專利強制授權制度對醫藥產業發展與藥物可近性之拮抗——各國法制比較與我國法制展望 - 政大學術集成

全文

(1)治政大the Development of Struggle of Patent Compulsory License on 立 ‧ 國. 學. Pharmaceutical Industry and Medicine Accessibility of the Public. ‧. Nat. y. Comparative Study of the Law in Major Countries and. n. er. io. al. sit. Prospect of Taiwan. Ch. engchi. i n U. v.

(2) ………………………………...1 ……………………………………...2 ………………………………...3 ………………………………………...4. 立. 政治大. ‧ 國. 學 ‧. …………………………………………………………6. Nat. io. sit. y. ……………….…….8. er. n. ……………..……………………….…….27 a. iv l C n hengchi U. ………………39 ……………………………………………43 9.

(3) …………………………………….45 TRIPS. 9. ………………...52 ……….56. 9. …………………………………………….65. 政治大 …………………………………………….67 立. ‧ 國. 學. ………………………………………….70. ‧. ………………….77. Nat. n. al. er. io. sit. y. …………………………………………….85. Ch. i n U. v. e n g…………………………….87 chi ……………………….93. ……………………………………….........99 ………………………………………………101 ……………………………………………….......106 ………………………………………...……………114.

(4) ………………………………………..……………122 ……………………………………………………..132. 立. 政治大. ‧. ‧ 國. 學. n. er. io. sit. y. Nat. al. Ch. engchi. i n U. v.

(5) 立. 政治大. ‧. ‧ 國. 學. n. er. io. sit. y. Nat. al. Ch. engchi. i n U. v. 2017.

(6) 2. 9. 9. 立. 政治大. ‧. ‧ 國. 學. n. er. io. sit. y. Nat. al. Ch. e n g c h9i. i n U. v.

(7) Abstract The protection of intellectual property rights includes moral interests, social interests and economic interests, but the three interests may conflict with each other. Patents of pharmaceutical product are the common cases. If the products are under the protection of patents, the price and accessibility will become the obstacles for obtaining essential medicines. The "compulsory license" system is considered to be a flexible instrument that can be used when patented drugs are required by patients.. 政治大 system on accessibility of立 medicines. In the second chapter, I points out the rule This research aims to analyze the possible impact of patent compulsory license. ‧ 國. 學. of operation of compulsory license from international conventions, introducing the current international conditions.. ‧. Chapter 3 describes the function of compulsory license, that the reconciliation and. y. Nat. io. sit. balance between the economic and public interests can be achieved in the patent system.. al. er. The opponents consider that economic harm would be caused by compulsory license.. n. v i n C hof the patent ownerUis not as great as the opponents However, the actual economic loss engchi describe. In contrast, the incentive for the abuse of the right can be effectively reduced through the existence of the compulsory license system. Chapter 4 focuses on how compulsory license system affect on public health policies. For developing countries, the establishment of a stable compulsory license system helps them to cross the initial barriers and start to foster their own pharmaceuticals industry. Building their own medicines supply chain helps them to achieve the accessibility of medicines. Chapter 5 illustrates the attitude toward compulsory license in developed and.

(8) developing countries. The chapter introduces means of compulsory license in the United States, Canada, India and other countries. It emphasizes that, whether compulsory license or other more powerful means, to retain a flexible method for social interests is important in the patent law system. Chapter 6 analyzes the history of Taiwan's patent law. This chapter emphasizes the impact on lack of flexibility about compulsory license, and it mentions the direction of the amendment to Taiwan Patent Law.. 立. 政治大. Key words: compulsory license, patent law, accessibility of medicines, public health. ‧. ‧ 國. 學. n. er. io. sit. y. Nat. al. Ch. engchi. i n U. v.

(9) 政治大. 立. ‧. ‧ 國. 學. 1. n. er. io. sit. y. Nat. al. Ch. engchi. i n U. v. 1. 2-3. 2015. 9 1.

(10) “ 2. 「. 立. 政治大. ‧. ‧ 國. 學. n. er. io. sit. y. Nat. al 、. Ch. engchi. i n U. v. 2. 89. http://www.rhythmsmonthly.com/magazine/content/89/msf.htm 2.

(11) 3. 立. 政治大. ‧. ‧ 國. 學. n. er. io. sit. y. Nat. al. Ch. engchi. i n U. v. 3. 3.

(12) 立. 政治 WTO 大. TRIPS. ‧. ‧ 國. 學. n. er. io. sit. y. Nat. al. Ch. engchi. i n U. v. TRIPS 31. 1. TRIPS. 31. 1. 4.


(14) 58. 1. 政治大. 學. ‧ 國. 立 Compulsory License. 5. 29. 67. “. n. al. er. io. sit. y. Nat. 33. ‧. 4. Ch. engchi. i n U. v. 92. 5. A. 2. 4. 396. 2015. 9 6.

(15) 5. (2). “ 1883 1900 1911. 1925. 1958. 治政大 affordability of patented inventions 立 ‧. ‧ 國. 學. 6. n. er. io. sit. y. Nat. a l1624 Ch. engchi. i n U. v. 14. 5. Each country of the Union shall have the right to take legislative measures providing for the grant of compulsory licenses(f) to prevent the abuses which might result from the exercise of the exclusive rights conferred by the patent(g), for example, failure to work(h). 6 Frankel, S., & Lai, J. C. (2015). Recognised and Appropriate Grounds for Compulsory Licences: Reclaiming Patent Law’s Social Contract. In Compulsory Licensing. Springer Berlin Heidelberg. p. 153. 7.

(16) 7. 1883. 8. 政治大 Paris Convention 立 for the Protection of Industrial Property. ‧ 國. 學. 1883. World. sit. 7. 9. n. al. er. io. 7. ”WIPO”. y. Nat 1884. ‧. Intellectual Property Organization,. Ch. engchi. i n U. v. 7. 8. 67. 156. 2011. 12. Gopalakrishnan, N. S., & Anand, M. (2015). Compulsory Licence Under Indian Patent Law. In Compulsory. Licensing. Springer Berlin Heidelberg. p. 13. 9. G.H.C. Bodenhausen. (. , Trans.). 1. 2000. 4. . 8.

(17) 10. A 11. 12. “. 立. 政治大. 14. Nat. n. al. er. io. sit. y. ‧. ‧ 國. 學 13. Ch. engchi. i n U. v. 10. 8 6-9 TRIPS Article 5 A. Patents: Importation of Articles; Failure to Work or Insufficient Working; Compulsory Licenses (2) Each country of the Union shall have the right to take legislative measures providing for the grant of compulsory licenses to prevent the abuses which might result from the exercise of the exclusive rights conferred by the patent, for example, failure to work. 12 (3) Forfeiture of the patent shall not be provided for except in cases where the grant of compulsory licenses would not have been sufficient to prevent the said abuses. No proceedings for the forfeiture or revocation of a patent may be instituted before the expiration of two years from the grant of the first compulsory license. 13 (4) A compulsory license may not be applied for on the ground of failure to work or insufficient working before the expiration of a period of four years from the date of filing of the patent application or three years from the date of the grant of the patent, whichever period expires last; it shall be refused if the patentee justifies his inaction by legitimate reasons. Such a compulsory license shall be non-exclusive and shall not be transferable, even in the form of the grant of a sub-license, except with that part of the enterprise or goodwill which exploits such license. 14 8 52-55 11. 9.

(18) 15. 立. ‧. ‧ 國. 學. 16. 政治大. n. al. er. io. sit. y. Nat 17. 19. Ch. engchi. i n U. v. 18. TRIPS. TRIPS. WTO 15 16 17 18 19. Cohen, S. (1979). Compulsory Licensing of Patents-The Paris Convention Model. Idea, 20, 153. 6 P.154 World Trade Organization WTO Agreement on Trade-Related Aspects of Intellectual Property Rights TRIPS Doha Declaration on the TRIPS Agreement and Public Health 10.

(19) WTO. WTO. TRIPS TRIPS. WTO TRIPS. TRIPS TRIPS. TRIPS TRIPS. 立. 政治大. TRIPS. ‧ 國. 學 ‧. 21. TRIPS. n. al. er. io. sit. y. Nat. 22. 20. TRIPS. Ch. engchi. i n U. TRIPS. 31. v. 7. 20. Halajian, D. (2012). Inadequacy of Trips & the Compulsory License: Why Broad Compulsory Licensing Is Not a Viable Solution to the Access to Medicine Program. Brook. J. Int'l L., 38, P.1196-1197. 21. 1.. Article 27 Patentable Subject Matter 1. Subject to the provisions of paragraphs 2 and 3, patents shall be available for any inventions, whether products or processes, in all fields of technology, provided that they are new, involve an inventive step and are capable of industrial application. Subject to paragraph 4 of Article 65, paragraph 8 of Article 70 and paragraph 3 of this Article, patents shall be available and patent rights enjoyable without discrimination as to the place of invention, the field of technology and whether products are imported or locally produced. 22 6 P.155. 11.

(20) a b. — c. 立. d. ‧ 國 n. al. er. io. sit. y. Nat. g. ‧. f. 學. e. 政治大. h. Ch. engchi. i n U. v. i. j. 12.

