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題名 再生醫療之專利保護--以比較法觀點論細胞治療專利適格性
Patent Protection for Regenerative Medicine – A Comparative Study on Patent Eligibility of Cell Therapy
作者 郭奕靚
Kuo, Yi-Jing
貢獻者 沈宗倫
Shen, Chung-Lun
郭奕靚
Kuo, Yi-Jing
關鍵詞 再生醫療
細胞治療
基因治療
CAR-T細胞療法
醫藥用途
瑞士型請求項
Mayo/Alice二步驟測試法
歐盟98/44/EC指令
專利適格性
可專利性
Regenerative medicine
Cell therapy
Gene therapy
CAR-T cell therapy
Medical use
Swiss-type claim
Mayo/Alice two-step test
Directive 98/44/EC
Patent eligibility
Patentability
日期 2023
上傳時間 6-Jul-2023 17:02:42 (UTC+8)
摘要 再生醫療領域之發明因經常利用血液、細胞、基因等為材料，故其專利保護難以避免涉及人體或生命可專利性之道德爭議。又，再生醫療精準化、個人化之治療模式，漸難如過去區別不同醫療方法發明，再作專利適格性判斷之方式，提供技術貢獻以適當專利保護。
美國最高法院近年所作Mayo v. Prometheus案、AMP v. Myriad案等判決，為影響美國近期再生醫療與生物醫藥領域發明專利適格判斷之重要指標。惟其實務應用上不明確及不可預期之疑義，以及診斷方法發明、用以替代既有組織功能之再生醫療發明難以取得專利適格地位之困境，係阻礙美國再生醫療發展之負面因素。公序良俗(ordre public)及道德係影響歐洲再生醫療相關發明專利適格性之要素之一，亦為歐洲與美國專利適格性判斷要件之重要差異。藉由歐盟98/44/EC指令之立法與導入，於歐洲，以人為技術方法介入所製得，而與自然存在者具相同結構之生物體自然產物相關發明，於排除道德爭議前提下，具專利適格性。醫療方法發明部分，歐洲除限縮不予專利項目之診斷方法發明的構成要件，並授予醫藥用途發明以物之專利保護。較之美國，歐洲對於再生醫療與生物醫藥相關發明之專利適格性採相對開放之態度。
為使再生醫療相關發明取得對應於技術貢獻之專利保護，本文建議可採用途/目的界定物，或醫藥用途發明具專利適格性等二種模式。又，本文建議我國較適當模式，係授予醫療用途界定之物發明專利保護，輔以修正藥事法專利連結規定與專利審查基準彙編，並終止瑞士型請求項之使用作為配套，以達平衡再生醫療技術發展與公眾利益之效。
Blood, cells and genes are widely used materials in the field of regenerative medicine. Patenting in the field thus inevitably involves controversies over the patentability of the human body or living beings. In addition, the development of precision and personalized medicine has blurred the lines between different medical methods. This makes it increasingly difficult to apply the existing criteria of patent eligibility, which were largely based on traditional categories of medical methods and their technical features.
The Supreme Court’s recent decisions including Mayo v. Prometheus and AMP v. Myriad underpin the current patent eligibility criteria for inventions in regenerative medicine and biotechnology in the U.S. However, the criteria are detrimental to innovations in these fields because their application lacks predictability and clarity; they also create barriers to obtaining patent protection for new diagnostic methods and for inventions that function as substitutes for human tissues or organs.
The subject matter eligibility law in Europe differs from the U.S. counterpart in an important respect: the role of the ordre public and morality exception. Such a difference between Europe and the U.S. is especially significant in the context of regenerative medicine. After the adoption and implementation of the Directive 98/44/EC, an invention derived from an element isolated from the human body or otherwise produced by means of a technical process, if it is not contrary to ordre public or morality, is patentable in Europe. In regard to medical methods, the scope of exclusion of diagnostic methods is interpreted narrowly, and inventions of second (and subsequent) medical use are subject to patent protection. On the whole, compared with the United States, Europe adopts a relatively open attitude towards patent eligibility for inventions related to regenerative medicine and biotechnology.
This thesis offers two models of subject matter eligibility for regenerative medicine to optimize its intellectual property protection. The first is to patent claims of products in a purpose-limited way, which is likely preferable in Taiwan. The second is to patent medical use claims. To strike a balance between innovation in regenerative medicine and public interests, the following strategies to implement the first model in Taiwan are suggested: granting (medical) use-limited product claims, amending the Pharmaceutical Affairs Acts and the Patent Examination Guidelines, as well as terminating Swiss-type claims.
參考文獻 壹、中文文獻

一、書籍
1.張仁平，專利審查基準及實務(上)--程序、發明(I)篇，3版，2021年2月。
2.謝銘洋，智慧財產權法，11版，2021年9月。
3.羅昌發，國際貿易法，1版，2004年9月。

二、專書論文
1.李素華，基因研究成果之專利保護及權利範圍—從美歐新近個案談基因專利權對公共衛生之影響，載：2011科技發展與法律規範雙年刊：健康、科學與人權，頁57-129， 2012年12月。
2.周伯翰，幹細胞相關研究之規範檢討，載：法學的實踐與創新－陳猷龍教授六秩華誕祝壽論文集(下冊)，頁90-137，2013年7月。

三、期刊論文
1.王服清，「歐盟生物科技發明指令 98/44/EC」的道德論辯－兼論檢視我國專利法制之問題，科技法學論叢，第4期，頁27-126，2009 年 10 月。
2.朱浩筠，In re Bilski 案看美國商業方法專利與適格標的判斷準則之發展，智慧財產權月刊，第121期，頁53-82，2009年1月。
3.李素華，我國藥品專利保護之現況與未來―從專利連結制度之研擬談起，智慧財產權月刊，第216期，頁5-8，2016年12月。
4.李素華，基因及基因醫藥之專利法制發展趨勢，法學新論，第4期，頁53-80，2008年11月。
5.沈宗倫，專利法之基本用語與法律體系概述，月旦法學教室，第141期，頁71-81，2014年6月。
6.周伯翰，生技產物或方法相關專利法制之研究，中正財經法學，第 18 期，頁93-214，2019年1月。
7.范建得、洪子洵、侯門，論基因專利實務發展及其評析，政大法學評論，第143期，頁373-416，2015年12月。
8.許曉芬，論歐洲專利公約下手術方法可專利性之最新發展—以歐洲專利局擴大上訴委員會G1/07案為中心，科技法學評論，第7卷第2期，頁93-128，2010年12月。
9.張仁平，由我國開放用途申請標的論用途發明專利之保護與審查(下)，智慧財產權月刊，第76 期，頁46-78，2005年4月。
10.陳秉訓，醫藥用途請求項及其專利有效性爭議--以明確性為中心，專利師，第39期，頁128-146，2019年10月。
11.陳豐年，專利權之歷史溯源與利弊初探，智慧財產權月刊 ，第156 期，頁63-87，2011年12月。
12.黃文儀，歐洲專利局上訴委員會及其決定，智慧財產權月刊，第120期，頁82-118，2008年12月。
13.黃美月、劉韋博，國際醫療合作促進國人健康-以八仙塵爆為例，臺灣醫界雜誌，第61:1期，頁34-37，2018年1月。
14.董安丹，從歐洲專利公約及美國專利法的規定談醫療方法發明及用途發明，智慧財產月刊，第61期，頁54-83，2004年1月。
15.簡文斌，國際基因治療產品開發研究與最新非臨床藥毒理法規科學審查考量，當代醫藥法規月刊，第106期，頁1-14，2019年8月。
16.謝銘洋、李素華，生技醫療產業所面對新興專利課題—基因檢測、細胞治療與基因治療之專利保護與權利限制，台灣科技法律與政策論叢，第4卷第2期，頁49-99，2007年6月。
17.謝銘洋、李素華、宋皇志，從歐洲觀點看幹細胞相關發明之可專利性，月旦法學雜誌，第118期，頁63-89，2005年3月。
18.謝龍昇，「自然法則」運用與個人化醫療診斷方法專利適格性判斷—從美國Mayo v. Prometheus案判決談起，高大法學論叢，第11卷第1期，頁163-234，2015年9月。

