A., Conner, D., . . . Huang, S.-M. (2001). Bioavailability and bioequivalence: an FDA regulatory overview. Pharmaceutical research, 18(12), 1645-1650.Commission, U. S. F. T. (2002). Generic Drug Entry Prior to Patient Expiration: An FTC Study: The Commission.Deloitte. (2020). 2020 醫療照護產業展望.Derzko, N. M. (2004). The Impact of Recent Reforms of the Hatch-Waxman Scheme on Orange Book Strategic Behavior and Pharmaceutical Innovation. Idea, 45, 165.EvaluatePharma. (2019). World_Preview_2019,Outlook to 2024. Retrieved fromFDA. (2018). Step 4: FDA Drug Review. Retrieved from https://www.fda.gov/patients/drug-development-process/step-4-fda-drug-reviewFDA. (2019). Statement on a new effort to improve transparency and predictability for generic drug applicants to help increase timely access to high-quality, lower cost generic drugs. Retrieved from https://www.fda.gov/news-events/press-announcements/statement-new-effort-improve-transparency-and-predictability-generic-drug-applicants-help-increaseFDA. (2020). Patent Certifications and Suitability Petitions. Retrieved from https://www.fda.gov/drugs/abbreviated-new-drug-application-anda/patent-certifications-and-suitability-petitionsFiercepharma. (2020). The top 20 drugs by global sales in 2019. Retrieved fromFlannery, E. J., & Hutt, P. B. (1985). Balancing competition and patent protection in the drug industry: The Drug Price Competition and Patent Term Restoration Act of 1984. Food, Drug, Cosmetic Law Journal, 40(3), 269-309.Frank, R. G. (2007). The ongoing regulation of generic drugs. New England Journal of Medicine, 357(20), 1993.FTC. (2009). Authorized Generics: An Interim Report. Retrieved fromFurrow, M. E. (2008). Pharmaceutical patent life-cycle management after KSR v. Teleflex. Food & Drug LJ, 63, 275.Hemphill, C. S., & Sampat, B. N. (2011). When do generics challenge drug patents? Journal of Empirical Legal Studies, 8(4), 613-649.Hemphill, C. S., & Sampat, B. N. (2012). Weak patents are a weak deterrent: Patent portfolios, the orange book listing standard, and generic entry in pharmaceuticals. In Standards, Patents and Innovations: International Journal of Industrial Organization, Volume 36.Johnson, J. M. (2002). In-depth interviewing. Handbook of interview research: Context and method, 1.Krause, C. (2001). Apotex, GlaxoSmithKline in generics battle over Paxil. Chemical Market Reporter, 259(21), 12-12.Krulwich, A. S. (1985). Statutory Reversal Roche v. Bolar: What You See Is Only the Beginning of What You Get. Food Drug Cosm. LJ, 40, 519.Lipsky, M. S., & Sharp, L. K. (2001). From idea to market: the drug approval process. The Journal of the American Board of Family Practice, 14(5), 362-367.Medicare Prescription Drug, Improvement, and Modernization Act of 2003, (2003).Mossinghoff, G. J. (1999). Overview of the Hatch-Waxman Act and its impact on the drug development process. Food & Drug LJ, 54, 187.Agreement on Trade-Related Aspects of Intellectual Property Right, (1996).Panattoni, L. E. (2011). The effect of Paragraph IV decisions and generic entry before patent expiration on brand pharmaceutical firms. Journal of health economics, 30(1), 126-145.Thomas, J. R. (2009). Patent" evergreening": Issues in Innovation and Competition.UnitedNations. (2019). World Population Prospects 2019 Retrieved from https://population.un.org/wpp/Publications/Files/WPP2019_10KeyFindings.pdfWeiswasser, E. S., & Danzis, S. D. (2003). The Hatch-Waxman act: History, structure, and legacy. Antitrust LJ, 71, 585.Wharton, J. S. (2003). Orange Book Listing of Patents under the Hatch-Waxman Act. . Louis ULJ, 47, 1027.Wheaton, J. J. (1985). Generic Competition and Pharmaceutical Innovation: The Drug Price Competition and Patent Term Restoration Act of 1984. Cath. UL Rev., 35, 433.