TRIPS ANLAŞMASI’NDA İLAÇ PATENTLERİNİN ZORUNLU LİSANSI
Yıl: 2020 Cilt: 0 Sayı: 41 Sayfa Aralığı: 277 - 306 Metin Dili: Türkçe İndeks Tarihi: 06-10-2020
TRIPS ANLAŞMASI’NDA İLAÇ PATENTLERİNİN ZORUNLU LİSANSI
Öz: Ülkeler ihtiyaç duydukları patentli ilaçlara zorunlu lisans yoluyla daha uygun koşullarda erişebilmektedirler. Zorunlu lisans,patent sahibinin rızası olmaksızın bir kamu otoritesi kararı ile devlete veya üçüncü kişilere verilen patent konusu buluşu kullanma yetkisidir. Zorunlu lisans sayesinde, bir yandan patent sahibinin menfaati uluslararası anlaşmalarda ve ulusal düzenlemelerde belirlenen ilke ve esaslar çerçevesinde korunurken; diğer yandan, toplumun patentli ilaçlara duyduğu ihtiyaç karşılanmaktadır. Bu çalışmada, ilaçlara erişim sorununun çözümünde zorunlu lisans kurumunun oynadığı rol, Ticaretle Bağlantılı Fikri Mülkiyet Anlaşması (TRIPS Anlaşması) bağlamında incelenmektedir. Bu çalışma, dört bölümdenoluşmaktadır. Birinci bölümde, ilaç buluşlarının patent korumasına alınması sürecinden bahsedilmektedir. İkinci bölümde, zorunlu lisans kurumunun genel esasları açıklanmaktadır. Üçüncü bölümde, ilaç patentleri hakkında zorunlu lisansa karar verilmesi süreci incelenmektedir. Son olarak, günümüze kadar ilaç patentleri yönünden zorunlu lisans uygulamasına değinilmektedir.
Anahtar Kelime: Compulsory Licensing of Pharmaceutical Patents in TRIPS Agreements
Öz: Countries can acquire the patented pharmaceutical products they need in better conditions due to compulsory licensing. Compulsory licensing is an authorisation of a government agency or a decision of a court that entitle someone to use the patented invention without patent holder’s consent. Due to compulsory licensing, on the one hand, the interest of patent holder is protected pursuant to international agreement; on the other hand, the pharmaceutical need of the public is met. In this article, the role of compulsory licensing in solving the problems of access to medicines is analysed. This analyse is made according to the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement). This article is settled under four section. In the first section, the process of accepting patent protection for pharmaceutical inventions is explained. Then, general principles of compulsory licensing is mentioned. Subsequently, the procedure of granting a compulsory licensing for a pharmaceutical patented invention is examined. Finally, the implementation of compulsory licensing for pharmaceutical inventions is assessed.
Anahtar Kelime: Belge Türü: Makale Makale Türü: Araştırma Makalesi Erişim Türü: Erişime Açık
- ABBOTT, Frederick M.: “Managing the Hydra: The Herculean Task of Ensuring Access to Essential Medicines”, in MASKUS, Keith E. /REICHMAN, Jerome H. (ed.), International Public Goods and Transfer of Technology under A Globalized Intellectual Property Regime, New York 2005, s. 393-424.
- ABBOTT, Frederick M. / PUYMBROECK, Rudolf V. Van: Compulsory Licensing for Public Health A Guide and Model Documents for Implementation of the Doha Declaration Paragraph 6 Decision, Washington 2005, http://documents.worldbank.org/curated/en/173701468337882214/Compulsory-licensing-for-public-healtha-guide-and-model-documents-for-implementation-of-the-Doha-Declaration-Paragraph-6-Decision (E. T. 08.04.2019).
- ATTARAN, Amir: “How Do Patents and Economic Policies Affect Access to Essential Medicines in Developing Countries?”, Health Affairs, 23(3), 2004, s. 155-166, https://www.healthaffairs.org/doi/pdf/10.1377/hlthaff.23.3.155 (E. T. 08.04.2019).
- ATTARAN, Amir / GILLESPIE-WHITE, Lee: “Do Patents for Antiretroviral Drugs Constrain Access to AIDS Treatment in Africa?”, The Journal of the American Medical Association, 286(15), 2001, s. 1886-1892, http://iipi.org/wp-content/uploads/2010/07/Antiretroviral_Article.pdf (E. T. 08.04.2019).
- AYİTER, Nuşin: “Milletlerarası İhtira Hukukunun Bugünkü Durumu ve İktisaden Geri Kalmış Ülkelerde İhtira Hukuku Problemleri”, Ankara Üniversitesi Hukuk Fakültesi Dergisi, 25(3), 1968, s. 137-165.