四、碩博士學位論文
林怡芊，歐盟 98/44 號生物技術發明保護指令中專利適格標的之研究，國立清華大學科技法律研究所碩士論文，2003年6月。

五、法院判決
智慧財產法院109年民專訴字第46號民事判決。

六、法規
1.專利法。
2.藥事法。

七、官方文件
1.專利法逐條釋義，經濟部智慧財產局，110 年6月版。
2.專利審查基準彙編第二篇發明專利實體審查(全)，經濟部智慧財產局，111年7月1日施行版。
3.衛生福利部衛授食字第1101460471號公告。
4.衛生福利部衛部醫字第1101668916號公告。

八、網路資料
1.IPKM智財保護資訊平台，歐盟專利、設計制度概要，https://ipkmdata.tipo.gov.tw/ipkm-web/ (最後瀏覽日：2023年2月14日)。
2.NHRI Communications第 366 期，幹細胞專利惹的禍?--專利和科學進步的辯論，http://enews2.nhri.org.tw/enews_list_new2_more.php?volume_indx=366&showx=showarticle&article_indx=7902 (最後瀏覽日：2023年2月14日)。
3.立法院法律系統，專利法法條沿革，https://lis.ly.gov.tw/lglawc/lawsingle?0^89C0184CC0069389C0180C790603A9C41A0CC42613A1C89C4CC0 (最後瀏覽日：2023年2月14日)。
4.沈家寧，幹細胞治療面面觀，2020年10月22日，https://celltherapy.mohw.gov.tw/education_page.htm?id=78 (最後瀏覽日：2023年2月13日)。
5.林泰元、黃彥華，細胞治療面面觀，為什麼我們需要細胞治療?，2022年3月18日，https://www.sancode.org.tw/activities_info.php?type=3&nid=163 (最後瀏覽日：2023年2月12日)。
6.科學Online，細胞色素 P450 (2014年4月22日)，https://highscope.ch.ntu.edu.tw/wordpress/?p=52911 (最後瀏覽日：2023年2月16日)。
7.陳耀昌，細胞治療是什麼?，2020年3月17日，https://celltherapy.mohw.gov.tw/education_page.htm?id=2 (最後瀏覽日：2023年2月12日)。
8.經濟部技術處, 產業技術評析-誘導式多功細胞於細胞治療上的發展與挑戰，2019年4月24日，https://www.moea.gov.tw/MNS/doit/industrytech/IndustryTech.aspx?menu_id=13545&it_id=232 (最後瀏覽日：2023年2月13日)。
9.經濟部智慧財產局，與貿易有關之智慧財產權協定(Agreement on Trade-Related Aspects of Intellectual Property Rights, TRIPS)公開內容，https://www.tipo.gov.tw/tw/cp-128-207126-bb3f9-1.html (最後瀏覽日：2023年2月12日)。
10.葉雲卿，淺談醫藥專利典型權利請求項，北美智權報第113期，http://www.naipo.com/Portals/1/web_tw/Knowledge_Center/Biotechnology/publish-18.htm (最後瀏覽日：2023年2月13日)。
11.衛生福利部，細胞治療技術資訊專區，https://celltherapy.mohw.gov.tw/index.htm (最後瀏覽日：2022年12月5日)。
12.衛生福利部公告：預告制定「再生醫療發展法」草案及「再生醫療施行管理條例」草案，https://join.gov.tw/policies/detail/b4b7f42f-6398-4b62-99c2-92fb6eb5ad72 (最後瀏覽日：2023年2月12日)。
13.衛生福利部新聞：衛生福利部深表遺憾，再生醫療雙法草案未能在立法院院會第10屆第7會期第11次會議審查，https://www.mohw.gov.tw/cp-6564-74670-1.html (最後瀏覽日：2023年6月2日)。
14.衛生福利部食品藥物管理署再生醫療製劑管理專區，再生醫療製劑相關演講簡報之「我國再生醫療製劑管理現況及未來展望」、「再生醫療管理現況及未來展望」內容，https://www.fda.gov.tw/TC/siteList.aspx?sid=12080 (最後瀏覽日：2023年6月2日)。

貳、英文文獻

一、專書論文
1. Golden, John M. (2017), Stem Cell Patents in the United States, in D. Matthews & H. Zech eds., Research Handbook on Intellectual Property and the Life Sciences 243-255 (Cheltenham, UK ; Northampton, MA : Edward Elgar).
2. Porter, Gerard (2009), The Drafting History of the European Biotechnology Directive, in A Plomer & P Torremans eds., Embryonic Stem Cell Patents: European Law and Ethics, 3-26 (New York: Oxford University Press).
3. Schneider, Ingrid (2014), Exclusions and Exceptions to Patent Eligibility Revisited: Examining the Political Functions of the "Discovery" and "Ordre Public" Clauses in the European Patent Convention and the Arenas of Negotiation, in Iñigo de Miguel Beriain & Carlos María Romeo Casabona eds., Synbio and Human Health, 145-173 (Dordrecht: Springer Netherlands).
4. Strandburg, Katherine J., (2014), Legal but unacceptable: Pallin v. Singerand physician patenting norms, in R. Dreyfuss & J. Ginsburg eds., Intellectual Property at the Edge: The Contested Contours of IP, 321-342 (Cambridge: Cambridge University Press).