(21) k (b). l. (f). — (i) (ii) (iii). 7. 立. 政治大. ‧ 國. 23. 學. . 23. ‧. Article 31 Other Use Without Authorization of the Right Holder Where the law of a Member allows for other use [7] of the subject matter of a patent without the authorization of the right holder, including use by the government or third parties authorized by the government, the following provisions shall be respected: (a) authorization of such use shall be considered on its individual merits; (b) such use may only be permitted if, prior to such use, the proposed user has made efforts to obtain authorization from the right holder on reasonable commercial terms and conditions and that such efforts have not been successful within a reasonable period of time. This requirement may be waived by a Member in the case of a national emergency or other circumstances of extreme urgency or in cases of public non-commercial use. In situations of national emergency or other circumstances of extreme urgency, the right holder shall, nevertheless, be notified as soon as reasonably practicable. In the case of public non-commercial use, where the government or contractor, without making a patent search, knows or has demonstrable grounds to know that a valid patent is or will be used by or for the government, the right holder shall be informed promptly; (c) the scope and duration of such use shall be limited to the purpose for which it was authorized, and in the case of semi-conductor technology shall only be for public non-commercial use or to remedy a practice determined after judicial or administrative process to be anti-competitive; (d) such use shall be non-exclusive; (e) such use shall be non-assignable, except with that part of the enterprise or goodwill which enjoys such use; (f) any such use shall be authorized predominantly for the supply of the domestic market of the Member authorizing such use; (g) authorization for such use shall be liable, subject to adequate protection of the legitimate interests of the persons so authorized, to be terminated if and when the circumstances which led to it cease to exist and are unlikely to recur. The competent authority shall have the authority to review, upon motivated request, the continued existence of these circumstances; (h) the right holder shall be paid adequate remuneration in the circumstances of each case, taking into account the economic value of the authorization; (i) the legal validity of any decision relating to the authorization of such use shall be subject to judicial review or other independent review by a distinct higher authority in that Member; (j) any decision relating to the remuneration provided in respect of such use shall be subject to judicial review or other independent review by a distinct higher authority in that Member; (k) Members are not obliged to apply the conditions set forth in subparagraphs (b) and (f) where such use is permitted to remedy a practice determined after judicial or administrative process to be anti-competitive. The need to correct anti-competitive practices may be taken into account in determining the amount of remuneration in such cases. Competent authorities shall have the authority to refuse termination of authorization if and when the conditions which led to such authorization are likely to recur;. n. er. io. sit. y. Nat. al. Ch. engchi. i n U. v. 13.

(22) TRIPS. 31. —. 24. TRIPS. 立. 政治大 31. y. Ch. er. al. sit. 27. 2005. n. TRIPS. TRIPS. ‧. ‧ 國. 學. io. WTO. Nat. 26. 25. TRIPS. i n U. e n g cTRIPS hi. v. 1. 1. (l) where such use is authorized to permit the exploitation of a patent ("the second patent") which cannot be exploited without infringing another patent ("the first patent"), the following additional conditions shall apply: (i) the invention claimed in the second patent shall involve an important technical advance of considerable economic significance in relation to the invention claimed in the first patent; (ii) the owner of the first patent shall be entitled to a cross-licence on reasonable terms to use the invention claimed in the second patent; and (iii) the use authorized in respect of the first patent shall be non-assignable except with the assignment of the second patent. 24 20 P.1202 25 World Health Organization. (n.d.). THE DOHA DECLARATION ON THE TRIPS AGREEMENT AND PUBLIC HEALTH. Retrieved Jan 30, 2017, from http://www.who.int/medicines/areas/policy/doha_declaration/en/ 26 6 P.156-157 27 Decision of 6 December 2005 WTO Doc. WT/L/641, 2005. 14.

(23) 2. 3.. 1 1967. 1971. 」. 2. 立. 1967. 政治大 1.. io. ” Berne and Paris-plus agreement”. al. n. TRIPS. Ch. eTRIPS ngchi. TRIPS. sit. y. Nat. TRIPS. 1. er. 」. ‧. ‧ 國. 學. 2.. i n U. v. TRIPS 28. TRIPS TRIPS. TRIPS. 28. 6. P.157 15.

(24) 29. TRIPS 30. TRIPS TRIPS. TRIPS. TRIPS. ‧ 國. 學. TRIPS. 立. 政治大. TRIPS. ‧. 1990. sit. n. al. er. io 31. y. Nat TRIPS. 2001. Ch. i n U. engchi. WTO. 2001. 11. 31. v. WTO TRIPS. 14. 29 30 31. 20 P.1202 6 P.160-161 WTO ——. TRIPS 2008. 2. 1. 16.

(25) Implementation of paragraph 6 of the Doha Declaration on the TRIPS Agreement and public health. 2005. 12. 6. WTO. 32. TRIPS. TRIPS Agreement. Amendment of the. TRIPS 31bis. TRIPS TRIPS. TRIPS TRIPS. 立. 政治大. ‧. ‧ 國. 學 er. io. sit. y. Nat. 2002. TRIPS. n. a l2016 1 1 2015 i v 11 n Ch U engchi 2033 1 33. 6. WTO. 34. TRIPS WHO TRIPS. 32. 66. 2008(66) P.20-26. WTO. (n.d.). The Doha Declaration explained. Retrieved Jan 30, 2017, from https://www.wto.org/english/tratop_e/dda_e/dohaexplained_e.htm#trips 34 wto.org. (2017). WTO | 2015 News items - WTO members agree to extend drug patent exemption for poorest members. [online] Available at: https://www.wto.org/english/news_e/news15_e/trip_06nov15_e.htm [Accessed 2 Jul. 2017]. 33. 17.

(26) 35. TRIPS. “. SARS. WHO. sit. y. WHO. n. al. er. io 「. ‧. ‧ 國. IHR. Nat. 「. 學. 36. 立. 政治大. IHR. Ch. engchi. WTO. i n U. v. 37. TRIPS 35. World Health Organization. (n.d.). THE DOHA DECLARATION ON THE TRIPS AGREEMENT AND. PUBLIC HEALTH. Retrieved Jan 21, 2017, from http://www.who.int/medicines/areas/policy/doha_declaration/en/ 36 37. 31 31. P.32 P.33 18.

(27) TRIPS TRIPS. TRIPS. 「. 「. TRIPS. ‧ 國. 12. 6. WTO. TRIPS. ‧. 39. 2005. 學. 31bis. 政治大. 立. 38. TRIPS. sit. n. al. er. io TRIPS. 31bis. y. Nat. WTO. 31-1. Ch. engchi. i n U. v. 31bis. WTO 31bis. 38. Abbott, Frederick M., Intellectual Property and Public Health: Meeting the Challenge of Sustainability (November 15, 2011). Global Health Programme Working Paper No. 7/2011; FSU College of Law, Public Law Research Paper No. 566. Available at SSRN: https://ssrn.com/abstract=1965458 or http://dx.doi.org/10.2139/ssrn.1965458 P.4 39 Implementation of paragraph 6 of the Doha Declaration on the TRIPS Agreement and public health. 19.

(28) TRIPS ” TRIPS. 31. 『 31. (k). (f). 40. 31bis. 政治大. 立. ‧ 國. ‧ y. WTO. sit. 2017. n. al. er. 41. io. 23. Nat. TRIPS 31bis 1. 學. WTO. 31bis. Ch. engchi. i n U. v. 1. patent linkage. 40. Correa, C. M., & World Health Organization. (2004). Implementation of the WTO General Council Decision on paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health. P.1. 41 Tipo.gov.tw. (2017). -TRIPS 31 1 1 23 . [online] Available at: https://www.tipo.gov.tw/ct.asp?xItem=613955&ctNode=7127&mp=3 [Accessed 11 Mar. 2017].. 20.

(29) 42. 1984. (Drug Price. Competition and Patent Restoration Act, 21 USC 355 HWA). 立. ‧ 國. ‧ y ANDA. aSection iv l C 505 (b)(2) Application n hengchi U rely on. n. FDA. sit. io. ANDA. 43. ”. er. Nat. HWA. Abbreviated New Drug Applications, 505(b)(2). HWA. 政治大. 學. HWA. Hatch-Waxman Act. HWA. Paper NDA. “. bioavailability. B/A. bioequivalentce. B/E. ANDA Paper NDA 42. . (2009).. (Patent Linkage)(. 43. 42. ).. ?. , 21(2), 25. P.26 21.

(30) FDA 44. ANDA. 立. 2.. 政治大 45. ‧. ‧ 國. 學. n. al. er. io. sit. y. Nat. 46. Ch. i n U. engchi. v. “ 44 45. 46. ; 128. 2014. 42 ,&. P.28-29 . (2010). , 39(4), 379 .. : :. . .. , 12.1: 22.

(31) 18 47. 6 3.. TRIPS. TRIPS. 立. 政治大 TRIPS. ‧. ‧ 國. 學. WTO. n. er. io. sit. y. Nat. al. Ch. engchi. i n U. v. 47. 46. P.129 23.

(32) 48. side letter. —. 49. 政治大. 立. 50. ‧. ‧ 國. 學. n. er. io. sit. y. Nat. al. Ch. engchi. i n U. v. 「. Trans-Pacific Strategic Economic Partnership Agreement The Trans-Pacific Partnership. TPP. TPP. Free Trade. 48. (2009) P.38. 49. Abbott, Frederick M., Trade in Medicines (September 11, 2015). in TRADE AND HEALTH: TOWARDS BUILDING A NATIONAL STRATEGY 117-40 (eds. R. Smith et al.), World Health Organization (2015); FSU College of Law, Public Law Research Paper No. 770; FSU College of Law, Law, Business & Economics Paper No. 16-5. Available at SSRN: https://ssrn.com/abstract=2659277., P.120-121 50 91 5 40-2. 2. 24.

(33) Agreement. FTA. FTA. TRIPS WTO. 2003. 8. 30. 6 FTA. WTO. TRIPS ”. 立 39.3. ‧. n. al. er. io. -. 53. -. TRIPS. sit. y. Nat. FTA. 20. -. 學. TRIPS. 51. TRIPS. ‧ 國. 52. 政治大. Ch 54. i eng - ch 55. i n U. v. 51. U.S.-Dominican Republic-Central America Free Trade Agreement DR-CAFTA Free Trade Agreement between the United States and Morocco 53 ARTICLE 17.9: PATENTS 1. Each Party shall make patents available for any invention, whether a product or process, in all fields of technology, provided that the invention is new, involves an inventive step, and is capable of industrial application. The Parties confirm that patents shall be available for any new uses or methods of using a known product. For the purposes of this Article, a Party may treat the terms “inventive step” and “capable of industrial application” as synonymous with the terms “non-obvious” and “useful”, respectively. https://ustr.gov/trade-agreements/free-trade-agreements/australian-fta/final-text 54 ARTICLE 15.9: PATENTS 2. Each Party shall make patents available for the following inventions: (a) plants, and (b) animals. In addition, the Parties confirm that patents shall be available for any new uses or methods of using a known product, including new uses of a known product for the treatment of humans and animals. https://ustr.gov/trade-agreements/free-trade-agreements/morocco-fta/final-text 55 ARTICLE 14.8: PATENTS 2. Each Party shall make patents available for plant inventions. In addition, the Parties confirm that patents shall be available for any new uses or methods of using a known product, including products to be used for 52. 25.

