Exclusive study on operation of 31 bis of trips-with special reference to public health
Keywords:
TRIPS, Article 31 Bis, Pharmaceutical ProductAbstract
World wars brought economic depression resulting in the need to regulate the trade relationship among the international community. Such a need to regulate trade relationships among world states compelled them to sign the General Agreement on Tariffs and Trade (GATT) agreement. The initial stages of GATT did not have provisions to protect Intellectual Property Rights. There were international conventions to address the issues concerning Trade aspects of intellectual property. The international conventions were like the Paris convention for protecting an invention, Berne for Copyright, Madrid for Trademarks etc… Several rounds of GATT gave birth to the World Trade Organization in 1995. The World Trade Organization (WTO) planned to bring unification of Intellectual Property Laws and enacted a new multilateral agreement on Trade-related aspects of Intellectual Property Rights (TRIPS). TRIPS are multifaceted agreements where many aspects of IPR are discussed. Article 31 bis of TRIPs agreement concerning public health will be critically analysed in this paper. Article 31 Bis was the result of the Doha declaration that deeply discussed the issue of Article 31 F and its gap in serving the countries that lack the manufacturing capacity to address their issues of accessibility and affordability to pharmaceutical products.
Downloads
References
Gandolfo G, International Trade Theory and Policy (Springer Science & Business Media 2013)
Taubman A, Wager H and Watal J, “A Handbook on the WTO TRIPS Agreement,” A Handbook on the WTO TRIPS Agreement (WTO 2012) <http://dx.doi.org/10.30875/5bf84e59-en> accessed February 16, 2022
“Current TRIPS Issues,” , A Handbook on the WTO TRIPS Agreement (Cambridge University Press 2020) <http://dx.doi.org/10.1017/9781108883511.012> accessed February 16, 2022
Lo Bianco F, “Comparative Patent Compulsory Licensing Under COVID-19” [2020] SSRN Electronic Journal
Bartelt S, “Compulsory Licences Pursuant to Trips Article 31 in the Light of the Doha Declaration on the Trips Agreement and Public Health” (2005) 6 The Journal of World Intellectual Property 283
Lo C, “Relations between the TRIPS Agreement and the Anti-Counterfeiting Trade Agreement: A Plurilateral Instrument Having Multilateral Functions with Little Multilateral Process” (2013) 48 Foreign Trade Review 105
Kennedy M, “Relation of TRIPS to Other WTO Agreements,” WTO Dispute Settlement and the TRIPS Agreement (Cambridge University Press) <http://dx.doi.org/10.1017/cbo9781316534748.007> accessed February 16, 2022
Ghidini G, “On TRIPS’ Impact on ‘Least Developed Countries’: The Effects of a ‘double Standards’ Approach” TRIPS and Developing Countries 132
Shanker D, “Para 6 Solution of the Doha Declaration, Article 30 of TRIPS and Non-Prohibition of Exports under the TRIPS Agreement” [2003] SSRN Electronic Journal
Singh S, “Impact of National and International Regulations on Indian Generic Drugs Industry,” Advances in Healthcare Information Systems and Administration (IGI Global 2017) <http://dx.doi.org/10.4018/978-1-5225-2414-4.ch004> accessed February 16, 2022.
