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https://nccur.lib.nccu.edu.tw/handle/140.119/149686
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| Title: | 後續創新藥品專利保護和可及性的兩難
The Dilemma of Patent Protection and Accessibility for Follow-on Pharmaceutical Innovation |
| Authors: | 陳培志 |
| Contributors: | 沈宗倫
陳培志 |
| Keywords: | 藥品專利
後續創新藥品
藥品可及性
藥品上市審查
Pharmaceutical patent
Follow-on pharmaceutical innovation
Accessibility
Drug approval regulations |
| Date: | 2024 |
| Issue Date: | 2024-02-01 13:02:52 (UTC+8) |
| Abstract: | 藥品產業最獨特之處是其與生命健康息息相關，而生命健康的價值異於其他商品，難以用市場價格衡量。除此之外，藥品產業還有其他特點，包括巨額的研發投資、漫長的開發週期、高度的不確定性以及藥品研發完成後相對較低的單位製造成本。藥品專利制度透過授予研發者一定時間的專屬權，取得市場獨佔優勢以利回收研發投入，研發藥廠得以持續投入研發創新。因此藥品專利保護對於推動藥品創新至關重要。雖然立意良善，也確實推動藥品研發，然而伴隨而來的高昂藥價卻限制了藥品的可及性(accessibility)，反而違背了研發藥品治療疾病的初衷。
在保護專利和維護病人權益之間取得平衡仍然是藥品產業利益相關者和政策制定者持續面臨的挑戰。而藥品後續創新(follow-on innovation)專利使得問題更加複雜。本質上，創新不論大小皆是研發的漸進過程，而在藥品領域漸進性的持續改良也是開創性突破的基礎。然而，並非所有的創新改良皆值得享有專利保護。區分何種藥品後續創新具有臨床價值而值得給予專利並非易事，因為專利審查通常在臨床試驗結果取得之前，而且對於藥品進入人體內的生化反應了解仍有侷限，尚無準則可以精準預測實際臨床療效。
儘管授予後續創新藥品專利可以鼓勵研發藥廠持續投入創新藥品研發，但同時也給予藥廠濫用專利制度的機會利用手段(例如,專利叢林和專利長青)不當延長獨占期限，限縮了藥品可及性，最終損害了公共衛生及病人用藥的權益，反而違背了藥品治病的初衷。本文將先就後續創新藥品可專利性標準的當前問題進行討論，試圖在促進創新和確保藥品可及性之間取得一個平衡，也藉此點出僅依賴專利制度解決此一困境的局限性。
鑒於問題的複雜性和專利制度的侷限性，本文提議超越專利制度的限制，充分利用與藥品上市相關的其他監管法規和政策，從更全面的角度，整合可運用的機制，或許可以在專利保護與病人權益之間找到一個更好的平衡。
The most distinctive aspect of the pharmaceutical industry lies in its profound connection with life and health, where the value of life and health differs from that of other commodities, making it challenging to quantify through market prices. The pharmaceutical industry also possesses other distinct characteristics, including substantial research and development investments, extended developmental timelines, inherent uncertainties, and relatively low manufacturing costs post-drug development. As a result, patent protection becomes imperative to incentivize ongoing R&D investments that drive innovation within this sector. While well-intentioned, this system has the side effect of high drug prices limiting accessibility, contradicting the initial purpose of drugs to help patients treat diseases.
Striking a balance between safeguarding innovation and upholding patent rights remains an ongoing challenge for both industry stakeholders and policymakers. The situation is further compounded by the concept of follow-on innovation within pharmaceutical R&D. Continual enhancement inherently accompanies any innovation process, and in the realm of pharmaceuticals, incremental advancements lay the foundation for groundbreaking medical breakthroughs. However, distinguishing which follow-on innovations have clinical value is challenging because patent examination occurs before clinical results are obtained, and there are limitations in understanding the biochemical reactions of drugs within the human body, with no guidelines to accurately predict actual clinical efficacy.
While the patent framework effectively encourages sustained investment in innovative medications, it has at times been exploited through practices like patent thickets and patent evergreening, which excessively prolong exclusivity periods, ultimately impairing the integrity of patent rights. This paper aims to deliberate on prevailing challenges concerning follow-on pharmaceutical innovation and patentability standards, striving to present a balanced perspective that fosters innovation while ensuring accessibility. It also underscores the limitations of relying solely on the patent system to resolve this conundrum.
