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題名 生物技術專利申請之書面說明要件―以抗原抗體技術領域判決為中心
Written Description in Biological Technology Patent Application―Focusing on the Judgments in the Field of Antigen and Antibody Technology
作者 王羿雯
Wang, Yi-Wen
貢獻者 沈宗倫
Shen, Chung-Lun
王羿雯
Wang, Yi-Wen
關鍵詞 生物科技
美國專利法
書面說明要件
抗原抗體技術
專利應用
Biological Technology
U.S. Patent Law
Written Description Requirement
Antigen-Antibody Technology
Patent Application
日期 2024
上傳時間 4-十月-2024 11:04:43 (UTC+8)
摘要 本文主要分為三大部分，內容涵蓋基因科技、美國專利法書面說明要件的判決發展演變，以及對臺灣專利法的影響和建議。 第一部分：介紹DNA、RNA和基因結構的基本背景知識，隨後，深入探討基因定序技術的發展歷程，以及各世代定序技術的差異。另外，延伸至抗原抗體領域，介紹抗體與抗原之間的作用和機制，並探討最新的免疫治療技術。這些技術展現生物醫藥領域的進展，及抗原抗體藥物在臨床治療中的應用。 第二部分：分析美國專利法第35章第112條的內容和影響，尤其針對第（a）項「書面說明要件（Written Description）」的法律解釋與實務操作。這一部分詳細回顧相關經典案例，分析這些判決對專利申請的具體影響，特別是抗原抗體領域的專利案件。透過這些案例，探討原告、被告在專利訴訟中的主要論點和法院的裁判思考，並分析判決如何影響專利說明書的撰寫和實務操作。 第三部分：回顧上述判決對美國生技產業實務影響，並討論臺灣專利法是否應採行「書面說明要件」。倘若引入「書面說明要件」的優缺點，探討對臺灣專利法第26條「書面說明要件」的潛在影響，及對生技產業的衝擊。考量到國際接軌需要，本部分將提出對臺灣專利法的建議，討論如何在不破壞現有法律體系的前提下，引入該要件以提升專利保護的完整性和專利審查有效性。 最後總結將對「書面說明要件」提出建議，期望在生技醫藥產業發展、抗原抗體技術領域和專利法規範三者間達成最佳的協調與平衡。希望本文能促進臺灣專利法國際化，提升專利保護效能，並推動生技產業進一步發展。
This thesis was divided into three main sections, covering gene technology, the evolution of suitcases regarding the written description requirement under U.S. patent law, and its impact on Taiwan’s patent law. First Section: It introduced the basic background knowledge of DNA, RNA, and gene structure, followed by an in-depth exploration of the development history of gene sequencing technologies and the differences among various generations of sequencing methods. Additionally, it extended into the field of antigens and antibodies, explaining the interactions and mechanisms between antibodies and antigens, and discussing the latest advancements in clinical immunotherapy. These technologies highlighted progress in the biomedicine field and the clinical applications of antibody drugs. Second Section: It analyzed the content and impact of Article 112 of Chapter 35 of U.S. patent law, particularly focusing on the section (a), the “written description requirement.” This section provided a detailed review of classic cases, examining how these rulings specifically affect patent applications, especially in the field of antibody-antigen patents. Through these cases, it explored the main arguments of plaintiffs and defendants in patent litigation, the court’s reasoning, and how the rulings influence the drafting of patent descriptions and practical operations. Third Section: It reviewed the influence on the afore-mentioned rulings on the U.S. biotech industry and discussed whether Taiwan’s patent law should adopt the “written description requirement.” It considered the pros and cons of introducing this requirement and explored its potential effects on Article 26 of Taiwan’s patent law regarding “written description＂or not. Given the need for international pace, this section offered suggestions for Taiwan’s patent law, discussing how to introduce this requirement without revising the existing article to enhance the integrity of patent protection and the effectiveness of patent examination. Finally, the conclusion provided suggestions on the “written description＂, aiming to achieve optimal coordination and balance among the development of the biomedical industry, the field of antigen-antibody technology, and patent regulation. It hoped to promote the internationalization of Taiwan’s patent law, enhance the effectiveness of patent protection, and further drive the development of the biotech industry.
