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TİCARETLE BAĞLANTILI FİKRÎ MÜLKİYET HAKLARI ANLAŞMASI ÇERÇEVESİNDE İLAÇ PATENTLERİNDE ZORUNLU LİSANS VE COVID-19 DÖNEMİNDE YAŞANAN BAZI GELİŞMELER

Yıl 2023, Cilt: 81 Sayı: 3, 103 - 186, 11.08.2023
https://doi.org/10.30915/abd.1141298

Öz

Çalışmamızda ilaç patentleri bakımından zorunlu lisans kurumu 1995 tarihli Ticaretle Bağlantılı Fikrî Mülkiyet Hakları Anlaşması çerçevesinde incelenmiştir. Çalışmada öncelikle ilaç patentleri ve sağlık hakkı arasındaki ilişki belirlenmiş ve ilaçların patentlenmesine ilişkin tarihsel sürece kısaca değinilmiştir. Ardından, Ticaretle Bağlantılı Fikrî Mülkiyet Hakları Anlaşması’na ilişkin genel bilgilere yer verilmiş ve anılan Anlaşma’da patentli ilaçlara erişimi artırmak üzere kullanılabilecek hükümler incelenmiştir. Bu hükümler arasından zorunlu lisansa ilişkin düzenlemeler ise ayrıntılı bir şekilde ele alınmıştır. Çalışmada ayrıca, kamu sağlığı ihtiyaçlarına cevap vermek üzere zorunlu lisans kurumuna ilişkin değişikliklere yol açan gelişmeler ve bu değişiklikler de anlatılmıştır. Çalışmanın son bölümünde ise COVID-19 pandemisi esnasında patentli ilaçlar bakımından zorunlu lisans kurumuna ilişkin dünya üzerinde yaşanan birtakım gelişmelere yer verilmiştir.

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COMPULSORY LICENSING OF DRUG PATENTS IN THE CONTEXT OF THE AGREEMENT ON TRADE-RELATED ASPECTS OF INTELLECTUAL PROPERTY RIGHTS AND SOME DEVELOPMENTS IN THE COVID-19 ERA

Yıl 2023, Cilt: 81 Sayı: 3, 103 - 186, 11.08.2023
https://doi.org/10.30915/abd.1141298

Öz

In this study, compulsory licensing of drug patents is examined in the context of the Agreement on Trade-Related Aspects of Intellectual Property Rights. First, the connection between drug patents and right to health is explained and a brief history of drug patenting is discussed. After that, some general informations on the Agreement on Trade-Related Aspects of Intellectual Property Rights and its provisions that can facilitate access to patented drugs are stated. Among these provisions, the one about the compulsory licensing is analyzed in detail. Furthermore, some events that cause the amendments in the compulsory licensing to address the needs of the public health and also those amendments themselves are discussed. In the last part of the study, some developments related with the compulsory licensing of drug patents throughout the world during the COVID-19 era are introduced.