- BACA, Rafael V.: “Compulsory Patent Licensing in Mexico in the 1990s: The Aftermath of NAFTA and the 1991 Industrial Property Law”, Transnational Lawyer, 8(1), 1995, s. 33-54.
- BAK, Başak: “İlaçta Zorunlu Patent Lisansı”, Ankara Barosu Dergisi, 3, 2001, s. 106-126.
- BAKER, Brook K.: “Arthritic Flexibilities For Accessing Medicines: Analysis of WTO Action Regarding Paragraph 6 of The Doha Declaration on The TRIPS Agreement And Public Health”, Indiana International & Comparative Law Review, 14(3), 2004, s. 613-715, https://journals.iupui.edu/index.php/iiclr/article/view/17822 (E. T. 08.04.2019).
- BEALL, Reed / KUHN, Randall: “Trends in Compulsory Licensing of Pharmaceuticals Since the Doha Declaration: A Database Analysis” PLoS Medicine, 9(1), 2012, s. 1-9, http://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1001154 (E. T. 08.04.2019).
- BREBECK, Stephan: The Failure of Compulsory Licensing of Pharmaceuticals in Least Developed Countries, http://duepublico.uni-duisburg-essen.de/servlets/DerivateServlet/Derivate-35046/Brebeck_Diss.pdf, (E. T. 08.04.2019).
- BURTON-MACLEOD, Jonathan: “Tipping Point: Thai Compulsory Licences Redefine Essential Medicines Debate”, Incentives for Global Public Health Patent Law and Access to Essential Medicines, (ed. POGGE, Thomas/RIMMER, Matthew/RUBENSTEIN, Kim), New York 2010, s. 406-424.
- COLLINS-CHASE, Charles T.: “The Case Against TRIPS-Plus Protection in Developing Countries Facing AIDS Epidemics”, University of Pennsylvania Journal of International Law, 29(3), 2008, s. 763-802.
- CORREA, Carlos M.: “Multilateral Agreements and Policy Opportunities”, in CIMOLI, Mario / DOSI, Giovanni / MASKUS, Keith E. / OKEDIJI, Ruth L. / REICHMAN, Jerome H. / STIGLITZ, Joseph E. (ed.), Intellectual Property Rights Legal and Economic Challenges for Development, Oxford 2014, s. 417-438.
- CORREA, Carlos M.: Integrating Public Health Concerns Into Patent Legislation in Developing Countries, Geneva 2000, http://apps.who.int/medicinedocs/en/d/Jh2963e/ (E. T. 08.04.2019). (Anılış: Integrating Public Health Concerns)
- CORREA, Carlos M.: Implementation of the WTO General Council Decision on paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health, Genova 2004, http://apps.who.int/medicinedocs/en/d/Js6159e/ (E. T. 08.04.2019). (Anılış: Implementation of the WTO General Council Decision)
- CORREA, Carlos M.: “The Use of Compulsory Licences in Latin America”, in HILTY, Reto M. / LIU, Kung-Chung (ed.), Compulsory Licensing, Heidelberg 2015, s. 43-60. (Anılış: The Use of Compulsory Licences)
- CORREA, Carlos M.: Trade Related Aspects of Intellectual Property Rights A Commentary on the TRIPS Agreement, Oxford 2007. (Anılış: A Commentary)
- CHENG, Huai-Chi / NI, Kuei-Jung: “The Boundary of a WTO Member’s Obligation to Comply with Art. 31(f) of the TRIPS Agreement – A Critical Review of Granting a Compulsory License on Philips CD-R Patents by Taiwan”, International Review of Intellectual Property and Competition Law, 2012, s. 885-901.
- CHIEN, Colleen: “Cheap Drugs at What Price to Innovation: Does the Compulsory Licensing of Pharmaceuticals Hurt Innovation?”, Berkeley Technology Law Journal, 18(3), 2003, s. 853-907, https://scholarship.law.berkeley.edu/btlj/vol18/iss3/3/ (E. T. 08.04.2019).
- CHOPRA, Madhavi: “Of the Big Daddy, the Underdog, the Mother Hen, and the Scapegoats: Balancing Pharmaceutical Innovation and Access to Healthcare in the Enforcement of Compulsory Patent Licensing in India, its Compliance with TRIPS, and Bayer v. Natco”, Santa Clara Journal of International Law,13(2), 2015, s. 333-374, https://scholarship.law.berkeley.edu/btlj/vol18/iss3/3/ (E. T. 08.04.2019).