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描述 碩士
國立政治大學
法律科際整合研究所
106652002
資料來源 http://thesis.lib.nccu.edu.tw/record/#G0106652002
資料類型 thesis
dc.contributor.advisor 沈宗倫zh_TW
dc.contributor.advisor Shen, Chung-Lunen_US
dc.contributor.author (作者) 王羿雯zh_TW
dc.contributor.author (作者) Wang, Yi-Wenen_US
dc.creator (作者) 王羿雯zh_TW
dc.creator (作者) Wang, Yi-Wenen_US
dc.date (日期) 2024en_US
dc.date.accessioned 4-十月-2024 11:04:43 (UTC+8)-
dc.date.available 4-十月-2024 11:04:43 (UTC+8)-
dc.date.issued (上傳時間) 4-十月-2024 11:04:43 (UTC+8)-
dc.identifier (其他 識別碼) G0106652002en_US
dc.identifier.uri (URI) https://nccur.lib.nccu.edu.tw/handle/140.119/153921-
dc.description (描述) 碩士zh_TW
dc.description (描述) 國立政治大學zh_TW
dc.description (描述) 法律科際整合研究所zh_TW
dc.description (描述) 106652002zh_TW
dc.description.abstract (摘要) 本文主要分為三大部分，內容涵蓋基因科技、美國專利法書面說明要件的判決發展演變，以及對臺灣專利法的影響和建議。 第一部分：介紹DNA、RNA和基因結構的基本背景知識，隨後，深入探討基因定序技術的發展歷程，以及各世代定序技術的差異。另外，延伸至抗原抗體領域，介紹抗體與抗原之間的作用和機制，並探討最新的免疫治療技術。這些技術展現生物醫藥領域的進展，及抗原抗體藥物在臨床治療中的應用。 第二部分：分析美國專利法第35章第112條的內容和影響，尤其針對第（a）項「書面說明要件（Written Description）」的法律解釋與實務操作。這一部分詳細回顧相關經典案例，分析這些判決對專利申請的具體影響，特別是抗原抗體領域的專利案件。透過這些案例，探討原告、被告在專利訴訟中的主要論點和法院的裁判思考，並分析判決如何影響專利說明書的撰寫和實務操作。 第三部分：回顧上述判決對美國生技產業實務影響，並討論臺灣專利法是否應採行「書面說明要件」。倘若引入「書面說明要件」的優缺點，探討對臺灣專利法第26條「書面說明要件」的潛在影響，及對生技產業的衝擊。考量到國際接軌需要，本部分將提出對臺灣專利法的建議，討論如何在不破壞現有法律體系的前提下，引入該要件以提升專利保護的完整性和專利審查有效性。 最後總結將對「書面說明要件」提出建議，期望在生技醫藥產業發展、抗原抗體技術領域和專利法規範三者間達成最佳的協調與平衡。希望本文能促進臺灣專利法國際化，提升專利保護效能，並推動生技產業進一步發展。zh_TW
dc.description.abstract (摘要) This thesis was divided into three main sections, covering gene technology, the evolution of suitcases regarding the written description requirement under U.S. patent law, and its impact on Taiwan’s patent law. First Section: It introduced the basic background knowledge of DNA, RNA, and gene structure, followed by an in-depth exploration of the development history of gene sequencing technologies and the differences among various generations of sequencing methods. Additionally, it extended into the field of antigens and antibodies, explaining the interactions and mechanisms between antibodies and antigens, and discussing the latest advancements in clinical immunotherapy. These technologies highlighted progress in the biomedicine field and the clinical applications of antibody drugs. Second Section: It analyzed the content and impact of Article 112 of Chapter 35 of U.S. patent law, particularly focusing on the section (a), the “written description requirement.” This section provided a detailed review of classic cases, examining how these rulings specifically affect patent applications, especially in the field of antibody-antigen patents. Through these cases, it explored the main arguments of plaintiffs and defendants in patent litigation, the court’s reasoning, and how the rulings influence the drafting of patent descriptions and practical operations. Third Section: It reviewed the influence on the afore-mentioned rulings on the U.S. biotech industry and discussed whether Taiwan’s patent law should