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  • MSF Briefing Document. “Compulsory Licenses The TRIPS Waiver and Access to COVID 19 Medical Technologies.” May 2021, https://msfaccess.org/sites/default/files/2021-05/COVID_TechBrief_MSF_AC_IP_CompulsoryLicensesTRIPSWaiver_ENG_21May2021_0.pdf.
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  • Odman Boztosun, Ayşe. “İlaçta Zorunlu Lisans Patenti.” içinde Erciyes Üniversitesi Hukuk Fakültesi I. Sağlık Hukuku Sempozyumu 8-9 Mayıs 2009, Editörler Murat Şen ve Ahmet Başözen 223-236, Kayseri: 2009.
  • Odman Boztosun, Ayşe. “İlaçta Zorunlu Lisans Patenti.” içinde Erciyes Üniversitesi Hukuk Fakültesi I. Sağlık Hukuku Sempozyumu 8-9 Mayıs 2009, Editörler Murat Şen ve Ahmet Başözen 223-236, Kayseri: 2009.
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  • Oser, Andreas. “The COVID-19 Pandemic: Stress Test for Intellectual Property and Pharmaceutical Laws.” GRUR International Journal of European and International IP Law 70, no. 9 (2021): 846-55.
  • Oser, Andreas. “The COVID-19 Pandemic: Stress Test for Intellectual Property and Pharmaceutical Laws.” GRUR International Journal of European and International IP Law 70, no. 9 (2021): 846-55.
  • Osipenko, Natalia. “Russia to Expand Grounds For Granting Compulsory Licenses.” 29 January 2021, https://www.petosevic.com/resources/news/2021/01/4419.
  • Osipenko, Natalia. “Russia to Expand Grounds For Granting Compulsory Licenses.” 29 January 2021, https://www.petosevic.com/resources/news/2021/01/4419.
  • Özcan Büyüktanır, Burcu G. “Türk Hukukunda İlaç Patentine Genel Bakış.” Hacettepe Hukuk Fakültesi Dergisi 2, S. 2 (2012): 76-88.
  • Özcan Büyüktanır, Burcu G. “Türk Hukukunda İlaç Patentine Genel Bakış.” Hacettepe Hukuk Fakültesi Dergisi 2, S. 2 (2012): 76-88.
  • Özdemir, Adnan. “Patent Yönünden Ticaretle Bağlantılı Fikrî Mülkiyet Hakları Anlaşmasının Temel İlaçlara Ulaşımda Getirdiği Kısıtlamalar.” Bursa Uludağ Üniversitesi İktisadi ve İdari Bilimler Fakültesi Dergisi 35, C. 2 (2016): 25-54.
  • Özdemir, Adnan. “Patent Yönünden Ticaretle Bağlantılı Fikrî Mülkiyet Hakları Anlaşmasının Temel İlaçlara Ulaşımda Getirdiği Kısıtlamalar.” Bursa Uludağ Üniversitesi İktisadi ve İdari Bilimler Fakültesi Dergisi 35, C. 2 (2016): 25-54.
  • Özsoy, Saadet Hande. Türk Hukukunda Patent Lisansı Sözleşmesi, Ankara: Turhan Kitabevi, 2011.
  • Özsoy, Saadet Hande. Türk Hukukunda Patent Lisansı Sözleşmesi, Ankara: Turhan Kitabevi, 2011.
  • Park, Rosalyn S. “The International Drug Industry: What the Future Holds for South Africa’s HIV/AIDS Patients.” Minnesota Journal of International Law 11 (2002): 125-54.
  • Park, Rosalyn S. “The International Drug Industry: What the Future Holds for South Africa’s HIV/AIDS Patients.” Minnesota Journal of International Law 11 (2002): 125-54.
  • Reuters. “Hungary's Richter Has Manufactured Remdesivir for 3,000 COVID-19 Patients.” 7 October 2020, https://www.reuters.com/article/us-health-coronavirus-remdesivir-richter-idUSKBN26S283.
  • Reuters. “Hungary's Richter Has Manufactured Remdesivir for 3,000 COVID-19 Patients.” 7 October 2020, https://www.reuters.com/article/us-health-coronavirus-remdesivir-richter-idUSKBN26S283.
  • Saraç, Tahir. Patentten Doğan Hakka Tecavüz ve Hakkın Korunması. Ankara: Seçkin Yayınevi, 2002.
  • Saraç, Tahir. Patentten Doğan Hakka Tecavüz ve Hakkın Korunması. Ankara: Seçkin Yayınevi, 2002.
  • Sekar, Deepika, Aishwarya H. “A Re-Look into Compulsory Licensing: After Natco v. Bayer.” Indian Journal of Intellectual Property Law 5 (2012): 67-80.
  • Sekar, Deepika, Aishwarya H. “A Re-Look into Compulsory Licensing: After Natco v. Bayer.” Indian Journal of Intellectual Property Law 5 (2012): 67-80.
  • Serohina, Nataliia, Pikhurets, Olena, Iasechko, Svitlana/Yevlakhova, Elvira, Lytvyn, Stepan, Miroshnykov, Ivan. “Application of Compulsory Licensing in the Context of the Covid-19 Coronavirus Pandemic.” Systematic Reviews in Pharmacy 2, no. 1 (2021): 334-42.
  • Serohina, Nataliia, Pikhurets, Olena, Iasechko, Svitlana/Yevlakhova, Elvira, Lytvyn, Stepan, Miroshnykov, Ivan. “Application of Compulsory Licensing in the Context of the Covid-19 Coronavirus Pandemic.” Systematic Reviews in Pharmacy 2, no. 1 (2021): 334-42.