(34) FTA. TRIPS. TRIPS US-DR-CAFTA56 57. FTA. FTA. TRIPS. FTA. 立. FTA. ‧ y. Nat. TRIPS. 學. ‧ 國. -. 政治大. sit. 58. io. . n. al. er. particular medical conditions, subject to the exclusions provided in Article 14.8.1 and the conditions of patentability. https://ustr.gov/trade-agreements/free-trade-agreements/bahrain-fta/final-text 56 Article 15.9: Patents 3. Nothing in this Chapter shall be construed to prevent a Party from excluding inventions from patentability as set out in Articles 27.2 and 27.3 of the TRIPS Agreement. Notwithstanding the foregoing, any Party that does not provide patent protection for plants by the date of entry into force of this Agreement shall undertake all reasonable efforts to make such patent protection available. Any Party that provides patent protection for plants or animals on or after the date of entry into force of this Agreement shall maintain such protection.. Ch. engchi. i n U. v. https://ustr.gov/trade-agreements/free-trade-agreements/cafta-dr-dominican-republic-central-america-fta/final-te xt 57 FINK, Carsten; REICHENMILLER, Patrick. Tightening TRIPS: Intellectual property provisions of US free trade agreements. 00 TRADE, DOHA, AND DEVELOPMENT, WORLD BANK. 2006, 289. P.290 58 ARTICLE 17.9: PATENTS 7. A Party shall not permit the use of the subject matter of a patent without the authorisation of the right holder except in the following circumstances: (a) to remedy a practice determined after judicial or administrative process to be anti-competitive under the Party’s laws relating to prevention of anti-competitive practices;17-16 or (b) in cases of public non-commercial use, or of national emergency, or other circumstances of extreme urgency, provided that: (i) the Party shall limit such use to use by the government or third persons authorised by the government; (ii) the Party shall ensure that the patent owner is provided with reasonable compensation for such use; and (iii) the Party may not require the patent owner to provide undisclosed information or technical know-how related to a patented invention that has been authorised for use in accordance with this paragraph. https://ustr.gov/trade-agreements/free-trade-agreements/australian-fta/final-text. 26.

(35) 59. TRIPS. WTO 60. FTA. 立. ‧ 國. 學. TRIPS. 政治大 ”. ‧ y. Nat. TRIPS. n TRIPS. Ch. engchi. er. io. al. sit. TRIPS. i n U. v. TRIPS. FTA 59. 57 P.291 Abbott, Frederick M., The Doha Declaration on the TRIPS Agreement and Public Health and the Contradictory Trend in Bilateral and Regional Free Trade Agreements (December, 27 2011). Quaker United Nations Office (Geneva) (QUNO), Occasional Paper No. 14, April 2004. Available at SSRN: https://ssrn.com/abstract=1977300., P.12 60. 27.

(36) FTA. 立. 政治大. ‧. ‧ 國. 學. n. er. io. sit. y. Nat. al. Ch. engchi. i n U. v. 28.

(37) social contract. 『. 、 20. 學. ‧ 國. 立. 政治大 “. “. ‧. n. er. io. sit. y. Nat. al. Ch. engchi. i n U. v. 61. 61. 6. P.150 29.

(38) 62. pseudo monopolies 『 penicillin. 63. 政治大. 立. TRIPS. n. al. TRIPS. Ch. TRIPS WTO. i n U 65. e n g c h8 i. 7. 66. er. io. 7. sit. y. Nat. TRIPS. ‧. ‧ 國. 學. 64. 8. v. 67. Canada Pharmaceutical Patents. 62 63 64 65 66. 6 6 6 6 Article7. P.151-152 P.152 P.158 P.159 Objectives. The protection and enforcement of intellectual property rights should contribute to the promotion of technological innovation and to the transfer and dissemination of technology, to the mutual advantage of producers and users of technological knowledge and in a manner conducive to social and economic welfare, and to a balance of rights and obligations. 67. 1.. Article 8. Principles. Members may, in formulating or amending their laws and regulations, adopt measures necessary to protect 30.

(39) TRIPS TRIPS. TRIPS. TRIPS 68. TRIPS TRIPS. 31 Michael Blakeney. TRIPS. 8. 8. 8. 7. 69. 8. ‧. TRIPS. n. al. er. io. sit. y. Nat. 70. 7. 政治大. 學. ‧ 國. 立. TRIPS. Ch. engchi. i n U. v. public health and nutrition, and to promote the public interest in sectors of vital importance to their socio-economic and technological development, provided that such measures are consistent with the provisions of this Agreement. 2.. Appropriate measures, provided that they are consistent with the provisions of this Agreement, may be. needed to prevent the abuse of intellectual property rights by right holders or the resort to practices which unreasonably restrain trade or adversely affect the international transfer of technology. 68 6 P.159 69 6 P.161 70 6 P.162. 31.

(40) 71. 立. ‧. ‧ 國. 學. io. ”. y. sit. Nat. 5. 3. 」. n. al. er. 2002. 3. 政治大. Ch. engchi. i n U. v. ” ”. 72. 71. Moonka, R., & Mukherjee, S. Marriage between Innovation Bride and Competition Groom: The way Forward., CPJ global review. vol. viii no. 1, P.147. July 2016. 72 71. 32.

(41) Essential Facilities Doctrine. 73. TRIPS. 31. 74. K. ”. 立. 政治Singapore 大 Patents Act 1994 75. ”. ‧. ‧ 國. 學. n. al. K. Ch. engchi. sit. 31. er. io K. y. Nat 31. TRIPS. i n U. v. 73. Ong, B. (2015). Compulsory Licences of Pharmaceutical Patents to Remedy Anti-Competitive Practices Under Article 31 (k) of the TRIPS Agreement: Can Competition Law Facilitate Access to Essential Medicines?. In Compulsory Licensing. Springer Berlin Heidelberg. p. 250 74. (b). (f). 75. Singapore Patent Act (Chapter 221, Revised Edition 2005): 55.—(1) Any interested person may apply to the court for the grant of a licence under a patent on the ground that the grant of the licence is necessary to remedy an anti-competitive practice.. 33.

(42) 76. TRIPS. 31. K. •. 76. 政治大. 立. ‧. ‧ 國. 學. Nat. n. al. er. io. sit. y. —. —. Ch. engchi. i n U. v. 77. TRIPS. 31. k. 76 77. 73 73. P.256 p.256-257 34.

(43) 78. TRIPS. 31. k. TRIPS. •. •. 立. 政治大. ‧. ‧ 國. 學 80. n. al. er. io. sit. y. Nat 1. Nelfinavir. 79. Ch. engchi. i n U. v. Efavirenz. 「. 2001. 78. 73 P.258 73 P.256 80 Correa, C. M. (2015). The use of compulsory licences in Latin America. In Compulsory Licensing. Springer Berlin Heidelberg. p. 50 79. 35.

(44) 62 2001. 「. Nelfinavir. Efavirenz. 81. STD/AIDS. /. AIDS. 2001 Nelfinavir. 40. Efavirenz. Efavirenz. 59. Nelfinavir. Roche. Merck Farmanguinhos. 政治大. 立. (Kaletra®). n. al. Abbott. Ch. sit. io. 2008. er. Nat Ritonavir (Kaletra®). y. Ritonavir. ‧. ‧ 國. 學. 2. Lopinavir. 82. engchi. i n U. Lopinavir. v. 2009 2012. 9 Kaletra®. 81. CORIAT, Benjamin, and Fabienne ORSI. "Pharmaceutical Patents, Generic Drugs and Public Health Under. The TRIPS Agreement The Case for Access to HIV-Care." P.12 82. 80. P.50 36.

(45) 54-68. 2009 - 2012. 83. 100. 立. 政治大. io. y. n. al. 87. Ch. engchi. sit. 84. 2. er. 31. Nat. TRIPS. ‧. ‧ 國. 學. —. 1000. i n U. 2. v. 83. 80 P.51 TRIPS 31 (l) where such use is authorized to permit the exploitation of a patent ( the second patent ) which cannot be exploited without infringing another patent ( the first patent ), the following additional conditions shall apply: (i) the invention claimed in the second patent shall involve an important technical advance of considerable economic significance in relation to the invention claimed in the first patent; (ii) the owner of the first patent shall be entitled to a cross-licence on reasonable terms to use the invention claimed in the second patent; and (iii) the use authorized in respect of the first patent shall be non-assignable except with the assignment of the second patent. 84. 37.

(46) 「. 5. 27. 1 1. 28. 1. al. n ”. 1. er. io 5. 27. sit. 28. ‧. 1. Nat. 28. 85. 學. TRIPS. 治政大 27 1. y. 立. ‧ 國. TRIPS. A. Ch. A. e n g c27h i. i n U. v. 1. 2. TRIPS. 85. 80. P.47 38.

(47) TRIPS. 7 86. Crown use. 立. 87. 政治大. ‧ 國. 學. 「. —. 「. ‧. n. er. io. sit. y. Nat. al. Ch. engchi. i n U. v. 86 87. 80 P.47-49 , et al. TRIPS. .. , 1.1: P.234.. (2004). 39.

(48) 88. 立. 政治大. ‧. ‧ 國. 學. n. er. io. sit. y. Nat. al. Ch. engchi 89. i n U. v. 88. Besen, S. M., & Raskind, L. J. (1991). An introduction to the law and economics of intellectual property. The Journal of Economic Perspectives, 5(1), P.3-4. 89 6 P.157. 40.

(49) 90. Christopher Cotropia involuntary breaking of exclusivity. 立. 政治大. ‧. ‧ 國. 學 y. sit. io. n. al. er. Nat. 91. Reichman. Ch. engchi. 91. i n U. v. Gervais. —. 90. Encaoua, D., Guellec, D., & Martinez, C. (2006). Patent systems for encouraging innovation: Lessons from economic analysis. Research policy, 35(9), P.1423. 91 6 P.162. 41.

(50) 92. Taylor. —. 學. Silberston. ‧. R D. ‧ 國. 立. 政治大. 0.75. n. er. io. sit. y. Nat. al. Ch. engchi. i n U. v. 93. 92. 6 P.163 Macdonald, S. (2004). When means become ends: considering the impact of patent strategy on innovation. Information Economics and Policy, 16(1), P.135. 93. 42.