Hingun M and Nizamuddin RM, “INCORPORATING ARTICLE 31bis FLEXIBILITIES ON TRIPS PUBLIC HEALTH INTO DOMESTIC PATENT SYSTEM: THE INESCAPABLE WAY FORWARD FOR MALAYSIA” (2020) 16 Journal International Studies 73
Organization LAD World Trade, WTO Analytical Index: Guide to WTO Law and Practice (Cambridge University Press 2012)
“IV.C.2c-2 Decision on Implementation of Paragraph 6 of the Doha Declaration on the Trips Agreement and Public Health (30 August 2003),” , International Law & World Order (Martinus Nijhoff Publishers) <http://dx.doi.org/10.1163/ilwo-ivc2c-2> accessed February 16, 2022
TRIPS and Pharmaceutical Patents: Obligations and Exceptions. (World Trade Organization 2010)
Hoen* E ’t, “TRIPS, Pharmaceutical Patents, and Access to Essential Medicines: A Long Way From Seattle to Doha,” Global Health (Routledge 2017) <http://dx.doi.org/10.4324/9781315254227-25> accessed February 16, 2022
Ferrone JD, “Compulsory Licensing during Public Health Crises: Bioterriorisms Mark on Global Pharmaceutical Patent Protection” Suffolk Transnational Law Review 385
Bjornberg J, “Brazil’s Recent Threat on Abbott’s Patent: Resoution or Retaliation?” [2006] Northwestern Journal of International Law & Business 211
Curti AM, “The WTO Dispute Settlement Understanding: An Unlikely Weapon in the Fight Against AIDS” (2001) 27 American Journal of Law & Medicine 469
Bradsher K, “Bayer Agrees to Charge Government a Lower Price for Anthrax Medicine” [2001] New York Times
Murthy D, “The Future of Compulsory Licensing: Deciphering the Doha Declaration on the TRIPs Agreement and Public Health” (2002) 17 American University International Law Review 1299
De Cock KM and others, “Prevention of Mother-to-Child HIV Transmission in Resource-Poor Countries” (2000) 283 JAMA 1175
World Trade Organization, “Public Health, Innovation, and Intellectual Property Rights: Report of the Commission on Intellectual Property Rights, Innovatation and Public Health” (World Health Organization 2006)
“WTO” (2005 News items - TRIPS and public health: chairpersons statement 2005) <http://www.wto.org/english/news_e/news05_e/trips_319_e.htm>.
Germano S, “Compulsory Licensing of Pharmaceuticals in Southeast Asia: Paving the Way for Greater Use of the TRIPS Flexibility in Low- and Middle-Income Countries” (2007) 76 University of Missouri Kansas City Law Review 273
World Trade Organization, “TRIPS: Drug Patents, Technical Note - Pharmaceutical Patents and the TRIPS Agreement” (World Trade Organization 2006)
Germano S, “Compulsory Licensing of Pharmaceuticals in Southeast Asia: Paving the Way for Greater Use of the TRIPS Flexibility in Low- and Middle-Income Countries” (2007) 76 University of Missouri Kansas City Law Review 273
Petition for a Compulsory License” <http://glivec.jinbo.net/Request_for_CL_Final_version.htm> accessed February 16, 2022
Landon V, “Pricing Dispute Leaves Patients Without Drugs” Swiss News Worldwide (2002) 13
CPTech, “Korea Patients Asking for Meeting with Novartis Arrested, Hospitalized” (Http://www.cptech.org/, 2003) <http://www.cptech.org/ip/health/gleevec/korea-arrest.html> accessed June 23, 2010
IIPRD, “The Facts of the Bayer Vs Cipla Case” (Www.iiprd.com, May 17, 2010) <https://www.iiprd.com/bayer-vs-cipla/. >
Bayer Corporation & Anr vs Union Of India & Ors on 9 February, 2010 (High Court of Delhi at New Delhi)
Kumar M, “Natco Pharma Ltd. Vs Bayer Corporation - A Landmark Case Of Compulsory License” LinkedIn (August 5, 2021) <https://www.linkedin.com/pulse/natco-pharma-ltd-vs-bayer-corporation-landmark-case-mukesh-kumar> accessed February 16, 2022
Raju Dr K.D, “The Debacle of Novartis Patent Case in India: Strict Interpretation of Patentability Criteria Under Article 27 of the Trips Agreement” [2007] SSRN Electronic Journal
“Novartis AG v Adarsh Pharma on 28 April 2004 - Judgement - LawyerServices” (LawyerServices) <https://www.lawyerservices.in/Novartis-AG-Versus-Adarsh-Pharma-2004-04-28> accessed February 16, 2022
“Novartis Set Back In India Patent Fight Over Glivec” Forbes (August 7, 2007) <https://www.forbes.com/2007/08/07/novartis-glivec-generics-markets-equity-cx_rd_0807markets02.html?sh=3d6b70d3472d> accessed February 16, 2022
Ando G, “Thai Government Expands Scope of Patent Breaking Strategy Amid Unrest in Asia” (2007) 32 World Market Research Centre-Global Insight
Datta PTJ, “Pfizer Worried Over Parallel Import of Norvasc into the Philippines” [2006] Business Line
Macan-Markar M, “Asian Govts Push Generic Drugs” (International Pioneers School 2006)
Tan R.D, “PITC Files Landmark Patent Case against Norvasc …even If Patent for Hypertension Drug to Expire in June.” (Pitc.gov.ph, 2007) <http://www.pitc.gov.ph/archives/patent_case.html> accessed June 15, 2010
Pharma Marketletter, “New Thailand Govt’s Compulsory Drug Licensing Policy Swings Back and Forth” [2008] Pharma Marketletter
Shashikant S, “Compulsory Licensing of Cancer Drugs in Thailand. Third World Network,” [2008] TWN Info Service on Health Issues.