二、期刊論文
1. Abinader, Luis Gil & Contreras, Jorge L. (2019), The Patentability of Genetic Therapies: CAR-T and Medical Treatment Exclusions Around The World, 34 American University International Law Review 705-762.
2. Akers, Noel J. (1999), The European Patent System: an introduction for patent searchers, 21(3) World Patent Information 135-163.
3. Bagley, Margo A. (2003), Patent First, Ask Questions Later: Morality and Biotechnology in Patent Law, 45(2) William and Mary Law Review 469-548.
4. Berrisch, Clara (2019), Second medical use claims and scope of protection- A work in progress since 1984, 2(1) Stockholm IP Law Review 38-47.
5. Caffarini, Ava (2013), Directed To or Encompassing a Human Organism: How Section 33 of the America Invents Act May Threaten the Future of Biotechnology, 12(4) J. Marshall Rev. Intell. Prop. L. 768-786.
6. Donnelly, Stephen R. (2011), The Patentability of Human Embryonic Stem Cells: Is the Inconsistent Application of the European Union Biotechnology Directive`s Moral Exclusion Clause Undermining Investor Confidence in Europe, Providing a Competitive Advantage to the United States?, 20 Dal J Leg Stud 151-182.
7. Eisenberg, Rebecca S. (2015), Diagnostics Need Not Apply, 21(2) J. Sci. & Tech. L. 256-286.
8. El-Kadiry, Abed El-Hakim & Rafei, Moutih & Shammaa, Riam (2021), Cell Therapy: Types, Regulation, and Clinical Benefits, 8:a7656029 Frontiers in Medicine, 1-24.
9. Federico, P.J. (1990), Operation for the Patent Act of 1790, 72 J. Pat. & Trademark Off. Soc`y 373.
10. Fendrick, Sarah E. & Zuhn, Donald L. Jr. (2015), Patentability of Stem Cells in the United States, 5(12):a020958 Cold Spring Harb Perspect Med. 1-6.
11. Fisher, Matthew (2017), Second medical indications and the Swiss-form claim: taming Frankenstein`s monster: Part 1 - solving one problem creates another, 39(9) European Intellectual Property Review 495-502.
12. Ho, Cynthia M. (2000), Patents, Patients, and Public Policy: An Incomplete Intersection at 35 U.S.C. 287 (c), 33 U.C. DAVIS L. REV. 601-675.
13. Jacques, Erik & Suuronen, Erik J. (2020), The Progression of Regenerative Medicine and its Impact on Therapy Translation, 13(3) Clin Transl Sci. 440-450.
14. Li, Joyce C. (2017), Preemption, Diagnostics, and the Machine-or-Transformation Test: Federal Circuit Refinement of Biotech Method Eligibility, 32 Berkeley Technology Law Journal 379–412.
15. Lysaght, Michael J. & Hazlehurst, Anne L. (2004), Tissue engineering: the end of the beginning, 10(1-2) Tissue Eng. 309-320.
16. Mao, Angelo S. & Mooney David J. (2015), Regenerative medicine: Current therapies and future directions, 112(47) Proc Natl Acad Sci U S A. 14452-11459.
17. Minssen, Timo & Nordberg, Ana (2015), The Evolution of the CJEU`s Case Law on Stem Cell Patents: Context, Outcome and Implications of Case C-364/13 International Stem Cell Corporation, 5 Nordic Intellectual Property Law Review 493-503.
18. Minssen, Timo & Schwartz, Robert M. (2016), Separating Sheep from Goats: A European View on the Patent Eligibility of Biomedical Diagnostic Methods, 3(2) Journal of Law and the Biosciences 365-372.
19. Peschel, Leisa Talbert (2008), Revisiting the Compromise of 35. U.S.C. § 287(c), 16 TEX. INTELL. PROP. L.J. 299-323.
20. Robole, Zachary M. (2022), Handling the Mayo Powder Keg: Emphasizing Preemption in § 101 Biotechnology Inquiries, 107 Minn. L. Rev. Headnotes 75-103.
21. Sampogna, Gianluca & Guraya, Salman Yousuf & Forgione, Antonello (2015), Regenerative medicine: Historical roots and potential strategies in modern medicine, 3(3) Journal of Microscopy and Ultrastructure 101-107.

三、碩博士學位論文
Başak Babaoğlu De Bruyne (2021), The Assessment of Gene Patents Granted in Medical Biotechnology Area in the EU and the US: A Law and Economics Approach, Universität Hamburg.

四、法院裁判與歐洲專利局上訴委員會決定
1. Alice Corp. Pty. Ltd. v. CLS Bank Int’l, 573 U.S. 208 (2014).
2. Association for Molecular Pathology v. Myriad Genetics Inc., 569 U.S. 576 (2013).
3. Association for Molecular Pathology v. United States Patent and Trademark Office, 702 F. Supp. 2d 181 (2010).
4. Athena Diagnostics, Inc. v. Mayo Collaborative Services, LLC, 927 F.3d 1333 (Fed. Cir. 2019).
5. Athena Diagnostics, Inc. v. Mayo Collaborative Services, LLC, No. 19-430, 140 S. Ct. 855 (Jan. 13, 2020).
6. Athena Diagnostics, Inc. v. Mayo Collaborative Services, LLC, 915 F.3d 743 (Fed. Cir. 2019).
7. Bilski v. Kappos, 561 U.S. 593 (2010).
8. CareDx, Inc. v. Natera, Inc., 40 F.4th 1371 (Fed. Cir. 2022).
9. Decision G 01/04 (Diagnostic methods), 16 December 2005.
10. Decision G 02/06 (Use of embryos/WARF), 25 November 2008.
11. Decision G 02/08 (Dosage regime/ABBOTT RESPIRATORY), 19 February 2010.
12. Decision G 03/19 (Pepper (follow-up to “Tomatoes II” and “Broccoli II”), 14 May 2020.
13. Decision G 05/83 (EISAI/Second Medical Indication), 5 December 1984.
14. Decision T 1374/04 (Stem cells/WARF), 7 April 2006
15. Diamond v. Chakrabarty, 447 U.S. 303 (1980).
16. Diamond v. Diehr, 450 U.S. 175, 185 (1981).
17. Ex parte Scherer, 103 U.S.P.Q. (BNA) 107 (Pat. Off. Bd. App. 1954).
18. Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U.S. 127 (1948).
19. Hikma Pharms. USA Inc. v. Vanda Pharms. Inc., No. 18–817, 140 S. Ct. 911 (Jan. 13, 2020).
20. Illumina, Inc. v. Ariosa Diagnostics, Inc., 967 F.3d 1319 (Fed. Cir. 2020).
21. In re Bilski, 545 F.3d 943 (Fed.Cir. 2008)
22. International Stem Cell Corporation v. Comptroller General of Patents, Designs and Trademarks, Case C-364/13, CJEU (Grand Chamber), 18 December 2014.
23. Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. 66 (2012).
24. Morton v. New York Eye Infirmary, 17 F. Cas. 879 (S.D.N.Y. 1862).
25. Oliver Brüstle v. Greenpeace eV., Case C-34/10, CJEU (Grand Chamber), 18 October 2011.
26. Parker v. Flook, 437 U.S. 584 (1978).
27. Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals, 887 F.3d 1117, 1121 (Fed. Cir. 2018).