(51) 94. 立. 政治大 95. ‧. ‧ 國. 學. n. er. io. sit. y. Nat. al. Ch. engchi. i n U. v. 94. 93 P.136-137 Ho, Cynthia M., Patent Breaking or Balancing? Separating Strands of Fact from Fiction Under TRIPS (February 14, 2009). North Carolina Journal of International Law and Commercial Regulation, Vol. 34, 2009; Loyola University Chicago School of Law Public Law and Legal Theory Research Paper Series No. 2009-003. Available at SSRN: https://ssrn.com/abstract=1218944, P.193 95. 43.

(52) 『. 立. 政治大. ‧. ‧ 國. 學. n. er. io. sit. y. Nat. al. 96. Ch. engchi. i n U. v. 97. 96 97. 6 P.157 93 P.148 44.

(53) access gap. R&D gap. neglected disease. 政治大. 立. 90. 10. 98. ‧. ‧ 國. 學 y. sit. io. 50. n. al. er. Nat. WHO. “. 2000. Ch. engchi. i n U. v. GDP. 20. 2010 2015 33. 2. GDP. 0.1%. Organization for Economic Co-operation and. 98. Kapczynski, A., Chaifetz, S., Katz, Z., & Benkler, Y. (2005). Addressing global health inequities: An open licensing approach for university innovations. Berkeley Technology Law Journal, P.1037. 45.

(54) Development. OECD. The World Bank R&D. 2008 2010. 0.27%. GDP 2014. 0.79%100. R&D. R&D 0.679%99. 2007. GDP 0.36%. GDP. 2010. 101. 0.73%. 立. 政治大. ‧. ‧ 國. 學. n. al. er. io. sit. y. Nat. 102. 2008. i n U. v. Médecins Sans Frontières (MSF) International MSF 80. Ch. e n g500c h i. MSF. 1999. 99. Data.worldbank.org. (2017). Research and development expenditure (% of GDP) | Data. [online] Available at: http://data.worldbank.org/indicator/GB.XPD.RSDV.GD.ZS?locations=NG-ZA-KE-MG-OM [Accessed 16 Apr. 2017]. 100 TheGlobalEconomy.com. (2017). Kenya R&D (research and development) expenditure - data, chart | TheGlobalEconomy.com. [online] Available at: http://www.theglobaleconomy.com/Kenya/Research_and_development/ [Accessed 16 Apr. 2017]. 101 The OECD. (2017). Research and development (R&D) - Gross domestic spending on R&D - OECD Data. [online] Available at: https://data.oecd.org/rd/gross-domestic-spending-on-r-d.htm [Accessed 16 Apr. 2017]. 102. Anatole Krattiger/ Global Challenges Division, WIPO (n.d.). Promoting access to medical innovation.. Retrieved March 4, 2017, from http://www.wipo.int/wipo_magazine/en/2013/05/article_0002.html. 46.

(55) MSF. 103. MDG. 立. 政治大. World Health Organization WHO. Model List of Essential. ‧ 國. 學. Medicines MLEM. ‧. WHO. MLEM. sit. n. al. er. io. LEM. y. Nat. List of Essential Medicines. MLEM. Ch. i n U. MLEM. engchi. MLEM. v. —. 103. Ford, N. (2004). Patents, access to medicines and the role of non-governmental organisations. Journal of Generic medicines, 1(2), P.139. 47.

(56) 104. WHO WHO. WHO. 60. 32. 58. 學. ‧ 國. 立. 政治大 60. ‧. IRPs. 3.5. 105. Nat. n. al. er. io. sit. y. 1.9. Ch. engchi. i n U. v. 104. Abbott, Frederick M., Intellectual Property and Public Health: Meeting the Challenge of Sustainability (November 15, 2011). Global Health Programme Working Paper No. 7/2011; FSU College of Law, Public Law Research Paper No. 566. Available at SSRN: https://ssrn.com/abstract=1965458 or http://dx.doi.org/10.2139/ssrn.1965458 P.7 105 Lu, Y., Hernandez, P., Abegunde, D., & Edejer, T. (2011). The world medicines situation 2011. Medicine expenditures. World Health Organization, Geneva. P.4.. 48.

(57) TRIPS. evergreen. 立. 政治大. ‧. ‧ 國. 學. Nat. n. al. er. io. sit. y. —. Ch. engchi. i n U. v. 106. 106. Ho, Cynthia M., Should All Drugs Be Patentable?: A Comparative Perspective (March 7, 2015). Vanderbilt Journal of Entertainment & Technology Law, Vol. 17, 2015; Loyola University Chicago School of Law Research Paper No. 2015-015. Available at SSRN: https://ssrn.com/abstract=2575147, P.297-298. 49.

(58) 1997. 立. 365. 政治大. 277. ‧. ‧ 國. 學. 107. 5000. n. 108. Ch. er. io. sit. y. Nat. al. i n U. MLEM. engchi. v. MLEM. WHO 109. 107 108 109. 103 103. P.140 P.137. WIPO, Patents and the WHO Model List of Essential Medicines (18th Edition): Clarifying the Debate on IP. and Access., Retrieved March 3, 2017, from http://www.wipo.int/meetings/en/doc_details.jsp?doc_id=334438. 50.

(59) 110. 立. 政治大』. ‧. ‧ 國. 學. —. n. al. er. io. sit. y. Nat. 111. Ch. engchi. generic competition. i n U. v. 110 111. 49 49. P.129-130 P.134-135 51.

(60) 112. TRIPS TRIPS. 立. ”. ‧. TRIPS. 113. 114. TRIPS. TRIPS. sit. n. al. er. io. TRIPS. India. y. Nat TRIPS. 1997. 學. Mailbox-U.S.. TRIPS. ‧ 國. WTO. 31 治政大. Ch. TRIPS. engchi. i n U. v. ”. TRIPS ”. WHO. — TRIPS 112. 49 P.134-135 ABBOTT, F. (2009). TRIPS Dispute Settlement Decisions. [online] Available at: http://www.ictsd.org/downloads/2009/10/abbott_trips_dsu.pdf [Accessed 12 Mar. 2017]. 114 Murthy, D. (2001). The future of compulsory licensing: deciphering the Doha Declaration on the TRIPS Agreement and public health. Am. U. Int'l L. Rev., 17, P.1327-1330. 113. 52.

(61) ” 115. TRIPS. TRIPS. 31. 31bis. TRIPS. 31. 30. 31. (f) TRIPS. TRIPS 31bis. 政治大. 立. ‧. ‧ 國. 學. n. al. f. 116. 31bis. Ch. engchi. er. io. 31. sit. y. Nat. TRIPS. i n U. v. 117. TRIPS. 115. 114 P.1331-1332 Reichman, J. H. (2009). Comment: compulsory licensing of patented pharmaceutical inventions: evaluating the options. The Journal of Law, Medicine & Ethics, 37(2), P.250. 117 APPENDIX TO THE ANNEX TO THE TRIPS AGREEMENT Assessment of Manufacturing Capacities in the Pharmaceutical Sector 116. 53.

(62) 118. 119. TRIPS. TRIPS. WTO. 政治大. 立. ‧. ‧ 國. 學. 120. TRIPS. 31bis. y. n. er. io. 31bis. al. WHO. Ch. WIPO. WHO. 31bis. sit. Nat. 31bis. engchi. i n U. v. WTO WIPO. WTO. 118. 40 P.29 1. For the purposes of this Decision: (a) (b) “eligible importing Member” means any least-developed country Member, and any other Member that has made a notification to the Council for TRIPS of its intention to use the system as an importer, it being understood that a Member may notify at any time that it will use the system in whole or in a limited way, for example only in the case of a national emergency or other circumstances of extreme urgency or in cases of public non-commercial use. It is noted that some Members will not use the system set out in this Decision as importing Members and that some other Members have stated that, if they use the system, it would be in no more than situations of national emergency or other circumstances of extreme urgency. Implementation of paragraph 6 of the Doha Declaration on the TRIPS Agreement and public health 120 Ho, C. M., (2007), A New World Order for Addressing Patent Rights and Public Health. Chicago-Kent Law Review, 82(3), 1492-1493 119. 54.

(63) 2013. 2. WHO. WIPO. WTO. IP WIPO WHO. 政治大 121. 立. ‧. ‧ 國. 學. n. al. er. io. sit. Nat. •. y. WTO. Ch. engchi. i n U. v. TRIPS. TRIPS 31bis. 6. 121. Abbott, Frederick M., Review: The Trilateral Study on Health, Intellectual Property, and Trade: The Virtue in Paving a Cleared Roadway (June 7, 2013). Journal of International Economic Law, Vol. 16, No. 2, Pgs. 493-503 (Oxford University Press 2013). Available at SSRN: https://ssrn.com/abstract=2276641 P.493-494. 55.

(64) 6 31bis. TRIPS. WTO. 122. 政治大. 立. ‧ 國. 學. The WHO Constitution. ‧. 1948. n. al. er. io. sit. y. Nat. “. Ch. engchi. i n U. v. 1966 2009. WHO. 135 1. 1978. 123. WHO. 2013. WHO WIPO. WTO. WIPO. WTO. 122. 121 P.498-499 Bartels, H. G., Beyer, P., Kampf, R., Krattiger, A., Mirza, Z., Taubman, A., & Watal, J. Promoting access to medical technologies and innovation. Intersections between public health intellectual property and trade., 2012 World Health Organization, World Intellectual Property Organization and World Trade Organization., P.41. (2013) 123. 56.

(65) ”. 《. 《. 治政 WHO Commission on Intellectual Property Rights, 大 Innovation and Public Health 立. CIPIH. ‧. ‧ 國. 學 Neglected diseases. 《. n. er. io. sit. y. Nat. al. Ch. engchi. i n U. v. 2011. 「. 2016. FDA. 124. Neglected tropical diseases. ”. WHO. 125. 124. FDA (n.d.). New Drugs at FDA: CDER's New Molecular Entities and New Therapeutic Biological Products. Retrieved March 10, 2017, from https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DrugInnovation/default.htm 125. WHO. (n.d.). Neglected tropical diseases. Retrieved March 10, 2017, from 57.