- CONDON, Bradly J. / SINHA, Tapen: Global Lessons from the AIDS Pandemic Economic, Financial, Legal and Political Implications, Heidelberg 2008.
- DANAWALA, Saba / ZHANG, Zoe: “Implications of TRIPS Flexibilities for Access to Non-communicable Disease Medicines in Lower and Middle Income Countries”, International Journal of Nursing and Health Care, 1(1), 2013, s. 1-11.
- DO AMARAL, Alberto: “Compulsory Licensing and Access to Medicine in Developing Countries”, SELA (Seminario en Latinoamérica de Teoría Constitucional y Política) Papers, Paper 47, 2005, http://digitalcommons.law.yale.edu/yls_sela/47 (E. T. 08.04.2019).
- DUROJAYE, Ebenezer: “Compulsory Licensing and Access to Medicines in Post Doha Era: What Hope for Africa?”, Netherlands International Law Review, 55(1), 2008, s. 33-71, https://papers.ssrn.com/sol3/papers.cfm?abstract_id=1528602 (E. T. 08.04.2019).
- EPPICH, Christopher K.: “Patenting Dilemma: Drugs for Profit Versus Drugs for Health”, Santa Clara Law Review, 43(1), 2002, s. 289-318, http://digitalcommons.law.scu.edu/lawreview/vol43/iss1/6/ (E. T. 08.04.2019).
- FISHER, William W. / RIGAMONTI, Cyrill P.: “The South Africa AIDS Controversy A Case Study in Patent Law and Policy”, Harvard Law School, 2005, https://cyber.harvard.edu/people/tfisher/South%20Africa.pdf (E. T. 08.04.2019).
- FORD, Sara M.: “Compulsory Licensing Provisions under the TRIPS Agreement: Balancing Pills And Patents”, American University International Law Review, 15(4), 2000, s. 941-974.
- GUENNIF, Samira: “Is Compulsory Licensing Bad for Public Health? Some Critical Comments on Drug Accessibility in Developing Countries”, Applied Health Economics and Health Policy, 15(5), 2017, s. 557-565.
- HO, Cynthia M. : Access to Medicine in the Global Economy, New York 2011, https://papers.ssrn.com/sol3/papers.cfm?abstract_id=1922803 (E. T. 08.04.2019).
- HSU, Locknie: “Regulatory Flexibilities and Tensions in Public Health and Trade - An Asian Perspective”, AJWH, 10(157), 2015, s.157-191,https://ink.library.smu.edu.sg /cgi/viewcontent.cgi?article=3726&context=sol_research (E. T. 08.04.2019).
- IIPI: Patent Protection and Access to HIV/AIDS Pharmaceuticals in Sub-Saharan Africa, 2000, http://www.wipo.int/export/sites/www/aboutip/en/studies/pdf/iipi_hiv.pdf (E. T. 08.04.2019).
- ISCTS-UNCTAD: Resource Book on TRIPS and Development: An Authoritative and Practical Guide to the TRIPS Agreement, New York 2005.
- KAMPF, Roger: Special Compulsory Licences for Export of Medicines: Key Features of WTO Members’ Implementing Legislation, 2015, https://www.wto.org/english/res_e/reser_e/ersd201507_e.pdf (E. T. 08.04.2019).
- KAYA, Arslan: “551 Sayılı ‘Patent Haklarının Korunması Hakkında Kanun Hükmünde Kararname’ ile Getirilen Zorunlu Lisans Sistemi”, İstanbul Üniversitesi Hukuk Fakültesi Mecmuası, 55(1-2), 1996, s. 335-367.
- KHOR, Martin: Patents, Compulsory Licenses and Access to Medicines: Some Recent Experiences, 2. Baskı, Penang 2009.
- KOÇAK, Hakan: Patent Hukukunda Kullanmama Nedeniyle Zorunlu Lisans, Ankara Üniversitesi, Sosyal Bilimler Enstitüsü, Ankara 2019.
- KUANPOTH, Jakkrit: “Compulsory Licences: Law and Practice in Thailand”, in HILTY, Reto M. / LIU, Kung-Chung (ed.), Compulsory Licensing, Heidelberg 2015, s. 61-78.
- LIN, Tsai-Yu: “Compulsory Licenses for Access to Medicines, Expropriation and Investor-State Arbitration Under Bilateral Investment Agreements – Are There Issues Beyond the TRIPS Agreement?”, International Review of Intellectual Property and Competition Law, 40(2), 2009, s. 152-173, https://papers.ssrn.com/sol3/papers.cfm?abstract_id=1676690 (E. T. 08.04.2019).
