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| Title: | 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 |
| Authors: | 郭奕靚
Kuo, Yi-Jing |
| Contributors: | 沈宗倫
Shen, Chung-Lun
郭奕靚
Kuo, Yi-Jing |
| Keywords: | 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 |
| Date: | 2023 |
| Issue Date: | 2023-07-06 17:02:42 (UTC+8) |
| Abstract: | 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. |
| Reference: | 壹、中文文獻
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三、期刊論文
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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)。
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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.
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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.
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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.
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七、網路資料
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| Description: | 碩士
國立政治大學
法學院碩士在職專班
106961045 |
| Source URI: | http://thesis.lib.nccu.edu.tw/record/#G0106961045 |
| Data Type: | thesis |
| Appears in Collections: | [法學院碩士在職專班] 學位論文
|
Files in This Item:
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| 104501.pdf | | 7224Kb | Adobe PDF2 | 139 | View/Open |
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