(66) 立. 政治大. —. ‧. ‧ 國. 學. n. er. io. sit. y. Nat. al. Ch. engchi. i n U. v. 126. http://www.who.int/gho/neglected_diseases/en/ 126. 49. P.117 58.

(67) GDP 127. 立. “. 政治大. ‧. ‧ 國. 學. n. er. io. sit. y. Nat. al. Ch. engchi. i n U. v. 128. 「. 127 128. 49 49. P.135-136 P.131 59.

(68) TRIPS. 129. 1. patent. exhaustion. 立. the first-sale doctrine). 政治大 130. ‧. ‧ 國. 學 ”. n. er. io. sit. y. Nat. al. Ch. engchi. i n U. v. 131. 129. 104. P.13. 49. P.132. 130 131. -. 19(8). P.25. 2007. 60.

(69) 2. generic drugs. 》. WTO 132. TRIPS TRIPS. 2016. 2005. 學. ‧ 國. 立. 治政大 65 2 1. ‧. n. Ch. engchi. er. io. al. 6. sit. y. Nat. TRIPS. i n U. v. TRIPS. 133. 132. 133. TRIPS 121. 5(2) P.498-499. P.69-124. 2008. 61.

(70) 『. 立. 20. 90. MPP. y. sit er. Ch. engchi. i n U. v. AIDS C. DNDi. al. n. DNDi. DNDi. ‧. ‧ 國. 學. io. MPP. MPP. Nat. DNDi. 《. 政治大. “. MPP. 62.

(71) 134. DNDi. MPP. 立. 政治大. ‧. ‧ 國. 學. n. er. io. sit. y. Nat. al. Ch. engchi. i n U. v. TRIPS. WTO TRIPS. 134. 104. P.30-31 63.

(72) TRIPS 1998 40. 2. 「 1997. TRIPS. 135. 政治大. 立. ‧. ‧ 國. 學 sit. al. n •. MPP. er. io. AIDS. y. Nat. ”. •. Ch. MPP. engchi. WHO. i n U. v. 90. 「 135. 103. P.141 64.

(73) 「. 136. 立. 政治大. ‧. ‧ 國. 學. n. er. io. sit. y. Nat. al. Ch. engchi. i n U. v. —. 136. Abbas, Muhammad Zaheer, Pros and Cons of Compulsory Licensing: An Analysis of Arguments (December 16, 2013). International Journal of Social Science and Humanity, Vol. 3, No. 3, May 2013. Available at SSRN: https://ssrn.com/abstract=2368116 P.255. 65.

(74) 137. 「. 立. 政治大. ‧. ‧ 國. 學. n. er. io. sit. y. Nat. al. Ch. engchi. i n U. v. 137. 104. P.34 66.

(75) 『. 立. 政治大. ‧. ‧ 國. 學 USTR. PhRMA. n. al. er. io. sit. y. PhRMA. Nat 139. 138. Ch. engchi. i n U. v. Vitamin Technologist, Inc. v. Wisconsin Alumni Research Foundation.. 140. Wisconsin Alumni Research Foundation D. Vitamin Technologist, Inc.. D 138. 5. P.158. 139. 5(2). P.121-126. 2009 140 Vitamin Technologists v. Wisconsin Alumni Research F., 146 F.2d 941 (9th Cir. 1945). 67.

(76) D D D Mercoid Corp. v. Mid-Continent Inv. Co., 141. injunction. 立. 政治大 D. ‧. ‧ 國. 學. n. al. y er. io. sit. Nat. 142. D. Ch. i n U. v. i e n28gUSC c h §1498. 28 U.S.C.. 1498. 141. Vitamin Technologists v. Wisconsin Alumni Research F., 146 F.2d 941 (9th Cir. 1945) It is now well established that a patentee may not put his property in the patent to a use contra to the public interest. The grant of a patent is the grant of a special privilege 'to promote the Progress of Science and useful Arts.’ Const. Art. I, Sec. 8. However, as stated in Mercoid Corp. v. Mid-Continent Inv. Co., 320 U.S. 661, 665, 64 S.Ct. 268, 271, it is not the private use but ‘ * * * the public interest which is dominant in the patent system. Pennock v. Dialogue, 2 Pet. 1, 7 L.Ed. 327; Kendall v. Winsor, 21 How. 322, 329, 16 L.Ed. 165; Adams v. Burke, 17 Wall. 453, 21 L.Ed. 700; Motion-Picture Co. v. Universal Film Co., supra, 243 U.S. pp. 510-511, 37 S.Ct. (416), 61 L.Ed. 871, L.R.A. 1917A, 1187, Ann. Cas. 1918A, 959; Morton Salt Co. v. G. S. Suppiger Co. (314 U.S. 488, 493, 62 S.Ct. 402, 86 L.Ed. 363); United States v. Masonite Corp., 316 U.S. 265, 278, 62 S.Ct. 1070, 1077, 86 L.Ed. 1461. * * * The patent is a privilege. But it is a privilege which is conditioned by a public purpose. * * * ’ 142 P.48-50 2000 6. 68.

(77) 1498 143. 144. 10 1498. 學. ‧ 國. 立. 政治大 sofosbuvir. Sovaldi®. 」. ‧ y Sovaldi®. n. al. er. io. sit. Nat. C. ”. Ch. 1498. engchi. ”. i n U. v. ”. 1980. ”Bayh-Dole Act”. 143. Kapczynski, A., & Kesselheim, A. S. (2016). ‘Government Patent Use’: A Legal Approach To Reducing Drug Spending. Health Affairs, 35(5), P.791-792. 144 143 P.793. 69.

(78) FDA. ”. 1498. 1984. ”. Hatch-Waxman. Act. 5 145. 政治大. 立. ‧ 國. 學 ”Paragraph 6 of the Doha Declaration on the. Nat. TRIPS Agreement and Public Health”. io. 9. n. al. ”Paragraph 6”. Ch. engchi. y. 30. sit. 8. er. WTO. ‧. 2003. Apo-TriAvir®. i n U. v. TRIPS. An Act to amend the Patent. Act and the Food and Drugs Act (The Jean Chrétien Pledge to Africa) 2005. 6. 2005. 5. 1 use of Patents for. International Humanitarian Purposes to Address Public Health Problems. CAmR146. 145. 143 P.794 Kohler, J. C., Lexchin, J., Kuek, V., & Orbinski, J. (2010). Canada's Access to Medicines Regime: Promise or Failure of Humanitarian Effort?. Healthcare Policy, 5(3), P.42 146. 70.

(79) TRIPS 2006. 8. Apotex. Apo-TriAvir®. WTO. 立. 9. y. 147. Ch. 7. Apotex. 2008. 9. 21,000. 13. engchi. i n U. v. CAmR. CAmR 2. 7. sit. 148. 9. n. al. Apotex. -. Apotex. er. io. WTO. ‧. 19.5. 2009. 7. 2007 2008. Nat. Apotex. 2007. 20. WTO. 。 24. 2007. ‧ 國. 4. 26. 學. 10. 治政大 Apotex Apo-TriAvir®. Apotex. Apotex. 2007. 300 CAmR Apotex. 147 148. 146. P.43. Lybecker, K. M., & Fowler, E. (2009). Compulsory licensing in Canada and Thailand: comparing regimes to. ensure legitimate use of the WTO rules. The Journal of Law, Medicine & Ethics, 37(2), 222-223. 71.

(80) Jack kay CAmR. 149. CAmR. CAmR 150. Apotex 1. 2004. Apo-TriAvir®. cocktail. 2005. ofzidovudine, lamivudine,. nevirapine. Rwanda. CAmR. combination. Apo-TriAvi®. 2006. 2. 立. GSK. ‧ 國. 學. CAmR. ‧. n. al. Apotex. Ch. Apotex. engchi. 。. i n U. Apotex. v. CAmR Apo-TriAvir® 151. Apotex Apotex. er. io. Apotex. sit. y. Nat. WTO CAmR. 21.03(l)(a). Apotex. Boehringer Ingelheim. 21.04(3)(c). CAmR. 政治大. Apo-TriAvir® Shire. Apotex. CAmR CAmR Jillian. 149. 146 P.43-44 146 P.43-44 151 Tsai, G. (2008). Canada's access to medicines regime: Lessons for compulsory licensing schemes under the WTO Doha Declaration. Va. J. Int'l L., 49, P.1077-1078 150. 72.

(81) Cohen-Kohler CAmR 152. ”. CAmR CAmR. Apotex. ”. CAmR. CAmR. CAmR. 治政大 CAmR 立 R. 學. D. ‧. ‧ 國. CAmR. CAmR. n. al. er. io. sit. y. Nat CAmR. Ch. WTO. engchi. i n U. CAmR. v. CAmR CAmR 21.04(3)(b). 152. 151. P.1080 73.

(82) CAmR CAmR CAmR CAmR. ” CAmR. CAmR CAmR CAmR. 政治大. 21.17. 學. CAmR. ‧ 國. 立 ”. ‧. n. er. io. sit. y. Nat. al. Ch. engchi. CAmR. i n U. v. 153. CAmR. 154. 153 154. 151 151. P.1083-1085 P.1085 74.

(83) -. TRIPS 31bis. TRIPS 31bis 31bis. CAmR. 31bis. 立. WTO. 學. ‧ 國. 155. 政治大 31bis. n. al. er. io. sit. Nat. ”. y. ‧. 31bis. WTO. Ch. engchi. i n U. v. 156. 31bis. 155. Ho, Cynthia M., Complicated Compulsory Licenses: The Waiver/Article31bis 'Solution' (February 2, 2011). Cynthia M. Ho, ACCESS TO MEDICINE IN THE GLOBAL ECONOMY: INTERNATIONAL AGREEMENTS ON PATENTS AND RELATED RIGHTS, Oxford University Press, April 2011; Loyola University Chicago School of Law Research Paper No. 2011-032. Available at SSRN: https://ssrn.com/abstract=1922825, P.217-218 156 155 P.218. 75.

(84) TRIPS. 30. 157. CAmR CAmR CAmR. 治政大 CAmR 立. TRIPS. ‧. ‧ 國. 學. 31. TRIPS. Nat. n. al. er. io. sit. y. CAmR. Ch. engchi. v iTRIPS n U. 158. 《. CAmR. 157 158. 155 151. P.219 P.1086 76.