- MALBON, Justin / LAWSON, Charles / DAVISON, Mark: The WTO Agreement on Trade-Related Aspects of Intellectual Property Rights-A Commentary, Northampton 2014.
- MITCHELL, Andrew D. / VOON, Tania: “The TRIPS Waiver As A Recognition of Public Health Concerns in the WTO”, in POGGE, Thomas / RIMMER, Matthew / RUBENSTEIN, Kim (ed.), Incentives for Global Public Health Patent Law and Access to Essential Medicines, New York 2010, s. 56-76.
- MUÑOZ TELLEZ, Viviana: “Dispute Settlement under the TRIPS Agreement: the United States–Brazil (2000) and United States–Argentina (2002) Patent Disputes”, in CORREA, Carlos M. (ed.), Research Handbook on the Interpretatıon and Enforcement of Intellectual Property Under WTO Rules, C. 2, Northampton 2010, s. 215-236.
- MURTHY, Divya: “The Future of Compulsory Licensing: Deciphering the Doha Declaration on the TRIPS Agreement and Public Health”, American University International Law Review, 17(6), 2002, s. 1299-1346.
- MUZAKA, Valbona: The Politics of Intellectual Property Rights and Access to Medicines, London 2011.
- NGUYEN, Tu Thanh: Competition Law Technology Transfer and the TRIPS Agreement Implications for Developing Countries, Northampton 2010.
- NKOMO, Marumo: “Rwanda’s New Intellectual Property Law and Compulsory Licensing for Export under the WTO: Not Qiıte a Panacea”, African Journal of International and Comparative Law, 21(2), 2013, s. 279-294.
- NUNO, Maura: “A Fair Return Approach to Pharmaceutical Compulsory Licensing”, Case Western Reserve Journal of International Law, 48(1), 2016, s. 395-415.
- ORTAN, Ali Necip: Patent Lisans Sözleşmesi, Ankara 1979.
- ODMAN BOZTOSUN, Ayşe: “İlaçta Zorunlu Lisans Uygulamaları”, in ŞEN, Murat / BAŞÖZEN Ahmet (ed.), I. Sağlık Hukuku Sempozyumu 8-9.5.2008, İstanbul 2009, s. 223-236.
- OKE, Emmanuel Kolawole: “Exploring the Flexibilities in TRIPS: Lessons from India’s Pharmaceutical Patent Law”, Commonwealth Law Bulletin, 41(1), 2015, s. 82-106, https://www.tandfonline.com/doi/full/10.1080/03050718.2015.1023817 (E. T. 08.04.2019).
- ONG, Burton: “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 HILTY, Reto M. / LIU, Kung-Chung (ed.), Compulsory Licensing, Heidelberg 2015, s. 235-266.
- POSSAS, Cristina de Albuquerque: “Compulsory Licensing in the Real World: the Case of ARV Drugs in Brazil”, in CORIAT, Benjamin (ed.), The Political Economy of HIV/AIDS in Developing Countries TRIPS Public Health Systems and Free Access, Northampton 2008, s. 150-166.
- REICHMAN, Jerome H.: “Compulsory Licensing of Patented Pharmaceutical Inventions: Evaluating the Options”, The Journal of Law, Medicine & Ethics, 37(2), 2009, s. 247-263.
- SEZGİN HUYSAL, Ayşegül: İlaç Patenti, İstanbul 2010.
- SULUK, Cahit / KENAROĞLU, Yasemin: Türk Fikri Mülkiyet Hukukunda Güncel Gelişmeler, İstanbul 2012.
- SUNDARAM, Jae: “Access to Medicines and the TRIPS Agreement: What Next for sub-Saharan Africa?”, Information & Communications Technology Law, 24(3), 2015, s. 242-261, https://www.tandfonline.com/doi/full/10.1080/13600834.2015.1084679 (E. T. 08.04.2019). (Anılış: Access to Medicines)
- SUNDARAM, Jae: “Brazil’s Implementation of TRIPS Flexibilities: Ambitious Missions, Early Implementation, and the Plans for Reform”, Information & Communications Technology Law, 23(2), 2014, s. 81-116.
- ŞEHİRALİ ÇELİK, Feyzan Hayal: “Patent Sisteminin İşlevleri ve Bu İşlevlerin Etkinliğini Sağlayan Yasal Düzenlemeler”, Banka ve Ticaret Hukuku Dergisi, 23(3), 2006, s. 103-154.