王棋祺. (2020). 終結新冠 藥物有曙光 !?葉志鴻：新冠肺炎治療藥物的現況與挑戰, 74. Retrieved from https://www.gbimonthly.com/2020/06/73034/台灣食品藥物管理署. (2020). 資料齊備日及銷售專屬期. Retrieved from https://plls.fda.gov.tw/DataStatement江浣翠. (2017). 論我國專利期間的調整與延長、資料專屬權與專利連結制度之發展現況--藥品智慧財產權保護相關修正草案評析. 智慧財產評論, 14:2, 79-120.吳東哲，陳桂恒. (2015). 美國藥品專利連結與橘皮書登錄制度相關規範：對台灣之影響. 法學文摘, 102.吳東哲；鄒昀廷. (2019). 各國藥品專利連結簡介. Retrieved from https://www.wispro.com/tw/2019/10/22/patent-linkage-2/李秉燊. (2019). 開誠布公：2019年美國專利連結下「Paragraph IV聲明清單」新增項目簡介. Retrieved from http://www.naipo.com/Portals/1/web_tw/Knowledge_Center/Biotechnology/IPNC_190724_1102.htm翁雅欣 (2019). Re: 中華民國製藥發展協會法律顧問翁雅欣書面意見陳翠華. (2008). 我國醫藥品專利權期間延長制度之探討（上）. 智慧財產權月刊.黃慧嫺. (2009). 專利連結 (Patent Linkage)-藥品研發與競爭之阻力或助力? 談藥品查驗登記程式與專利權利狀態連結之發展 (下). 科技法律透析, 21(3), 32-48.黃慧嫻. (2006). 論製藥產業研發活動試驗免責之適用－以美國法院之相關判決見解演進為例. 科技法律透析, 18(1), 30-50. doi: 10.7062/STLR.200601.0030鄒昀廷. (2020). “搶注”治療新冠肺炎瑞德西韋專利佔便宜？藥商吉利德才是贏家. Retrieved from https://www.inquartik.com.tw/inq-china-coronavirus-patents-gilead-portfolio/滕沛倫. (2020). 醫藥品專利生命週期管理——以瑞德西韋為例. 專利師 42, 17-29.潘中道、胡龍騰. (2010). 研究方法：步驟化學習指南(第二版)（Ranjit Kumar 原著）: 臺北：學富文化.觀點Genet. (2019). 《血癌藥REVLIMID》與學名藥廠Natco和美時完成協議 原廠Celgene股價大漲表態拖延戰術奏效. Retrieved from http://www.genetinfo.com/investment/featured/item/24966.html?start=2 描述 碩士
國立政治大學
科技管理與智慧財產研究所
107364205資料來源 http://thesis.lib.nccu.edu.tw/record/#G0107364205 資料類型 thesis dc.contributor.advisor 宋皇志 zh_TW dc.contributor.author (Authors) 洪淑瑗 zh_TW dc.contributor.author (Authors) Hung, Shu-Yuan en_US dc.creator (作者) 洪淑瑗 zh_TW dc.creator (作者) Hung, Shu-Yuan en_US dc.date (日期) 2020 en_US dc.date.accessioned 1-Dec-2020 15:03:32 (UTC+8) - dc.date.available 1-Dec-2020 15:03:32 (UTC+8) - dc.date.issued (上傳時間) 1-Dec-2020 15:03:32 (UTC+8) - dc.identifier (Other Identifiers) G0107364205 en_US dc.identifier.uri (URI) http://nccur.lib.nccu.edu.tw/handle/140.119/132903 - dc.description (描述) 碩士 zh_TW dc.description (描述) 國立政治大學 zh_TW dc.description (描述) 科技管理與智慧財產研究所 zh_TW dc.description (描述) 107364205 zh_TW dc.description.abstract (摘要) 隨著新興科技發展以及人口數成長趨動下，同時醫療及藥品的需求也不斷增加，藥品為藥廠帶來豐厚利潤，專利幫助藥品在市場中站穩優勢地位。美國擁有專利連結制度，將專利與藥品許可證做連結，達到鼓勵原廠創新，及促進學名藥廠挑戰原廠專利，幫助學名藥上市。美國將此制度作為簽訂雙邊或多邊貿易協定之籌碼，我國亦在2019年公告並正式實行專利連結制度，由於美國施行該制度已逾30年，台灣藥廠勢必會參考美國製藥產業競爭樣態，進行商業策略規劃。本研究試圖透過梳理專利制度與藥廠競爭行為影響，希望可以了解製藥產業在專利登錄及專利挑戰的競爭行為。利用深度訪談法與文獻分析法，藉以回答研究問題，企圖宏觀描述專利連結制度下之製藥產業的競爭行為與針對過去相關爭議進行探究。研究發現專利連結制度與美國藥廠競爭關係環環相扣，過去為之詬病的是有原廠會濫登專利或是原廠濫訴學名藥廠，進而拖延學名藥上市之現象。關於專利登錄問題，經過多次修法，已明確規定橘皮書可登錄專利類型，並且原廠必須切結誠實登錄專利。本研究認為由於登錄專利得以取得學名藥上市前通知，因此原廠希望盡可能地登錄專利，但伴隨不實登錄會有罰則，並且濫登之專利難以在未來訴訟中獲勝，實務上藥廠會考量到訴訟成本、效益以及股價變動等面向，並不是隨意興訟，受訪者亦認為現行美國原廠主要都會遵循法規。若真的對於專利與藥品的相關性存疑，在現行法律的規範下，若有爭議則由法院裁決。對學名藥廠來說，藥品專利公開減少檢索成本，降低學名藥上市後面臨侵權訴訟機會；但整體而言，透過專利挑戰使學名藥有機會在原廠藥仍有專利權時提前上市，可以獲取更大的利益，同時讓消費者更早獲取較廉價之藥品。現有的法律使得原廠與學名藥廠間相互抗衡，也因此可以刺激製藥產業不斷進步，藥廠亦可研發新藥與販售學名藥，藥廠間競爭關係不斷變動，如何在專利連結制度與競爭激烈的環境下獲利，是藥廠須持續關注的議題。 