(85) 159. CAmR TRIPS. Paragraph 6 CAmR. CAmR. TRIPS. CAmR. 立. Apo-TriAvir. 政治大. CAmR. ‧. ‧ 國. 學 Paragraph 6. n. al. er. io. sit. y. Nat. 160. Ch. engchi. i n U. v. TRIPS 1911 1991. The Patents and Designs Act of 1911. 1911. 1911. 159 160. 151 151. P.1088 P.1096 77.

(86) 1948. 1949. 3. 1911. 立. 1950. 1959. ‧ y. sit. n. al. er. io 1970. 1950. 161. Nat. 1970. G. 學. ‧ 國. 32. 治政 22 23 23大 A. Ch. engchi. i n U. v. TRIPS 1970 TRIPS. 1999 Patent Act 1999. 1999. 161. 8. P. P.13-15 78.

(87) Exclusive Marketing Rights EMR 62005. 2005. 3. 23. 1970 162. TRIPS. 2005 1970. 1. 5. 1. 1. 92 A 163. TRIPS. 80. 70. 政治大. 立. TRIPS 164. ‧. ‧ 國. 學. Bayer v.s. Nacto. sit. y. Nat. 1. Nexavar. n. al. er. io. TRIPS. Bayer v.s. Nacto Bayer. Ch. Nexavar. i n U. v. 2008. e n g Sorafenib c h i Tosylate Natco ”. Nexavar. 84. Nexavar. 162. Ram, P. (2005). India's New TRIPS-Complaint Patent Regime between Drug Patents and the Right to Health. Chi.-Kent J. Intell. Prop., 5, 195. 163 Nair, G. G. (2008). Impact of TRIPS on Indian pharmaceutical industry., J Intellec Prop Rights, September 2008, P.438 Available at http://nopr.niscair.res.in/handle/123456789/2029 164 163 P.441. 79.

(88) Nexavar Nexavar Natco 6. 7. Bayer. TRIPS. ”. TRIPS Nacto Sorafenib. 9000. 280,000. 4600. 政治大 USTR. 學. ‧ 國. 立. 150. USTR. ‧. GIPC. n. al. er. io. sit. y. Nat. 25. Ch. engchi. 165. 2. C. i n U. v. Solvadi®. TRIPS. 165. Banerjee, A. (2016). The Law and Politics of Pharmaceutical Patents in India. In Innovation and IPRs in China and India. Springer Singapore, P.153. 80.

(89) C FDA 8.4. 2014. Gilead Sciences Solvadi®. 900. 立. 90. 政治大 166. Solvadi®. ‧. ‧ 國. 學 y. Nat. io. 2007. 1,000. Efavirenz. sit. 12. 1. er. 2013. Solvadi®. n. a lMerck v Merck i n Ch engchi U Efavirenz. Efavirenz Merck 2007. 1.59 5. Merck 1.10 Efavirenz. 167. 166. Duggan, M., Garthwaite, C., & Goyal, A. (2016). The market impacts of pharmaceutical product patents in developing countries: Evidence from India. The American Economic Review, 106(1), P.100 167 80 P.52-53. 81.

(90) 363. 7. 2009. 2. 2010. ”. Ritonavir. Ritonavir. 治政大 Lamivudine Abacavir 立. ‧. al. n. 29. sit. 2006. Ch. er. io. 11. Merck. engchi. v. Efavirenz. National Health Insurance NHI 2011. 1. i n U. Efavirenz. 50. 2007. 2003. y. Nat. 2006. 168. 學. ‧ 國. 2012. 25. 169. Kaletra® Lopinavir. Efavirenz. Kaletra®. Ritonavir Kaletra®. 2,200. 168. 80 P.53-54 Suwan-In, N. (2012). Compulsory License, a Long Debate on Trips Agreement Interpretation: Discovering the Truth of Thailand's Imposition on Pharmaceutical Patents. Asian J. WTO & Int'l Health L & Pol'y, 7, P.238. 169. 82.

(91) NHI. 250,000. Efavirenz. 2012. 170. Kaletra® Plavix Plavix. NHI 171. NHI 2008. Docetaxel Letrozole Erlotinib. 立. 政治大. ‧. ‧ 國. 學 100,000. n. al. er. io. sit. y. Nat. 30,000. Imatinib. Ch. engchi. i vGlivec® n U. Imatinib. Glivec®. TRIPS. TRIPS. 170 171. 169 169. P.239 P.239 83.

(92) 172. Kaletra® Aluvia®. Aluvia® 173. — TRIPS. —. 立. TRIPS. TRIPS. 政治大. 50,000. n. al. er. io. sit. y. Nat. Kaletra. ‧. ‧ 國. 學. TRIPS. Ch. engchi. i n U. v. 174. 172 173 174. 169 P.240-241 95 P.180-181 95 P.182 84.

(93) 1997. Medicines Act 15. c. 2000 1600. 治政大 12000-15000 立 HIV. ‧ sit. n. al. er. io 176. Ch. 301. y. 2001. Nat. TRIPS. 學. ‧ 國. HIV. HIV. 175. engchi. i n U. —. v. Kaletra®. 175. Bass, N. A. (2002). Implications of the TRIPS Agreement for Developing Countries: Pharmaceutical Patent Laws in Brazil and South Africa in the 21st Century. Geo. Wash. Int'l L. Rev., 34, P.211 176 175 P.213. 85.

(94) 177. 『. 立. 政治大. ‧. ‧ 國. 學. n. er. io. sit. y. Nat. al. Ch. engchi. i n U. v. 《. 177. 95. P.183-184 86.

(95) 1.. 1944. -1993 9. 政治大 69. y. sit. io. n. al. 67. Ch. er. -2012. 9. 72. ‧. 1994. 67. Nat. 2.. 67. 學. ‧ 國. 立. 70. 70. engchi U. v ni 72. 3.. 2013 78. 87 178. 178. 44. P.74-81 2014. 06. 87.

(96) CD-R. 1.. v.s.. CD-R. 立. 學. ‧ 國. (1). 政治大. 1987. ‧. CD-R. 5. n. aCD-R l C h. CD-R. er. io. sit. y. Nat. “. engchi. i n U. v. 179. 88. 10. 12. 5. 10 3. 10. 179. & P.92. 2006. 3 88.

(97) 90. 90 90 2. 3. 1. 20. 21. 1. 3 4 5. 90 91. 4 7. 30. 5 12. 4. 14. 09318600520. ‧. io. b. 1. 76 76. TRIPS. n. al. 1. Ch. i e76n g c h 1. 1 31. i n U. TRIPS. y. 31. Nat. 31. 76. 7. 學. ‧ 國. 立. TRIPS. 93. 政治大. sit. 26. 2. er. 93. b. v. 180. (2). 180. 95. 2783 89.

(98) 181. 立. 政治大. ‧. ‧ 國. 學 y. al. n. 1. sit. io. 76. er. 182. Nat. 。. CD-R. Ch. engchi. i n U. v. TRIPS. 181. Ftc.gov.tw. (2017). . [online] Available at: http://www.ftc.gov.tw/internet/main/doc/docDetail.aspx?uid=1207&docid=13170 [Accessed 4 Apr. 2017]. 182 95 6 16 09506170420. 90.

(99) 183. 政治大. 立. y. WHO Check List for Influenza Pandemic Preparedness Planning. io. “. sit. WHO. Nat. 2005. n. al. er. (1). ‧. ‧ 國. 學. 2.. 184. 16. Ch. e n g10% chi. 0.7% 《. 2005. 10. i n U. v10%. 31 2005. 12. 8 129988. 185. 183. 106-110 184 185. & 2009 183 P.119. -. 7(2). 79 P.4 2006 91.

(100) (2) 76 1 WTO. TRIPS. (b) (c). 立. 政治大 “ H5N1. ‧. ‧ 國. 學. n. al. H5N1. Ch. engchi. er. io. 6. sit. y. Nat 186. ”. i n U. 60. 20. v. TRIPS. 186. . (2017). . [online] Available at: http://www.cdc.gov.tw/professional/qa.aspx?treeid=beac9c103df952c4&nowtreeid=fc22f73076dc1471 [Accessed 15 May 2017].. 92.

(101) 187. 立. 政治大. ‧. ‧ 國. 學. n. er. io. sit. y. Nat. al. Ch. engchi. i n U. v. 187. WTO 4(1). TRIPS P.202 2007. -. 93.

(102) “ bioavailability (BA). TRIPS. 『. TRIPS. 政治大. Bilateralism. WTO. 學. ‧ 國. 立 TRIPS. ‧ y. n. al. er. io. sit. Nat. 188. Ch. TRIPS. engchi. i n U. v. TRIPS ”. WTO. 188. 87. P.237-241 94.

(103) 189. 立. 政治大. n. al. er. io. sit. y. Nat. TRIPS. 『. ‧. ‧ 國. 學. TRIPS. Ch. engchi. i n U. v. TRIPS “. 」. 189. 60. P.3 95.

(104) TRIPS 190. 『. y. sit. a l27 Ch. n. TRIPS. er. 191. io. 2. TRIPS. 5(A)(2). Nat. TRIPS. TRIPS. ‧. 31. non-working. 學. ‧ 國. 立. 政治大. 1. engchi. i n U. v. TRIPS 192. 190. 87 P.242-243 Article 2 Intellectual Property Conventions 1. In respect of Parts II, III and IV of this Agreement, Members shall comply with Articles 1 through 12, and Article 19, of the Paris Convention (1967). 2. Nothing in Parts I to IV of this Agreement shall derogate from existing obligations that Members may have to each other under the Paris Convention, the Berne Convention, the Rome Convention and the Treaty on Intellectual Property in Respect of Integrated Circuits. 2 1. 1967 2. 191. 192. Mercurrio, B., & Tyagi, M. (2010). Treaty interpretation in WTO dispute settlement: the outstanding question of the legality of local working requirements. Minn. J. Int'l L., 19, 286.. 96.