五、法規
1. 35 U.S.C. § 101.
2. 35 U.S.C. § 102.
3. 35 U.S.C. § 103.
4. 35 U.S.C. 287 (c).
5. Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions.
6. European Patent Convention (1973).
7. European Patent Convention. (2020).
8. Implementing Regulations to the Convention on the Grant of European Patents.
9. Leahy-Smith America Invents Act, Pub. L. No. 112-29, § 33(a), 125 Stat. 284, 340 (2011).
10. Patents Act 1977 (UK).
11. U.S. CONST. art. I, § 8, cl. 8.

六、官方文件
1. 149 CONG. REC. H7248 (daily ed. July 22, 2003).
2. 157 CONG. REC. E1177 (daily ed. June 23, 2011) (statement of Rep. Christopher H. Smith).
3. 2014 Interim Guidance on Patent Subject Matter Eligibility, 79 Fed. Reg. 74,618 (Dec. 16 2014), available at https://www.govinfo.gov/content/pkg/FR-2014-12-16/pdf/2014-29414.pdf (Last visited: 2023/2/13).
4. 2019 Revised Patent Subject Matter Eligibility Guidance, 84 Fed. Reg. 50 (Jan. 7, 2019), available at https://www.govinfo.gov/content/pkg/FR-2019-01-07/pdf/2018-28282.pdf (Last visited: 2023/2/13).
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描述 碩士
國立政治大學
法學院碩士在職專班
106961045
資料來源 http://thesis.lib.nccu.edu.tw/record/#G0106961045
資料類型 thesis
dc.contributor.advisor 沈宗倫zh_TW
dc.contributor.advisor Shen, Chung-Lunen_US
dc.contributor.author (Authors) 郭奕靚zh_TW
dc.contributor.author (Authors) Kuo, Yi-Jingen_US
dc.creator (作者) 郭奕靚zh_TW
dc.creator (作者) Kuo, Yi-Jingen_US
dc.date (日期) 2023en_US
dc.date.accessioned 6-Jul-2023 17:02:42 (UTC+8)-
dc.date.available 6-Jul-2023 17:02:42 (UTC+8)-
dc.date.issued (上傳時間) 6-Jul-2023 17:02:42 (UTC+8)-
dc.identifier (Other Identifiers) G0106961045en_US
dc.identifier.uri (URI) http://nccur.lib.nccu.edu.tw/handle/140.119/145932-
dc.description (描述) 碩士zh_TW
dc.description (描述) 國立政治大學zh_TW
dc.description (描述) 法學院碩士在職專班zh_TW
dc.description (描述) 106961045zh_TW
dc.description.abstract (摘要) 再生醫療領域之發明因經常利用血液、細胞、基因等為材料，故其專利保護難以避免涉及人體或生命可專利性之道德爭議。又，再生醫療精準化、個人化之治療模式，漸難如過去區別不同醫療方法發明，再作專利適格性判斷之方式，提供技術貢獻以適當專利保護。
美國最高法院近年所作Mayo v. Prometheus案、AMP v. Myriad案等判決，為影響美國近期再生醫療與生物醫藥領域發明專利適格判斷之重要指標。惟其實務應用上不明確及不可預期之疑義，以及診斷方法發明、用以替代既有組織功能之再生醫療發明難以取得專利適格地位之困境，係阻礙美國再生醫療發展之負面因素。公序良俗(ordre public)及道德係影響歐洲再生醫療相關發明專利適格性之要素之一，亦為歐洲與美國專利適格性判斷要件之重要差異。藉由歐盟98/44/EC指令之立法與導入，於歐洲，以人為技術方法介入所製得，而與自然存在者具相同結構之生物體自然產物相關發明，於排除道德爭議前提下，具專利適格性。醫療方法發明部分，歐洲除限縮不予專利項目之診斷方法發明的構成要件，並授予醫藥用途發明以物之專利保護。較之美國，歐洲對於再生醫療與生物醫藥相關發明之專利適格性採相對開放之態度。
為使再生醫療相關發明取得對應於技術貢獻之專利保護，本文建議可採用途/目的界定物，或醫藥用途發明具專利適格性等二種模式。又，本文建議我國較適當模式，係授予醫療用途界定之物發明專利保護，輔以修正藥事法專利連結規定與專利審查基準彙編，並終止瑞士型請求項之使用作為配套，以達平衡再生醫療技術發展與公眾利益之效。		zh_TW
dc.description.abstract (摘要) Blood, cells and genes are widely used materials in the field of regenerative medicine. Patenting in the field thus inevitably involves controversies over the patentability of the human body or living beings. In addition, the development of precision and personalized medicine has blurred the lines between different medical methods. This makes it increasingly difficult to apply the existing criteria of patent eligibility, which were largely based on traditional categories of medical methods and their technical features.
The Supreme Court’s recent decisions including Mayo v. Prometheus and AMP v. Myriad underpin the current patent eligibility criteria for inventions in regenerative medicine and biotechnology in the U.S. However, the criteria are detrimental to innovations in these fields because their application lacks predictability and clarity; they also create barriers to obtaining patent protection for new diagnostic methods and for inventions that function as substitutes for human tissues or organs.
The subject matter eligibility law in Europe differs from the U.S. counterpart in an important respect: the role of the ordre public and morality exception. Such a difference between Europe and the U.S. is especially significant in the context of regenerative medicine. After the adoption and implementation of the Directive 98/44/EC, an invention derived from an element isolated from the human body or otherwise produced by means of a technical process, if it is not contrary to ordre public or morality, is patentable in Europe. In regard to medical methods, the scope of exclusion of diagnostic methods is interpreted narrowly, and inventions of second (and subsequent) medical use are subject to patent protection. On the whole, compared with the United States, Europe adopts a relatively open attitude towards patent eligibility for inventions related to regenerative medicine and biotechnology.
This thesis offers two models of subject matter eligibility for regenerative medicine to optimize its intellectual property protection. The first is to patent claims of products in a purpose-limited way, which is likely preferable in Taiwan. The second is to patent medical use claims. To strike a balance between innovation in regenerative medicine and public interests, the following strategies to implement the first model in Taiwan are suggested: granting (medical) use-limited product claims, amending the Pharmaceutical Affairs Acts and the Patent Examination Guidelines, as well as terminating Swiss-type claims.		en_US
dc.description.tableofcontents 第一章 緒論 1
第一節 研究動機與目的 1
第二節 研究方法與架構 2
第二章 再生醫療發明專利保護與適格性標的 4
第一節 發明專利保護之理論基礎與內涵 4
第一項 發明專利保護之理論基礎 4
第二項 發明專利適格性及可專利性要件 6
第三項 專利適格性重要國際條約--與貿易有關之智慧財產權協定(TRIPS協定) 8
第一款 TRIPS協定概說 8
第二款 TRIPS協定專利適格性條款 10
第二節 再生醫療發展與專利適格性標的 11
第一項 再生醫療發展趨勢 11
第二項 細胞治療技術概說 13
第一款 細胞治療領域 13
第二款 基因修飾之細胞治療領域 15
第三項 細胞治療專利適格性標的 17
第三章 美國再生醫療專利適格性規範體系 20
第一節 美國專利法專利適格性規範與發展 20
第一項 美國專利法專利適格性規範 20
第二項 美國專利適格性司法排除項目 22
第三項 Mayo/Alice二步驟測試法 25
第四項 美國專利適格性規範爭議、近期發展與修法方向 31
第二節 醫療行為侵權免責-美國專利法第287條第3項 34
第一項 美國專利法第287條第3項概說 35
第二項 免除專利侵權責任要件 36
第三節 Leahy-Smith 美國發明法案 38
第一項 Leahy-Smith 美國發明法案概說 38
第二項 人類體專利適格性-- Leahy-Smith美國發明法案第33條第1項 39
第四節 美國再生醫療發明相關專利適格性重要案例 41
第一項 方法發明專利適格性重要案例 41
第一款 Mayo Collaborative Services v. Prometheus Laboratories, Inc.,566 U.S. 66 (2012) 41
第二款 Athena Diagnostics, Inc. v. Mayo Collaborative Services, LLC, 915 F.3d 743 (Fed. Cir. 2019) 47
第三款 Vanda Pharms. Inc. v. West-Ward Pharms. Int’l Ltd., 887 F.3d 1117 (Fed. Cir. 2018) 52
第二項 物之發明專利適格性重要案例 57
第一款 Association for Molecular Pathology v. Myriad Genetics Inc., 569 U.S. 576 (2013) 57
第五節 小結 61
第四章 歐洲再生醫療專利適格性規範體系 65
第一節 歐洲專利公約專利適格性規範與發展 65
第一項 歐洲專利公約概說 65
第二項 歐洲專利公約專利適格性規範 67
第三項 歐洲專利公約例外不予專利項目 68
第四項 歐洲瑞士型請求項(Swiss-type Claim)發展 72
第五項 歐洲專利公約專利適格性規範近期發展方向 74
第二節 歐盟生物科技專利保護指令(Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions, Directive 98/44/EC) 76
第一項 歐盟98/44/EC指令立法背景 76
第二項 歐盟98/44/EC指令專利適格性規範 78
第三項 歐盟98/44/EC指令例外不予專利項目 79
第四項 歐盟98/44/EC指令專利適格性規範近期發展方向 82
第三節 歐洲再生醫療發明相關專利適格性重要案例 83
第一項 方法發明專利適格性重要案例 83
第一款 Decision G 01/04 (Diagnostic methods), Enlarged Board of Appeal of the EPO, 16 December 2005 83
第二項 物之發明專利適格性重要案例 89
第一款 Decision G 02/06 (Use of embryos/WARF), Enlarged Board of Appeal of the EPO, 25 November 2008 89
第二款 Oliver Brüstle v. Greenpeace eV., Case C-34/10, CJEU (Grand Chamber), 18 October 2011 95
第三款 International Stem Cell Corporation v. Comptroller General of Patents, Designs and Trademarks, Case C-364/13, CJEU (Grand Chamber), 18 December 2014 100
第四節 小結 104
第五章 美、歐再生醫療專利適格性規範啟示及我國制度再檢視 108
第一節 美、歐再生醫療專利適格性規範啟示 108
第一項 美、歐再生醫療專利適格性規範差異 108
第二項 美、歐再生醫療專利適格性規範差異評析與建議 112
第二節 我國再生醫療專利適格性規範體系 119
第一項 我國專利法專利適格性規範與發展 119
第一款 我國專利法專利適格性規範 119
第二款 我國例外不予專利項目 120
第二項 我國瑞士型請求項發展 125
第一款 我國瑞士型請求項概說 125
第二款 我國瑞士型請求項現況 126
第三節 我國再生醫療專利適格性規範評析與建議採行策略 129
第一項 我國再生醫療專利適格性規範與評析 129
第二項 我國再生醫療專利適格性規範建議 132
第六章 結論 137
參考文獻 140		zh_TW
dc.format.extent 7398343 bytes-
dc.format.mimetype application/pdf-
dc.source.uri (資料來源) http://thesis.lib.nccu.edu.tw/record/#G0106961045en_US
dc.subject (關鍵詞) 再生醫療zh_TW
dc.subject (關鍵詞) 細胞治療zh_TW
dc.subject (關鍵詞) 基因治療zh_TW
dc.subject (關鍵詞) CAR-T細胞療法zh_TW
dc.subject (關鍵詞) 醫藥用途zh_TW
dc.subject (關鍵詞) 瑞士型請求項zh_TW
dc.subject (關鍵詞) Mayo/Alice二步驟測試法zh_TW
dc.subject (關鍵詞) 歐盟98/44/EC指令zh_TW
dc.subject (關鍵詞) 專利適格性zh_TW
dc.subject (關鍵詞) 可專利性zh_TW
dc.subject (關鍵詞) Regenerative medicineen_US
dc.subject (關鍵詞) Cell therapyen_US
dc.subject (關鍵詞) Gene therapyen_US
dc.subject (關鍵詞) CAR-T cell therapyen_US
dc.subject (關鍵詞) Medical useen_US
dc.subject (關鍵詞) Swiss-type claimen_US
dc.subject (關鍵詞) Mayo/Alice two-step testen_US
dc.subject (關鍵詞) Directive 98/44/ECen_US
dc.subject (關鍵詞) Patent eligibilityen_US
dc.subject (關鍵詞) Patentabilityen_US
dc.title (題名) 再生醫療之專利保護--以比較法觀點論細胞治療專利適格性zh_TW
dc.title (題名) Patent Protection for Regenerative Medicine – A Comparative Study on Patent Eligibility of Cell Therapyen_US
dc.type (資料類型) thesisen_US
dc.relation.reference (參考文獻) 壹、中文文獻