“Safeguarding the Health Sector in Times of Macroeconomic Instability - Policy Lessons for Low and Middle-Income Countries” (2008) 21 International Journal of Health Care Quality Assurance
Pannarunothai S, Patmasiriwat D and Srithamrongsawat S, “Universal Health Coverage in Thailand: Ideas for Reform and Policy Struggling” (2004) 68 Health Policy 17
Fuller T, “Thailand Takes on Drug Industry, and May Be Winning” New York Times (2007)
IV.C.2c-3 PROTOCOL AMENDING THE TRIPS AGREEMENT.” International Law & World Order: Weston’s & Carlson’s Basic Documents, n.d. Accessed January 23, 2022. https://doi.org/10.1163/2211-4394_rwilwo_sim_032408.
Nicholas , Vincent. “TRIP-Ing Up: The Failure of TRIPS Article 31bis.” Gonzaga Journal of International Law 2020, March 8, 2021.
Adelman H, “Canadian Policy in Rwanda,” The Path of a Genocide (Routledge 2017) <http://dx.doi.org/10.4324/9781315133744-11> accessed January 22, 2022
Development Dimensions of Intellectual Property in Indonesia: Access to Medicines, Transfer of Technology and Competition. 2011. United nations Conference on trade and development.
Dutfield, Graham, Lois Muraguri, and Florian Leverve. “Exploring the Flexibilities of TRIPS to Promote Biotechnology in Developing Countries.” Research Handbook on the Protection of Intellectual Property under WTO Rules, n.d. Accessed January 23, 2022. https://doi.org/10.4337/9781849806596.00023.
Spina Ali’, Gabriele. “Article 39(3) TRIPS : Understanding the Obligations, Exploiting the Flexibilities.” The University of Hong Kong Libraries. Accessed January 23, 2022. http://dx.doi.org/10.5353/th_991044046592503414.
J.F. Hornbeck . “Free Trade Agreements: U.S. Promotion and Oversight of Latin American Implementation .”Inter-American Development Bank , December 2009.
Subhan, Junaid. “Scrutinized: The TRIPS Agreement and Public Health.” McGill Journal of Medicine 9, no. 2 (December 1, 2020). https://doi.org/10.26443/mjm.v9i2.445.
Volman, Lucas. “The TRIPS Article 31 Tug of War Developing Country Compulsory Licensing of Pharmaceutical Patents and Developed Country Retaliation.” Center for Open Science, July 17, 2018. http://dx.doi.org/10.31228/osf.io/6cxaj.
Published
How to Cite
Issue
Section
Copyright (c) 2022 International journal of health sciences
This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.
Articles published in the International Journal of Health Sciences (IJHS) are available under Creative Commons Attribution Non-Commercial No Derivatives Licence (CC BY-NC-ND 4.0). Authors retain copyright in their work and grant IJHS right of first publication under CC BY-NC-ND 4.0. Users have the right to read, download, copy, distribute, print, search, or link to the full texts of articles in this journal, and to use them for any other lawful purpose.
Articles published in IJHS can be copied, communicated and shared in their published form for non-commercial purposes provided full attribution is given to the author and the journal. Authors are able to enter into separate, additional contractual arrangements for the non-exclusive distribution of the journal's published version of the work (e.g., post it to an institutional repository or publish it in a book), with an acknowledgment of its initial publication in this journal.
This copyright notice applies to articles published in IJHS volumes 4 onwards. Please read about the copyright notices for previous volumes under Journal History.