  • Sezgin Huysal, Ayşegül. İlaç Patenti. İstanbul: Vedat Kitapçılık, 2010.
  • Sezgin Huysal, Ayşegül. İlaç Patenti. İstanbul: Vedat Kitapçılık, 2010.
  • Skyes, Alan O. “TRIPS, Pharmaceuticals, Developing Countries, and the Doha Solution.” Chicago Journal of International Law 3, no. 1 (2002): 47-68.
  • Skyes, Alan O. “TRIPS, Pharmaceuticals, Developing Countries, and the Doha Solution.” Chicago Journal of International Law 3, no. 1 (2002): 47-68.
  • Silver, Samantha, Maclean, Lindsay. “COVID-19 Vaccine Development and Compulsory Licensing.” 14 May 2020, https://kennedyslaw.com/thought-leadership/article/covid-19-vaccine-development-and-compulsory-licensing. Silverman, Ed. “First Generic Version of Gilead’s Remdesivir Will Be Sold by a Bangladesh Drug Maker.” 22 May 2020, https://www.statnews.com/pharmalot/2020/05/22/gilead-remdesivir-covid19-coronavirus-beximco-patent/.
  • Silver, Samantha, Maclean, Lindsay. “COVID-19 Vaccine Development and Compulsory Licensing.” 14 May 2020, https://kennedyslaw.com/thought-leadership/article/covid-19-vaccine-development-and-compulsory-licensing. Silverman, Ed. “First Generic Version of Gilead’s Remdesivir Will Be Sold by a Bangladesh Drug Maker.” 22 May 2020, https://www.statnews.com/pharmalot/2020/05/22/gilead-remdesivir-covid19-coronavirus-beximco-patent/.
  • South Centre. “The Doha Declaration on TRIPS and Public Health Ten Years Later: The State of Implementation.” Policy Brief 7, no. 7 (2001): 1-12.
  • South Centre. “The Doha Declaration on TRIPS and Public Health Ten Years Later: The State of Implementation.” Policy Brief 7, no. 7 (2001): 1-12.
  • Şehirali Çelik, Feyzan Hayal. “Patent Sisteminin İşlevleri ve Bu İşlevlerin Etkinliğini Sağlayan Yasal Düzenlemeler.” Banka ve Ticaret Hukuku Dergisi 24, S. 3 (2008): 103-154.
  • Şehirali Çelik, Feyzan Hayal. “Patent Sisteminin İşlevleri ve Bu İşlevlerin Etkinliğini Sağlayan Yasal Düzenlemeler.” Banka ve Ticaret Hukuku Dergisi 24, S. 3 (2008): 103-154.
  • ‘t Hoen, Ellen. “COVID-19 and the Comeback of Compulsory Licensing.” 23 March 2020, https://medicineslawandpolicy.org/2020/03/covid-19-and-the-come-back-of-compulsory-licensing/.
  • ‘t Hoen, Ellen. “COVID-19 and the Comeback of Compulsory Licensing.” 23 March 2020, https://medicineslawandpolicy.org/2020/03/covid-19-and-the-come-back-of-compulsory-licensing/.
  • Tekinalp, Ünal. Fikrî Mülkiyet Hukuku. 5. Baskı. İstanbul: Vedat Kitapçılık, 2012.
  • Tekinalp, Ünal. Fikrî Mülkiyet Hukuku. 5. Baskı. İstanbul: Vedat Kitapçılık, 2012.
  • Tellez, Viviana Munoz. “The COVID-19 Pandemic: R&D and Intellectual Property Management for Access to Diagnostics Medicines and Vaccines.” South Centre, no. 73 (2020): 1-8. https://www.southcentre.int/wp-content/uploads/2020/04/PB73_The-COVID-19-Pandemic-RD-and-Intellectual-Property-Management-for-Access-to-Diagnostics-Medicines-and-Vaccines_EN-3.pdf.
  • Tellez, Viviana Munoz. “The COVID-19 Pandemic: R&D and Intellectual Property Management for Access to Diagnostics Medicines and Vaccines.” South Centre, no. 73 (2020): 1-8. https://www.southcentre.int/wp-content/uploads/2020/04/PB73_The-COVID-19-Pandemic-RD-and-Intellectual-Property-Management-for-Access-to-Diagnostics-Medicines-and-Vaccines_EN-3.pdf.
  • Tsai, George. “Canada's Access to Medicines Regime: Lessons for Compulsory Licensing Schemes under the WTO Doha Declaration.” Virginia Journal of International Law 49, no. 4 (2009): 1063-98.
  • Tsai, George. “Canada's Access to Medicines Regime: Lessons for Compulsory Licensing Schemes under the WTO Doha Declaration.” Virginia Journal of International Law 49, no. 4 (2009): 1063-98.
  • Tyupa, Vsevolod, Bankovskiy, Anton, Dzahafarova, Daria. “Russia Expands Grounds for Issuing Compulsory Licences in Healthcare.” 22 June 2021, https://www.cms-lawnow.com/ealerts/2021/06/russia-expands-grounds-for-issuing-compulsory-licences-in-healthcare.
  • Tyupa, Vsevolod, Bankovskiy, Anton, Dzahafarova, Daria. “Russia Expands Grounds for Issuing Compulsory Licences in Healthcare.” 22 June 2021, https://www.cms-lawnow.com/ealerts/2021/06/russia-expands-grounds-for-issuing-compulsory-licences-in-healthcare.