In light of these complexities, the paper advocates transcending the confines of the patent system and capitalizing on supplementary regulations and policies encompassing drug development. This broader approach is proposed as a means to address the limitations intrinsic to an exclusive reliance on the patent system. |
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22. Esai Co. v. Dr. Reddy's Laboratories, Ltd., 533 F.3d 1353 (Fed. Cir. 2008).
23. Takeda v. Alphapharm, 492 F.3d 1350 (Fed. Cir. 2007).
24. Application of COES, 173 F.2d 1021 (C.C.P.A. 1949).
25. Ex parte RALSTON AND HARWOOD, 84 U.S.P.Q. 381 (1950).
26. Ex parte Kosolapoff, 93 U.S.P.Q. 230.
27. In re Mills, 281 F.2d 218 (Fed. Cir. 1960).
28. In re Wiechert, 370 F.2d 927 (C.C.P.A. 1967).
29. Application of Williams, 171 F.2d 319 (C.C.P.A. 1948).
30. Emory University v. Glaxo Welcome, Inc., 44 USPQ2d 1407 (N. D. Ga. 1997).
31. Forest Laboratories, Inc. v. Ivax Pharmaceuticals, Inc., 501 F.3d 1263 (Fed. Cir. 2007).
32. Aventis v. Lupin, 499 F.3d 1293 (Fed. Cir. 2007).
33. In re Merck & Co., 800 F.2d 1091 (Fed. Cir. 1986).
34. Incyte Corporation v Concert Pharmaceuticals Inc., 4764828 WL (2017).
35. SUN PHARMACEUTICAL INDUSTRIES, INC., f/d/b/a Concert Pharmaceuticals, Inc., v. INCYTE CORPORATION, 2023 WL 5370639 (Fed. Cir. Aug. 22, 2023).
36. Schering Corp. v. Geneva Pharmaceuticals, Inc., 339 F.3d 1373 (Fed. Cir. 2004).
(四) Legal Rules, Regulations
1. TRIPS: Agreement on Trade-Related Aspects of Intellectual Property Rights, Apr. 15, 1994, Marrakesh Agreement Establishing the World Trade Organization, Annex 1C, 1869 U.N.T.S. 299, 33 I.L.M. 1197 (1994) [hereinafter TRIPS Agreement] (1994).
2. Food, Drug, and Cosmetic Act 21 U.S.C.
3. U.S. Patent Law 35 U.S.C.
4. Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (2003).
5. Manual of Patent Examining Procedure (MPEP) (The United States Patent and Trademark Office Ninth Edition ed. 2020).
6. The Patents Act 1970 (2005).
7. Generating Antibiotic Incentives Now Act of 2011, H.R.2182, 112th Cong. (2011).
(五) Government Document
1. FDA Grants Accelerated Approval for Alzheimer’s Drug (U.S. FDA 2021).
2. Executive Order on Promoting Competition in the American Economy (The White House ed., 2021).
3. CMS Fast Facts (Center for Medicare and Medicaid Services ed., 2023).
4. Patents and Exclusivity (FDA/CDER SBIA CHRONICLES 2015).
5. FACT SHEET_ Executive Order on Promoting Competition in the American Economy _ The White House (The White House ed., 2021).
6. Janet Woodcock, Letter from FDA to PTO (U.S. Food and Drug Administration ed., 2021).
7. Vidal Katherine K, PTO Response to FDA (U.S. PTO ed., 2022).
(六) Conference Paper
1. WIPO, Follow-on Innovation and Intellectual Property (World Intellectual Property Organization 2007).
2. Carlos M Correa, Guidelines for pharmaceutical patent examination: examining pharmaceutical patents from a public health perspective (United Nations Development Programme 2016).
3. Carlos María Correa, Guidelines for the examination of pharmaceutical patents: developing a public health perspective – A Working Paper (ICTSD Châtelaine 2007).
4. Jonathan J Darrow & Aaron S Kesselheim, Incentivizing antibiotic development: why isn’t the Generating Antibiotic Incentives Now (GAIN) act working? § 7 (Oxford University Press US 2020).
5. ICTSD/UNCTAD, Intellectual Property Rights: Implications for Development (2003).
6. Mandeep Dhallwal & Tenu Avafla, High-Level Panel on Access to Health Technologies Final Report to United Nations, United Nations Development Programme (2016).