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7.范建得、洪子洵、侯門，論基因專利實務發展及其評析，政大法學評論，第143期，頁373-416，2015年12月。
8.許曉芬，論歐洲專利公約下手術方法可專利性之最新發展—以歐洲專利局擴大上訴委員會G1/07案為中心，科技法學評論，第7卷第2期，頁93-128，2010年12月。
9.張仁平，由我國開放用途申請標的論用途發明專利之保護與審查(下)，智慧財產權月刊，第76 期，頁46-78，2005年4月。
10.陳秉訓，醫藥用途請求項及其專利有效性爭議--以明確性為中心，專利師，第39期，頁128-146，2019年10月。
11.陳豐年，專利權之歷史溯源與利弊初探，智慧財產權月刊 ，第156 期，頁63-87，2011年12月。
12.黃文儀，歐洲專利局上訴委員會及其決定，智慧財產權月刊，第120期，頁82-118，2008年12月。
13.黃美月、劉韋博，國際醫療合作促進國人健康-以八仙塵爆為例，臺灣醫界雜誌，第61:1期，頁34-37，2018年1月。
14.董安丹，從歐洲專利公約及美國專利法的規定談醫療方法發明及用途發明，智慧財產月刊，第61期，頁54-83，2004年1月。
15.簡文斌，國際基因治療產品開發研究與最新非臨床藥毒理法規科學審查考量，當代醫藥法規月刊，第106期，頁1-14，2019年8月。
16.謝銘洋、李素華，生技醫療產業所面對新興專利課題—基因檢測、細胞治療與基因治療之專利保護與權利限制，台灣科技法律與政策論叢，第4卷第2期，頁49-99，2007年6月。
17.謝銘洋、李素華、宋皇志，從歐洲觀點看幹細胞相關發明之可專利性，月旦法學雜誌，第118期，頁63-89，2005年3月。
18.謝龍昇，「自然法則」運用與個人化醫療診斷方法專利適格性判斷—從美國Mayo v. Prometheus案判決談起，高大法學論叢，第11卷第1期，頁163-234，2015年9月。