zh_TW dc.description.abstract (摘要) With the development of emerging technologies and the trend of population growth, the demand for medical therapy and drugs is also increasing. Brand drugs have brought huge profits to pharmaceutical companies, and patents help Brand drugs to monopoly the market. The United States has a patent linkage system, which links patents with drug licenses to encourage original manufacturers to innovate and promote generic drug companies to challenge brand drug patents. The United States uses this system as a bargaining chip for signing bilateral or multilateral trade agreements. Taiwan also announced and officially implemented the patent linkage system in 2019. Since the United States has implemented the system for more than 30 years, Taiwanese pharmaceutical companies will inevitably refer to the competition in the US pharmaceutical industry.This study attempts to sort out the impact of the patent system and the competitive behavior of pharmaceutical companies, hoping to understand the pharmaceutical industry`s competitive behaviors in patent registration and patent challenges. Using in-depth interviews and literature analysis methods to answer research questions, this study attempts to describe the competitive behavior of the pharmaceutical industry under the patent linkage system and explores related disputes.The study has found that the patent linkage system is closely related to the competition between American pharmaceutical companies. In the past, there was a controversial issue that the original manufacturer would abuse the patent and delay the generic drugs into the market by suing. The patent registration issue has been clearly stipulated after many amendments to the law. The Orange Book can register certain types of patents, and the original manufacturer must be responsible for the honest registration of the patent. In addition, the registered patent can obtain the pre-market notice of the generic drug. Although the original manufacturer wants to register the patent as much as possible, there are penalties for false registration. In practice, pharmaceutical companies will also consider litigation costs, benefits, and stock price changes before suing other companies. The interviewees also believe that the current US original companies will mainly follow regulations. If there is any doubt about the relevance of patents and medicines, this problem would get into the court, and the court shall decide. For generic companies, the disclosure of drug patents reduces search costs and reduces the opportunity for infringement litigation after generic drugs into the market. However, on the whole, through patent challenges, generic drugs have the opportunity to be listed in advance when the original drug still has patent rights. Therefore, the more generic drugs into the market, the cheaper drug and the bigger profit the consumers would obtain.In the pharmaceutical industry, the compete among original companies and generic companies is getting more and more fierce and complex. In the future, the pharmaceutical company may also develop new drugs and sell generic drugs. How to profit from the patent linkage system and face the fierce competition environment is an important issue that pharmaceutical companies must continue to pay attention to. en_US dc.description.tableofcontents 第一章 緒論 1第一節 研究背景與動機 1第二節 研究目的與問題 4第三節 研究限制 5第二章 文獻探討 6第一節 Hatch-Waxman ACT介紹 6壹、立法背景 6貳、立法目的與藥品上市程序規定 8參、Hatch-Waxman Act相關規定 11第二節 專利連結制度 14壹、專利登錄階段 14貳、專利挑戰階段 16第三節 橘皮書與橘皮書專利 