7. Sabine Vogler, Payer policies to support innovation and access to medicines in the WHO European Region, 3 World Health Organization. Regional Office for Europe. https://apps. who. int/iris/handle/10665/361753. License: CC BY-NC-SA (2022).
8. The role of competition in the pharmaceutical sector and its benefits for consumers (United Nations Conference on Trade and Development 2015).
(七) Patent
1. Nelson Edward, Hyzaar Patent: Combinations of Angiotensin-II Receptor Anatagonists and Duiretics (World Intellectual Property Organization ed., MERCK & CO. 1994).
2. Nazaneen Pourkavoos, Janumet Patent: PHARMACEUTICAL CMPOSITIONS OF A COMBINATION OF METFORMIN AND A DIPEPTDYL PEPTIDASE-IV INHIBITOR (U.S. Patent and Trade Office ed., Merck Sharp & Dohme Corp. 2010).
3. Neal Ward, PAROXETINE HYDROCHLORIDE FORMA (United States Patent and Trademark Office ed., SmithKline Beecham Corporation, Philadelphia, Pa. 2000).
4. Bruce Joseph Roser & Arcadio Gracia De Castro, COMPOSITION AND METHOD FOR CONTROLLED RELEASE IN.JECTIONS § US 6,623,762 B2 (United States Patent ed., 2003).
5. Randy Lee Webb & Gary Michael Ksander, Pharmaceutical compositions comprising valsartan and nep inhibitors (Novartis AG 2003).
6. Sacubitril / Valsartan Application (Novartis AG 2007).
(八) News Paper
1. Mark Terry, Fallout Continues as Third FDA Panel Member Resigns Over Aduhelm Approval, BioSpace, Jun. 11. 2021.
2. Robert King, CMS proposes narrowly covering controversial Alzheimer's drug Aduhelm for patients in clinical trials, FIERCE Healthcare, Jan. 11, 2022.
3. Robert Weissman, The evergreen patent system, Multinational Monitor Jun. 2002.
4. Merck, Merck-News-Release-12-13-22-Moderna-and-Merck-Announce-mRNA-4157_V940-an-Investigational-Personalized-mRNA-Cancer, Merck Company Announcement, Dec. 13. 2022.
5. James Love, Monopoly Medicine: The Built-in Inefficiencies of a Patent-Based Pharmaceutical R&D System, Multinational Monitor Jul/Aug 2004. 2004.
6. Robin Harding, Takeda to pay $2.7bn to settle Actos cancer claims, Financial Times, April 29. 2015.
7. Harris By Gardiner & Adams Chris, Delay, Delay, Delay --- AstraZeneca and Other Drug Companies Step Up Lawsuits to Slow Generics --- The `Metabolite Defense', Wall Street Journal, Jul 17. 2001.
8. Anju Ghangurde, Novartis’ Entresto Faces Challenge From Natco In India, SCRIP, Jan. 29, 2019.
9. Fox Mandal, Delhi HC Stays Patent Granted to Novartis Drug “Entresto”, Fox Mandal Foundation, 2023.
10. Fierce Pharma, FDA Approves Merck's VICTRELIS™ (boceprevir), First-in-Class Oral Hepatitis C Virus (HCV) Protease Inhibitor, Fierce Pharma, May 13, 2011.
11. Andrew Pollack, Harvoni, a Hepatitis C Drug From Gilead, Wins F.D.A. Approval, The New York Times, 2014.
12. Pill Taylor, BMS' daclatasvir scuppered by decision to drop companion drug, PMLiVE, 2014.
13. Angus Liu, Gilead’s stealing hep C share with its cut-rate Eplusa and Harvoni generics, Fierce Pharma, Sep. 16, 2019.
14. Pharmaceutical Technology, Is the GAIN Act stimulating antibiotic R&D?, Pharmaceutical Technology, 2018.
15. John Gapper, The painfully high price of Humira is patently wrong, Financial Times, 2023.
(九) Web Page
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| Description: | 碩士
國立政治大學
法學院碩士在職專班
105961021 |
| Source URI: | http://thesis.lib.nccu.edu.tw/record/#G0105961021 |
| Data Type: | thesis |
| Appears in Collections: | [法學院碩士在職專班] 學位論文
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