四、碩博士學位論文
林怡芊，歐盟 98/44 號生物技術發明保護指令中專利適格標的之研究，國立清華大學科技法律研究所碩士論文，2003年6月。

五、法院判決
智慧財產法院109年民專訴字第46號民事判決。

六、法規
1.專利法。
2.藥事法。

七、官方文件
1.專利法逐條釋義，經濟部智慧財產局，110 年6月版。
2.專利審查基準彙編第二篇發明專利實體審查(全)，經濟部智慧財產局，111年7月1日施行版。
3.衛生福利部衛授食字第1101460471號公告。
4.衛生福利部衛部醫字第1101668916號公告。

八、網路資料
1.IPKM智財保護資訊平台，歐盟專利、設計制度概要，https://ipkmdata.tipo.gov.tw/ipkm-web/ (最後瀏覽日：2023年2月14日)。
2.NHRI Communications第 366 期，幹細胞專利惹的禍?--專利和科學進步的辯論，http://enews2.nhri.org.tw/enews_list_new2_more.php?volume_indx=366&showx=showarticle&article_indx=7902 (最後瀏覽日：2023年2月14日)。
3.立法院法律系統，專利法法條沿革，https://lis.ly.gov.tw/lglawc/lawsingle?0^89C0184CC0069389C0180C790603A9C41A0CC42613A1C89C4CC0 (最後瀏覽日：2023年2月14日)。
4.沈家寧，幹細胞治療面面觀，2020年10月22日，https://celltherapy.mohw.gov.tw/education_page.htm?id=78 (最後瀏覽日：2023年2月13日)。
5.林泰元、黃彥華，細胞治療面面觀，為什麼我們需要細胞治療?，2022年3月18日，https://www.sancode.org.tw/activities_info.php?type=3&nid=163 (最後瀏覽日：2023年2月12日)。
6.科學Online，細胞色素 P450 (2014年4月22日)，https://highscope.ch.ntu.edu.tw/wordpress/?p=52911 (最後瀏覽日：2023年2月16日)。
7.陳耀昌，細胞治療是什麼?，2020年3月17日，https://celltherapy.mohw.gov.tw/education_page.htm?id=2 (最後瀏覽日：2023年2月12日)。
8.經濟部技術處, 產業技術評析-誘導式多功細胞於細胞治療上的發展與挑戰，2019年4月24日，https://www.moea.gov.tw/MNS/doit/industrytech/IndustryTech.aspx?menu_id=13545&it_id=232 (最後瀏覽日：2023年2月13日)。
9.經濟部智慧財產局，與貿易有關之智慧財產權協定(Agreement on Trade-Related Aspects of Intellectual Property Rights, TRIPS)公開內容，https://www.tipo.gov.tw/tw/cp-128-207126-bb3f9-1.html (最後瀏覽日：2023年2月12日)。
10.葉雲卿，淺談醫藥專利典型權利請求項，北美智權報第113期，http://www.naipo.com/Portals/1/web_tw/Knowledge_Center/Biotechnology/publish-18.htm (最後瀏覽日：2023年2月13日)。
11.衛生福利部，細胞治療技術資訊專區，https://celltherapy.mohw.gov.tw/index.htm (最後瀏覽日：2022年12月5日)。
12.衛生福利部公告：預告制定「再生醫療發展法」草案及「再生醫療施行管理條例」草案，https://join.gov.tw/policies/detail/b4b7f42f-6398-4b62-99c2-92fb6eb5ad72 (最後瀏覽日：2023年2月12日)。
13.衛生福利部新聞：衛生福利部深表遺憾，再生醫療雙法草案未能在立法院院會第10屆第7會期第11次會議審查，https://www.mohw.gov.tw/cp-6564-74670-1.html (最後瀏覽日：2023年6月2日)。
14.衛生福利部食品藥物管理署再生醫療製劑管理專區，再生醫療製劑相關演講簡報之「我國再生醫療製劑管理現況及未來展望」、「再生醫療管理現況及未來展望」內容，https://www.fda.gov.tw/TC/siteList.aspx?sid=12080 (最後瀏覽日：2023年6月2日)。

貳、英文文獻

一、專書論文
1. Golden, John M. (2017), Stem Cell Patents in the United States, in D. Matthews & H. Zech eds., Research Handbook on Intellectual Property and the Life Sciences 243-255 (Cheltenham, UK ; Northampton, MA : Edward Elgar).
2. Porter, Gerard (2009), The Drafting History of the European Biotechnology Directive, in A Plomer & P Torremans eds., Embryonic Stem Cell Patents: European Law and Ethics, 3-26 (New York: Oxford University Press).
3. Schneider, Ingrid (2014), Exclusions and Exceptions to Patent Eligibility Revisited: Examining the Political Functions of the "Discovery" and "Ordre Public" Clauses in the European Patent Convention and the Arenas of Negotiation, in Iñigo de Miguel Beriain & Carlos María Romeo Casabona eds., Synbio and Human Health, 145-173 (Dordrecht: Springer Netherlands).
4. Strandburg, Katherine J., (2014), Legal but unacceptable: Pallin v. Singerand physician patenting norms, in R. Dreyfuss & J. Ginsburg eds., Intellectual Property at the Edge: The Contested Contours of IP, 321-342 (Cambridge: Cambridge University Press).