- T’HOEN, Ellen F. M.: “TRIPS, Pharmaceutical Patents and Access to Essential Medicines: Seattle, Doha and Beyond”, s. 39-67, https://tr.scribd.com/document/346537509/tHoen (E. T. 08.04.2019).
- TEKİNALP, Ünal: Fikri Mülkiyet Hukuku, İstanbul 2012.
- THANITCUL, Sakda / BRASLOW, Matthew Lim: “Compulsory Licensing of Chronic Disease Pharmaceuticals in Thailand”, Thai Journal of Pharmaceutical Sciences, 37(2), 2013, s. 61-83.
- VELÁSQUEZ, Germán: Intellectual Property, Public Health and Access to Medicines in International Organizations, Geneva 2017, https://www.southcentre.int/research-paper-78-july-2017/ (E. T. 08.04.2019).
- WEISSMAN, Robert: Remuneration Guidelines for Non-Voluntary Use of A Patent on Medical Technologies, 2005, http://apps.who.int/iris/bitstream/10665/69199/1/WHO_TCM_2005.1_eng.pdf (E. T.08.04.2019).
- World Health Organization: World Malaria Report 2017, http://www.who.int/malaria/publications/world-malaria-report-2017/report/en/ (E. T. 08.04.2019).
- World Trade Organization / World Intellectual Property Organization / World Health Organization: Promoting Access to Medical Technologies and Innovation, 2013, https://www.wto.org/english/res_e/booksp_e/pamtiwhowipowtoweb13_e.pdf (E. T. 08.04.2019).
| APA | KOÇAK H (2020). TRIPS ANLAŞMASI’NDA İLAÇ PATENTLERİNİN ZORUNLU LİSANSI. , 277 - 306. |
| Chicago | KOÇAK HAKAN TRIPS ANLAŞMASI’NDA İLAÇ PATENTLERİNİN ZORUNLU LİSANSI. (2020): 277 - 306. |
| MLA | KOÇAK HAKAN TRIPS ANLAŞMASI’NDA İLAÇ PATENTLERİNİN ZORUNLU LİSANSI. , 2020, ss.277 - 306. |
| AMA | KOÇAK H TRIPS ANLAŞMASI’NDA İLAÇ PATENTLERİNİN ZORUNLU LİSANSI. . 2020; 277 - 306. |
| Vancouver | KOÇAK H TRIPS ANLAŞMASI’NDA İLAÇ PATENTLERİNİN ZORUNLU LİSANSI. . 2020; 277 - 306. |
| IEEE | KOÇAK H "TRIPS ANLAŞMASI’NDA İLAÇ PATENTLERİNİN ZORUNLU LİSANSI." , ss.277 - 306, 2020. |
| ISNAD | KOÇAK, HAKAN. "TRIPS ANLAŞMASI’NDA İLAÇ PATENTLERİNİN ZORUNLU LİSANSI". (2020), 277-306. |
| APA | KOÇAK H (2020). TRIPS ANLAŞMASI’NDA İLAÇ PATENTLERİNİN ZORUNLU LİSANSI. Türkiye Adalet Akademisi Dergisi, 0(41), 277 - 306. |
| Chicago | KOÇAK HAKAN TRIPS ANLAŞMASI’NDA İLAÇ PATENTLERİNİN ZORUNLU LİSANSI. Türkiye Adalet Akademisi Dergisi 0, no.41 (2020): 277 - 306. |
| MLA | KOÇAK HAKAN TRIPS ANLAŞMASI’NDA İLAÇ PATENTLERİNİN ZORUNLU LİSANSI. Türkiye Adalet Akademisi Dergisi, vol.0, no.41, 2020, ss.277 - 306. |
| AMA | KOÇAK H TRIPS ANLAŞMASI’NDA İLAÇ PATENTLERİNİN ZORUNLU LİSANSI. Türkiye Adalet Akademisi Dergisi. 2020; 0(41): 277 - 306. |
| Vancouver | KOÇAK H TRIPS ANLAŞMASI’NDA İLAÇ PATENTLERİNİN ZORUNLU LİSANSI. Türkiye Adalet Akademisi Dergisi. 2020; 0(41): 277 - 306. |
| IEEE | KOÇAK H "TRIPS ANLAŞMASI’NDA İLAÇ PATENTLERİNİN ZORUNLU LİSANSI." Türkiye Adalet Akademisi Dergisi, 0, ss.277 - 306, 2020. |
| ISNAD | KOÇAK, HAKAN. "TRIPS ANLAŞMASI’NDA İLAÇ PATENTLERİNİN ZORUNLU LİSANSI". Türkiye Adalet Akademisi Dergisi 41 (2020), 277-306. |