18第四節 製藥產業競爭概況與爭議 20第五節 小結 22第三章 研究設計 24第一節 研究流程 24第二節 研究架構 25第三節 研究方法 26第四節 資料蒐集 27壹、深度訪談與次級資料 27貳、訪談大綱 28第四章 研究結果與討論 29第一節 專利登錄階段 30壹、原廠與學名藥廠觀點 30貳、橘皮書專利登錄之爭議 36第二節 專利挑戰階段 43壹、原廠與學名藥廠觀點 43貳、藥廠間專利侵權訴訟 49參、原廠濫訴之爭議 52肆、小結 56第五章 結論與建議 58第一節 研究結論 58第二節 學術貢獻 61第三節 實務貢獻 63第四節 後續研究建議 66參考文獻 67 zh_TW dc.format.extent 1639127 bytes - dc.format.mimetype application/pdf - dc.source.uri (資料來源) http://thesis.lib.nccu.edu.tw/record/#G0107364205 en_US dc.subject (關鍵詞) 專利連結 zh_TW dc.subject (關鍵詞) 專利登錄 zh_TW dc.subject (關鍵詞) 專利挑戰 zh_TW dc.subject (關鍵詞) 藥廠競爭 zh_TW dc.subject (關鍵詞) 橘皮書 zh_TW dc.subject (關鍵詞) Patent Linkage en_US dc.subject (關鍵詞) Patent Listing en_US dc.subject (關鍵詞) Patent Challenge en_US dc.subject (關鍵詞) Competition in pharmaceuticals en_US dc.subject (關鍵詞) Orange Book en_US dc.title (題名) 美國專利連結制度對於藥廠間競爭行為影響之探究 zh_TW dc.title (題名) Exploring the Competitive Behaviors among Pharmaceutical Companies under the U.S. Patent Linkage System en_US dc.type (資料類型) thesis en_US dc.relation.reference (參考文獻) Baker, B. K. (2008). Ending drug registration apartheid: taming data exclusivity and patent/registration linkage. American journal of law & medicine, 34(2-3), 303-344.Bansal, I. S., Sahu, D., Bakshi, G., & Singh, S. (2009). Evergreening–a controversial issue in pharma milieu.Bhardwaj, R., Raju, K., & Padmavati, M. (2013). The impact of patent linkage on marketing of generic drugs.Branstetter, L., Chatterjee, C., & Higgins, M. J. (2016). Regulation and welfare: evidence from paragraph IV generic entry in the pharmaceutical industry. The RAND Journal of Economics, 47(4), 857-890.Chen, M.-L., Shah, V., Patnaik, R., Adams, W., Hussain, A., Conner, D., . . . Huang, S.-M. (2001). Bioavailability and bioequivalence: an FDA regulatory overview. Pharmaceutical research, 18(12), 1645-1650.Commission, U. S. F. T. (2002). Generic Drug Entry Prior to Patient Expiration: An FTC Study: The Commission.Deloitte. (2020). 2020 醫療照護產業展望.Derzko, N. M. (2004). The Impact of Recent Reforms of the Hatch-Waxman Scheme on Orange Book Strategic Behavior and Pharmaceutical Innovation. Idea, 45, 165.EvaluatePharma. (2019). World_Preview_2019,Outlook to 2024. Retrieved fromFDA. (2018). Step 4: FDA Drug Review. Retrieved from https://www.fda.gov/patients/drug-development-process/step-4-fda-drug-reviewFDA. (2019). Statement on a new effort to improve transparency and predictability for generic drug applicants to help increase timely access to high-quality, lower cost generic drugs. Retrieved from https://www.fda.gov/news-events/press-announcements/statement-new-effort-improve-transparency-and-predictability-generic-drug-applicants-help-increaseFDA. (2020). Patent Certifications and Suitability Petitions. Retrieved from https://www.fda.gov/drugs/abbreviated-new-drug-application-anda/patent-certifications-and-suitability-petitionsFiercepharma. (2020). The top 20 drugs by global sales in 2019. Retrieved fromFlannery, E. J., & Hutt, P. B. (1985). Balancing competition and patent protection in the drug industry: The Drug Price Competition and Patent Term Restoration Act of 1984. Food, Drug, Cosmetic Law Journal, 40(3), 269-309.Frank, R. G. (2007). The ongoing regulation of generic drugs. New England Journal of Medicine, 357(20), 1993.FTC. (2009). Authorized Generics: An Interim Report. Retrieved fromFurrow, M. E. (2008). Pharmaceutical patent life-cycle