  • United Nations. “Report of the High Commissioner of the Human Rights Commission on Economic, Social and Cultural Rights, The Impact of the Agreement on Trade-Related Aspects of Intellectual Property Rights on Human Rights, E/CN.4/Sub.2/2001/13,” 27 June 2001, https://digitallibrary.un.org/record/446005#record-files-collapse-header.
  • United Nations. “Report of the High Commissioner of the Human Rights Commission on Economic, Social and Cultural Rights, The Impact of the Agreement on Trade-Related Aspects of Intellectual Property Rights on Human Rights, E/CN.4/Sub.2/2001/13,” 27 June 2001, https://digitallibrary.un.org/record/446005#record-files-collapse-header.
  • Vincent, Nicholas G. “TRIP-ing Up: The Failure of TRIPS Article 31bis.” Gonzaga Journal of International Law 24, no. 1 (2020): 1-38.
  • Vincent, Nicholas G. “TRIP-ing Up: The Failure of TRIPS Article 31bis.” Gonzaga Journal of International Law 24, no. 1 (2020): 1-38.
  • Wang, Richard Li-dar. “Ancillary Orders of Compulsory Licensing and Their Compatibility with the TRIPS Agreement.” Marquette Intellectual Property Law Review 18, no. 1 (2014): 87-105.
  • Wang, Richard Li-dar. “Ancillary Orders of Compulsory Licensing and Their Compatibility with the TRIPS Agreement.” Marquette Intellectual Property Law Review 18, no. 1 (2014): 87-105.
  • Weissman, Robert. "Long, Strange Trips: The Pharmaceutical Industry Drive to Harmonize Global Intellectual Property Rules, and the Remaining WTO Legal Alternatives Available to Third World Countries." University of Pennsylvania Journal of International Economic Law 17, no. 4 (1996): 1069-126.
  • Weissman, Robert. "Long, Strange Trips: The Pharmaceutical Industry Drive to Harmonize Global Intellectual Property Rules, and the Remaining WTO Legal Alternatives Available to Third World Countries." University of Pennsylvania Journal of International Economic Law 17, no. 4 (1996): 1069-126.
  • WIPO. “Germany: Act on the Protection of the Population in the Event of an Epidemic Situation of National Importance.” 27 March 2020, https://www.wipo.int/news/en/wipolex/2020/article_0008.html.
  • WIPO. “Germany: Act on the Protection of the Population in the Event of an Epidemic Situation of National Importance.” 27 March 2020, https://www.wipo.int/news/en/wipolex/2020/article_0008.html.
  • Wong, Hilary. “The Case for Compulsory Licensing During COVID-19.” Journal of Global Health 10, no. 1 (2020): 1-5.
  • Wong, Hilary. “The Case for Compulsory Licensing During COVID-19.” Journal of Global Health 10, no. 1 (2020): 1-5.
  • World Health Organization, World Intellectual Property Organization, World Trade Organization. Promoting Access to Medical Technologies and Innovation, 2. Edition, https://www.wto.org/english/res_e/booksp_e/who-wipo-wto_2020_e.pdf, İsviçre: 2020.
  • World Health Organization, World Intellectual Property Organization, World Trade Organization. Promoting Access to Medical Technologies and Innovation, 2. Edition, https://www.wto.org/english/res_e/booksp_e/who-wipo-wto_2020_e.pdf, İsviçre: 2020.
  • Xiangxiu, Wang, Yiying, Wang: Exploring the Compulsory Licensing System for Pharmaceutical Patents During the COVID-19 Pandemic, Journal of WTO and China 2021, vol. 11, no. 2, s. 62-82.
  • Xiangxiu, Wang, Yiying, Wang: Exploring the Compulsory Licensing System for Pharmaceutical Patents During the COVID-19 Pandemic, Journal of WTO and China 2021, vol. 11, no. 2, s. 62-82.
  • Yalçıner, Uğur. “İlaç ve Patent – Türkiye’de ve Dünyada Son Gelişmeler.” Ankara Barosu Fikrî Mülkiyet ve Rekabet Hukuku Dergisi 2, S. 3 (2001): 15-44.
  • Yalçıner, Uğur. “İlaç ve Patent – Türkiye’de ve Dünyada Son Gelişmeler.” Ankara Barosu Fikrî Mülkiyet ve Rekabet Hukuku Dergisi 2, S. 3 (2001): 15-44.
Toplam 146 adet kaynakça vardır.

Ayrıntılar

Birincil Dil Türkçe
Konular Hukuk
Bölüm Araştırma Makalesi
Yazarlar

Ahunur Açıkgöz 0000-0002-8301-7072

Yayımlanma Tarihi 11 Ağustos 2023
Yayımlandığı Sayı Yıl 2023 Cilt: 81 Sayı: 3

Kaynak Göster

Chicago Açıkgöz, Ahunur. “TİCARETLE BAĞLANTILI FİKRÎ MÜLKİYET HAKLARI ANLAŞMASI ÇERÇEVESİNDE İLAÇ PATENTLERİNDE ZORUNLU LİSANS VE COVID-19 DÖNEMİNDE YAŞANAN BAZI GELİŞMELER”. Ankara Barosu Dergisi 81, sy. 3 (Ağustos 2023): 103-86. https://doi.org/10.30915/abd.1141298.