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| Title: | 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 |
| Authors: | 王羿雯
Wang, Yi-Wen |
| Contributors: | 沈宗倫
Shen, Chung-Lun
王羿雯
Wang, Yi-Wen |
| Keywords: | 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 |
| Date: | 2024 |
| Issue Date: | 2024-10-04 11:04:43 (UTC+8) |
| Abstract: | 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. |
| Reference: | 一、 中文（依姓氏筆畫排序）
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（二） 網路資料
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（三） 判決
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8. Juno Therapeutics, Inc. v. Kite Pharma, Inc., 10 F.4th 1330 (Fed. Cir. 2021), (United States Court of Appeals, Federal Circuit Aug 26, 2021).
9. Montclair v. Ramsdell, 107 U.S. 147 (1883), (U.S. Supreme Court March 5, 1883).
10. Noelle v. Lederman., 355 F.3d 1343 (Fed. Cir. 2004), (United States Court of Appeals, Federal Circuit Jan 20, 2004).
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19. In re Ruschig, 343 F.2d 965 (C.C.P.A. 1965), (United States Court of Customs and Patent Appeals Apr 22, 1965).
20. Rengo Co. Ltd. v. Molins Mach. Co., 657 F.2d 535 (3d Cir. 1981), (United States Court of Appeals, Third Circuit Jul 20, 1981).
21. Evans v. Eaton, 20 U.S. (7 Wheat.) 356 (1822). (U.S.). |
| Description: | 碩士
國立政治大學
法律科際整合研究所
106652002 |
| Source URI: | http://thesis.lib.nccu.edu.tw/record/#G0106652002 |
| Data Type: | thesis |
| Appears in Collections: | [法律科際整合研究所] 學位論文
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