二、期刊論文
1. Abinader, Luis Gil & Contreras, Jorge L. (2019), The Patentability of Genetic Therapies: CAR-T and Medical Treatment Exclusions Around The World, 34 American University International Law Review 705-762.
2. Akers, Noel J. (1999), The European Patent System: an introduction for patent searchers, 21(3) World Patent Information 135-163.
3. Bagley, Margo A. (2003), Patent First, Ask Questions Later: Morality and Biotechnology in Patent Law, 45(2) William and Mary Law Review 469-548.
4. Berrisch, Clara (2019), Second medical use claims and scope of protection- A work in progress since 1984, 2(1) Stockholm IP Law Review 38-47.
5. Caffarini, Ava (2013), Directed To or Encompassing a Human Organism: How Section 33 of the America Invents Act May Threaten the Future of Biotechnology, 12(4) J. Marshall Rev. Intell. Prop. L. 768-786.
6. Donnelly, Stephen R. (2011), The Patentability of Human Embryonic Stem Cells: Is the Inconsistent Application of the European Union Biotechnology Directive`s Moral Exclusion Clause Undermining Investor Confidence in Europe, Providing a Competitive Advantage to the United States?, 20 Dal J Leg Stud 151-182.
7. Eisenberg, Rebecca S. (2015), Diagnostics Need Not Apply, 21(2) J. Sci. & Tech. L. 256-286.
8. El-Kadiry, Abed El-Hakim & Rafei, Moutih & Shammaa, Riam (2021), Cell Therapy: Types, Regulation, and Clinical Benefits, 8:a7656029 Frontiers in Medicine, 1-24.
9. Federico, P.J. (1990), Operation for the Patent Act of 1790, 72 J. Pat. & Trademark Off. Soc`y 373.
10. Fendrick, Sarah E. & Zuhn, Donald L. Jr. (2015), Patentability of Stem Cells in the United States, 5(12):a020958 Cold Spring Harb Perspect Med. 1-6.
11. Fisher, Matthew (2017), Second medical indications and the Swiss-form claim: taming Frankenstein`s monster: Part 1 - solving one problem creates another, 39(9) European Intellectual Property Review 495-502.
12. Ho, Cynthia M. (2000), Patents, Patients, and Public Policy: An Incomplete Intersection at 35 U.S.C. 287 (c), 33 U.C. DAVIS L. REV. 601-675.
13. Jacques, Erik & Suuronen, Erik J. (2020), The Progression of Regenerative Medicine and its Impact on Therapy Translation, 13(3) Clin Transl Sci. 440-450.
14. Li, Joyce C. (2017), Preemption, Diagnostics, and the Machine-or-Transformation Test: Federal Circuit Refinement of Biotech Method Eligibility, 32 Berkeley Technology Law Journal 379–412.
15. Lysaght, Michael J. & Hazlehurst, Anne L. (2004), Tissue engineering: the end of the beginning, 10(1-2) Tissue Eng. 309-320.
16. Mao, Angelo S. & Mooney David J. (2015), Regenerative medicine: Current therapies and future directions, 112(47) Proc Natl Acad Sci U S A. 14452-11459.
17. Minssen, Timo & Nordberg, Ana (2015), The Evolution of the CJEU`s Case Law on Stem Cell Patents: Context, Outcome and Implications of Case C-364/13 International Stem Cell Corporation, 5 Nordic Intellectual Property Law Review 493-503.
18. Minssen, Timo & Schwartz, Robert M. (2016), Separating Sheep from Goats: A European View on the Patent Eligibility of Biomedical Diagnostic Methods, 3(2) Journal of Law and the Biosciences 365-372.
19. Peschel, Leisa Talbert (2008), Revisiting the Compromise of 35. U.S.C. § 287(c), 16 TEX. INTELL. PROP. L.J. 299-323.
20. Robole, Zachary M. (2022), Handling the Mayo Powder Keg: Emphasizing Preemption in § 101 Biotechnology Inquiries, 107 Minn. L. Rev. Headnotes 75-103.
21. Sampogna, Gianluca & Guraya, Salman Yousuf & Forgione, Antonello (2015), Regenerative medicine: Historical roots and potential strategies in modern medicine, 3(3) Journal of Microscopy and Ultrastructure 101-107.

三、碩博士學位論文
Başak Babaoğlu De Bruyne (2021), The Assessment of Gene Patents Granted in Medical Biotechnology Area in the EU and the US: A Law and Economics Approach, Universität Hamburg.

四、法院裁判與歐洲專利局上訴委員會決定
1. Alice Corp. Pty. Ltd. v. CLS Bank Int’l, 573 U.S. 208 (2014).
2. Association for Molecular Pathology v. Myriad Genetics Inc., 569 U.S. 576 (2013).
3. Association for Molecular Pathology v. United States Patent and Trademark Office, 702 F. Supp. 2d 181 (2010).
4. Athena Diagnostics, Inc. v. Mayo Collaborative Services, LLC, 927 F.3d 1333 (Fed. Cir. 2019).
5. Athena Diagnostics, Inc. v. Mayo Collaborative Services, LLC, No. 19-430, 140 S. Ct. 855 (Jan. 13, 2020).
6. Athena Diagnostics, Inc. v. Mayo Collaborative Services, LLC, 915 F.3d 743 (Fed. Cir. 2019).
7. Bilski v. Kappos, 561 U.S. 593 (2010).
8. CareDx, Inc. v. Natera, Inc., 40 F.4th 1371 (Fed. Cir. 2022).
9. Decision G 01/04 (Diagnostic methods), 16 December 2005.
10. Decision G 02/06 (Use of embryos/WARF), 25 November 2008.
11. Decision G 02/08 (Dosage regime/ABBOTT RESPIRATORY), 19 February 2010.
12. Decision G 03/19 (Pepper (follow-up to “Tomatoes II” and “Broccoli II”), 14 May 2020.
13. Decision G 05/83 (EISAI/Second Medical Indication), 5 December 1984.
14. Decision T 1374/04 (Stem cells/WARF), 7 April 2006
15. Diamond v. Chakrabarty, 447 U.S. 303 (1980).
16. Diamond v. Diehr, 450 U.S. 175, 185 (1981).
17. Ex parte Scherer, 103 U.S.P.Q. (BNA) 107 (Pat. Off. Bd. App. 1954).
18. Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U.S. 127 (1948).
19. Hikma Pharms. USA Inc. v. Vanda Pharms. Inc., No. 18–817, 140 S. Ct. 911 (Jan. 13, 2020).
20. Illumina, Inc. v. Ariosa Diagnostics, Inc., 967 F.3d 1319 (Fed. Cir. 2020).
21. In re Bilski, 545 F.3d 943 (Fed.Cir. 2008)
22. International Stem Cell Corporation v. Comptroller General of Patents, Designs and Trademarks, Case C-364/13, CJEU (Grand Chamber), 18 December 2014.
23. Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. 66 (2012).
24. Morton v. New York Eye Infirmary, 17 F. Cas. 879 (S.D.N.Y. 1862).
25. Oliver Brüstle v. Greenpeace eV., Case C-34/10, CJEU (Grand Chamber), 18 October 2011.
26. Parker v. Flook, 437 U.S. 584 (1978).
27. Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals, 887 F.3d 1117, 1121 (Fed. Cir. 2018).