(105) TRIPS TRIPS. 27. 27. 1. 193. 27.1 27.2. 27.3. 27.1. 政治— 大. 27.2. 立. ‧. ‧ 國. 學 y. 5. n. al. Ch. 194. engchi. er. io. sit. Nat. 27. i n U. v. 27. TRIPS. 27. 27. 193. Article 27 Patentable Subject Matter 1. Subject to the provisions of paragraphs 2 and 3, patents shall be available for any inventions, whether products or processes, in all fields of technology, provided that they are new, involve an inventive step and are capable of industrial application. (5) Subject to paragraph 4 of Article 65, paragraph 8 of Article 70 and paragraph 3 of this Article, patents shall be available and patent rights enjoyable without discrimination as to the place of invention, the field of technology and whether products are imported or locally produced. 194 192 P.310. 97.

(106) 195. TRIPS. TRIPS TRIPS 「 TRIPS. 196. 立. 31bis. 學. ‧ 國. TRIPS. WTO. 政治大 31bis. 『. ‧. n. al. er. io. sit. y. Nat. 31bis. Ch. 31bis. ”. engchi. i n U. v. 31bis. 31bis. 195 196. 192. P.313. Moschini, GianCarlo, "Intellectual Property Rights and the World Trade Organization: Retrospect and. Prospects" (2003).CARD Working Papers. Paper 351. Available at: http://lib.dr.iastate.edu/card_workingpapers/351. P.1 98.

(107) 31bis 197. 立. 政治大. ‧ 國. 學 198. ‧. n. er. io. sit. y. Nat. al. Ch. engchi. i n U. v. 199. CAmR. 197 198 199. 155 178 178. P.220 P.81 P,81-87 99.

(108) 200. 83. 立. ‧. ‧ 國. 學. 201. 政治大. n. er. io. sit. y. Nat. al. Ch. engchi. i n U. v. 200. 75 12 24 83 1 21 67 Tipo.gov.tw. (2017). . [online] Available at: https://www.tipo.gov.tw/ct.asp?xItem=219689&ctNode=6726&mp=1 [Accessed 4 Jul. 2017]. 201. 100.

(109) TRIPS ” TRIPS TRIPS. 立. 政治 TRIPS 大. ‧ 國. 學. FTA. ‧. Nat. n. al. er. io. sit. y. FTA. Ch. engchi. i n U. v. 『. 101.

(110) 「. 立. 政治大. 『. ‧. ‧ 國. 學. n. er. io. sit. y. Nat. al. Ch. engchi. i n U. v. 《. 」 1982. 1982 Nairobi 102.

(111) Conference. 202. 203. 立. 政治大. n. er. io. sit. y. ‧. ‧ 國. 學. Nat. 20. al. 20. Ch. engchi. i n U. v. 」. 204. 202. Gontijo, C. Changing the patent system from the Paris Convention to the TRIPS Agreement. P.26. 2005 Xiong, P.(2012). An International Law Perspective on the Protection of Human Rights in the TRIPS Agreement: An Interpretation of the TRIPS Agreement in Relation to the Right to Health (Vol. 108). Martinus Nijhoff Publishers., P.58 204 202 P.28 203. 103.

(112) TRIPS TRIPS 31bis. 90. 205. 91. 206. 21.03 90. 91. CAmR. 『. 立. 政治大. ‧. ‧ 國. 學 y. sit. io. n. al. er. 90. Nat. 205. 206. 207. Ch. engchi. i n U. v. 91. 207. 104.


(114) 9. 2. G.H.C. Bodenhausen. (2004). 立. ‧ 國. 91-105. 4-12. io. (2007). al. n. 4.. 2006. P.25-58 5.. . (2007).. Ch. WTO. engchi. 2008. 7.. 2008. 2. 1. .. i n U. v. TRIPS .. 6.. ‧. 79. , Trans.). 學. 2006. 215-246. Nat. 3.. &. (. 政治大. TRIPS. , 1(1) 2.. 4. y. 1.. 2000. sit. 2015. er. 1.. , 4(1), 157-207.. WTO. TRIPS. 66 20-26. 106.

(115) 8.. (2008). TRIPS 5(2). 9.. (2009). (Patent Linkage)(. 10.. ? ). 21(2). 24-37. 156. 63-87. (2009) 5(2). 11.. 105-138. &. (2010). : 39(4). 12.. 2011 &. 349-406. 政治大. 立. :. 12(1). 學. 14.. (2014). ‧ 國. 13.. P.69-124.. 117-191. 44. ‧. 2014. 73-90. n. er. io. sit. y. Nat. al. 1.. (2000). 2.. (2009). Ch. engchi. i n U. v. 」 1. 2.. https://www.tipo.gov.tw/mp.asp?mp=1 http://www.cdc.gov.tw/rwd/professional. 107.

(116) 1. Hilty, R. and Liu, K. (2015). Compulsory licensing. Heidelberg: Springer. 2. Xiong, P. (2012). An international law perspective on the protection of human rights in the TRIPS Agreement: An interpretation of the TRIPS Agreement in relation to the right to health. Martinus Nijhoff Publishers. 3. Bartels, H. G., Beyer, P., Kampf, R., Krattiger, A., Mirza, Z., Taubman, A., & Watal, J.. 治政 (2012). Promoting access to medical technologies and大 innovation. Intersections between 立 ‧. ‧ 國. 學. public health intellectual property and trade.. sit. y. Nat. 1. Lu, Y., Hernandez, P., Abegunde, D., & Edejer, T. The World Medicines Situation 2011:. n. al. er. io. Medicine Expenditures. 2011. Geneva, Switzerland: World Health Organization, 3.. i n U. v. 2. Gopalakrishnan, N. S., & Anand, M. (2015). Compulsory Licence Under Indian Patent. Ch. engchi. Law. In Compulsory Licensing (pp. 11-42). Springer Berlin Heidelberg. 3. Correa, C. M. (2015). The use of compulsory licences in Latin America. In Compulsory Licensing (pp. 43-60). Springer Berlin Heidelberg. 4. Maume, P. (2015). Compulsory Licensing in Germany. In Compulsory Licensing (pp. 95-120). Springer Berlin Heidelberg. 5. Frankel, S., & Lai, J. C. (2015). Recognised and Appropriate Grounds for Compulsory Licences: Reclaiming Patent Law’s Social Contract. In Compulsory Licensing (pp. 149-164). Springer Berlin Heidelberg.. 108.

(117) 6. Ong, B. (2015). Compulsory Licences of Pharmaceutical Patents to Remedy Anti-Competitive Practices Under Article 31 (k) of the TRIPS Agreement: Can Competition Law Facilitate Access to Essential Medicines?., In Compulsory Licensing (pp. 235-265). Springer Berlin Heidelberg. 7. Banerjee, A. (2016). The Law and Politics of Pharmaceutical Patents in India. In Innovation and IPRs in China and India (pp. 143-158). Springer Singapore.. 立. 政治大. ‧ 國. 學. 1. Besen, S. M., & Raskind, L. J. (1991). An introduction to the law and economics of. ‧. intellectual property. The Journal of Economic Perspectives, 5(1), 3-27.. sit. y. Nat. 2. Murthy, D. (2001). The future of compulsory licensing: deciphering the Doha Declaration. n. al. er. io. on the TRIPS Agreement and public health. Am. U. Int'l L. Rev., 17, 1299.. i n U. v. 3. Bass, N. A. (2002). Implications of the TRIPS Agreement for Developing Countries:. Ch. engchi. Pharmaceutical Patent Laws in Brazil and South Africa in the 21st Century. Geo. Wash. Int'l L. Rev., 34, 191. 4. Macdonald, S. (2004). When means become ends: considering the impact of patent strategy on innovation. Information Economics and Policy, 16(1), 135-158. 5. Ford, N. (2004). Patents, access to medicines and the role of non-governmental organisations. Journal of Generic medicines, 1(2), 137-145.. 109.

(118) 6. Kapczynski, A., Chaifetz, S., Katz, Z., & Benkler, Y. (2005). Addressing global health inequities: An open licensing approach for university innovations. Berkeley Technology Law Journal, 1031-1114. 7. Ram, P. (2005). India's New TRIPS-Complaint Patent Regime between Drug Patents and the Right to Health. Chi.-Kent J. Intell. Prop., 5, 195. 8. Encaoua, D., Guellec, D., & Martinez, C. (2006). Patent systems for encouraging innovation: Lessons from economic analysis. Research policy, 35(9), 1423-1440. 9. Tsai, G. (2008). Canada's access to medicines regime: Lessons for compulsory licensing. 治政 schemes under the WTO Doha Declaration. Va. J. Int'l大 L., 49, 1063. 立 ‧ 國. 學. 10. Reichman, J. H. (2009). Comment: compulsory licensing of patented pharmaceutical inventions: evaluating the options. The Journal of Law, Medicine & Ethics, 37(2),. ‧. 247-263.. sit. y. Nat. 11. Lybecker, K. M., & Fowler, E. (2009). Compulsory licensing in Canada and Thailand:. n. al. er. io. comparing regimes to ensure legitimate use of the WTO rules. The Journal of Law, Medicine & Ethics, 37(2), 222-239.. Ch. engchi. i n U. v. 12. Kohler, J. C., Lexchin, J., Kuek, V., & Orbinski, J. (2010). Canada's Access to Medicines Regime: Promise or Failure of Humanitarian Effort?. Healthcare Policy, 5(3), 40. 13. Mercurrio, B., & Tyagi, M. (2010). Treaty interpretation in WTO dispute settlement: the outstanding question of the legality of local working requirements. Minn. J. Int'l L., 19, 275. 14. Suwan-In, N. (2012). Compulsory License, a Long Debate on Trips Agreement Interpretation: Discovering the Truth of Thailand's Imposition on Pharmaceutical Patents. Asian J. WTO & Int'l Health L & Pol'y, 7, 225.. 110.