adopt the “written description requirement.” It considered the pros and cons of introducing this requirement and explored its potential effects on Article 26 of Taiwan’s patent law regarding “written description＂or not. Given the need for international pace, this section offered suggestions for Taiwan’s patent law, discussing how to introduce this requirement without revising the existing article to enhance the integrity of patent protection and the effectiveness of patent examination. Finally, the conclusion provided suggestions on the “written description＂, aiming to achieve optimal coordination and balance among the development of the biomedical industry, the field of antigen-antibody technology, and patent regulation. It hoped to promote the internationalization of Taiwan’s patent law, enhance the effectiveness of patent protection, and further drive the development of the biotech industry.en_US
dc.description.tableofcontents 中文摘要 I Abstract II 第一節 研究動機及目的 1 第二節 研究範圍與方法 3 第三節 研究架構與內容 3 第二章 基因科技 5 第一節 基因科技名詞解釋 5 第二節 基因定序科技之發展 7 第一項 第一代定序 7 第二項 次世代定序 8 第三項 第三代定序 10 第三節 精準醫療 11 第一項 定義 12 第二項 發展 13 第三項 臨床應用 13 第四節 抗原抗體藥物背景介紹 15 第一項 免疫學名詞解釋 15 第二項 抗體藥物與技術發展 17 第三項 癌症免疫治療 22 第四項 免疫藥物與治療之專利爭議 35 第五節 小結 37 第三章 美國專利法第112條第(A)項書面說明要件 39 第一節 美國專利法第112條介紹 39 第二節 書面說明要件判決綜覽 42 第一項 Evans v. Eaton案 42 第二項 In re Ruschig案 43 第三節 生物技術領域書面說明要件判決演變 45 第一項 生物技術領域之特性 45 第二項 Amgen, Inc. v. Chugai Pharmaceutical, Co. LTD案 46 第三項 Fiers v. Revel 案 49 第四項 Regents of the University of California v. Eli Lilly & Co.案 52 第五項 Ariad Pharms, Inc. v. Eli Lilly & Co.案 55 第四節 書面說明要件適用解釋與測試法 59 第一項 文義解釋 59 第二項 歷史解釋 61 第三項 代表性物種測試法 63 第四項 希望或計畫測試法 64 第五節 小結 64 第四章 抗原抗體技術領域書面說明要件判決與審查 66 第一節 抗原抗體判決專利演變 66 第一項 Hybritech Inc. v. Monoclonal Antibodies, Inc. 案 67 第二節 新特徵抗原測試法案例 72 第一項 Noelle v. Lederman 案 72 第二項 Capon v. Eshhar 案 77 第三項 Centocor Ortho Biotech Inc. v. Abbott Labs 案 82 第四項 Abbvie Deutschland GMBH v. Janssen Biotech, Inc. 案 89 第三節 代表性物種測試法案例 94 第一項 Amgen Inc. v. Sanofi 案 94 第二項 Juno Therapeutics, Inc. v. Novartis International AG 案 99 第三項 Juno Therapeutics, Inc. v. Kite Pharma, Inc. 案 102 第二節 小結 106 第五章 書面說明要件在我國專利法之實踐 108 第一節 美國、歐盟 108 第二節 臺灣 113 第三節 臺灣專利法第26條之審查討論 115 第一項 美國現況 115 第二項 臺灣專利法第26條實務判決與學說現況 118 第三項 生技產業影響 129 第四節 小結 130 第六章 結論 132 參考文獻 134zh_TW
dc.source.uri (資料來源) http://thesis.lib.nccu.edu.tw/record/#G0106652002en_US
dc.subject (關鍵詞) 生物科技zh_TW
dc.subject (關鍵詞) 美國專利法zh_TW
dc.subject (關鍵詞) 書面說明要件zh_TW
dc.subject (關鍵詞) 抗原抗體技術zh_TW
dc.subject (關鍵詞) 專利應用zh_TW
dc.subject (關鍵詞) Biological Technologyen_US
dc.subject (關鍵詞) U.S. Patent Lawen_US
dc.subject (關鍵詞) Written Description Requirementen_US
dc.subject (關鍵詞) Antigen-Antibody Technologyen_US
dc.subject (關鍵詞) Patent Applicationen_US
dc.title (題名) 生物技術專利申請之書面說明要件―以抗原抗體技術領域判決為中心zh_TW
dc.title (題名) Written Description in Biological Technology Patent Application―Focusing on the Judgments in the Field of Antigen and Antibody Technologyen_US
dc.type (資料類型) thesisen_US
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