五、法規
1. 35 U.S.C. § 101.
2. 35 U.S.C. § 102.
3. 35 U.S.C. § 103.
4. 35 U.S.C. 287 (c).
5. Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions.
6. European Patent Convention (1973).
7. European Patent Convention. (2020).
8. Implementing Regulations to the Convention on the Grant of European Patents.
9. Leahy-Smith America Invents Act, Pub. L. No. 112-29, § 33(a), 125 Stat. 284, 340 (2011).
10. Patents Act 1977 (UK).
11. U.S. CONST. art. I, § 8, cl. 8.

六、官方文件
1. 149 CONG. REC. H7248 (daily ed. July 22, 2003).
2. 157 CONG. REC. E1177 (daily ed. June 23, 2011) (statement of Rep. Christopher H. Smith).
3. 2014 Interim Guidance on Patent Subject Matter Eligibility, 79 Fed. Reg. 74,618 (Dec. 16 2014), available at https://www.govinfo.gov/content/pkg/FR-2014-12-16/pdf/2014-29414.pdf (Last visited: 2023/2/13).
4. 2019 Revised Patent Subject Matter Eligibility Guidance, 84 Fed. Reg. 50 (Jan. 7, 2019), available at https://www.govinfo.gov/content/pkg/FR-2019-01-07/pdf/2018-28282.pdf (Last visited: 2023/2/13).
5. Brief for United States, Hikma Pharms. USA Inc. v. Vanda Pharms. Inc., No. 18–817, 2019 WL 6699397.
6. EPO, Guidelines for Examination in the European Patent Office, available at https://www.epo.org/law-practice/legal-texts/guidelines.html (Last visited: 2023/2/14).
7. S.4734 - Patent Eligibility Restoration Act of 2022, available at https://www.congress.gov/bill/117th-congress/senate-bill/4734 (Last visited: 2023/2/13).
8. USPTO Memorandum of June 7, 2018, Recent Subject Matter Eligibility Decision: Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals, available at www.uspto.gov/patents/laws/examination-policy/memoranda-examining-corps (Last visited: 2023/2/13).
9. USPTO Memorandum of September 20, 2011, Claims Directed to or Encompassing a Human Organism, available at www.uspto.gov/patents/laws/examination-policy/memoranda-examining-corps (Last visited: 2023/2/13).
10. USPTO, Manual of Patent Examining Procedure (MPEP) §2105 (Rev. 9 of the 8th edition, Aug. 2012), available at https://www.uspto.gov/web/offices/pac/mpep/old/index.htm (Last visited: 2023/2/14).
11. USPTO, Manual of Patent Examining Procedure (MPEP) §2105, available at https://www.uspto.gov/web/offices/pac/mpep/s2105.html (Last visited: 2023/2/13).
12. USPTO, Manual of Patent Examining Procedure (MPEP) §2106, available at https://www.uspto.gov/web/offices/pac/mpep/s2106.html (Last visited: 2023/2/13).
13. USPTO, October 2019 Patent Eligibility Guidance Update, available at https://www.uspto.gov/sites/default/files/documents/peg_oct_2019_update.pdf (Last visited: 2023/2/13).
14. USPTO, Subject matter eligibility Examples 1-36, available at https://www.uspto.gov/sites/default/files/documents/101_examples_1to36.pdf (Last visited:2023/2/13).

七、網路資料
1. Alliance for Regenerative Medicine, Regenerative Medicine: Disrupting the Status Quo (2021), available at https://alliancerm.org/sector-report/2021-annual-report/ (Last visited: 2030/2/12).
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3. EPO, Enlarged Board of Appeal, available at https://www.epo.org/law-practice/case-law-appeals/eba.html (Last visited: 2023/2/14).
4. EPO, Extension states, available at https://www.epo.org/about-us/foundation/extension-states.html (Last visited: 2023/2/14).
5. EPO, Governance, available at https://www.epo.org/about-us/governance.html (Last visited: 2023/2/14).
6. EPO, Guide for applicants: PCT procedure before the EPO (Euro-PCT Guide), available at https://www.epo.org/applying/international/guide-for-applicants/html/e/ga_c1_6.html (Last visited: 2023/2/14).
7. EPO, Member states of the European Patent Organisation, available at https://www.epo.org/about-us/foundation/member-states.html (Last visited: 2023/2/14).
8. EPO, The EPO at a glance, available at https://www.epo.org/about-us/at-a-glance.html (Last visited: 2023/2/14).
9. EPO, Validation states, available at https://www.epo.org/about-us/foundation/validation-states.html (Last visited: 2023/2/14).
10. Espacenet Patent search, WO9622362A1, available at https://worldwide.espacenet.com/patent/search/family/023484566/publication/WO9622362A1?q=WO%2096%2F22362 (Last visited: 2023/3/10).
11. European Patent Register, EP 1040185, available at https://register.epo.org/application?number=EP98966817&lng=en&tab=main (Last visited: 2023/2/15).
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13. Hikma Pharms. USA Inc. v. Vanda Pharms. Inc., No. 18–817, Petition for a Writ of Certiorari (Dec 27 2018), available at https://www.supremecourt.gov/docket/docketfiles/html/public/18-817.html (Last visited: 2023/2/16).
14. Kari Barnes, The Patent Eligibility Restoration Act of 2022. What You Need to Know (Aug 05, 2022), available at https://www.foxrothschild.com/publications/the-patent-eligibility-restoration-act-of-2022-what-you-need-to-know (Last visited: 2023/2/13).
15. Michael Cicero, The Journey Begins: Legislation Introduced to Clarify U.S. Patent Eligibility Law, (Aug 05, 2022), available at https://insights.taylorenglish.com/post/102hudb/the-journey-begins-legislation-introduced-to-clarify-u-s-patent-eligibility-law (Last visited: 2023/2/13).
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17. National Cancer Institute, Cell Therapy: Harnessing Cells of the Immune System to Fight Cancer, available at https://www.cancer.gov/research/annual-plan/scientific-topics/cell-therapy (Last visited: 2023/2/12.
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19. PEW Charitable Trusts, FDA’s Framework for Regulating Regenerative Medicine Will Improve Oversight - Further action needed to facilitate development of safe, effective treatments, available at https://www.pewtrusts.org/en/research-and-analysis/reports/2019/10/17/fdas-framework-for-regulating-regenerative-medicine-will-improve-oversight (Last visited: 2030/2/12).
20. Thom Tillis, Tillis Introduces Landmark Legislation to Restore American Innovation (Aug 3, 2022), https://www.tillis.senate.gov/2022/8/tillis-introduces-landmark-legislation-to-restore-american-innovation (Last visited: 2023/2/13).
21. U.S. Food & Drug Administration, Approved Cellular and Gene Therapy Products (Dec 16, 2022), available at https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/approved-cellular-and-gene-therapy-products (Last visited: 2023/2/13).
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