(119) 15. Moonka, R., & Mukherjee, S.. 2016. Marriage between Innovation Bride and. Competition Groom: The way Forward. CPJ Global Review. Vol. VIII No. 1 16. Kapczynski, A., & Kesselheim, A. S. (2016). ‘Government Patent Use’: A Legal Approach To Reducing Drug Spending. Health Affairs, 35(5), 791-797. 17. Duggan, M., Garthwaite, C., & Goyal, A. (2016). The market impacts of pharmaceutical product patents in developing countries: Evidence from India. The American Economic Review, 106(1), 99-135. 18. Weatherall, K. (2016). Safeguards for Defendant Rights and Interests in International. 治政 Intellectual Property Enforcement Treaties. Am. U. Int'l大 L. Rev., 32, 211. 立 ‧. ‧ 國. 學. 」. 1. World Health Organization http://www.who.int/en/. sit. y. Nat. 2. World Trade Organization https://www.wto.org/. n. al. er. io. 3. World Intellectual Property Organization http://www.wipo.int/portal/en/index.html 4. U.S. Food & Drug Administration FDA. Ch. i n U. v. https://www.fda.gov/. engchi. 5. Nair, G. G. (2008). Impact of TRIPS on Indian pharmaceutical industry., J INTELLEC PROP. RIGHTS,. SEPTEMBER. 2008,. P.438. Available. at. http://nopr.niscair.res.in/handle/123456789/2029 6. Ho, Cynthia M., Patent Breaking or Balancing? Separating Strands of Fact from Fiction Under TRIPS (February 14, 2009). North Carolina Journal of International Law and Commercial Regulation, Vol. 34, 2009; Loyola University Chicago School of Law Public Law and Legal Theory Research Paper Series No. 2009-003. Available at SSRN: https://ssrn.com/abstract=1218944 7. Ho, Cynthia M., Complicated Compulsory Licenses: The Waiver/Article31bis 'Solution'. 111.

(120) (February 2, 2011). Cynthia M. Ho, ACCESS TO MEDICINE IN THE GLOBAL ECONOMY: INTERNATIONAL AGREEMENTS ON PATENTS AND RELATED RIGHTS, Oxford University Press, April 2011; Loyola University Chicago School of Law. Research. Paper. No.. 2011-032.. Available. at. SSRN:. https://ssrn.com/abstract=1922825 8. Abbott, Frederick M., Intellectual Property and Public Health: Meeting the Challenge of Sustainability (November 15, 2011). Global Health Programme Working Paper No. 7/2011; FSU College of Law, Public Law Research Paper No. 566. Available at SSRN:. 治政大 https://ssrn.com/abstract=1965458 or http://dx.doi.org/10.2139/ssrn.1965458 立 ‧ 國. 學. 9. Abbott, Frederick M., The Doha Declaration on the TRIPS Agreement and Public Health and the Contradictory Trend in Bilateral and Regional Free Trade Agreements (December,. ‧. 27 2011). Quaker United Nations Office (Geneva) (QUNO), Occasional Paper No. 14,. sit. y. Nat. April 2004. Available at SSRN: https://ssrn.com/abstract=1977300. n. al. er. io. 10. Abbott, Frederick M., Review: The Trilateral Study on Health, Intellectual Property, and. i n U. v. Trade: The Virtue in Paving a Cleared Roadway (June 7, 2013). Journal of International. Ch. engchi. Economic Law, Vol. 16, No. 2, Pgs. 493-503 (Oxford University Press 2013). Available at SSRN: https://ssrn.com/abstract=2276641 11. Abbas, Muhammad Zaheer, Pros and Cons of Compulsory Licensing: An Analysis of Arguments (December 16, 2013). International Journal of Social Science and Humanity, Vol. 3, No. 3, May 2013. Available at SSRN: https://ssrn.com/abstract=2368116 12. Ho, Cynthia M., Should All Drugs Be Patentable?: A Comparative Perspective (March 7, 2015). Vanderbilt Journal of Entertainment & Technology Law, Vol. 17, 2015; Loyola University Chicago School of Law Research Paper No. 2015-015. Available at SSRN:. 112.

(121) https://ssrn.com/abstract=2575147 13. Abbott, Frederick M., Trade in Medicines (September 11, 2015). in TRADE AND HEALTH: TOWARDS BUILDING A NATIONAL STRATEGY 117-40 (eds. R. Smith et al.), World Health Organization (2015); FSU College of Law, Public Law Research Paper No. 770; FSU College of Law, Law, Business & Economics Paper No. 16-5. Available at SSRN: https://ssrn.com/abstract=2659277. 立. 政治大. ‧. ‧ 國. 學. n. er. io. sit. y. Nat. al. Ch. engchi. i n U. v. 113.

(122) Implementation of paragraph 6 of the Doha Declaration on the TRIPS Agreement and public health208 The General Council, Having regard to paragraphs 1, 3 and 4 of Article IX of the Marrakesh Agreement Establishing the World Trade Organization (“the WTO Agreement”);. 政治大 pursuant to paragraph 2 of立 Article IV of the WTO Agreement;. Conducting the functions of the Ministerial Conference in the interval between meetings. Declaration. (WT/MIN(01)/DEC/2) (the. on. the. TRIPS. Agreement. and. Public. Health. ‧. ‧ 國. the. 學. Noting. Declaration ) and, in particular, the instruction of the. y. Nat. io. sit. Ministerial Conference to the Council for TRIPS contained in paragraph 6 of the. al. er. Declaration to find an expeditious solution to the problem of the difficulties that WTO. n. v i n Members with insufficient or C no manufacturing capacities in the pharmaceutical sector hengchi U could face in making effective use of compulsory licensing under the TRIPS Agreement and to report to the General Council before the end of 2002;. Recognizing, where eligible importing Members seek to obtain supplies under the system set out in this Decision, the importance of a rapid response to those needs consistent with the provisions of this Decision; 208. Wto.org. (2017). WTO | intellectual property (TRIPS) - Implementation of paragraph 6 ofthe Doha Declaration on the TRIPS Agreement and public health. [online] Available at: https://www.wto.org/english/tratop_e/trips_e/implem_para6_e.htm [Accessed 2 Jul. 2017].. 114.

(123) Noting that, in the light of the foregoing, exceptional circumstances exist justifying waivers from the obligations set out in paragraphs (f) and (h) of Article 31 of the TRIPS Agreement with respect to pharmaceutical products; Decides as follows:. 1.. (a). For the purposes of this Decision:. 治政 means any patented大 product, or product manufactured. pharmaceutical product. 立. ‧ 國. 學. through a patented process, of the pharmaceutical sector needed to address the public health problems as recognized in paragraph 1 of the Declaration. It is understood that. ‧. active ingredients necessary for its manufacture and diagnostic kits needed for its use. sit. n. al. er. io. (b). y. Nat. would be included; (1). eligible importing Member. Ch. i n U. v. means any least-developed country Member, and any. engchi. other Member that has made a notification (2) to the Council for TRIPS of its intention to use the system as an importer, it being understood that a Member may notify at any time that it will use the system in whole or in a limited way, for example only in the case of a national emergency or other circumstances of extreme urgency or in cases of public non-commercial use. It is noted that some Members will not use the system set out in this Decision as importing Members (3) and that some other Members have stated that, if they use the system, it would be in no more than situations of national emergency or other circumstances of extreme urgency;. 115.

(124) (c). exporting Member. means a Member using the system set out in this Decision to. produce pharmaceutical products for, and export them to, an eligible importing Member.. 2.. The obligations of an exporting Member under Article 31(f) of the TRIPS. Agreement shall be waived with respect to the grant by it of a compulsory licence to the extent necessary for the purposes of production of a pharmaceutical product(s) and its export to an eligible importing Member(s) in accordance with the terms set out below in this paragraph:. 立. 政治大. ‧ 國. 學. (a) the eligible importing Member(s) (4) has made a notification (2) to the Council for. sit. y. Nat. n. al. er. specifies the names and expected quantities of the product(s) needed (5);. io. (i). ‧. TRIPS, that:. (ii). Ch. engchi. i n U. v. confirms that the eligible importing Member in question, other than a least. developed country Member, has established that it has insufficient or no manufacturing capacities in the pharmaceutical sector for the product(s) in question in one of the ways set out in the Annex to this Decision; and. (iii) confirms that, where a pharmaceutical product is patented in its territory, it has granted or intends to grant a compulsory licence in accordance with Article 31 of the TRIPS Agreement and the provisions of this Decision (6);. 116.

(125) (b) the compulsory licence issued by the exporting Member under this Decision shall contain the following conditions:. (i). only the amount necessary to meet the needs of the eligible importing Member(s). may be manufactured under the licence and the entirety of this production shall be exported to the Member(s) which has notified its needs to the Council for TRIPS;. (ii). 治政大 identified as being produced products produced under the licence shall be clearly 立 ‧ 國. 學. under the system set out in this Decision through specific labelling or marking. Suppliers should distinguish such products through special packaging and/or special. ‧. colouring/shaping of the products themselves, provided that such distinction is feasible. n. al. er. io. sit. y. Nat. and does not have a significant impact on price; and. i n U. v. (iii) before shipment begins, the licensee shall post on a website (7) the following information:. Ch. engchi. - the quantities being supplied to each destination as referred to in indent (i) above; and the distinguishing features of the product(s) referred to in indent (ii) above;. (c) the exporting Member shall notify (8) the Council for TRIPS of the grant of the licence, including the conditions attached to it (9). The information provided shall include the name and address of the licensee, the product(s) for which the licence has. 117.

(126) been granted, the quantity(ies) for which it has been granted, the country(ies) to which the product(s) is (are) to be supplied and the duration of the licence. The notification shall also indicate the address of the website referred to in subparagraph (b)(iii) above.. 3.. Where a compulsory licence is granted by an exporting Member under the system. set out in this Decision, adequate remuneration pursuant to Article 31(h) of the TRIPS Agreement shall be paid in that Member taking into account the economic value to the. 治政大in the exporting Member. Where importing Member of the use that has been authorized 立 ‧ 國. 學. a compulsory licence is granted for the same products in the eligible importing Member, the obligation of that Member under Article 31(h) shall be waived in respect of those. ‧. products for which remuneration in accordance with the first sentence of this paragraph. n. al. er. io. sit. y. Nat. is paid in the exporting Member.. i n U. v. 4. In order to ensure that the products imported under the system set out in this Decision are. Ch. engchi. used for the public health purposes underlying their importation, eligible importing Members shall take reasonable measures within their means, proportionate to their administrative capacities and to the risk of trade diversion to prevent re-exportation of the products that have actually been imported into their territories under the system. In the event that an eligible importing Member that is a developing country Member or a least-developed country Member experiences difficulty in implementing this provision, developed country Members shall provide, on request and on mutually agreed terms and conditions, technical and financial cooperation in order to facilitate its implementation.. 118.