management after KSR v. Teleflex. Food & Drug LJ, 63, 275.Hemphill, C. S., & Sampat, B. N. (2011). When do generics challenge drug patents? Journal of Empirical Legal Studies, 8(4), 613-649.Hemphill, C. S., & Sampat, B. N. (2012). Weak patents are a weak deterrent: Patent portfolios, the orange book listing standard, and generic entry in pharmaceuticals. In Standards, Patents and Innovations: International Journal of Industrial Organization, Volume 36.Johnson, J. M. (2002). In-depth interviewing. Handbook of interview research: Context and method, 1.Krause, C. (2001). Apotex, GlaxoSmithKline in generics battle over Paxil. Chemical Market Reporter, 259(21), 12-12.Krulwich, A. S. (1985). Statutory Reversal Roche v. Bolar: What You See Is Only the Beginning of What You Get. Food Drug Cosm. LJ, 40, 519.Lipsky, M. S., & Sharp, L. K. (2001). From idea to market: the drug approval process. The Journal of the American Board of Family Practice, 14(5), 362-367.Medicare Prescription Drug, Improvement, and Modernization Act of 2003, (2003).Mossinghoff, G. J. (1999). Overview of the Hatch-Waxman Act and its impact on the drug development process. Food & Drug LJ, 54, 187.Agreement on Trade-Related Aspects of Intellectual Property Right, (1996).Panattoni, L. E. (2011). The effect of Paragraph IV decisions and generic entry before patent expiration on brand pharmaceutical firms. Journal of health economics, 30(1), 126-145.Thomas, J. R. (2009). Patent" evergreening": Issues in Innovation and Competition.UnitedNations. (2019). World Population Prospects 2019 Retrieved from https://population.un.org/wpp/Publications/Files/WPP2019_10KeyFindings.pdfWeiswasser, E. S., & Danzis, S. D. (2003). The Hatch-Waxman act: History, structure, and legacy. Antitrust LJ, 71, 585.Wharton, J. S. (2003). Orange Book Listing of Patents under the Hatch-Waxman Act. . Louis ULJ, 47, 1027.Wheaton, J. J. (1985). Generic Competition and Pharmaceutical Innovation: The Drug Price Competition and Patent Term Restoration Act of 1984. Cath. UL Rev., 35, 433.王棋祺. (2020). 終結新冠 藥物有曙光 !?葉志鴻：新冠肺炎治療藥物的現況與挑戰, 74. Retrieved from https://www.gbimonthly.com/2020/06/73034/台灣食品藥物管理署. (2020). 資料齊備日及銷售專屬期. Retrieved from https://plls.fda.gov.tw/DataStatement江浣翠. (2017). 論我國專利期間的調整與延長、資料專屬權與專利連結制度之發展現況--藥品智慧財產權保護相關修正草案評析. 智慧財產評論, 14:2, 79-120.吳東哲，陳桂恒. (2015). 美國藥品專利連結與橘皮書登錄制度相關規範：對台灣之影響. 法學文摘, 102.吳東哲；鄒昀廷. (2019). 各國藥品專利連結簡介. Retrieved from https://www.wispro.com/tw/2019/10/22/patent-linkage-2/李秉燊. (2019). 開誠布公：2019年美國專利連結下「Paragraph IV聲明清單」新增項目簡介. Retrieved from http://www.naipo.com/Portals/1/web_tw/Knowledge_Center/Biotechnology/IPNC_190724_1102.htm翁雅欣 (2019). Re: 中華民國製藥發展協會法律顧問翁雅欣書面意見陳翠華. (2008). 我國醫藥品專利權期間延長制度之探討（上）. 智慧財產權月刊.黃慧嫺. (2009). 專利連結 (Patent Linkage)-藥品研發與競爭之阻力或助力? 談藥品查驗登記程式與專利權利狀態連結之發展 (下). 科技法律透析, 21(3), 32-48.黃慧嫻. (2006). 論製藥產業研發活動試驗免責之適用－以美國法院之相關判決見解演進為例. 科技法律透析, 18(1), 30-50. doi: 10.7062/STLR.200601.0030鄒昀廷. (2020). “搶注”治療新冠肺炎瑞德西韋專利佔便宜？藥商吉利德才是贏家. Retrieved from https://www.inquartik.com.tw/inq-china-coronavirus-patents-gilead-portfolio/滕沛倫. (2020). 醫藥品專利生命週期管理——以瑞德西韋為例. 專利師 42, 17-29.潘中道、胡龍騰. (2010). 研究方法：步驟化學習指南(第二版)（Ranjit Kumar 原著）: 臺北：學富文化.觀點Genet. (2019). 《血癌藥REVLIMID》與學名藥廠Natco和美時完成協議 原廠Celgene股價大漲表態拖延戰術奏效. Retrieved from http://www.genetinfo.com/investment/featured/item/24966.html?start=2 zh_TW dc.identifier.doi (DOI) 10.6814/NCCU202001796 en_US
